ACEI-GAP Package Insert

SCHEDULING STATUS:

Not scheduled

PROPRIETARY NAME AND DOSAGE FORM:

ACEI-GAP (CAPSULE)

COMPOSITION:

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

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

The Renin Angiotensin System (RAS) is a regulatory cascade that plays an essential role in the regulation of blood pressure, electrolyte and volume homeostasis. Inappropriate stimulation of the RAS has been associated with hypertension.

Vitamin D is a potent endocrine suppressor of renin biosynthesis to regulate RAS. It is speculated that the pandemic of vitamin D deficiency might be related to, or induced by, the overstimulation of the renin angiotensin system, as seen in hypertension, heart attack, stroke and hypertrophy of the left ventricle and vascular smooth muscle cells.
Vitamin D deficiency was identified as a potential marker for risk of stroke and cardiovascular disease.

ACE inhibitors (ACEIs) are used in the management of hypertension, congestive heart failure, myocardial infarction and left ventricular systolic dysfunction. Captopril and enalapril are ACEIs producing their action by having a prominent zinc binding moiety which binds to zinc in the active site of the angiotensin converting enzyme (ACE).

It should be noted that diseases such as diabetes and hypertension might also enhance zinc deficiency. The deficiency in zinc caused by ACEIs has recently been confirmed.

INDICATIONS:

ACEI-GAP capsules assist in the maintenance of the essential nutrients that may be depleted as a result of high blood pressure and the treatment thereof.

CONTRAINDICATIONS:

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

WARNINGS AND SPECIAL PRECAUTIONS:

ACEI-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:

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

ACEI-GAP are red and white hard gelatin capsules.

PRESENTATION:

ACEI-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 THE PACKAGE INSERT:

To be allocated


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