| Product Name: | Fluoxetine Tablets IP |
| Brand Name: | Generic |
| Strength: | 10mg, 20mg, 40mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antidepressants, Central nervous system |
| Indication: | Fluoxetine is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). |
| Storage: | Store below 30 °C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Fluoxetine Tablets IP 10mg
- Fluoxetine Tablets IP 20mg
- Fluoxetine Tablets IP 40mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Fluoxetine Tablets IP 10mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine………………10mg
Excipients………………………………………….q.s
Colour: Titanium Dioxide IP - Fluoxetine Tablets IP 20mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine…………………20mg
Excipients……………………………………………q.s
Colour: Ponceau 4 R - Fluoxetine Tablets IP 40mg
Each film coated tablet contains:
Fluoxetine Hydrochloride IP
Equivalent to Fluoxetine………………….40mg
Excipients…………………………………………q.s
Colour: Sunset yellow
THERAPEUTIC INDICATIONS:
Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class. It is used for the treatment of the major depressive disorder, obsessive–compulsive disorder, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder.
CAUTION & SCHEDULE:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
STORAGE & DOSAGE:
Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the physician.