Citalopram 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Citalopram hydrobromide

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

N06AB04

INN (International Name):

Citalopram hydrobromide

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300

Patient Information leaflet

Citalopram 10mg, 20mg and 40mg
film-coated Tablets
Important things you need to know about citalopram
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Citalopram treats depression and panic disorders but it will not work
straight away. Like all medicines, it can
have side-effects. It is important that you and your doctor talk about
the benefits and the possible unwanted
effects of the medicine before you start taking it.
• Citalopram should not be taken by children or teenagers under 18
(see section 6 on page 4).
• Citalopram will not work straight away. You may feel worse before
feeling better after starting the medicine.
Your doctor should ask to see you again 2 or 3 weeks after you first
start taking the medicine. Tell your
doctor if you feel no better. (see section 3 on page 2).
• You may find it helpful to tell a relative or close friend that
you are depressed or have an anxiety disorder,
and ask them to read this leaflet. You might ask them to tell you if
they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour
(see section 2 on page 1).
• If you feel restless or feel like you cannot keep still, go to
your doctor. If you keep on taking more citalopram
each day, it may make these feelings worse. (see section 5 on page 3).
• Talk to your doctor before you stop taking citalopram. If you stop
taking it suddenly or miss a dose you
may get unwanted effects. (see section 4, on page 3).
• Taking some other medicines with citalopram can cause problems.
You may need to talk to your doctor
first. (See section 2 on page 1).
• If you are pregnant or planning to get pregnant, talk to your
doctor before taking citalopram. (See section 2
on page 1).
Read the rest 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Citalopram 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Citalopram 10mg Tablets: 1 film-coated_ _tablet contains 12.495 mg
citalopramhydrobromide, equivalent to 10 mg Citalopram.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, white tablets with a diameter of 6mm
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 1-2 week periods.
_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).
_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.
_Elderly patients (>65 years of age): _
For elderly patients the dose should be decreased to half of the
recommended dose,
e.g. 10-20mg per day. The recommended maximum dose for the elderly is
20mg/daily.
_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 230ml/min).
_Reduced hepatic function: _
An initial dose of 10mg 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 20mg daily.
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