INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SCHERIPROCT SUPPOSITORIES

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

SCHERIPROCT SUPPOSITORIES

COMPOSITION
1 suppository contains prednisolone caproate (1,4-pregnadiene-3,20-dione-11beta-17alpha,21-triol-21-caproate) 1,3 mg and cinchocaine hydrochloride as the hydrochloride of (2-butoxy-N-(2-diethylaminoethyl)cinchonamide) 1 mg.

PHARMACOLOGICAL CLASSIFICATION
A. 11.8 Suppositories.

PHARMACOLOGICAL ACTION
Prednisolone exerts an antiinflammatory and antipruritic effect. Capillary dilatation, intercellular oedema and tissue infiltration regress; capillary proliferation is suppressed.
As a local anaesthetic, cinchocaine eases the pain.

INDICATIONS
Short term symptomatic relief of perianal discomfort, inflammation and itching caused by thrombosed haemorrhoids, anal fissure and pruritus ani.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
Viral infections, primary bacterial or fungal infections in the treatment area. Secondary infections of the skin in the absence of appropriate antiinfective therapy. Known sensitivity to local anaesthetics.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, Scheriproct should not be used during pregnancy.
The excretion of effective amounts of glucocorticoid with the breast milk is improbable.

WARNINGS
This product should not be used continuously for more than 7 days. If symptoms do not disappear quickly, discontinue treatment and consult your doctor. Certain anal disorders require specific treatment and a proctological examination. In case of bleeding, consult a doctor promptly.

DOSAGE AND DIRECTIONS FOR USE
The anal region should be cleaned thoroughly before using Scheriproct, which is best applied after defaecation.
Unless otherwise prescribed by the doctor, generally insert one suppository daily high into the rectum. If symptoms are severe, insert one suppository two to three times on the first day.
The consistency of suppositories that have become softened by warmth should be restored by immersion in cold water before the covering is removed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
In infants, long-term continuous therapy with topical corticosteroids should be avoided. Occlusion is not appropriate on the perineum. Adrenal suppression can occur, even without occlusion. There is a risk of developing skin atrophy following extensive therapy. The application of unusually large quantities of topical corticoids may result in the absorption of systemically active amounts of corticoid. Infections or secondarily infected dermatoses definitely require additional therapy with antibiotics or chemotherapeutic agents. This treatment can often be topical, but for heavy infections systemic antibacterial therapy may be necessary. If fungal infections are present, a topically active antimycotic should be applied. Allergic skin reactions may occur.
Inadvertent contact of the preparation with the eyes should be avoided. Careful handwashing after use is recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the case of accidental oral intake of the preparation (eg by swallowing several suppositories) mainly systemic effects of the local anaesthetic cinchocaine hydrochloride are to be expected, which, according to the dose, may manifest themselves as severe cardiovascular (depression to cessation of cardiac function) and CNS symptoms (convulsions; inhibition to arrest of respiratory function).

IDENTIFICATION
Yellowish-white suppositories without cosmetic defects.

PRESENTATION
Boxes containing 12 suppositories packed in aluminium foil strips.

STORAGE INSTRUCTIONS
Store below 25°C. Do not refrigerate. For shelf-life, please refer to the imprint on the pack. Keep out of reach of children.

REGISTRATION NUMBER
E/11.8/0668

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
Randjespark
Midrand        1685
P O Box 5278
Halfway House        1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
3 August 2000

SCHERING (PTY) LTD
(Reg No: 1964/009072/07)
Subsidiary of
Schering AG        Germany

Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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