| Product Name: | Mirtazapine Tablet USP |
| Brand Name: | Generic |
| Strength: | 7.5mg, 15mg, 30mg, 45mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 50s, 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: | Anti-depressant |
| Indication: | Mirtazapine is an antidepressant medicine. It’s used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Mirtazapine Tablet USP 7.5mg
- Mirtazapine Tablet USP 15mg
- Mirtazapine Tablet USP 30mg
- Mirtazapine Tablet USP 45mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Mirtazapine Tablet USP 7.5mg
Each film-coated tablet contains:
Mirtazapine USP ………………………………….7.5mg
Excipients………………………………………. q.s.
Colour: Ferric Oxide of Red USP - Mirtazapine Tablet USP 15mg
Each film-coated tablet contains:
Mirtazapine USP ………………………………….15mg
Excipients………………………………………. q.s.
Colour: Ferric Oxide of Yellow USP - Mirtazapine Tablet USP 30mg
Each film-coated tablet contains:
Mirtazapine USP ………………………………….30mg
Excipients………………………………………. q.s.
Colour: Ferric Oxide of Black USP - Mirtazapine Tablet USP 45mg
Each film-coated tablet contains:
Mirtazapine USP ………………………………….45mg
Excipients………………………………………. q.s.
Colour: Titanium dioxide
THERAPEUTIC INDICATIONS:
Mirtazapine is an antidepressant medicine. It’s used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety. It works by increasing the amount of mood-enhancing chemicals called noradrenaline and serotonin in your brain. Mirtazapine is only available on prescription.
THERAPEUTIC INDICATIONS:
Mirtazapine is an antidepressant medicine. It’s used to treat depression and sometimes obsessive-compulsive disorder (OCD) and anxiety. It works by increasing the amount of mood-enhancing chemicals called noradrenaline and serotonin in your brain. Mirtazapine is only available on prescription.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the 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).
Dosage: As directed by the Physician.