PROCTOSEDYL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HYDROCORTISONE ; CINCHOCAINE HYDROCHLORIDE ; ESCULOSIDE ; FRAMYCETIN SULFATE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C05AA01

INN (International Name):

HYDROCORTISONE ; CINCHOCAINE HYDROCHLORIDE ; ESCULOSIDE ; FRAMYCETIN SULFATE

Dosage:

5/5/10/10 Milligram

Pharmaceutical form:

Suppositories

Prescription type:

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

Therapeutic area:

hydrocortisone

Authorization status:

Not marketed

Authorization date:

1978-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proctosedyl Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 5mg of Hydrocortisone, 5mg of Cinchocaine
Hydrochloride, 10mg of Aesculin and 10mg of
Framycetin Sulphate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppositories
Off-white, torpedo shaped, homogenous suppositories.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the local management of pain, pruritus and inflammation associated
with internal or external haemorrhoids, and such
haemorrhoidal complications as fissures, proctitis, perianal eczema,
and post-operative states.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Application to external surface or by means of the cannula into the
rectum, twice daily and after each bowel
movement.
Treatment should last for a week.
Administration
Topical, Intrarectal and perianal
4.3 CONTRAINDICATIONS
1.
Use in the presence of untreated infections of viral, tuberculous or
fungal origin.
2.
Use in patients hypersensitive to the active ingredients or any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Continuous treatment for longer than three weeks should be avoided in
patients under the age of three years
because of the possibility of adrenocortical suppression and growth
retardation.
2.
Continuous application without interruption will result in local
atrophy of the skin, striate, and superficial
vascular dilation.
3.
Prolonged use of an anti-infective may result in the development of
super-infection due to organisms, including
fungi, resistant to that anti-infective.
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