Proctofoam

1. Name Of The Medicinal Product

Proctofoam HC Rectal Foam

2. Qualitative And Quantitative Composition

Hydrocortisone acetate             1.0% w/w

Pramocaine hydrochloride        1.0% w/w

For a full list of excipients see section 6.1

3. Pharmaceutical Form

Rectal foam

4. Clinical Particulars

4.1 Therapeutic Indications

For the short term (not more than 5 - 7 days) relief of the symptoms of itching, irritation, discomfort or pain associated with local, non infective anal or perianal conditions.

4.2 Posology And Method Of Administration

One applicator full per rectum two or three times daily and after each bowel evacuation (up to a maximum of four times daily). For perianal administration, apply a small quantity on two fingers.

Not recommended for use in children.

4.3 Contraindications

Hypersensitivity to pramocaine hydrochloride or to any component of the preparation.

Bacterial, viral or fungal infection.

4.4 Special Warnings And Precautions For Use

Not for prolonged use. Contact sensitisation to local anaesthetics is common following prolonged application.

Seek medical advice if symptoms worsen, or do not improve within 7 days or if bleeding occurs.

Shake vigorously before use, use at room temperature, keep out of the reach of children. For external use only.

Rectal examination must be performed to exclude serious pathology before initiating treatment with Proctofoam.

Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety for use in pregnancy and lactation has not been established.

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities to foetal development including cleft palate and intrauterine growth retardation. There may be a very small risk of such effects in the human foetus. No data is available on the use of topical corticosteroids and local anaesthetic agents in nursing mothers. However, the product has been used by nursing mothers for many years without apparent ill consequence.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Although uncommon at this dosage; local burning, irritation, allergic dermatitis, secondary infection and skin atrophy may occur. Systemic absorption of topical corticosteroids has produced reversible suppression of the hypothalamic - pituitary - adrenal axis and manifestations of Cushing's syndrome.

A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.

4.9 Overdose

Excess use of topical corticosteroids may produce systemic adverse effects.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pramocaine hydrochloride is a surface anaesthetic and thus relieves the pain of anal and perianal conditions.

The use of steroids in inflammatory conditions is well known.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetyl alcohol

Emulsifying wax

Methyl parahydroxybenzoate

Polyoxyethylene (10), stearyl ether

Propylene glycol

Propyl parahydroxybenzoate

Triethanolamine

Purified water

Propellant HP-70 Consisting of:

- Isobutane

- Propane

6.2 Incompatibilities

Compatibility with barrier methods of contraception has not been demonstrated.

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Pressurised container containing flammable propellant. Protect from sunlight. Do not expose to temperatures above 50^oC. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition - no smoking. Do not pierce or burn, even after use.

Do not refrigerate. Store below 25^oC.

6.5 Nature And Contents Of Container

Aerosol canister containing 20 g of product plus 1.2 g of inert propellant. A 10% overage of product and propellant is included to ensure the required number of doses can be achieved.

6.6 Special Precautions For Disposal And Other Handling

1. Shake the canister vigorously for 30 seconds before each use.

For internal use

2. Withdraw the plunger slowly until it stops at the catch line.

3. Holding UPRIGHT, insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers.

4. Fill applicator so that the foam fills about ¼ of the applicator body. Only a short press is needed to do this.

5. Wait until foam has stopped expanding.

6. Repeat steps 4 & 5 until the foam expands to just reach the “Fill” line. This normally takes 2 - 4 short press/waits.

7. Stand with one leg raised on a chair, or lie down on your side. Insert gently into the back passage and push the plunger fully into the applicator.

For external use

8. Expel a small quantity of foam onto a tissue, pad or two fingers and apply the foam to the affected area.

These instructions are provided on the leaflet with illustrations to assist understanding.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

249 West George Street

Glasgow

G2 4RB

UK

Trading as:

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

8. Marketing Authorisation Number(S)

PL 15142/0089

9. Date Of First Authorisation/Renewal Of The Authorisation

02 July 2007

10. Date Of Revision Of The Text

23^rd September 2010