Citalopram 20 mg Film-coated tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Citalopram hydrobromide

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06AB; N06AB04

INN (International Name):

Citalopram hydrobromide

Dosage:

20 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:

2006-03-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM 10 MG FILM-COATED TABLETS
CITALOPRAM 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 only. 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM
3.
HOW TO TAKE CITALOPRAM
4.
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CITALOPRAM
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
Citalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a group of medicines known as
antidepressants. These medicines help to normalise the levels of
serotonin in the brain.
Disturbances in the serotonin system of the brain are key factors in
the development of depression and related
disorders.
Citalopram is used for the treatment of depression (including the
prevention of the recurrence of symptoms) and
panic disorders in adults.
_Depression _
is characterised by low/depressed mood, lack of energy, melancholia,
feelings of little or no worth,
sleeping disorders, withdrawal and being unable to cope with daily
tasks. Depression may also be accompanied by
suicidal thoughts. Depressed patients may further suffer from symptoms
of anxiety.
_Panic disorder _
is characterised by patients developing unexpected attacks of intense
panic or anxiety when faced
with particular situations or due to the fear of experiencing new
attacks. Precisely what triggers the attacks varies
from patient to patient. The attacks recur when the pat

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2021
CRN00C943
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram 20 mg Film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of Citalopram (as hydrobromide).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, coated, biconvex, scored on both sides with side
scores.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of depressive illness in the initial phase and as
maintenance against potential relapse/recurrence in adults.
Citalopram is also indicated in the treatment of panic disorder with
or without agoraphobia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treating depression Adults_
The recommended starting dose is a single oral dose of 20 mg per day.
Depending on individual patient response, the dose
may be increased to a maximum of 40 mg daily.
Following treatment initiation, an antidepressant effect should not be
expected for at least two weeks. Treatment should
continue until the patient has been free of symptoms for 4-6 months.
In patients with recurrent depression (unipolar)
maintenance therapy may need to be continued for a number of years to
prevent new episodes. Citalopram should be
withdrawn slowly; it is advised that the dose is gradually reduced
over 1-2 week periods.
_Treating Panic Disorder Adults_
A single oral dose of 10 mg daily is recommended for the first week
before increasing the dose to 20 mg daily. Dependent 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 per day. The recommended
maximum dose for th