SSRI-GAP Package Insert

SCHEDULING STATUS:

Not scheduled

PROPRIETARY NAME AND DOSAGE FORM:

SSRI-GAP (CAPSULE)

COMPOSITION:

Each capsule contains:
Vitamin B12 0,1 mg
Vitamin D3 800 IU
Folic acid 0,4 mg
List of Excipients: Colloidal anhydrous silica, microcrystalline cellulose and magnesium stearate.

PHAMRMACOLOGICAL CLASSIFICATION:

D 22.2 Vitamins, Others

PHARMACOLOGICAL ACTION:

Early studies could link low folic acid levels to a poor response to treatment for depression. e.g fluoxetine and is also associated with a poorer response to treatment in major depressive disorder.
Homocysteine levels also have a negative correlation to folate levels in depressed patients. In depressed patients homocysteine levels may rise.
Lower folate and B12, and raised homocysteine levels can be a risk factor also for late life depression.
Folic acid and oral Vitamin B supplementation may be beneficial in lowering the homocysteine levels in individuals with low serum folate levels and can therefore be seen to improve the action of fluoxetine.

Folic acid supplementation have shown an increase in response to medication in both naïve and treatment-resistant patients, irrespective of whether a deficiency could be shown or not.

Vitamin D deficiency is associated with low mood and some impairment on cognitive performance especially in older adults. More recent analysis and or studies confirmed this association.
Insufficient levels of vitamin D were also seen in patients with psychosis.

INDICATIONS:

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

CONTRAINDICATIONS:

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

WARNINGS and SPECIAL PRECAUTIONS:

SSRI-GAP capsule 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. 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:

There is an increased risk of hypercalcemia if Vitamin D is given with thiazide diuretics or calcium. Cholestyramine or colostipol 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 DIRECTION 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 ITS TREATMENT:

No known symptoms of overdosage have been established. 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.

IDENTIFCATION:

SSRI-GAP are white and cerise pink hard gelatin capsules.

PRESENTATION:

SSRI-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 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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