Citalopram 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Citalopram hydrobromide

Available from:

Zentiva Pharma UK 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; GTIN: 5000283630159

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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).
• 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).
• 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).
• 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).
• 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).
• Taking some other medicines with citalopram can cause problems.
You may need to talk to your
doctor first (see section 2).
• If you are pregnant or planning to get pregnant, talk to your
doctor before taking citalopram (see
section 2).
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 or pharmacist.
• This medici

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Citalopram 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg citalopram (as hydrobromide)
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
White, 6mm round, biconvex tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of depressive illness in the initial phase and as
maintenance against potential
relapse/recurrence. Citalopram is also indicated in the treatment of
panic disorder with or
without agoraphobia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treating depression _
_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. In
general, improvement in patients starts after 1 week, but may only
become evident from the
second week of therapy. As with all antidepressant medicinal products,
dosage should be
reviewed and adjusted, if necessary, within 3 - 4 weeks of initiation
of therapy and thereafter
as judged clinically appropriate. Although there may be an increased
potential for
undesirable effects at higher doses, if after some weeks on the
recommended dose
insufficient response is seen, some patients may benefit from having
their dose increased up
to a maximum of 40 mg a day (see section 5.1). Dosage adjustments
should be made
carefully on an individual patient basis, to maintain the patient at
the lowest effective dose.
Patients with depression should be treated for a sufficient period of
at least six months to
ensure that they are free from symptoms.
_Treating panic disorder_
_Adults: _
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. Patients should be started on 10 mg/day and
the dose gradually
increased in 10 mg steps according to the patient's response up to the
recommended dose. A
low initial starting