Pregabalin Sustained Release Capsules 150mg Technical Specification:
| Product Name: | Pregabalin Sustained Release Capsules 150mg |
| Brand Name: | Pregal |
| Strength: | 75mg, 150mg |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Anticonvulsant, Anti-Epileptic, Anti-anxiety |
| Indication: | Pregabalin is used to treat epilepsy and anxiety. It’s also taken to treat nerve pain. Nerve pain can be caused by different conditions including diabetes and shingles, or an injury. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pregabalin Sustained Release Capsules 150mg (Pregal)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pregabalin Sustained Release Capsules 150mg
Each hard gelatin Capsule contains:
Pregabalin……………….150mg
Excipients………………….q.s
Approved colour used in empty capsules.
THERAPEUTIC INDICATIONS:
Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep 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].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Pregabalin Sustained Release Capsules 75mg (Pregal)
B) Pregabalin Sustained Release Capsules 150mg (Pregal)
B) Pregabalin Sustained Release Capsules 150mg (Pregal)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Pregabalin Sustained Release Capsules 75mg
Each hard gelatin Capsule contains:
Pregabalin……………….75mg
Excipients………………….q.s
Approved colour used in empty capsules.
B) Pregabalin Sustained Release Capsules 150mg
Each hard gelatin Capsule contains:
Pregabalin……………….150mg
Excipients………………….q.s
Approved colour used in empty capsules.
Each hard gelatin Capsule contains:
Pregabalin……………….75mg
Excipients………………….q.s
Approved colour used in empty capsules.
B) Pregabalin Sustained Release Capsules 150mg
Each hard gelatin Capsule contains:
Pregabalin……………….150mg
Excipients………………….q.s
Approved colour used in empty capsules.
THERAPEUTIC INDICATIONS:
Pregabalin is an anticonvulsant, analgesic and anxiolytic medication used to treat epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome, opioid withdrawal and generalized anxiety disorder. Its use in epilepsy is as an add-on therapy for partial seizures.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP 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.
Read enclosed leaflet before use.
KEEP 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].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
