Citalopram Teva 10 mg film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Citalopram

Commercializzato da:

Teva Pharma B.V.

Codice ATC:

N06AB; N06AB04

INN (Nome Internazionale):

Citalopram

Dosaggio:

10 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

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

Area terapeutica:

Selective serotonin reuptake inhibitors; citalopram

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2007-01-19

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CITALOPRAM TEVA 10 MG FILM-COATED TABLETS
CITALOPRAM TEVA 20 MG FILM-COATED TABLETS
CITALOPRAM TEVA 40 MG FILM-COATED TABLETS
Citalopram
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 TEVA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM TEVA FILM-COATED
TABLETS
3. HOW TO TAKE CITALOPRAM TEVA FILM-COATED TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CITALOPRAM TEVA FILM-COATED TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT CITALOPRAM TEVA FILM-COATED TABLETS IS AND WHAT IT IS USED FOR

Citalopram Teva film-coated tablets belongs to a group of
antidepressants known as
selective serotonin reuptake inhibitors (SSRIs).

Citalopram Teva film-coated tablets is used for the treatment of
depression (major
depressive episodes).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM TEVA FILM-COATED
TABLETS
DO NOT TAKE CITALOPRAM TEVA FILM-COATED TABLETS

If you are allergic to citalopram or any of the other ingredients of
this medicine (listed in
section 6).

If you are taking, or have taken in the last 2 weeks an antidepressant
medicine of the type
called monoamine oxidase inhibitors (MAOIs) e.g. selegiline or
moclobemide.

If you are treated with linezolid (an antibiotic medicine) unless you
are under close
observation and monitoring of blood pressure.

If you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an
examination to evalua

Scheda tecnica

Health Products Regulatory Authority
06 August 2021
CRN00C7VY
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Citalopram Teva 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coatedtablet contains 10 mg citalopram (as hydrobromide).
Excipients with known effect
Each tablet contains 13,334 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Round, white tablets with a diameter of 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Citalopram should be withdrawn slowly, it is advised that
the dose is gradually reduced over 1-2 week periods.
_Adults_
Citalopram should be administered as a single oral dose of 20 mg
daily.
Dependent
on
individual
patient
response,
the
dose
may
be
increased
to
a
maximum
of
40
mg
daily.
_Paediatric population_
Citalopram should not be used in the treatment of children and
adolescents under the age of 18 years (see section 4.4).
_Elderly (>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.
_Renal impairment_
Dosage adjustment is not required if the patient has mild to moderate
renal impairment. Caution is advised in patients with
severe renal impairment (creatinine clearance less than 30ml/min, see
section 5.2).
_Hepatic impairment_
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 hepatic f