Clomipramine HCl Tablets 75mg Technical Specification:
Product Name: | Clomipramine HCl Tablets 75mg |
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 75mg (Clomipramine)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- 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 country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Clomipramine HCl Tablets 25gm (Clomipramine)
B) Clomipramine HCl Tablets 50mg (Clomipramine)
C) Clomipramine HCl Tablets 75mg (Clomipramine)
B) Clomipramine HCl Tablets 50mg (Clomipramine)
C) Clomipramine HCl Tablets 75mg (Clomipramine)
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
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.
– 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.
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 country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.