Citalopram 10mg 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:

10mg

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: 5015915904041

Taarifa za kipeperushi

Citalopram belongs to a group of antidepressants known
as selective serotonin reuptake inhibitors (SSRIs).
Citalopram is used for the treatment of:
• Depressive illnesses (major depressive episodes)
• Panic disorder with or without agoraphobia
(e.g. strong fear of leaving the house, entering shops,
or fear of public places).
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 MAO (monoamine oxidase)
inhibitors:
- e.g. the antidepressant moclobemide or
- you are treated with the non-selective MAO-inhibitor
linezolid (an antibiotic medicine) unless you are
under close observation and monitoring of blood
pressure.
- The irreversible MAO-inhibitor selegiline (medicine
for Parkinson’s disease) may be used in
combination with citalopram in daily doses not
exceeding 10 mg selegiline per day (see “Other
medicines and Citalopram”).
- If you have taken irreversible MAO-inhibitors
within the last two weeks or if you have taken a
reversible MAO-inhibitor (RIMA) within the time
prescribed in the relevant patient information leaflet
of the RIMA (see “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 (see “Other medicines and Citalopram”).
• If you are born with or have had an episode of
abnormal heart rhythm (seen at ECG; an examination
to evaluate how the heart is functioning)
• If you take medicines for heart rhythm problems or
that may affect the heart’s rhythm.
_Also refer to the section “Other medicines and _
_Citalopram” below._
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Citalopram.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR
DEPRESSION OR ANXIETY DISORDER
If you are depressed and/or have anxiety disorders you
can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
antidepressants, since these medicines all take time to
work, usually about t

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Citalopram 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg of citalopram (as hydrobromide).
Excipient with known effect:
Each_ _film-coated tablet contains 10.93 mg of lactose (as
monohydrate)_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet without a score line
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depressive episodes.
Treatment of panic disorder with or without agoraphobia
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.
ADULTS:
Treatment of major depressive episodes
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. 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 to
give
adequate protection against the possibility of a relapse.
Treatment of panic disorder
A single oral dose of 10 mg 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. THIS IS TO
AVOID
PARADOX REACTIONS (I.E. PANIC, ANXIETY) (SEE SECTION 4.4).
The first therapeutic effects usually appear after 2 – 4 weeks. Full
therapeutic
response may take up to 3 months to develop. It may be necessary to
continue
treatment for several months. Documentation from clinical efficacy
studies
exceeding 6 months is insufficient.
ELDERLY:
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 elderly
patients is 20 mg daily.
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