STATIN-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME (AND DOSAGE FORM):

STATIN-GAP ( CAPSULE)

COMPOSITION:

Each capsule contains:
HydroQsorb (Co-enzyme Q10) 50 mg
Vitamin D3 800 I.U
List of Excipients: Colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate.

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

The depletion of the essential nutrient Co-enzyme Q10 (CoQ10) by the cholesterol lowering drugs, HMG-CoA reductase inhibitors (statins), is of concern. The prevalence and severity of Co-enzyme Q10 (CoQ10) deficiency is increasing noticeably. Statin-induced CoQ10 deficiency is completely preventable by supplemental CoQ10 with no adverse effects on cholesterol lowering or anti-inflammatory properties of the statin drugs.
It has been showed that the intensity of muscle pain muscle weakness, muscle cramps and tiredness decreased by supplementation with Coenzyme Q10 in patients with statin associated myopathy (SAM).

Vitamin D deficiency is associated with myalgia, which is resolved with the correction of the vitamin D deficiency. Myalgias associated with statin therapy may also be resolved with correction of vitamin D deficiency.
Studies have associated vitamin D deficiency with statin associated myalgias, and suggested that increasing vitamin D levels can reverse the myalgia.

The US FDA issued a warning regarding the use of high-dose simvastatin and its risk of myopathy. A lower incidence of adverse muscle events with high dose simvastatin 80 mg was found in patients with higher vitamin D levels.

INDICATIONS:

STATIN-GAP assist in the maintenance of the essential nutrients that may be depleted as a result of the treatment of high cholesterol.

CONTRAINDICATIONS:

STATIN-GAP is contraindicated for individuals allergic or sensitive to any of the listed ingredients.

WARNINGS AND SPECIAL PRECAUTIONS:

Statin-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. 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.
No other 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:

Excessive intake of vitamin D may lead to the development of hyperphosphataemia or hyperkalaemia. No other known side effects have been established. If any side effects occur please consult your healthcare practitioner immediately.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF 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:

STATIN-GAP capsules are white and maroon hard gelatin capsules.

PRESENTATION:

Stain-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.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

To be allocated

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