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

Logo EFAMOL® G Capsules

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME:
(and dosage form)

EFAMOL® G Capsules

COMPOSITION:
Each capsule contains:
13 mg
Vitamin E, 500 mg Evening Primrose Oil which supplies approximately 40 mg gammalinolenic acid (GLA) and 350 mg linoleic acid.

PHARMACOLOGICAL CLASSIFICATION:
A 22.1.4 Multivitamins. Other.

PHARMACOLOGICAL ACTION:
EFAMOL
® G is a dietary supplement rich in gamma-linolenic acid (GLA) and the essential fatty acid linoleic acid as well as Vitamin E.

INDICATIONS:
Intended for use as a dietary supplement where a deficiency of Vitamin E exists. EFAMOL
® G is also indicated in all cases where an increased poly-unsaturate ratio is recommended.

CONTRA-INDICATIONS:
There are no known contra-indications.

WARNINGS:
EFAMOL
® G may have the potential to make manifest undiagnosed temporal lobe epilepsy, especially in schizophrenic patients and/or those who are receiving known epileptogenic medicines such as phenothiazines. Physicians are advised to monitor carefully the effects of EFAMOL® G in patients on epileptogenic medicines, or in any individuals with a history of epilepsy.

DOSAGE AND DIRECTIONS FOR USE:
Take two capsules two to three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, indigestion, loose stools, mood changes and headaches have been reported. In less frequent cases hypersensitivity reactions including rash and abdominal pain have been reported. It should be noted that hypersensitivity reactions may require close medical surveillance and that such reactions may occur particularly in patients who have a history of food or other allergies.
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:
Oval, natural coloured, soft gelatin capsules containing a yellow to yellow-green oil, imprinted with a “triangular logo”in white ink. Long axis 14 mm, short axis 9 mm.

PRESENTATION:
Securitainers containing 180 capsules. Blister pack containing 90 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
T1013 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Efamed (Pty) Ltd
355 Kent Road
Ferndale
RANDBURG
2194
Reg No 80/00639/07

DISTRIBUTED BY
Adcock Ingram Ltd
Private Bag X69
Bryanston, 2021

for
Efamed (Pty) Ltd

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1998

® Registered Trade Mark

                02/98
        Britepak

Updated on this site: December 2000

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