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

Logo FEFOL-VIT Spansule Capsules

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

FEFOL-VIT Spansule Capsules

COMPOSITION:
Each capsule contains:
Dried Ferrous Sulphate 150 mg
Folic Acid 0,5 mg
Thiamine mononitrate 2 mg
Riboflavin 2 mg
Pyridoxine Hydrochloride 1 mg
Nicotinamide 10 mg
Ascorbic Acid 50 mg
PHARMACOLOGICAL CLASSIFICATION:
A.22.1.2 Vitamins for prenatal use.

PHARMACOLOGICAL ACTION:
FEFOL-VIT
capsules are formulated to release most of the iron in the upper small intestine, where absorption is greatest, and not in the stomach where gastric irritation may be produced. Not more than 20 per cent of the ferrous sulphate is available for immediate absorption, the remainder being formulated for release over a period of three to four hours. All the vitamins are available for immediate absorption.

INDICATIONS:
FEFOL-VIT
is a haematinic containing added vitamins. It is recommended for prophylaxis of iron and folic acid deficiency during pregnancy where an inadequate diet calls for supplementary vitamins B and C.

CONTRA-INDICATIONS:
The folic acid contained in FEFOL-VIT capsules is unlikely to mask pernicious anaemia should this condition be present; pregnancy during pernicious anaemia is very rare. Do not use in patients with a known iron overload.

DOSAGE AND DIRECTIONS FOR USE:
ADULTS ONLY
One FEFOL-VIT capsule a day by mouth throughout pregnancy. It is recognised that some pregnant patients may need a higher prophylactic dose of iron because of dietary and other factors. Such patients may require two capsules a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea and other gastro-intestinal symptoms sometimes encountered during iron therapy, are unlikely to occur with FEFOL-VIT capsules.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdosage with ferrous sulphate include acute epigastric pain and nausea and vomiting; haematemesis is common and shock may develop. Hours or days may elapse with no further signs or symptoms; offensive black stools may then be passed, and signs of acute encephalopathy may appear with headache and confusion progressing to coma. If the patient survives, liver necrosis may develop with a fatal outcome. Treatment consists of the induction of vomiting and/or gastric lavage except when the patient is severely shocked, together with supportive symptomatic measures.

Desferrioxamine, 10 g in 50 mL water, should be introduced into the stomach; this compound may also be given intravenously or intramuscularly if indicated. As the ferrous sulphate in FEFOL-VIT is in delayed-release form, absorption may be prolonged. Saline cathartics may be of use for hastening the evacuation of the spansule pellets.

IDENTIFICATION:
Hard gelatin capsule with a clear colourless body and an opaque white cap containing a mixture of coral-red, orange-yellow and pale yellow and white spherical pellets.

PRESENTATION:
FEFOL-VIT
capsules are available in containers of 50 and 250.

STORAGE INSTRUCTIONS:
FEFOL-VIT
capsules should be stored below 25°C in a dry place, and dispensed in moisture-proof containers.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
G/22.1.2/102

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd
6 Carey Street,
Wynberg Ext. 6,
Johannesburg, 2090

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
09.03.1995

P1562

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