CITALOPRAM 20 OETHMAAN TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Oethmaan Biosims (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CITALOPRAM HYDROBROMIDE EQUIVALENT TO CITALOPRAM 20,0 mg

Authorization status:

Registered

Authorization date:

2005-03-06

Patient Information leaflet

APPLICANT: Oethmaan Biosims (Pty) Ltd
SAHPRA APPROVAL DATE:
09 June 2022
PRODUCT:
CITALOPRAM 20 OETHMAAN
DOSAGE FORM AND STRENGTH:
Each capsule contains citalopram hydrobromide
equivalent to 20 mg citalopram
Initial:
09/06/2022
Page 1 of 14
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S5
CITALOPRAM 20 OETHMAAN (FILM-COATED TABLETS)
Citalopram
Contains sugar (23,0 mg lactose monohydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN CITALOPRAM 20
OETHMAAN.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
CITALOPRAM 20 OETHMAAN 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 CITALOPRAM 20 OETHMAAN is and what it is used for
2. What you need to know before you take CITALOPRAM 20 OETHMAAN
3. How to take CITALOPRAM 20 OETHMAAN
4. Possible side effects
5. How to store CITALOPRAM 20 OETHMAAN
6. Contents of the pack and other information
APPLICANT: Oethmaan Biosims (Pty) Ltd
SAHPRA APPROVAL DATE:
09 June 2022
PRODUCT:
CITALOPRAM 20 OETHMAAN
DOSAGE FORM AND STRENGTH:
Each capsule contains citalopram hydrobromide
equivalent to 20 mg citalopram
Initial:
09/06/2022
Page 2 of 14
1.
WHAT CITALOPRAM 20 OETHMAAN IS AND WHAT IT IS USED FOR
CITALOPRAM 20 OETHMAAN contain the active substance citalopram which
is one of a group
of medicines called selective serotonin re-uptake inhibitors (SSRI)
antidepressants.
CITALOPRAM 20 OETHMAAN is used for:
•
Depression and prevention of relapse.
•
Panic disorders.
•
Obsessive-compulsive disorder (OCD).
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CITALOPRAM 20 OETHMAAN
DO NOT TAKE CITALOPRAM 20 OETHMAAN:
•
If you are allergic (hypersensitive) to citalopram or any of the
ingredients in the formulation
(see “What CITALOPRAM 20 OETHMAAN contains”).
•
If you are taking any other medication for depression such as
m

Summary of Product characteristics

APPLICANT: Oethmaan Biosims (Pty) Ltd
SAHPRA APPROVAL DATE:
09 June 2022
PRODUCT:
CITALOPRAM 20 OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains citalopram hydrobromide
equivalent to 20 mg citalopram
Initial:
09/06/2022
Page 1 of 33
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S5
1. NAME OF THE MEDICINE:
CITALOPRAM 20 OETHMAAN (Film-coated tablets)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each CITALOPRAM 20 OETHMAAN film-coated tablet contains: citalopram
hydrobromide
equivalent to 20 mg citalopram.
Contains sugar (23,0 mg lactose monohydrate).
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White, oblong, biconvex film-coated tablets with a one-sided notch and
embossment C20.
APPLICANT: Oethmaan Biosims (Pty) Ltd
SAHPRA APPROVAL DATE:
09 June 2022
PRODUCT:
CITALOPRAM 20 OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains citalopram hydrobromide
equivalent to 20 mg citalopram
Initial:
09/06/2022
Page 2 of 33
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS
CITALOPRAM 20 OETHMAAN is indicated for the treatment of:
•
Depression and prevention of relapse
•
Panic disorders with or without agoraphobia
•
Obsessive-compulsive disorder (OCD)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_DEPRESSION: _
20 mg a day as a single dose. Dosage may be increased by 20 mg a day
at intervals of at least
one week to a maximum of 60 mg depending on the patient’s response.
_ _
_PANIC DISORDER: _
10 mg a day as a single dose for the first week then increasing to 20
mg a day. The dose may
be increased thereafter as required to a maximum of 60 mg a day
depending on the patient's
response.
_ _
_OBSESSIVE COMPULSIVE DISORDER: _
APPLICANT: Oethmaan Biosims (Pty) Ltd
SAHPRA APPROVAL DATE:
09 June 2022
PRODUCT:
CITALOPRAM 20 OETHMAAN
DOSAGE FORM AND STRENGTH:
Each tablet contains citalopram hydrobromide
equivalent to 20 mg citalopram
Initial:
09/06/2022
Page 3 of 33
20 mg a day as a single dose. This dose can be increased by 20 mg
increments to a maximum
of 60 mg a day