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

Logo EPOGAM Capsules
SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

EPOGAM Capsules

COMPOSITION:
Each capsule contains:
40 mg gamolenic acid (GLA)
and 10 mg Vitamin E

PHARMACOLOGICAL CLASSIFICATION:
A/13.4.2/ Dermatological preparations. Antipruritics. Other.

PHARMACOLOGICAL ACTION:
Gamolenic acid (GLA) is normally formed within the body from the dietary polyunsaturated fatty acid, linoleic acid. Patients with atopic eczema have been reported to have lower than normal levels of GLA and its metabolites. Since GLA and its metabolites are required for normal skin health, this biochemical abnormality may contribute to the skin problems in atopic eczema. Administration of Epogam raises the blood levels of GLA and substances derived from it.
Epogam also contains 10 mg Vitamin E (d-alpha tocopheryl acetate) as an in vivo antioxidant.

INDICATIONS:
The symptomatic relief of itch due to atopic eczema.

CONTRA-INDICATIONS:
None known.

WARNINGS:
Interactions: Epogam may have the potential to make manifest undiagnosed temporal lobe epilepsy, especially in schizophrenic patients and/or those who are receiving known epileptogenic drugs such as phenothiazines. Physicians are advised to monitor carefully the effects of Epogam in patients on epileptogenic drugs, or in any individuals with a history of epilepsy. No epileptic events have been reported in patients not being treated with phenothiazines.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 4 - 6 capsules twice daily.
Children: Aged 1 - 12 years: 2 - 4 capsules twice daily. When children cannot swallow the capsules, the latter may be snipped open and the oil swallowed directly, or mixed with milk or put onto bread. No formal studies have been carried out in children under the age of 1 year.
It is suggested that patients start treatment at the highest recommended dose.

Some patients may not begin to show a clinical response to treatment for 8 - 12 weeks due to the gradual onset of action of Epogam. Once a clinical response has been achieved the treatment may be stopped or continued at a lower maintenance dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, indigestion, loose stools, mood changes and headaches have been reported.
Precautions: As with any oil, ingestion on an empty stomach may cause nausea in which case the capsules should be taken with meals.
Pregnancy: Safety in pregnancy has not been established.
Lactation: No known contra-indications.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The only symptom noted in a few cases has been loose stools, sometimes accompanied by abdominal pains.

IDENTIFICATION:
Oblong soft gelatin capsules for oral administration, containing clear yellow to yellow-green oil, printed with EPOGAM.

PRESENTATION:
Securitainers containing 240 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in tightly closed containers. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
V/13.4.2/183

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SCOTIA Pharmaceuticals (Pty) Ltd
355 Kent Avenue
Ferndale
RANDBURG
2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1990

DISTRIBUTED BY:
G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven, Johannesburg.

Code 4147-2-6/91

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