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Logo EPOGAM SNIP-OFF CAPSULES
SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

EPOGAM SNIP-OFF CAPSULES

COMPOSITION:
Each capsule contains:
80 mg gamolenic acid (GLA) and 20 mg Vitamin E, as an in vivo antioxidant

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 SNIP-OFF raises the blood levels of GLA and substances derived from it.

EPOGAM SNIP-OFF also contains 20 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 SNIP-OFF 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 SNIP-OFF 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:
The snip off neck should be cut off and the capsule squeezed to express the contents which may be swallowed directly or mixed with milk or put onto bread or other food.
Children: Aged 1-12 years: 1- 2 capsules twice daily, providing a total daily dose of 2 - 4 capsules.
No formal studies have been carried out in children under the age of 1 year.
Adults: 2 - 3 capsules twice daily, providing a total daily dose of 4 - 6 capsules.
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 SNIP-OFF. 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 medication 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 capsule with snip-off top for oral administration, containing a clear yellow to yellow-green oil, printed with EPOGAM.

PRESENTATION:
Securitainers containing 60 capsules.

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

REGISTRATION NUMBER:
Z/13.4.2/79

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 1992

Code 4160-1-12/91

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