Citalopram 40 ct

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 40 mg/stuk

Beschikbaar vanaf:

Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

N06AB04

INN (Algemene Internationale Benaming):

CITALOPRAMHYDROBROMIDE SAMENSTELLING overeenkomend met ; ; CITALOPRAM 40 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:

2002-04-02

Bijsluiter

Citalopram, NL/H/0460/002-003, 07.12.20
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CITALOPRAM 20 CT, FILMOMHULDE TABLETTEN
CITALOPRAM 40 CT, FILMOMHULDE TABLETTEN
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_
is and what it is used for
2.
What you need to know before you take
_Citalopram_
3.
How to take
_Citalopram_
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 belongs to a group of antidepressants called selective
serotonin re-uptake inhibitors (SSRIs).
Everyone has a substance called serotonin in the brain. Low levels of
serotonin are thought to be a cause of
depression. It is not fully understood how citalopram works, but it
may help by increasing the amount of
serotonin in the brain.
_CITALOPRAM_ IS USED TO TREAT
●
depression (major depressive episodes)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _CITALOPRAM_
DO NOT TAKE _CITALOPRAM_
●
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 recently taken medicines called
MONOAMINE OXIDASE INHIBITORS
(MAOIs;
amongst others used to treat depression, e.g. moclobemide). You may
have to wait for up to 14 days
after quitting the use of a MAOI. The MAOI selegiline (used to treat
Parkinson’s disease) may be
used, but not in doses exceeding 10 mg per day. When changing from
_Citalopram_
to MAOIs, you
have to wait for at least s

Productkenmerken

Citalopram, NL/H/0460/002-003, 07.12.20
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Citalopram 20 ct, filmomhulde tabletten
Citalopram 40 ct, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
20 MG
Each film-coated tablet contains 20 mg citalopram (as hydrobromide).
40 MG
Each film-coated tablet contains 40 mg citalopram (as hydrobromide).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
20 MG
Round, white tablets with a break-line and diameter of 8 mm.
40 MG
Round, white tablets with a break-line and diameter of 10 mm.
The tablet 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
Citalopram should be administered as a single oral dose, either in the
morning or in the evening. The tablets
can be taken with or without food, but with fluid.
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.
Use in children and adolescents under 18 years of age
Citalopram should not be used in the treatment of children and
adolescents under the age of 18 years (see
section 4.4).
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.
Citalopram, NL/H/0460/002-003, 07.12.20
2
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.
Reduced renal function
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).
Reduced hepatic function
An initial dose of 10 mg daily for the first two weeks of