PPI-GAP Package Insert

SCHEDULING STATUS:

Not Scheduled

PROPRIETARY NAME AND DOSAGE FORM:

PPI-GAP (CAPSULE)

COMPOSITION:

Each capsule contains:
Vitamin B12 0,05 mg
Magnesium 60 mg
List of Excipients: Colloidal anhydrous silica and magnesium stearate

PHARMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

Proton pump inhibitors (PPI) depresses absorption of vitamin B12.
Vitamin B12 status declines during prolonged PPI use in older adults.
PPIs have been associated with an increased risk of vitamin and mineral deficiencies impacting vitamin B12, vitamin C, calcium, iron and magnesium metabolism.

PPI use can inhibit the active magnesium transport in the intestine. PPI-associated hypomagnesaemia is a rare, but potentially life-threatening.

The US Food and Drug Administration advised that long-term use of PPI can induce hypomagnesaemia. Thus although mechanism and incidence rate remain unclear, there seems little doubt that PPIs may cause hypomagnesaemia. All PPIs were associated with hypomagnesaemia, with esomeprazole having the lowest risk and pantoprazole having the highest risk. The risk of PPI-associated hypomagnesaemia was higher in males and the elderly population.

Cases of PPI induced hypomagnesaemia show severe symptoms of magnesium depletion and identification of its causation was only possible through withdrawal of the PPI.

INDICATIONS:

PPI-GAP capsules assist in the maintenance of the essential nutrients that may be depleted as a result of the treatment of reflux and gastric ulcers.

CONTRAINDICATIONS:

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

WARNINGS AND SPECIAL PRECAUTIONS:

PPI-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 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:

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:

PPI-GAP capsules are yellow and white hard gelatin capsules.

PRESENTATION:

PPI-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 APPLICANT:

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