PROCTOFOAM H.C. 1 / 1 %w/w Rectal Foam

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE ACETATE, PRAMOCAINE HYDROCHLORIDE

Available from:

Meda Health Sales Ireland Limited

ATC code:

C05AA01

INN (International Name):

HYDROCORTISONE ACETATE, PRAMOCAINE HYDROCHLORIDE

Dosage:

1 / 1 %w/w

Pharmaceutical form:

Rectal Foam

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Corticosteroids

Authorization status:

Transfer Pending

Authorization date:

2007-04-27

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proctofoam H.C. 1.0% w/w & 1.0% w/w Rectal Foam.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrocortisone Acetate
1.0 % w/w
Pramocaine Hydrochloride
1.0 % w/w
Excipients: contains cetyl alcohol 0.300% w/w, methyl
parahydroxybenzoate (E216) 0.050% w/w, propyl
parahydroxybenzoate (E218) 0.005%w/w and propylene glycol 7.000% w/w.
Also contains cetostearyl alcohol as a
constituent of emulsifying wax.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Rectal foam.
White, aerosol 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. In the management of
anorectal inflammation fissures,
pain and oedema
associated with haemorrhoids or occurring post-operatively pruritis
ani.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3 CONTRAINDICATIONS
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.
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.
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