Topiramate Tablets USP 25mg Technical Specification:
| Product Name: | Topiramate Tablets USP 15mg |
| Brand Name: | Generics |
| Strength: | 15mg, 25mg, 50mg, 100mg, 200mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 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, Anticonvulsant, Central Nervous System |
| Indication: | Topiramate medicine is used to treat epilepsy and migraine – NHS. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Topiramate Tablets USP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Topiramate Tablets USP 25mg
Each film-coated tablet contains:
Topiramate USP……………………25mg
Excipients…………………………q.s.
Colour: Yellow Oxide of Iron
THERAPEUTIC INDICATIONS:
Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep 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 below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
| Attach dispensing label as per end county. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Topiramate Tablets USP 15mg
b) Topiramate Tablets USP 25mg
c) Topiramate Tablets USP 50mg
d) Topiramate Tablets USP 100mg
e) Topiramate Tablets USP 200mg
b) Topiramate Tablets USP 25mg
c) Topiramate Tablets USP 50mg
d) Topiramate Tablets USP 100mg
e) Topiramate Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Topiramate Tablets USP 15mg
Each film-coated tablet contains:
Topiramate USP……………………15mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
b) Topiramate Tablets USP 25mg
Each film-coated tablet contains:
Topiramate USP……………………25mg
Excipients…………………………q.s.
Colour: Yellow Oxide of Iron
c) Topiramate Tablets USP 50mg
Each film-coated tablet contains:
Topiramate USP……………………50mg
Excipients…………………………q.s.
Colour: Sunset Yellow
d) Topiramate Tablets USP 100mg
Each film-coated tablet contains:
Topiramate USP……………………100mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
e) Topiramate Tablets USP 200mg
Each film-coated tablet contains:
Topiramate USP……………………200mg
Excipients…………………………q.s.
Colour: Quinoline Yellow Lake
Each film-coated tablet contains:
Topiramate USP……………………15mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
b) Topiramate Tablets USP 25mg
Each film-coated tablet contains:
Topiramate USP……………………25mg
Excipients…………………………q.s.
Colour: Yellow Oxide of Iron
c) Topiramate Tablets USP 50mg
Each film-coated tablet contains:
Topiramate USP……………………50mg
Excipients…………………………q.s.
Colour: Sunset Yellow
d) Topiramate Tablets USP 100mg
Each film-coated tablet contains:
Topiramate USP……………………100mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
e) Topiramate Tablets USP 200mg
Each film-coated tablet contains:
Topiramate USP……………………200mg
Excipients…………………………q.s.
Colour: Quinoline Yellow Lake
THERAPEUTIC INDICATIONS:
Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP 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 below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
