| Product Name: | Primaquine Phosphate Tablets BP 7.5mg |
| Brand Name: | Generic |
| Strength: | 7.5mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antimalarial |
| Indication: | Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Primaquine Phosphate Tablet BP 7.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Primaquine Phosphate Tablet BP 7.5mg
Each film-coated tablet contains:
Primaquine Phosphate BP
Equivalent to Primaquine………………..7.5mg
Excipients…………………………………………q.s.
Colour: Ponceau 4 R
THERAPEUTIC INDICATIONS:
Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. Specifically, it is used for malaria due to Plasmodium vivax and Plasmodium ovale along with other medications and for prevention if other options cannot be used.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician
Adult dosage should not exceed 1 tablet daily for 14 days.
Discontinue promptly if signs suggestive of haemolytic anaemia occur (i.e., darkening of urine, marked fall of haemoglobin, of erythrocyte count).