| Product Name: | Paroxetine HCL SR Tablets IP |
| Brand Name: | Generic |
| Strength: | 12.5mg, 20mg, 25mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antidepressants |
| Indication: | Paroxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It works by increasing the levels of serotonin, a chemical messenger in the brain. This improves mood and physical symptoms of depression and also relieves symptoms of panic and obsessive disorders. |
| Storage: | Store at a temperature not exceeding 30℃. Store in a cool, dry & dark place Protects from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paroxetine HCL SR Tablets IP 12.5mg
- Paroxetine HCL SR Tablets IP 20mg
- Paroxetine HCL SR Tablets IP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Paroxetine HCL SR Tablets IP 12.5mg
Each film coated Sustained Release tablet contains:
Paroxetine Hydrochloride IP
Equivalent to Paroxetine………………………12.5mg
Excipients………………………………………………q.s
Colour: Ponceau 4R - Paroxetine HCL SR Tablets IP 20mg
Each film coated Sustained Release tablet contains:
Paroxetine Hydrochloride IP
Equivalent to Paroxetine………………………20mg
Excipients………………………………………………q.s
Colour: Ferric Oxide (Yellow) USP-NF - Paroxetine HCL SR Tablets IP 25mg
Each film coated Sustained Release tablet contains:
Paroxetine Hydrochloride IP
Equivalent to Paroxetine………………………25mg
Excipients………………………………………………q.s
Colour: Sunset Yellow FCF
THERAPEUTIC INDICATIONS:
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It works by increasing the levels of serotonin, a chemical messenger in the brain. This improves mood and physical symptoms of depression and also relieves symptoms of panic and obsessive disorders.
CAUTION & SCHEDULE:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children
Tablet to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store at a temperature not exceeding 30℃.
Store in a cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
