| Product Name: | Lamotrigine Tablets USP |
| Brand Name: | Generics |
| Strength: | 25mg,50mg, 100mg, 200mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| 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, Anticonvulsant |
| Indication: | Lamotrigine tablet use to treat epilepsy and bipolar disorder – NHS. |
| Storage: | Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lamotrigine Tablets USP 25mg
- Lamotrigine Tablets USP 50mg
- Lamotrigine Tablets USP 100mg
- Lamotrigine Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lamotrigine Tablets USP 25mg
Each uncoated tablet contains:
Lamotrigine USP……………….25mg
Excipients………………………………q.s. - Lamotrigine Tablets USP 50mg
Each uncoated tablet contains:
Lamotrigine USP……………….50mg
Excipients………………………………q.s. - Lamotrigine Tablets USP 100mg
Each uncoated tablet contains:
Lamotrigine USP……………….100mg
Excipients………………………………q.s. - Lamotrigine Tablets USP 200mg
Each uncoated tablet contains:
Lamotrigine USP……………….200mg
Excipients………………………………q.s.
THERAPEUTIC INDICATIONS:
Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug.
CAUTION & WARNING:
CAUTION
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.