Citalopram 20mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Citalopram hydrobromide

Inapatikana kutoka:

Sandoz Ltd

ATC kanuni:

N06AB04

INN (Jina la Kimataifa):

Citalopram hydrobromide

Kipimo:

20mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030300; GTIN: 5015915904058

Taarifa za kipeperushi

CITALOPRAM 20 MG AND 40 MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
SZ00000LT000
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.
Content of the pack and other information
Citalopram belongs to the group of so-called SSRIs
(selective serotonin re-uptake inhibitors) and is used to
treat depressive illnesses (episodes of major depression).
People who are depressed have lower levels of the
substance serotonin in their brain than others.
Citalopram may help by increasing the level of serotonin.
DO NOT TAKE CITALOPRAM
•
If you are allergic (hypersensitive) to citalopram or any
of the other ingredients of this medicine (listed
section 6).
•
If you are taking MAO (monoamine oxidase) inhibitors
(medicines used for treatment of depression or
Parkinson’s disease). The MAO-inhibitor selegiline may
be used in combination with citalopram, albeit not
more than 10 mg per day.
• If you have recently taken MAO-inhibitors.
Depending on the type of MAO-inhibitor you used to
use, you may have to wait for up to 14 days after
stopping the MAO-inhibitor before starting with
Citalopram (see also “Other medicines and Citalopram”).
If you stop taking Citalopram and want to start using
MAO-inhibitors, you have to wait for at least 7 days.
•
If you are taking linezolid (an antibiotic medicine)
•
If you are born

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Citalopram Sandoz 20mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 24.99 mg citalopramhydrobromide,
equivalent to 20
mg citalopram
Excipients with known effect:
Each_ _film-coated tablet contains 23 mg lactose monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White oblong biconvex film-coated tablet with a one sided notch and
the embossment
C20
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
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. Citalopram should be withdrawn slowly, it is
advised that
the dose is gradually reduced over a period of at least one to two
weeks.
Adults
The recommended starting dose is 20 mg citalopram per day. If
necessary, the dose
can be increased to a maximum of 40 mg per day, depending on the
individual
response of the patient.
Older people (>65 years of age)
For older people the dose should be decreased to half of the
recommended dose, e.g
10-20 mg per day. Depending on the individual response of the patient,
the dose can
be increased to a maximum of 20 mg/day.
Children and adolescents under the age of 18
Citalopram should not be used in the treatment of children and
adolescents under the
age of 18 years (see section 4.4).
Reduced renal function
Dosage adjustment is not required if the patient has mild to moderate
renal
impairment. No information is available on treatment of patients with
severe renal
impairment (creatinine clearance less than 20 ml/min).
Reduced hepatic function:
An initial do