GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Opipramol Hydrochloride Tablets 50mg
B) Opipramol Hydrochloride Tablets 100mg
B) Opipramol Hydrochloride Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Opipramol Hydrochloride Tablets 50mg
Each film coated tablet contains:
Opipramol Hydrochloride……………50mg
Excipients…………………………………….q.s
Colour: Lake of Erythrosine
B) Opipramol Hydrochloride Tablets 100mg
Each film coated tablet contains:
Opipramol Hydrochloride……………….100mg
Excipients………………………………………….q.s
Colour: Quinoline yellow WS
Each film coated tablet contains:
Opipramol Hydrochloride……………50mg
Excipients…………………………………….q.s
Colour: Lake of Erythrosine
B) Opipramol Hydrochloride Tablets 100mg
Each film coated tablet contains:
Opipramol Hydrochloride……………….100mg
Excipients………………………………………….q.s
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
Opipramol is an antidepressant. It is used in the prevention and treatment of mental illnesses and anxiety disorders. This medicine functions by restoring the chemical balance in the brain.
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 psychiatrist only.
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 psychiatrist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end county.
Dispense in tight container.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end county.
Opipramol Hydrochloride Tablets 100mg Technical Specification:
| Product Name: | Opipramol Hydrochloride Tablets |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg |
| Dosage Form: | Tablets (Uncoated) |
| 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: | Anti-Anxiety, Antidepressants |
| Indication: | Opipramol is used for therapy of general somatoform and anxiety disorders. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- A) Opipramol Hydrochloride Tablets 50mg
- B) Opipramol Hydrochloride Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- A) Opipramol Hydrochloride Tablets 50mg
Each film-coated tablet contains:
Opipramol Hydrochloride……………50mg
Excipients…………………………………….q.s
Colour: Lake of ErythrosinB) - Opipramol Hydrochloride Tablets 100mg
Each film-coated tablet contains:
Opipramol Hydrochloride……………….100mg
Excipients………………………………………….q.s
Colour: Quinoline yellow WS
THERAPEUTIC INDICATIONS:
Opipramol is an antidepressant. It is used in the prevention and treatment of mental illnesses and anxiety disorders. This medicine functions by restoring the chemical balance in the brain.
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 psychiatrist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
Dosage: As directed by the psychiatrist.
Attach dispensing label as per end county.
