(and dosage form):
1 g ointment contains prednisolone caproate (1,4-pregnadiene-3,20-dione-11beta-17alpha,21-triol-21-caproate) 1,9 mg and cinchocaine hydrochloride as the hydrochloride of (2-butoxy-N-(2-diethylaminoethyl)cinchonamide) 5 mg.
A. 11.8 Anal suppositories and ointments.
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.
Short term symptomatic relief of perianal discomfort, inflammation and itching caused by thrombosed haemorrhoids, anal fissure and pruritus ani.
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.
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 apply twice daily. On the first day, for faster symptomatic relief, up to four times. Smear a little ointment (about the size of a pea) around the anus and in the anal ring with a finger and use the finger-tip to overcome the resistance of the sphincter. Before applying within the rectum, the enclosed nozzle should be screwed on to the tube. However, for very inflamed and hence painful lesions it is advisable initially to apply the ointment internally with the finger.
Protruding lumps should be thickly smeared and carefully pressed back with the finger.
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 a few grams of the ointment) 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).
Colourless to slightly yellowish translucent ointment.
White coloured aluminium tubes, interior wall coated with epoxy resin, containing 15 or 30 g.
Store below 25°C. For shelf-life, please refer to the imprint on the pack. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT
Schering (Pty) Ltd
(Reg No: 1964/009072/07)
106 Sixteenth Road
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)
Schering AG Germany
Updated on this site: April 2003
Current: January 2005
Source: Pharmaceutical Industry
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