CILIFT 20 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmacare Limited û Woodmead

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

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

Authorization status:

Registered

Authorization date:

2003-07-03

Patient Information leaflet

_APPLICANT: _
Pharmacare Ltd
MODULE 1
1.3.2
_PRODUCT NAME: _
CILIFT 20 MG TABLET
_DOSAGE FORM AND STRENGTH: _
Each tablet contains Citalopram Hydrobromide
equivalent to 20 mg of Citalopram
24 May 2022
Page 1 of 21
1.3.2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
CILIFT 20 MG TABLET
CITALOPRAM HYDROBROMIDE
CONTAINS SUGAR: LACTOSE MONOHYDRATE 75 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CILIFT 20
MG TABLET
•
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.
•
CILIFT 20 mg TABLET 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 CILIFT 20 mg TABLET is and what it is used for
2.
What you need to know before you take CILIFT 20 mg TABLET
3.
How to take CILIFT 20 mg TABLET
4.
Possible side effects
5.
How to store CILIFT 20 mg TABLET
6.
Contents of the pack and other information
IMPLEMENTATION DATE
24 May 2022
_APPLICANT: _
Pharmacare Ltd
MODULE 1
1.3.2
_PRODUCT NAME: _
CILIFT 20 MG TABLET
_DOSAGE FORM AND STRENGTH: _
Each tablet contains Citalopram Hydrobromide
equivalent to 20 mg of Citalopram
24 May 2022
Page 2 of 21
1.
WHAT CILIFT 20 MG TABLET IS AND WHAT IT IS USED FOR
CILIFT 20 mg TABLET belongs to a group of antidepressants called
Selective Serotonin
Reuptake Inhibitors (SSRIs). These medicines act on the
serotonin-system in the brain by
increasing the serotonin level. Disturbances in the serotonin-system
are considered an
important factor in the development of depression and related
diseases.
CILIFT 20 mg TABLET is used for the:
•
Treatment of depression and prevention of the return of the
depression.
•
Treatment of panic disorder with or without fear of public places or
open spaces
(agoraphobia).
•
Treatment of obsessive compulsive disorder (OCD).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CILIFT 20 MG TABLET
DO NOT TAKE CILIFT 20 MG

Summary of Product characteristics

_APPLICANT: _
Pharmacare Ltd
MODULE 1
1.3.1.1
_PRODUCT NAME: _
CILIFT 20 MG TABLET
_DOSAGE FORM AND STRENGTH: _
Each tablet contains Citalopram Hydrobromide
equivalent to 20 mg of Citalopram
24 May 2022_ _
_ _Page 1 of 33
1.3.1.1 PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
1. NAME OF THE MEDICINE
CILIFT 20 MG TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of CILIFT 20 mg TABLET contains citalopram hydrobromide
equivalent to 20 mg
citalopram.
Contains sugar: Lactose monohydrate 75 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
CILIFT 20 mg TABLET is a round, white to off-white, biconvex
film-coated tablet, bisected on
one side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
CILIFT 20 mg TABLET is indicated for the treatment of:
•
Depression and prevention of relapse.
•
Panic disorder with or without agoraphobia.
IMPLEMENTATION DATE
24 May 2022
_APPLICANT: _
Pharmacare Ltd
MODULE 1
1.3.1.1
_PRODUCT NAME: _
CILIFT 20 MG TABLET
_DOSAGE FORM AND STRENGTH: _
Each tablet contains Citalopram Hydrobromide
equivalent to 20 mg of Citalopram
24 May 2022_ _
_ _
_ _Page 2 of 33
•
Obsessive compulsive disorder (OCD).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
TREATING DEPRESSION
CILIFT 20 mg TABLET should be administered as a single oral dose of 20
mg (1 tablet) daily.
Dependent on individual patient response, this may be increased to a
maximum of 40 mg
(two tablets) daily.
The dose may be taken in the morning or the evening, not necessarily
with food.
_Duration of treatment_
The antidepressant effect usually sets in after 2 to 4 weeks.
Treatment with CILIFT 20 mg
TABLET is symptomatic and must therefore be continued for an
appropriate length of time,
usually up to 6 months after recovery in order to prevent relapse._ _
TREATING PANIC DISORDER
A single dose of 10 mg (half a tablet) daily is recommended for the
first week before
increasing the dose to 20 mg (1 tablet) daily. The dose may be further
increased, up to a
maximum of 40 mg (2 tablets) dai