GENERIC NAME OF THE MEDICINAL PRODUCT:

Clomipramine HCl Tablets USP 25gm
Clomipramine HCl Tablets USP 50mg
Clomipramine HCl Tablets USP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Clomipramine HCl Tablets USP 25gm
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………...25mg
Excipients………………………………………q.s.
Colour: Ponceau 4R

b) Clomipramine HCl Tablets USP 50mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………...50mg
Excipients………………………………………q.s.
Colour: Iron Oxide Red

c) Clomipramine HCl Tablets USP 75mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………75mg
Excipients………………………………………q.s.
Colour: D&C Red 27 Lake

THERAPEUTIC INDICATIONS:

Clomipramine Tablets are indicated for the treatment of:
– the symptoms of depressive illness especially where sedation is required
– obsessional and phobic states
– adjunctive treatment of cataplexy associated with narcolepsy.

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 Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Clomipramine HCl Tablets USP Technical Specification:

Product Name:
 Clomipramine HCl Tablets USP
Brand Name: CLOMIPRAMINE
Strength: 25gm, 50mg, 75mg
Dosage Form: Tablet (Film-coated)
Route of Administration: Via oral Route
Packing: 100s, 500s.1000s
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: Clomipramine is used to treat obsessive compulsive disorder (OCD). OCD is a nervous condition wherein a person has recurring thoughts or ideas or does repetitive things because they are anxious. Clomipramine is a tricyclic antidepressant (TCA).
Storage: Do not store above 30°C.Oral solution: Store in the original container to protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Clomipramine HCl Tablets USP 25gm
  • Clomipramine HCl Tablets USP 50mg
  • Clomipramine HCl Tablets USP 75mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Clomipramine HCl Tablets USP 25gm
Each film coated Tablet Contains:
Clomipramine Hydrochloride………………25mg
Excipients………………………………………q.s.
Colour: Ponceau 4R

b) Clomipramine HCl Tablets USP 50mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride………………50mg
Excipients………………………………………q.s.
Colour: Iron Oxide Red

c) Clomipramine HCl Tablets USP 75mg
Each film coated Tablet Contains:
Clomipramine Hydrochloride……………75mg
Excipients………………………………………q.s.
Colour: D&C Red 27 Lake

THERAPEUTIC INDICATIONS:

  • Clomipramine Tablets are indicated for the treatment of:
    – the symptoms of depressive illness especially where sedation is required
    – obsessional and phobic states
    – adjunctive treatment of cataplexy associated with narcolepsy.

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 Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.
Attach dispensing label as per end county.