| Product Name: | Clopidogrel & Aspirin Capsules |
| Brand Name: | Generics |
| Strength: | 75mg+75mg |
| Dosage Form: | Capsule (Hard Gelatine) |
| Route of Administration: | Via oral Route |
| Packing: | 100s, 150s, 200s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antiplatelet, Anti-Hyperlipidaemic |
| Indication: | This Capsule is a combination of three medicines: Aspirin / Acetylsalicylic acid, and Clopidogrel. Aspirin and Clopidogrel are antiplatelet medicines. They work by preventing the platelets from sticking together and decrease the formation of harmful blood clots. |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Clopidogrel & Aspirin Capsules 75mg+75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Clopidogrel & Aspirin Capsules 75mg+75mg
Each hard gelatin capsule contains:
Clopidogrel Bisulphate Tablet IP
Clopidogrel Bisulphate IP
Equivalent to Clopidogrel ………….75mg
(As Two film coated tablets)
Colour: Sunset Yellow Lake
Aspirin IP……………………………75mg
(As enteric coated pellets)
Colour: Titanium Dioxide IP
Excipients…………………………… q.s.
Approved colors used in capsule shells.
(Brilliant Blue FCF, Ponceau 4R, Sunset Yellow, Carmoisine)
THERAPEUTIC INDICATIONS:
This Capsule is a combination of three medicines: Aspirin / Acetylsalicylic acid, and Clopidogrel. Aspirin and Clopidogrel are antiplatelet medicines. They work by preventing the platelets from sticking together and decrease the formation of harmful blood clots.
CAUTION & WARNING:
CAUTION:
- Not be used in children below 12 years of age expect under medical advice.
- SWALLOW WHOLE DO NOT CHEW OR CRUSH.
- Do not take this product during the last three months of pregnancy unless directed by a doctor. Aspirin taken near the time of delivery may cause bleeding problems to both mother child.
SCHEDULE “H” Prescription Drug Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze.
Dosage: As directed by the Physician.