CILORAM 20 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Novagen Pharma (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:

2008-01-04

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S5
CILORAM 20 MG, FILM-COATED TABLET
Citalopram hydrobromide
Contains sugar
(lactose monohydrate)
CILORAM 20 mg contains 45,72 mg lactose monohydrate per film-coated
tablet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CILORAM.
-
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.
-
CILORAM 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 CILORAM is and what it is used for
2. What you need to know before you take CILORAM
3. How to take CILORAM
4. Possible side effects
5. How to store CILORAM
6. Contents of the pack and other information
1. WHAT CILORAM IS AND WHAT IT IS USED FOR
CILORAM belongs to a group of antidepressants called Selective
Serotonin Reuptake Inhibitors (SSRI’s). These
medicine act on the serotonin system in the brain by increasing the
serotonin level which plays a role in treating
depression and related substances.
CILORAM is used for:
Treatment of depression and when you feel better, to prevent these
symptoms from recurring.
Treatment of panic disorder with or without an anxiety disorder in
which you fear and avoid places or situations where
you might feel panicked, trapped, helpless or embarrassed.
Treatment of obsessive compulsive disorder (OCD).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CILORAM
DO NOT TAKE CILORAM:
•
if you are hypersensitive (allergic) to citalopram hydrobromide
_ _
or any of the other ingredients of CILORAM
(see section 6).
•
if you have severely impaired kidney function (creatinine clearance of
less than 30 ml/min).
•
if you have an inborn heart condition where you may have irregular
heartbeats (QT-prolongation).
•
if you are taking a medicine called ‘pimozide’ (see ‘
OTHER MEDICINES AND CILORAM’
).
•
if you are taking medicines that fall into the clas

Summary of Product characteristics

PROFESSIONAL INFORMATION
SCHEDULING STATUS
S5
1. NAME OF THE MEDICINE
CILORAM 20 mg (Film-coated Tablet)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains citalopram hydrobromide equivalent to
20 mg citalopram.
Contains sugar (lactose monohydrate 45,72 mg).
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
White coloured, biconvex, capsule-shaped film coated tablets debossed
with 'A' on one side and with a score-line
in between '0' and '6' on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CILORAM 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 40 mg depending on the patient's response.
_Duration of treatment _
- The antidepressant effect usually sets in after 2 to 4 weeks.
Treatment with CILORAM 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.
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 40 mg a day depending on the patient's
response.
Obsessive-Compulsive Disorder
20 mg a day as a single dose. This dose can be increased by 20 mg
increments to a maximum of 40 mg a day
depending on the patient's response.
_Duration of treatment_
- The onset of action in treating OCD is 2 – 4 weeks with further
improvement over time.
_ _
Special populations
_Elderly _
10 mg -
_ _
20 mg a day as a single dose. Depending on the patient's response, the
dose can be increased to a maximum
of 20 mg a day.
_ _
_Reduced hepatic function _
An initial dose of 10 mg daily for the first two weeks of treatment is
recommended in patients with mild or
moderate h