Meda Health Sales

Proctofoam H.C. 1.0% w/w & 1.0% w/w Rectal Foam

For excipients, see section 6.1.

Rectal foam.

White, aerosol foam.

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. In the management of anorectal inflammation fissures, pain and oedema associated with haemorrhoids or occurring post-operatively pruritis ani.

One applicator full per rectum (3 to 5 mg hydrocortisone acetate) 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.

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

Use in the presence of infections of viral, treponemal, fungal, tuberculosis, or untreated bacterial origin.

Use in the presence of ulcerations, fistulae or perforations.

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.

Some systemic absorption of corticosteroid will occur and this possibility should be borne in mind in relation to general disorders in electrolyte, mineral glucose and nitrogen equilibrium, and to the general inflammatory and immune responses.

None known.

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.

None known.

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.

Excess use of topical corticosteroids may produce systemic adverse effects.

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.

Not applicable.

Not applicable.

Cetyl alcohol

Emulsifying wax (containing cetostearyl alcohol and sorbitan ester)

Methyl parahydroxybenzoate (E218)

Polyoxyethylene (10), stearyl ether

Propylene glycol

Propyl parahydroxybenzoate (E216)

Trolamine

Purified water

Propellant HP-70 consisting of:

Isobutane

Propane

Compatibility with barrier methods of contraception have not been demonstrated.

30 months.

Do not store above 25°C. Do not refrigerate.

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

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.

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

2. For internal use

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. Press down gently on the canister top with your fingers, so that the foam fills about ¼ of the applicator body. Only a short press is needed to do this.

5. Wait for a few seconds until the foam stops expanding.

DO NOT fill the applicator in one go. Always release the canister top after a short press.

6. Repeats steps 4 & 5 above until the foam expands to just reach the 'Fill' line.

This normally takes 2 to 4 shot 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.

8. For external use

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.

Meda Health Sales Ireland Limited

Unit 34/35, Block A

Dunboyne Business Park

Dunboyne

Co. Meath

Ireland

PA1332/5/1

Date of first authorisation: 1st April1978

Date of last renewal: 1st April 2008

February 2011