Zotex-C Syrup

Pronunciation: KOE-deen/fen-ill-EF-rin/peer-IL-a-meen
Generic Name: Codeine/Phenylephrine/Pyrilamine
Brand Name: Examples include Pro-Red AC and Zotex-C

Zotex-C Syrup is used for:

Treating symptoms of the common cold, flu, or hay fever, and other upper respiratory allergies such as cough, congestion, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. Zotex-C Syrup may also be used for other conditions as determined by your doctor.

Zotex-C Syrup is a narcotic antitussive (cough suppressant), antihistamine, and decongestant combination. The antitussive works by suppressing the cough center in the brain. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose. The decongestant shrinks swollen nasal passages, which relieves nasal congestion.

Do NOT use Zotex-C Syrup if:

• you are allergic to any ingredient in Zotex-C Syrup or any other codeine-related medicine (eg, dihydrocodeine)


• you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zotex-C Syrup:

Some medical conditions may interact with Zotex-C Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of alcohol or drug abuse, dependence on narcotics, or suicidal thoughts or behaviors


• if you have increased pressure in the head, an unusual growth in the brain (eg, tumor), a recent head injury, Parkinson disease, Reye syndrome, the blood disease porphyria, or a blockage of your stomach, bowel, or bladder


• if you have a history of epilepsy or seizures, asthma or other breathing problems (eg, sleep apnea), stomach or intestinal problems, chronic constipation, liver problems, glaucoma, an enlarged prostate gland or other prostate problems, difficulty urinating, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke


• if you have recently had abdominal surgery

Some MEDICINES MAY INTERACT with Zotex-C Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, ketorolac, MAO inhibitors (eg, phenelzine), naltrexone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Zotex-C Syrup may be increased, including dangerous sleepiness and a decrease in the ability to breathe


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Rifampin or risperidone because the effectiveness of Zotex-C Syrup may be decreased


• Bromocriptine or hydantoins (eg, phenytoin) because the actions and side effects may be increased by Zotex-C Syrup


• Guanadrel, guanethidine, mecamylamine, methyldopa, mexiletine, or reserpine because the effectiveness may be decreased by Zotex-C Syrup


• Naltrexone because the effectiveness of Zotex-C Syrup will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids. You must not take naltrexone until you have stopped taking Zotex-C Syrup for 7 to 10 days and after a naloxone challenge test is negative.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zotex-C Syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zotex-C Syrup:

Use Zotex-C Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zotex-C Syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Zotex-C Syrup and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zotex-C Syrup.

Important safety information:

• Zotex-C Syrup may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zotex-C Syrup. Using Zotex-C Syrup alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Do not drink alcohol while you are using Zotex-C Syrup. Avoid taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Zotex-C Syrup. Zotex-C Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.


• Use Zotex-C Syrup with caution in the ELDERLY because they may be more sensitive to its effects, especially possible breathing problems and drowsiness.


• Use Zotex-C Syrup with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Zotex-C Syrup can cause harm to the fetus. If you become pregnant while taking Zotex-C Syrup, discuss with your doctor the benefits and risks of using Zotex-C Syrup during pregnancy. Zotex-C Syrup is excreted in breast milk. If you are or will be breast-feeding while you are using Zotex-C Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

Use of Zotex-C Syrup can lead to TOLERANCE. When using for an extended period, Zotex-C Syrup may not work as well and may require different dosing. Talk with your doctor if Zotex-C Syrup stops working well.

Long-term use of Zotex-C Syrup can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness, when pain relief is more important. If using Zotex-C Syrup for an extended period of time, do not suddenly stop taking Zotex-C Syrup without your doctor's approval. WITHDRAWAL symptoms have occurred when Zotex-C Syrup is suddenly stopped and may include anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping use of Zotex-C Syrup.

Possible side effects of Zotex-C Syrup:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; flushing or redness of face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zotex-C side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.

Proper storage of Zotex-C Syrup:

Store Zotex-C Syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zotex-C Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Zotex-C Syrup, please talk with your doctor, pharmacist, or other health care provider.


• Zotex-C Syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zotex-C Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Zotex-C resources

• Zotex-C Side Effects (in more detail)
• Zotex-C Use in Pregnancy & Breastfeeding
• Zotex-C Drug Interactions
• Zotex-C Support Group
• 0 Reviews for Zotex-C - Add your own review/rating

Compare Zotex-C with other medications

• Cold Symptoms
• Cough and Nasal Congestion

ferumoxytol Intravenous

fer-ue-MOX-i-tol

Commonly used brand name(s)

In the U.S.

• Feraheme

Available Dosage Forms:

• Solution

Uses For ferumoxytol

Ferumoxytol injection is an iron replacement product that is used to treat iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD).

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

ferumoxytol is available only with your doctor's prescription.

Before Using ferumoxytol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ferumoxytol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ferumoxytol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ferumoxytol injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ferumoxytol injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving ferumoxytol injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of ferumoxytol. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Iron overload—Use is not recommended in patients with this condition.

Proper Use of ferumoxytol

A nurse or other trained health professional will give you ferumoxytol in a hospital. ferumoxytol is given through a needle placed in one of your veins. A second dose will be given 3 to 8 days after your first dose.

Precautions While Using ferumoxytol

It is very important that your doctor check your progress at regular visits to make sure that ferumoxytol is working properly. Blood tests may be needed to check for unwanted effects.

ferumoxytol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive ferumoxytol.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin using ferumoxytol, or when the dose is increased.

Before you have any medical tests, tell the medical doctor in charge that you are using ferumoxytol. The results of some tests (e.g., magnetic resonance imaging or MRI) may be affected by ferumoxytol.

ferumoxytol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• blurred vision


• chest pain


• confusion


• difficult or labored breathing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fever


• rapid weight gain


• shortness of breath


• sweating


• tightness in the chest


• tingling of the hands or feet


• unusual tiredness or weakness


• unusual weight gain or loss


• wheezing

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• chest discomfort


• cough


• decreased urine output


• difficulty with swallowing


• dilated neck veins


• dizziness


• extreme fatigue


• fainting


• fast, pounding, or irregular heartbeat or pulse


• hives


• irregular breathing


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of consciousness


• nausea or vomiting


• no blood pressure or pulse


• pain in the shoulders, arms, jaw, or neck


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• stopping of the heart


• swelling of the face, fingers, feet, or lower legs


• troubled breathing


• unconsciousness


• unresponsiveness


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Abdominal or stomach pain


• back pain


• headache


• muscle spasms

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ferumoxytol Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More ferumoxytol Intravenous resources

• Ferumoxytol Intravenous Side Effects (in more detail)
• Ferumoxytol Intravenous Use in Pregnancy & Breastfeeding
• Ferumoxytol Intravenous Drug Interactions
• Ferumoxytol Intravenous Support Group
• 0 Reviews for Ferumoxytol Intravenous - Add your own review/rating

Compare ferumoxytol Intravenous with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia

Carboplatin 10 mg / ml Intravenous Infusion

1. Name Of The Medicinal Product

Carboplatin 10 mg/ml Intravenous Infusion

2. Qualitative And Quantitative Composition

Carboplatin 10 mg/ml

For excipients, see 6.1

3. Pharmaceutical Form

Solution for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Antineoplastic agent indicated in the treatment of:

• ovarian carcinoma of epithelial origin

• small cell lung carcinoma.

4.2 Posology And Method Of Administration

Dosage and Administration

The recommended dose of carboplatin in previously untreated adults with normal renal function is 400mg/m², given as a single short term intravenous infusion over 15 to 60 minutes. Alternatively, the Calvert formula shown below may be used to determine dosage:

Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]

Target AUC	Planned Chemotherapy	Patient Treatment status
5-7 mg/ml.min	single agent carboplatin	previously untreated
4-6 mg/ml.min	single agent carboplatin	previously treated
4-6 mg/ml.min	carboplatin plus cyclophosphamide	previously untreated

Note: With the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m².

Therapy should not be repeated until 4 weeks after the previous carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

Initial dosage should be reduced by 20-25% in patients with risk factors such as previous myelosuppressive therapy and/or poor performance status.

Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin.

Impaired renal function: In patients with impaired renal function, dosage of carboplatin should be reduced (refer to Calvert formula) and haematological nadirs and renal function monitored.

Combination Therapy

The optimal use of carboplatin in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.

Elderly

Dosage adjustment may be necessary in elderly patients.

Paediatric patients:

There is insufficient information to support a dosage recommendation in the paediatric population.

.

4.3 Contraindications

Carboplatin is contraindicated in patients with severe myelosuppression, pre-existing severe renal impairment (with creatinine clearance of less than 20 ml per minute) and a history of severe allergic reaction to carboplatin or other platinum containing compounds. Dosage adjustment may allow use in the presence of mild renal impairment (see Section 4.2).

4.4 Special Warnings And Precautions For Use

Warnings:

Myelosuppression as a result of carboplatin treatment is closely related to the renal clearance of the drug. Therefore, in patients with abnormal renal function, or who are receiving concomitant therapy with nephrotoxic drugs, myelosuppression, especially thrombocytopenia, may be more severe and prolonged.

The occurrence, severity and protraction of toxicity is likely to be greater in patients who have received extensive prior treatment for their disease, have poor performance status and are advanced in years. Renal function parameters should be assessed prior to, during and after carboplatin therapy.

Peripheral blood counts (including platelets, white blood cells and haemoglobin) should be followed during and after therapy. Combination therapy with other myelosuppressive drugs may require modification of dosage/timing of schedules in order to minimise additive effects.

Carboplatin courses should not, in general, be repeated more frequently than every 4 weeks in order to ensure that the nadir in blood counts has occurred and there has been recovery to a satisfactory level.

Infrequent allergic reactions to carboplatin have been reported, e.g. erythematous rash, fever with no apparent cause or pruritus. Rarely, anaphylaxis, angio oedema and anaphylactoid reactions including bronchospasm, urticaria and facial oedema have occurred. These reactions are similar to those observed after administration of other platinum containing compounds and may occur within minutes. The incidence of allergic reactions may increase with previous exposure to platinum therapy; however, allergic reactions have been observed upon initial exposure to carboplatin. Patients should be observed carefully for possible allergic reactions and managed with appropriate therapy, including antihistamines, adrenaline and/or glucocorticoids.

Precautions

Carboplatin should only be administered under the supervision of a qualified physician who is experienced in the use of chemotherapeutic agents. Diagnostic and treatment facilities should be readily available for management of therapy and possible complications.

Peripheral blood counts and renal function tests should be monitored closely. Blood counts should be performed prior to commencement of carboplatin therapy and at weekly intervals thereafter. This will monitor toxicity and help determine the nadir and recovery of haematological parameters and assist in subsequent dosage adjustments. Lowest levels of platelets are generally seen between days 14 and 21 of initial therapy. A greater reduction is seen in patients who previously received extensive myelosuppressive chemotherapy. Lowest levels of white cells occur generally between days 14 and 28 of initial therapy. If levels fall below 2000 cells/mm³ or platelets less than 100,000 cells/mm³ then postponement of carboplatin therapy until bone barrow recovery is evident, should be considered. This recovery usually takes 5 to 6 weeks. Transfusions may be necessary and dosage reductions recommended for subsequent treatment.

The incidence and severity of nephrotoxicity may increase in patients who have impaired kidney function before carboplatin treatment. It is not clear whether an appropriate hydration programme might overcome such an effect but dosage reduction or discontinuation of therapy is required in the presence of severe alteration in renal function test. Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy.

Neurological evaluation and an assessment of hearing should be performed on a regular basis. Neurotoxicity, such as paraesthesia, decreased deep tendon reflexes and ototoxicity are more likely seen in patients previously treated with cisplatin.

Aluminium-containing equipment should not be used during preparation and administration of carboplatin (see Section 4.5).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes, catheters or IV administration sets that contain aluminium parts which may come into contact with carboplatin, should not be used for the preparation or administration of the drug.

Concurrent therapy with nephrotoxic or ototoxic drugs such as aminoglycosides, vancomycin, capreomycin and diuretics, may increase or exacerbate toxicity due to carboplatin induced changes in renal clearance.

Combination therapy with other myelosuppressive agents may require dose changes or rescheduling of doses in order to minimise the additive myelosuppressive effects.

4.6 Pregnancy And Lactation

Safe use of carboplatin in pregnancy has not been established. Both men and women receiving carboplatin should be informed of the potential risk of adverse effects on reproduction (see Section 5.3). Women of childbearing potential should be fully informed of the potential hazard to the foetus should they become pregnant during carboplatin therapy. Carboplatin should not be used in pregnant women or women of childbearing potential who might become pregnant unless the potential benefits to the mother outweigh the possible risks to the foetus.

Most forms of chemotherapy have been associated with reduction of oogenesis and spermatogenesis and patients receiving carboplatin should be warned of this potential. Although not reported with carboplatin, this has been reported with other platinum agents. Recovery of fertility after exposure can occur but is not guaranteed.

It is not known whether carboplatin is excreted in breast milk. To avoid possible harmful effects in the infant, breast-feeding is not advised during carboplatin therapy.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Myelosuppression is the dose limiting toxic reaction of carboplatin. It is generally reversible and not cumulative when carboplatin is used as a single agent at recommended frequencies of administration. Adverse reactions which have occurred in studies to date can be grouped under the following systems:

Blood and the lymphatic system disorders: Leucopenia (55%), thrombocytopenia (32%) and anaemia (59%) of patients. Transfusion support has been required in about 20% of patients. Haemolytic uraemic syndrome has been reported. Infectious complications and haemorrhagic complications have also been reported.

Respiratory, thoracic and mediastinal disorders: Pulmonary fibrosis has been reported very rarely, manifested by tightness of the chest and dyspnoea. This should be considered if a pulmonary hypersensitivity state is excluded (see General disorders below).

Gastrointestinal disorders: Nausea and vomiting (53%), nausea only in 25%. Nausea and vomiting are generally delayed until 6 to 12 hours after administration of carboplatin, are readily controlled or prevented with antiemetics and disappear within 24 hours. Diarrhoea occurred in 6% and constipation in 3% of patients. Abdominal pain and cramps have also been reported.

Nervous system disorders: Mild peripheral neuropathy occurred in 6% of patients and dysgeusia in less than 1% of patients. Parasthesias present prior to treatment, especially if caused by cisplatin, may persist or worsen during carboplatin therapy. (See Precautions).

Eye disorders: Transient visual disturbances, sometimes including transient sight loss, have been reported rarely with platinum therapy. This is usually associated with high dose therapy in renally impaired patients.

Ear and labyrinth disorders: A subclinical decrease in hearing acuity in the high frequency range (4000-8000 Hz), determined by audiogram, occurred in 15% of patients. Clinical ototoxicity also manifested itself as tinnitus (1% of patients). Hearing loss as a result of cisplatin therapy may give rise to persistent or worsening symptoms. At higher than recommended doses, in common with other ototoxic agents, clinically significant hearing loss has been reported to occur in paediatric patients when carboplatin is administered.

Hepato-biliary disorders: Transient increases in liver enzymes have been reported in some patients. Alkaline phosphatase was increased in 30% of patients, with aspartate aminotransferase (15% patients) and elevated serum bilirubin (4% patients) occurring less frequently.

Renal and urinary disorders: Renal toxicity is not usually dose limiting. However, a decrease in creatinine clearance is observed in approximately 25% of patients. A rise in uric acid (25%) and, less frequently, a rise in serum creatinine (7%) and blood urea nitrogen (16%) have also been observed. Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy.

General disorders: Rarely anaphylaxis and anaphylactic-like reactions have been reported including tachycardia, bronchospasm, dyspnoea, hypotension, wheezing, urticaria, facial oedema and facial flushing. Erythematous rash, fever and pruritis have been observed in less than 2% of patients treated. These were reactions similar to those seen after cisplatin therapy but in a few cases no cross-reactivity was present.

Decreased serum levels of magnesium (37% patients), potassium (16% patients) and calcium (5% patients) have occurred although not severe enough to cause clinical symptoms. Decreased serum sodium has also been reported although it is normally insufficient to require treatment. There have also been rare reports of hyponatraemia.

Asthenia is very commonly reported. Rare events have included alopecia (2%), a flu-like syndrome (1%) and reaction at the injection site (<1%). Cases of anorexia have been reported.

4.9 Overdose

No overdosage occurred during clinical trials. If necessary, however, the patient may need supportive treatment relating to myelosuppression, renal and hepatic impairment. Reports of doses up to 1600mg/m² indicate patients feeling extremely ill with diarrhoea and alopecia developing.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: Antineoplastic agent LO1X A02

Carboplatin, like Cisplatin, interferes with DNA intrastrand and interstrand crosslinks in cells exposed to the drug. DNA reactivity has been correlated with cytotoxicity.

Paediatric patients:

Safety and efficacy in children have not been established.

5.2 Pharmacokinetic Properties

After a 1-hour infusion (20-520mg/m²), plasma levels of total platinum and free (ultrafilterable) platinum decay biphasically following first order kinetics. For free platinum, the initial phase (t alpha) half life is approximately 90 minutes and the later phase (t beta) half life approximately 6 hours. All free platinum is in the form of carboplatin in the first 4 hours after administration.

Carboplatin is excreted primarily by glomerular filtration in urine, with recovery of 65% of a dose within 24 hours. Most of the drug is excreted within the first 6 hours. Approximately 32% of a given dose of carboplatin is excreted unchanged.

Protein binding of carboplatin reaches 85-89% within 24 hours of administration, although during the first 4 hours, only up to 29% of the dose is protein bound. Patients with poor renal function may require dosage adjustments due to altered pharmacokinetics of carboplatin.

Carboplatin clearance has been reported to vary by 3- to 4- fold in paediatric patients. As for adult patients, literature data suggest that renal function may contribute to the variation in carboplatin clearance.

5.3 Preclinical Safety Data

Carboplatin has been shown to be embryotoxic and teratogenic in rats. It is mutagenic in vivo and in vitro and although the carcinogenic potential of carboplatin has not been studied, compounds with similar mechanisms of action and mutagenicity have been reported to be carcinogenic.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for Injections

6.2 Incompatibilities

Aluminium-containing equipment should not be used (see Section 4.5).

6.3 Shelf Life

Clear glass and Onco-Tain^® vials: 2 years

Onco-Vials^®: 18 months

In use:

Carboplatin solution for infusion may be further diluted in Glucose 5% and administered as an intravenous infusion. The infusion solution is chemically stable when stored for 96 hours at both 2-8ºC and 22ºC.

Carboplatin solution for infusion may also be further diluted in Sodium Chloride 0.9% and administered as an intravenous infusion. The infusion solution is chemically stable for up to 24 hours when stored at 2-8ºC and up to 8 hours when stored at 22ºC.

From a microbiological point of view however, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Clear glass and Onco-Tain^® vials;

Do not store above 25^°C. Keep container in the outer carton.

Onco-Vials^®;

Store between 2-8^°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

Carboplatin Intravenous Infusion is supplied in individually packed clear glass, Onco-Tain^® vials and Onco-Vials^®, containing either 5 ml, 15 ml, 45 ml or 60 ml of a sterile solution of carboplatin 10 mg per ml. Onco-Vials^® are registered in the UK only.

Not all presentations listed above may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Handling:

Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents.

Contamination

In the event of contact of carboplatin with eyes or skin, wash affected area with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of skin. Medical advice should be sought if the eyes are affected.

In the event of a spillage, two operators should put on gloves and mop up the spilled material with a sponge kept for that purpose. In the event of a powder spillage, cover with a cloth and moisten with water before mopping up. Rinse the area twice with water. Put all solutions and sponges in a plastic bag, seal and label with the words 'CYTOTOXIC WASTE' and incinerate.

Disposal

Syringes and ONCO-VIALS^®, containers, absorbent materials, solutions and other material which have come into contact with carboplatin should be placed in a thick plastic bag or other impervious container and incinerated at 1000°C.

Directions for use of the ONCO-VIAL^®

ONCO-VIALS^® should be used with the appropriate Hospira administration device.

7. Marketing Authorisation Holder

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW,

United Kingdom

8. Marketing Authorisation Number(S)

PL 04515/0050

9. Date Of First Authorisation/Renewal Of The Authorisation

20^th July 2005

10. Date Of Revision Of The Text

19^th May 2009

11. LEGAL CATEGORY

POM

Beconase Hayfever Relief for Adults 0.05% Nasal Spray

1. Name Of The Medicinal Product

Beconase Hayfever Relief for Adults 0.05% Nasal Spray

2. Qualitative And Quantitative Composition

50 micrograms beclometasone dipropionate per 100 mg actuation.

For excipients, see Section 6.1.

3. Pharmaceutical Form

Nasal spray, suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Beconase Hayfever Relief for Adults is indicated for the treatment of seasonal allergic rhinitis (hayfever) in adults aged 18 and over.

4.2 Posology And Method Of Administration

Beconase Hayfever Relief for Adults is for administration by the intranasal route only.

Adults aged 18 and over: The recommended dosage is two sprays into each nostril morning and evening (400 micrograms/day). Once control has been established, it may be possible to maintain control with fewer sprays. A dosage regimen of one spray into each nostril morning and evening has been shown to be efficacious in some patients. However, should the symptoms recur, patients should revert to the recommended dosage of two sprays into each nostril morning and evening. The minimum dose should be used at which effective control of symptoms is maintained. Total daily administration should not exceed eight sprays (400 micrograms).

Beconase Hayfever Relief for Adults quickly starts to reduce inflammation and swelling in the nose. For full therapeutic benefit Beconase Hayfever Relief for Adults should be used regularly.

If symptoms have not improved after 7 days treatment, medical advice must be sought.

Beconase Hayfever Relief for Adults is not recommended for children or adolescents under 18 years of age.

4.3 Contraindications

Beconase Hayfever Relief for Adults is contra-indicated in patients with a history of hypersensitivity to any of its components.

4.4 Special Warnings And Precautions For Use

Systemic effects of nasal corticosteroids may occur, particularly at high doses when used for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Medical advice should be sought before using Beconase Hayfever Relief for Adults by patients using other forms of corticosteroid treatments such as asthma medications, tablets, injections, similar nasal sprays, eye or nose drops, creams, ointments.

This product should not be used continuously for longer than 1 month without medical advice.

Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contra-indication to treatment with Beconase Hayfever Relief for Adults.

Although Beconase Hayfever Relief for Adults will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances, necessitate appropriate additional therapy particularly to control eye symptoms.

Medical advice should be sought before using Beconase Hayfever Relief for Adults in the case of recent injury or surgery to the nose, or problems with ulceration in the nose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Beconase Hayfever Relief for Adults delivers beclometasone dipropionate directly to the nasal mucosa and so minimises systemic exposure.

The use of beclometasone dipropionate should be avoided during pregnancy unless thought essential by the doctor.

Lactation: No specific studies examining the transference of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk, but at the dosages used for direct intranasal administration there is low potential for significant levels in breast milk.

Beconase Hayfever Relief for Adults should not be used during lactation without consulting a doctor.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rare cases of nasal septal perforation have been reported following the use of intranasal corticosteroids.

As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.

Rare cases of raised intra-ocular pressure, glaucoma or cartaract in association with intranasal formulations of beclometasone dipropionate have been reported.

Very rare cases of hypersensitivity reactions including rashes, urticaria, pruritus and erythema, and oedema of the eyes, face, lips and throat, anaphylactoid / anaphylactic reactions, dyspnoea and/or bronchospasm have been reported.

4.9 Overdose

The only harmful effect that follows inhalation of large amounts of the drug over a short time period is suppression of hypothalamic-pituitary adrenal (HPA) function. No special emergency action need be taken. HPA function recovers in a day or two after discontinuation of treatment with Beconase Hayfever Relief for Adults.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Following topical administration, beclometasone 17,21-dipropionate (BDP) produces potent anti-inflammatory and vasoconstrictor effects.

BDP is a pro-drug with weak corticosteroid receptor binding affinity. It is hydrolysed via esterase enzymes to the highly active metabolite beclometasone -17-monopropionate (B-17-MP), which has high topical anti-inflammatory activity.

Beclometasone dipropionate offers a preventative background treatment for hayfever when taken prior to allergen challenge. After which, with regular use, BDP can continue to prevent allergy symptoms from reappearing.

5.2 Pharmacokinetic Properties

Absorption

Following intranasal administration of BDP in healthy males, the systemic absorption was assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following intranasal administration is 44% (95% CI 28%, 70%). After intranasal administration, <1% of the dose is absorbed by the nasal mucosa. The remainder, after being cleared from the nose, either by drainage or mucocilary clearance, is available for absorption from the gastrointestinal tract. Plasma B-17-MP is almost entirely due to conversion of BDP absorbed from the swallowed dose.

Following oral administration of BDP the systemic absorption was also assessed by measuring the plasma concentrations of its active metabolite B-17-MP, for which the absolute bioavailability following oral administration is 41% (95% CI 27%, 62%).

Following an oral dose, B-17-MP is absorbed slowly with peak plasma levels reached 3-5 hours after dosing.

Metabolism

BDP is cleared very rapidly from the circulation and plasma concentrations are undetectable (< 50pg/ml) following oral or intranasal dosing. There is rapid metabolism of the majority of the swallowed portion of BDP during its first passage through the liver. The main product of metabolism is the active metabolite (B-17-MP). Minor inactive metabolites, beclometasone -21-monopropionate (B-21-MP) and beclometasone (BOH), are also formed but these contribute little to systemic exposure.

Distribution

The tissue distribution at steady-state for BDP is moderate (201) but more extensive for B-17-MP (4241). Plasma protein binding of BDP is moderately high (87%).

Elimination

The elimination of BDP and B-17-MP are characterised by high plasma clearance (150 and 1201/h) with corresponding terminal elimination half-lives of 0.5h and 2.7h. Following oral administration of tritiated BDP, approximately 60% of the dose was excreted in the faeces within 96 hours mainly as free and conjugated polar metabolites. Approximately 12% of the dose was excreted as free and conjugated polar metabolites in the urine.

5.3 Preclinical Safety Data

None reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Avicel RC 591 (Microcrystalline Cellulose and Carboxymethylcellulose Sodium)

Anhydrous Dextrose for parenteral use

Benzalkonium Chloride (added as Benzalkonium Chloride solution)

Phenylethyl Alcohol

Polysorbate 80

Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months. After first opening the shelf life is 3 months.

6.4 Special Precautions For Storage

Beconase Hayfever Relief for Adults should not be stored above 30°C. Keep container in the outer carton. Do not refrigerate.

6.5 Nature And Contents Of Container

Beconase Hayfever Relief for Adults is supplied in a 20ml plastic bottle fitted with a tamper resistant, metering atomising pump and nasal applicator. A combined nasal adaptor/actuator covered with a dust cap is fitted on the pump. The bottle provides 100 sprays.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

Trading as

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0617

9. Date Of First Authorisation/Renewal Of The Authorisation

20/03/2003

10. Date Of Revision Of The Text

05/10/2011

Thioplex

Generic Name: thiotepa (Injection route)

thye-oh-TEP-a

Commonly used brand name(s)

In the U.S.

• Thioplex

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrogen Mustard

Uses For Thioplex

Thiotepa belongs to the group of medicines called alkylating agents. It is used to treat some kinds of cancer.

Thiotepa interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by thiotepa, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects do not occur for months or years after the medicine is used.

Before you begin treatment with thiotepa, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Thiotepa is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, thiotepa is used in certain patients with the following medical conditions:

• Cancer in the membranes that cover and protect the brain and spinal cord (the meninges)

Before Using Thioplex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information about the use of thiotepa in children.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of thiotepa in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or


• Kidney stones (history of)—Thiotepa may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection—Thiotepa can reduce immunity to infection

• Kidney disease or


• Liver disease—Effects may be increased because of slower removal of thiotepa from the body

Proper Use of Thioplex

While you are using thiotepa, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Thiotepa sometimes causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using Thioplex

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Before having any kind of surgery, including dental surgery, make sure the medical doctor or dentist in charge knows that you are taking this medicine.

While you are being treated with thiotepa, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Thiotepa may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. Other people living in your household should not take or should not have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Thiotepa can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Thioplex Side Effects

Along with their needed effects, medicines like thiotepa can sometimes cause unwanted effects such as blood problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• unusual bleeding or bruising

Rare

• Skin rash


• tightness of throat


• wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Joint pain


• pain at place of injection or instillation


• swelling of feet or lower legs

Rare

• Sores in mouth and on lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Dizziness


• hives


• loss of appetite


• missing menstrual periods


• nausea and vomiting

This medicine may cause a temporary loss of hair in some people. After treatment with thiotepa has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Thioplex side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Thioplex resources

• Thioplex Side Effects (in more detail)
• Thioplex Use in Pregnancy & Breastfeeding
• Thioplex Drug Interactions
• Thioplex Support Group
• 0 Reviews for Thioplex - Add your own review/rating

• Thioplex Concise Consumer Information (Cerner Multum)


• Thiotepa Prescribing Information (FDA)


• Thiotepa Professional Patient Advice (Wolters Kluwer)


• Thiotepa MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Thioplex with other medications

• Bladder Cancer
• Breast Cancer
• Cancer
• Lymphoma
• Ovarian Cancer
• Serosal Cavity Neoplastic Disease

Lipantil Micro 200

Please keep this leaflet. You may need to read it again.

Lipantil Micro 200 mg capsules

(fenofibrate)

Lipantil Micro 200 mg capsules

(fenofibrate)

Please read this leaflet carefully before you start to take Lipantil Micro 200. It may not answer all your questions,
so if you are not sure about anything, please ask your doctor or a pharmacist.

What is in your capsules?

Each orange Lipantil Micro 200 capsule contains 200 milligrams (mg) of fenofibrate. This is the active ingredient. Fenofibrate is one of a group of medicines known as lipid modifying drugs (see below).

Each capsule also contains the following inactive ingredients:

Lactose monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.

The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127) and ferrous oxide (E 172).

Lipantil Micro 200 capsules are made by:

Laboratoires Fournier SA

Rue des Prés Potets

21121 Fontaine Les Dijon

France

The Marketing Authorisation Holder is:

Solvay Healthcare Limited

Southampton

SO18 3JD

United Kingdom

Lipid modifying drugs

Lipantil Micro 200 belongs to a group of medicines known as lipid modifying drugs (of the type commonly known as fibrates). It is used to reduce the level of cholesterol and triglycerides in your blood when a low-fat diet and other non-medicinal treatments such as weight reduction or exercise have failed. Lipantil Micro 200 can often increase the amount of a “good” type of cholesterol, called HDL or High Density Lipoprotein cholesterol.

What pack sizes are available for Lipantil Micro 200?

Lipantil Micro 200 comes in blister packs of 28 capsules.

Why your doctor wants you to take Lipantil Micro 200.

Lipids and Dyslipidaemia

By taking blood tests, your doctor has discovered that you have too much cholesterol or triglyceride in your blood. These are fatty substances (lipids). You may not have noticed any symptoms. This condition is called hyperlipidaemia or dyslipidaemia.

Risks from too much cholesterol or triglyceride

Too much cholesterol can put you at risk of developing coronary heart disease. A “bad” type of cholesterol called Low Density Lipoprotein cholesterol (LDL) can fur up the walls of your major arteries. This can lead to important blood vessels in the heart, brain or limbs becoming blocked. High levels of triglyceride in your blood can also increase the risk of coronary heart disease.

Before you take Lipantil Micro 200.

Before you take your capsules, tell your doctor if any of the following apply to you.

• You suffer from liver or kidney disease or gallbladder disease.


• You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain).


• You have been allergic or reacted badly to fenofibrate, Lipantil Micro 200 or to similar drugs, or any of the
  inactive ingredients in this medicine.


• You have known photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid modifying drugs) or ketoprofen (an anti-inflammatory drug).


• You are pregnant, breast-feeding, or planning to get pregnant.


• You are taking anticoagulants to thin your blood (for example,Warfarin).


• You are taking other lipid modifying drugs (for example, drugs known as “statins” or “fibrates”).


• You suffer from hypothyroidism (underactive thyroid gland).


• You have a high alcohol intake.


• You are taking fenofibrate and ciclosporin (an immunosuppressant).


• You have been told by your doctor that you cannot tolerate some sugars.

How to take Lipantil Micro 200.

It is important to take your capsules as your doctor tells you to. Also, please read the label on the packet.

The usual dose for adults is one capsule a day. Swallow the capsules with water. It is important to take the capsules with food, as they won’t work as well if your stomach is empty.

Children should not take Lipantil Micro 200.

Do not worry if you forget to take a dose of Lipantil Micro 200. Take the next dose with your next meal and then carry on taking your capsules as usual. If you do forget to take your medicine do not take two doses at the same time. If you are worried about this, talk to your doctor or pharmacist.

Other information.

Dyslipidaemia needs treating for a long period of time. Do not stop taking the medicine unless your doctor tells you to, or the capsules make you feel unwell. Also, you should continue with your low-fat diet.

If you see another doctor, or go to hospital, tell them that you are taking Lipantil Micro 200, as there are some medicines that you should not take with Lipantil Micro 200. Let your doctor know if you need to take any other medicines.

What to do if you take too many capsules.

If you accidentally take too many capsules, or you think that a child has swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Side-effects.

All medicines can sometimes cause some side-effects.

Most people will not have any side-effects while they are taking these capsules. If the side-effects don’t go away after a few days, or you feel unwell in any other way, talk to your doctor before you take your next dose. Tell your doctor straight away if you have any muscular aches or cramps.

Most commonly reported side-effects include:

• Gastro-intestinal (stomach and intestine):
  
  
  • Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence).
  • Uncommon: Pancreatitis (inflammation of the pancreas leading to abdominal pain).


• Cardiovascular system:
  
  
  • Uncommon: formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood
    clots (pulmonary embolism).


• Skin:
  
  
  • Reactions such as rashes, pruritus (itching), urticaria (raised red blisters on the skin) or photosensitivity reactions (sensitivity to sunlight, sun lamps and sunbeds). In individual cases photosensitivity with erythema (flushing/redness), vesiculation (raised boils) or nodulation (solid swelling).


• Neurological disorders: Headache.


• General disorders: Fatigue.


• Disorders of the ear: Vertigo.

Less frequently reported side-effects include:

• Liver: Raised serum transaminases (various liver enzymes) may be found in some patients. Hepatitis (inflammation
  of the liver) has been reported very rarely, symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), abdominal pain and pruritus (itching).


• Muscle: Myalgia (muscle pain),myositis (muscle inflammation), muscle cramps and weakness and rhabdomyolysis (muscle breakdown). These side-effects are usually reversible when the drug is withdrawn.


• Gallstones (stones formed from cholesterol): Some people have developed gallstones while taking fenofibrate.


• Other side-effects: Sexual asthenia (a lack of sex drive), alopecia (loss of hair), decrease in haemoglobin (oxygen carrying pigment in blood), leukopenia (decrease in white blood cells), slight increases in urea and creatinine
  (substances excreted in urine) and very rare cases of interstitial pneumopathies (a chronic disease of the lung tissues) have been reported in a very small number of people.

If you experience any other side-effects that are not mentioned in this leaflet, please let your doctor or pharmacist know immediately.

How to store your capsules.

Do not store this medicine above 30° Centigrade. Keep this medicine in the original package. Keep all medicines where
children cannot see or reach them.

Do not take these capsules after the expiry date printed on the packet. Take any capsules that are out of date, or
which you no longer need, back to your pharmacist.

These capsules are for you. Only a doctor can prescribe Lipantil Micro 200 capsules for you. Never give them to anyone else.

This leaflet was approved in July 2007.

Lipantil is a registered trademark

442151F

tea tree topical

Generic Name: tea tree topical (TEE TREE TOP i kal)

Brand Names:

What is tea tree topical?

The use of tea tree topical in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Tea tree topical is also known as Melaleuca alternifolia and tea tree oil.

Tea tree topical has been used for cuts, stings, acne, and burns.

Tea tree topical has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of tea tree topical may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Tea tree topical may also have uses other than those listed in this medication guide.

What is the most important information I should know about tea tree topical?

Tea tree topical is intended for external use only. Do not ingest tea tree topical products.

Tea tree topical has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of tea tree topical may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. There have been instances where herbal/health supplements have been sold which were contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Who should not use tea tree topical?

Before using tea tree topical, talk to your doctor, pharmacist, or health care professional if you have allergies (especially to plants), have any medical condition, or if you use other medicines or other herbal/health supplements. Tea tree topical may not be recommended in some situations.

Do not use tea tree topical without first talking to your doctor if you are pregnant or could become pregnant. It is not known whether tea tree topical will harm an unborn baby. Do not use tea tree topical without first talking to your doctor if you are breast-feeding a baby. It is also not known whether tea tree topical will harm a nursing infant. There is no information available regarding the use of tea tree topical by children. Do not give any herbal/health supplement to a child without first talking to the child's doctor.

How should I use tea tree topical?

The use of tea tree topical in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care professional is advisable. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial, and coordination of treatment among all health care providers involved may be advantageous.

Tea tree topical is intended for external use only. Do not ingest tea tree topical products.

If you choose to use tea tree topical, use it as directed on the package or as directed by your doctor, pharmacist, or other health care provider.

Store tea tree topical as directed on the package. In general, tea tree topical should be protected from light.

What happens if I miss a dose?

No information is available regarding a missed dose of tea tree topical. Consult your doctor, pharmacist, or health care professional if you require further information.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a tea tree topical overdose are not known.

What should I avoid while using tea tree topical?

There are no restrictions on food, beverages, or activity while using tea tree topical, unless otherwise directed by your health care provider.

Tea tree topical side effects

Although rare, allergic reactions to tea tree topical may occur. Stop using tea tree topical and seek emergency medical attention if you experience symptoms of a serious allergic reaction including difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives.

Skin rash has been reported infrequently with the use of tea tree topical. Contact your doctor or health care provider if you develop a rash or other skin irritation with the use of tea tree topical.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tea tree topical?

Interactions between tea tree topical and other prescription or over-the-counter medicines or herbal/health supplements have not been reported. Talk to your doctor, pharmacist, or health care professional before using tea tree topical if you are using any other oral or topical medicines or supplements.

More tea tree topical resources

• Tea tree topical Support Group
• 0 Reviews for Tea tree - Add your own review/rating

Compare tea tree topical with other medications

• Acne
• Bacterial Skin Infection
• Burns, External
• Skin and Structure Infection
• Skin Infection

Where can I get more information?

• Your doctor, pharmacist, or health care provider may have more information about tea tree topical.