CLOMIDEP TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CLOMIPRAMINE HYDROCHLORIDE 25,0 mg

Authorization status:

Registered

Authorization date:

2004-12-10

Patient Information leaflet

Applicant: Ranbaxy Pharmaceuticals (Pty) Ltd
Product name: CLOMIDEP
Dosage form: Film-coated tablets
Strength: 25 mg clomipramine hydrochloride /tablet
Amended proposed patient information leaflet
Type IA
IN
– C.I.0.1; Type IA
IN/
IB – C.I.0.2.a/b; Type IB- C.1.2a
Response to CCR dated 08/12/2017
Version: Clean Copy
Date of Submission: 23 March 2022
Page 1 of 10
APPROVED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S5
CLOMIDEP FILM-COATED TABLETS
CLOMIPRAMINE HYDROCHLORIDE
CONTAINS SUGAR: LACTOSE MONOHYDRATE 68,0 MG.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CLOMIDEP
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care provider.
•
CLOMIDEP has been prescribed for you personally and you should not
share your medicine with other people. It
may harm them, even if their symptoms are the same as yours.
WHAT IS IN THIS LEAFLET
1. What CLOMIDEP is and what it is used for
2. What you need to know before you take CLOMIDEP
3. How to take CLOMIDEP
4. Possible side effects
5. How to store CLOMIDEP
6. Contents of the pack and other information
1. WHAT CLOMIDEP IS AND WHAT IT IS USED FOR
CLOMIDEP is used to treat depression, including recurrent depressive
disorders or major depression.
Other psychological conditions that can be treated with CLOMIDEP are:
-
Obsessive compulsive disorders
-
Muscular weakness (cataplexy) associated with recurrent attacks of
extreme sleepiness (narcolepsy) in
adults.
-In children aged above 5 years, CLOMIDEP is used to treat
obsessive-compulsive disorders.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOMIDEP
Applicant: Ranbaxy Pharmaceuticals (Pty) Ltd
Product name: CLOMIDEP
Dosage form: Film-coated tablets
Strength: 25 mg clomipramine hydrochloride /tablet
Amended proposed patient information leaflet
Type IA
IN
– C.I.0.1; Type IA
IN/
IB – C.I.0.2.a/b; Type IB- C.1.2a
Response to CCR dated 08/12/2017
Version: Clean Copy
Date of Submission: 23 March 2022
Page 2 of 10
DO NOT T

Summary of Product characteristics

Applicant: Ranbaxy Pharmaceuticals (Pty) Ltd
Product name: CLOMIDEP
Dosage form: Film-coated tablets
Strength: 25 mg clomipramine hydrochloride /tablet
Amended proposed professional information
Type IA
IN
– C.I.0.1; Type IA
IN/
IB – C.I.0.2.a/b; Type IB- C.1.2a
Response to CCR dated 08/12/2017
Version: Clean Copy
Date of Submission: 23 March 2022
Page 1 of 18
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS: S5
1. NAME OF THE MEDICINE
CLOMIDEP FILM-COATED TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains clomipramine hydrochloride BP 25 mg.
Preservative: Sodium methylparaben 0,028 % m/m.
Contains sugar: Lactose monohydrate 68,0 mg/tablet
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets_ _
A blue coloured, circular film-coated tablet having a break line on
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:
•
Treatment of depressive episodes, recurrent depressive disorders or
major depression.
•
Cataplexy accompanying narcolepsy.
•
Obsessive-compulsive syndromes.
CHILDREN AND ADOLESCENTS:
Obsessive-compulsive syndromes in children 5 years of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Applicant: Ranbaxy Pharmaceuticals (Pty) Ltd
Product name: CLOMIDEP
Dosage form: Film-coated tablets
Strength: 25 mg clomipramine hydrochloride /tablet
Amended proposed professional information
Type IA
IN
– C.I.0.1; Type IA
IN/
IB – C.I.0.2.a/b; Type IB- C.1.2a
Response to CCR dated 08/12/2017
Version: Clean Copy
Date of Submission: 23 March 2022
Page 2 of 18
Medical supervision is essential.
Before initiating treatment with CLOMIDEP, any pre-existing
hypokalaemia should be treated (see section 4.4)
The dosage should be determined individually and adapted to the
patient’s condition.
The lowest dose possible, in order to achieve an optimal therapeutic
effect should be used and the dosage should
be built up gradually to ensure maximum tolerability. Caution should
be exercised in elderly and adolescen