Citalopram 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Citalopram hydrobromide

Available from:

Sigma Pharmaceuticals Plc

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
Citalopram10 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 12.5 mg citalopram hydrobromide
equivalent to 10
mg citalopram.
Excipients with known effect: Lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white circular biconvex film-coated tablet debossed with
'10' on
one side and plain on the other.
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
_Adults_
_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.
In general, improvement in patients starts after one 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 to 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 6 months
to ensure that they are free from symptoms.
_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