CIPRAMIL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CITALOPRAM HYDROBROMIDE

Available from:

Imbat Limited

ATC code:

N06AB04

INN (International Name):

CITALOPRAM HYDROBROMIDE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

citalopram

Authorization status:

Authorised

Authorization date:

2009-04-24

Patient Information leaflet

_Page 1 of 2 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL
® 20MG FILM-COATED TABLETS
Citalopram (as hydrobromide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE

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 symptoms are the
same as yours.

If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Cipramil is and what it is used for
2.
Before you take Cipramil
3.
How to take Cipramil
4.
Possible side effects
5.
How to store Cipramil
6.
Further information
1. WHAT CIPRAMIL IS AND WHAT IT IS USED
FOR
HOW DOES CIPRAMIL WORK
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a group of medicines known as antidepressants.
These medicines help to correct certain chemical imbalances in
the brain which are causing the symptoms of your illness.
WHAT IS CIPRAMIL USED FOR
Cipramil 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.
Your doctor, however, may prescribe Cipramil for another
purpose. Ask your doctor if you have any questions about why
Cipramil has been prescribed for you.
2. BEFORE YOU TAKE CIPRAMIL
DO NOT TAKE CIPRAMIL

if you are allergic (hypersensitive) to citalopram or any of the
other ingredients of Cipramil

at the same time as taking medication known as monoamine
oxidase inhibitors (MAOIs)

at the same time as taking pimozide

if you were born with or have an episode of abnormal heart
rhythm (seen at ECG; an examination to evaluate how the
heart is functioning

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cipramil 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains citalopram hydrobromide equivalent to
10 mg citalopram.
Excipients: includes lactose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK_
Round, white tablets with ‘CL’ embossed on one side and plain on
the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of 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
ADULTS
Depression
Citalopram should be administered as a single oral dose of 20 mg
daily. Dependent on individual patient response this
may be increased to a maximum of 40 mg daily.
Panic Disorder
A single oral dose of 10 mg is recommended for the first week before
increasing the dose to 20 mg daily. The dose may
be further increased, up to a maximum of 40 mg daily dependent on
individual patient response.
OCD
An initial dose of 20 mg daily recommended.
Dependent on individual patient response, the dose may be increased to
a maximum of 40 mg daily.
Elderly patients (>65 years of age)
For elderly patients the dose should be decreased to half the
recommended dose, e.g. 10-20 mg daily. The
recommended maximum dose for the elderly is 20 mg daily.
Children & Adolescents (< 18 years)
Cipramil should not be used in the treatment of children and
adolescents under the age of 18 years (see section
4.4 Special warnings and precautions for use).
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
hepatic impairment. Depending on individual patient response, the dose
may be increased to a maximum of 20 mg
daily. Caution and extra careful dose titration is advised in patients
with severely reduced