Cipramil 10 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Citalopram

Available from:

Lundbeck ( Ireland ) Limited

ATC code:

N06AB; N06AB04

INN (International Name):

Citalopram

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Selective serotonin reuptake inhibitors; citalopram

Authorization status:

Marketed

Authorization date:

1995-09-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL 10 AND 20 MG FILM-COATED TABLETS
Citalopram (as hydrobromide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Cipramil is and what it is used for
2.
What you need to know before you take Cipramil
3.
How to take Cipramil
4.
Possible side effects
5.
How to store Cipramil
6.
Contents of the pack and other information
1.
WHAT CIPRAMIL IS AND WHAT IT IS USED FOR
HOW DOES CIPRAMIL WORK
Cipramil 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.
WHAT IS CIPRAMIL USED FOR
Cipramil contains citalopram and is used for the treatment of
depression and when you feel better, to
help prevent these symptoms recurring.
Further, Cipramil is used for long-term treatment to prevent the
occurrence of new depressive episodes
in patients who have recurrent depression.
Cipramil is also beneficial in relieving symptoms in patients prone to
panic attacks.
Ask your doctor if you have any questions about why Cipramil has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPRAMIL
DO NOT TAKE CIPRAMIL:
•
if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in
section 6)
•
if you take other medicines which belong to a group called monoamine
oxidase inhibitors
(MAOIs). MAOIs include medicines such as phenelzine, iproniazid,
isocarboxazid, nialamide,
tranylcypromine, selegiline (used in the treatme

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2023
CRN00DF18
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cipramil 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg citalopram (as 12.49 mg citalopram
hydrobromide).
Excipient with known effect: Lactose monohydrate 18.4 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, film-coated tablets marked ‘CL’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Depressive illness in the initial phase and as maintenance against
potential relapse/recurrence.
Cipramil is also indicated in the treatment of panic disorder with or
without agoraphobia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Depression_
_Adults:_
Citalopram should be administered as a single oral dose of 20 mg
daily.
Depending on individual patient response, the dose may be increased to
a maximum of 40 mg daily.
_Duration of treatment:_
The antidepressant effect usually sets in after 2 to 4 weeks.
Treatment with antidepressants 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. In patients
with recurrent depression (unipolar) maintenance therapy may need to
be continued for a number of years to prevent new
episodes.
_Panic Disorder_
_Adults:_
A single oral dose of 10 mg is recommended for the first week before
increasing the dose to 20 mg daily. Depending on
individual patient response, the dose may be increased to a maximum of
40 mg daily.
Duration of treatment:
Maximum effectiveness of citalopram in treating panic disorder is
reached after about 3 months and the response is
maintained during continued treatment.
Elderly patients ( > 65 years of age)
For elderly patients the dose should be decreased to half of the
recommended dose, e.g. 10-20 mg daily. The recommended
maximum dose for the elderly is 20 mg daily.
Health Products Regulatory A