CHEMO-GAP Package Insert

SCHEDULING STATUS:

Not scheduled

PROPRIETARY NAME AND DOSAGE FORM:

CHEMO-GAP (Capsule)

COMPOSITION:

Each capsule contains:
Zinc 15 mg
Magnesium 60 mg
Vitamin D3 800 IU
List of Excipients: Colloidal anhydrous silica, magnesium stearate

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

Zinc plays an important role in transcription factor function, antioxidant defence and DNA repair. Dietary deficiencies in zinc can contribute to single- and double-strand DNA breaks and oxidative modifications to DNA that increase risk for cancer development. Zinc accumulation exhibits anti- proliferative effects via its induction of mitochondrial apoptogenesis. Zinc accumulation also inhibits the invasive/migration activities in malignant prostate cells through zinc activation of specific intracellular signalling pathways. Consequently, these effects impose anti-tumour actions by zinc.

The incidence of hypomagnesaemia at any point during chemotherapy was 43 %. Cisplatin has the potential to produce both mild and severe side effects. The only toxicity was grade 1 hypomagnesaemia. Additional in-vitro experiments compromise cisplatin’s chemotherapeutic efficacy. These results support developing more conservative magnesium replacement guidelines for reducing cisplatin-induced AKI in cancer patients at risk for magnesium deficiency.

Vitamin D deficiency and insufficiency may contribute to musculoskeletal symptoms and bone loss observed in women taking aromatase inhibitors (AIs).

INDICATIONS:

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

CONTRAINDICATIONS:

CHEMO-GAP is contra-indicated for individuals allergic or sensitive to any of the listed ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:

CHEMO-GAP capsules 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. Doses in excess of the prescribed amount may lead to hypervitaminosis.

INTERACTIONS:

There is an increased risk of hypercalcemia if vitamin D is given with thiazide diuretics or calcium. Cholestyramine or colestipol hydrochloride administration may result in decreased intestinal absorption of vitamin D analogs. 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:

Excessive intake of vitamin D may lead to development of hyperphosphataemia or hyperkalaemia. If any side effects occur please consult your healthcare practitioner immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

The acute or chronic administration of excessive amounts of vitamin D or enhanced responsiveness to normal amounts of the vitamin leads to a number of clinical syndromes that are the result of deranged calcium metabolism. If suspected overdose occurs please consult your healthcare practitioner immediately. Treatment should be symptomatic and supportive.

IDENTIFICATION:

CHEMO-GAP capsules are brown and white hard gelatin capsules.

PRESENTATION:

CHEMO-GAP capsules are packed in PVC/PVDC/Aluminium blister packs of 30 capsules.
Blisters are kept inside a cardboard box.

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 HOLDER OF THE CERTIFICATE OF REGISTRATION:

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

To be allocated

Download Insert