ANUGESIC HC
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
PRAMOCAINE HYDROCHLORIDE HYDROCORTISONE ACETATE BENZYL BENZOATE BISMUTH OXIDE BALSAM PERU ZINC OXIDE BISMUTH SUBGALLATE
Available from:
Pfizer Healthcare Ireland
Pharmaceutical form:
Suppositories
Authorization date:
2000-03-15
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anugesic HC Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
The product is a buff coloured suppository.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anugesic HC Suppositories are indicated for the comprehensive symptomatic treatment of severe and acute
discomfort or pain associated with internal and external haemorrhoids, proctitis, cryptitis, anal fissures,
pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intrarectal.
ADULTS: Remove plastic cover and insert one suppository into the anus at night, in the morning and after
each evacuation.
Not to be taken orally.
ELDERLY (over 65 years): As for adults.
CHILDREN: Not recommended.
4.3 CONTRAINDICATIONS
Tubercular, fungal and viral lesions including herpes simplex, vaccinia and varicella.
History of sensitivity to any of the constituents.
Each 2.8 g suppository contains:
Pramocaine Hydrochloride
27
mg
Hydrocortisone Acetate
5
mg
Benzyl Benzoate
33
mg
Bismuth oxide
24
mg
Balsam Peru
49
mg
Zinc Oxide
296
mg
Bismuth Subgallate
59
mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/01/2012_
_CRN 2110627_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with all products containing topical steroids the possibility of systemic absorption should be borne in
mind.
Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than
seven days is not recommended.
Following symptomatic relief definitive diagnosis should be established.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS
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