Citalopram STADA 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 10 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

N06AB04

INN (Algemene Internationale Benaming):

CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Citalopram

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2002-03-12

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
CITALOPRAM STADA 10 MG 20 MG 40 MG, FILMOMHULDE TABLETTEN
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 STADA is and what it is used for
2. What you need to know before you take Citalopram STADA
3. How to take Citalopram STADA
4. Possible side effects
5. How to store Citalopram STADA
6. Contents of the pack and other information
1. WHAT CITALOPRAM STADA IS AND WHAT IT IS USED FOR
Citalopram STADA is an antidepressant. It belongs to a group of
medicines called selective
serotonin re-uptake inhibitors (SSRIs).
Citalopram STADA is used to:
•
treat episodes of major depression
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CITALOPRAM STADA
DO NOT TAKE CITALOPRAM STADA
•
if you are allergic to citalopram or any of the other ingredients of
this medicine (listed in
section 6)
•
if you are taking a type of medicine known as a monoamine oxidase
(MAO) inhibitor. These
medicines are normally used for treatment of depression or
Parkinson’s disease. The MAO-
inhibitor selegiline may be taken at the same time as citalopram,
provided the dose of
selegiline is not more than 10 mg per day
•
if you have recently taken MAO-inhibitors. Depending on the type of
MAO-inhibitor, you may
have to wait for up to 14 days after stopping the MAO-inhibitor before
starting to take
Citalopram (see also “Other medicines and Citalopram STADA”). If
you stop taking
Citalopram and you want to start taking an MAO-inhibitor, you will
have to wait for at least
7 day

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Citalopram STADA 10 mg filmomhulde tabletten
Citalopram STADA 20 mg filmomhulde tabletten
Citalopram STADA 40 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Citalopram STADA 10 mg film-coated tablet
Each film-coated tablet contains 12.495 mg citalopram hydrobromide,
equivalent to 10 mg
citalopram.
Citalopram STADA 20 mg film-coated tablet
Each film-coated tablet contains 24.99 mg citalopram hydrobromide,
equivalent to 20 mg
citalopram.
Citalopram STADA 40 mg film-coated tablet
Each film-coated tablet contains 49.98 mg citalopram hydrobromide,
equivalent to 40 mg
citalopram.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
Citalopram STADA 10 mg film-coated tablet
Round, white tablets with a diameter of 6 mm.
Citalopram STADA 20 mg film-coated tablet
Round, white tablets with a break-line and diameter of 8 mm.
The tablets can be divided into equal doses.
Citalopram STADA 40 mg film-coated tablet
Round, white tablets with a break-line and diameter of 10 mm.
The tablets can be divided into equal
doses
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_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.
_SPECIAL POPULATIONS _
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 older people 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
30 ml/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