VALPRO-GAP Package Insert

SCHEDULING STATUS:

Not scheduled

PROPRIETARY NAME AND DOSAGE FORM:

VALPRO-GAP (CAPSULE)

COMPOSITION:

Each capsule contains:
Zinc 15 mg
Folic acid 0,4 mg
Vitamin B12 0,1 mg
Vitamin B6 10 mg
List of excipients: Acetyl-L-carnitine, colloidal anhydrous silica, magnesium stearate

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

It has been demonstrated that epilepsy decreases zinc and chromium concentrations in all patients. Chronic deficiency in red blood cell magnesium (RBC Mg) and serum zinc (sZn) has also been demonstrated. Studies have demonstrated that serum and red blood cell folate levels were reduced in some children with epilepsy. They further indicated that red blood cells (RBC) and serum folate were significantly lower in patients on polytherapy than in those on monotherapy. It has also been demonstrated that serum vitamin B12 levels were low in some patients. Vitamin B6 deficiency may cause seizures in adult patients with chronic alcoholism.

INDICATIONS:

VALPRO-GAP capsules assist in the maintenance of the essential nutrients that may be depleted as a result of epilepsy and the treatment thereof.

CONTRAINDICATIONS:

VALPRO-GAP is contraindicated in individuals allergic or sensitive to any of the listed ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:

VALPRO-GAP has not been evaluated by the Medicines Control Council. This product is not intended to diagnose, treat, cure or prevent any disease. Health supplements are intended only to complement health or supplement the diet.
Vitamin preparations containing folic acid should be avoided by patients with pernicious anaemia because folic acid may actually potentiate neurologic complications of vitamin B12 deficiency. Doses in excess of the prescribed amount may lead to hypervitaminosis and /or mineral toxicity.

INTERACTIONS:

No known interactions have been established. If you suspect any interactions please consult your healthcare practitioner immediately.

PREGNANCY AND LACTATION:

Safety during pregnancy and lactation has not been established. Please consult your healthcare practitioner prior to use.

DOSAGE AND DIRECTIONS FOR USE:

Adult: Take one (1) capsule daily.
Do not exceed the recommended daily dosage.

SIDE EFFECTS:

No known side effects have been established. If any side effects occur please consult your healthcare practitioner immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

If suspected overdose occurs please consult your healthcare practitioner immediately. Treatment should be symptomatic and supportive.

IDENTIFICATION:

VALPRO-GAP capsules are purple and white hard gelatin capsules.

PRESENTATION:

VALPRO-GAP capsules are packed in PVC/PVDC/Aluminium blister packs of 30 capsules.

STORAGE INSTRUCTIONS:

Store at or below 25 °C.
KEEP OUT OF REACH OF CHILDREN
Store in unit carton until before use.

REGISTRATION NUMBER:

To be allocated

NAME AND BUSINESS ADDRESS OF THE APPLICANT:

Adcock Ingram Limited
1 New Road, Erand Gardens
Midrand, 1685
www.adcock.com

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

To be allocated

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