(and dosage form):
Purified suprarenal extract 1.0 g (= 20 mg corticosteroids);
glycosaminoglycan polysulphate 0.2 g;
salicylic acid 2.0 g; per 100.0 g gel.
Category A 13.4.2 Dermatological preparations: Other
Mobilat is a preparation for local application. The gel base serves as a vehicle for the active ingredients and renders possible a percutaneous absorption. It has anti-inflammatory, anti-exudative, anti-hyaluronidase and anti-coagulant, anti-rheumatic and keratolytic effects.
As adjunctive therapy in traumatic soft tissue conditions, epicondylitis, tendovaginitis and muscular rheumatism.
Herpes simplex, vaccinia or varicella.
Safety in pregnancy has not been established.
DOSAGE AND DIRECTIONS FOR USE
Five to 15 cm of gel are applied to the afflicted area once or several times daily. If a dressing is applied, the dose should be increased.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Mobilat gel may affect the blood coagulation time with a consequent danger of haemorrhage. Dermatitis may occur. Long-term continuous treatment with Mobilat gel should be avoided as far as possible as this may cause atrophic changes in the skin, leading to loss of elasticity, thinning, dilatation of superficial blood vessels, and purpura, telangiectasiae and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used. Systemic absorption of Mobilat gel may occur particularly under the following conditions: when large quantities are used or when application is made to wide areas of the body, or to damaged skin, and when the occlusive dressing technique is applied. Depression of the hypothalamic pituitary adrenal axis with consequent suppression of the adrenal glands may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Increased susceptibility to infection, hypoglycaemia and benign intracranial hypertension have been reported. Concomitant antimicrobial therapy is required with secondary microbial skin infection. Keep away from eyes.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side-effects. Treatment is symptomatic.
Tubes of 25 g, 50 g, 100 g.
Store in a cool place, below 25°C. Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF APPLICANT
SWISSPHARM (PTY.) LTD.
BYK GULDEN S.A. (PTY) LTD.
Bryanston Gate 2
170 Curzon Road, Bryanston
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 July 1986
LUITPOLD PHARMA MÜNCHEN
Südafrika 006710 000 235 0-03/93
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