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

Logo MOBILAT® Gel

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MOBILAT® Gel

COMPOSITION
Purified suprarenal extract                1.0 g (= 20 mg corticosteroids);
glycosaminoglycan polysulphate        0.2 g;
salicylic acid                                2.0 g; per 100.0 g gel.

PHARMACOLOGICAL CLASSIFICATION
Category A 13.4.2 Dermatological preparations: Other

PHARMACOLOGICAL ACTION
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.

INDICATIONS
As adjunctive therapy in traumatic soft tissue conditions, epicondylitis, tendovaginitis and muscular rheumatism.

CONTRA-INDICATIONS
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.

IDENTIFICATION
Opaque gel

PRESENTATION
Tubes of 25 g, 50 g, 100 g.

STORAGE INSTRUCTIONS
Store in a cool place, below 25°C. Keep out of reach of children.

REGISTRATION NUMBER
E/13.4.2/63

NAME AND BUSINESS ADDRESS OF APPLICANT
SWISSPHARM (PTY.) LTD.
Subsidiary of
BYK GULDEN S.A. (PTY) LTD.
Bryanston Gate 2
170 Curzon Road, Bryanston
SANDTON, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 July 1986

Manufactured by
LUITPOLD PHARMA MÜNCHEN

Südafrika                 006710 000 235 0-03/93

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