| Product Name: | Carbamazepine Tablets USP |
| Brand Name: | Generics |
| Strength: | 200mg, 400mg |
| Dosage Form: | Tablets (Film-Coated) |
| Route of Administration: | Via oral Route |
| Packing: | 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Epileptic, Antipsychotic, Anticonvulsant, |
| Indication: | Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia) |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Carbamazepine Tablets USP 200mg
- Carbamazepine Tablets USP 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Carbamazepine Tablets USP 200mg
Each tablet contains:
Carbamazepine USP……………….200mg
Excipients……………………………. q.s.
Colures: D&C Yellow 11 - Carbamazepine Tablets USP 400mg
Each Film-Coated tablet contains:
Carbamazepine USP…………………400mg
Excipients……………………………. q.s.
Colures: Orange 4
THERAPEUTIC INDICATIONS:
Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia).
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:
Do not freeze.
Store below 25°C in a dry place.
Keep the container tightly closed in order to protect it from moisture.
Dosage:As directed by the Physician.