OC-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME AND DOSAGE FORM:

OC-GAP (CAPSULE)

COMPOSITION:

Each capsule contains:
Vitamin B6 10 mg
Vitamin B12 0,1 mg
Folic acid 0,4 mg
Zinc 15 mg
List of Excipients: Colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose.

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

Oral contraceptives (OC)s are among the most frequently used drugs in developed countries. There are subtle OC-induced nutritional side effects that are lesser known but important to take note of e.g. the depletion of B vitamins.

The influence of especially the estrogen containing OC on vitamins has already been known for many years.

A dietary vitamin B6 deficiency may result in low serotonin levels and/or reduced conversion of tryptophan to niacin. Furthermore, vitamin B6 is important to keep homocysteine levels normal as well as for gluconeogenesis and glycogenolysis, immune functions, and haemoglobin formation. Women taking estrogen-progestin combinations demonstrated vitamin B6 deficiency.

Pyridoxal 5-phosphate (PLP) and pyridoxamine 5-phosphate (PMP) are the active coenzyme forms of vitamin B6. Vitamin B6 coenzymes take part in a wide variety of physiological functions including more than 100 enzymatic reactions, mostly concerned with protein metabolism. A large-scale population-based study from the United States determined that plasma PLP concentrations were significantly reduced in 75% of women taking OCs who did not use dietary supplements.

It is not exactly clear how serum vitamin B12 levels is reduced in OC users. The total vitamin B12 binding capacity of the serum was significantly lower in women using OCs compared to non-users. The mechanism behind the low serum levels of vitamin B12 in patients using OCs seem to be different from the one causing the low serum levels of folate since there is no correlation between the levels of the two substances, and folate therapy does not correct the low serum levels of vitamin B12 in OC users. Numerous studies have confirmed the earlier findings of the negative influence of OCs on folate status. Women using OCs also had lower plasma zinc levels than women who were not.

Vitamin B6, B12 and the minerals zinc and selenium are decreased, even at the low dose OC currently being used by the market. The risk of neural tube defects and homocysteine increase were viewed as serious. It is however fortunately well established that a combination of vitamin B6, B12 and folic acid lower homocysteine levels.

INDICATIONS:

OC-GAP capsules assist in the maintenance of the essential nutrients that may be depleted as a result of oral contraceptive treatment.

CONTRAINDICATIONS:

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

WARNINGS AND SPECIAL PRECAUTIONS:

OC-GAP has not been evaluated by the Medicines Control Council. This product is not intended to diagnose, treat, cure or prevent any disease. This product is intended only to complement health or supplement the diet.
Doses in excess of the prescribed amount may lead to hypervitaminosis. 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.

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:

No known symptoms of overdosage have been established. If suspected overdose occurs please consult your healthcare practitioner immediately. Treatment should be symptomatic and supportive.

IDENTIFICATION:

OC-GAP capsules are pink and white hard gelatin capsules.

PRESENTATION:

OC-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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