A) Dosulepin Tablets BP 25mg
B) Dosulepin Tablets BP 50mg
C) Dosulepin Tablets BP 75mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Dosulepin Tablets BP 25mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP……….25mg
Excipients……………………………………q.s.
Colours: Lake brilliant blue
B) Dosulepin Tablets BP 50mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP…………50mg
Excipients……………………………………. q.s.
Colours: Indigo carmine aluminum lake
C) Dosulepin Tablets BP 75mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP………….75mg
Excipients………………………………………q.s.
Colours: Iron oxide Red
Each film coated tablet contains:
Dothiepin Hydrochloride BP……….25mg
Excipients……………………………………q.s.
Colours: Lake brilliant blue
B) Dosulepin Tablets BP 50mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP…………50mg
Excipients……………………………………. q.s.
Colours: Indigo carmine aluminum lake
C) Dosulepin Tablets BP 75mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP………….75mg
Excipients………………………………………q.s.
Colours: Iron oxide Red
THERAPEUTIC INDICATIONS:
Dosulepin is used in the treatment of anxiety disorder and depression. It is used in patients intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Dosulepin Tablets BP 75mg Technical Specification:
| Product Name: | Dosulepin Tablets BP 75mg |
| Brand Name: | DROTHITAJ |
| Strength: | 25mg, 50mg, 75mg |
| Dosage Form: | Tablets (Film coated) |
| 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: | Antidepressants, Central nervous system |
| Indication: | It is used to treat symptoms of depression (low mood) such as: Feeling sad. Feeling hopeless or worthless. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Dosulepin Tablets BP 75mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Dosulepin Tablets BP 75mg
Each film coated tablet contains:
Dothiepin Hydrochloride BP……….75mg
Excipients……………………………………q.s.
Colours: Iron oxide Red
THERAPEUTIC INDICATIONS:
Dosulepin is used in the treatment of anxiety disorder and depression. It is used in patients intolerant of or unresponsive to alternative other treatment options for depression. Dosulepin is a tricyclic antidepressant.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Take whole tablet with water.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
