Citalopram 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Citalopram hydrobromide

Available from:

Tillomed Laboratories Ltd

ATC code:

N06AB04

INN (International Name):

Citalopram hydrobromide

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5024655001774

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
CITALOPRAM 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated_ _tablet contains 49.98 mg citalopram hydrobromide,
equivalent to 40 mg citalopram.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets
Round, white film-coated tablets with a break-line and diameter of 10
mm.
The tablet 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
Posology
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 Citalopram should be withdrawn slowly; it is advised that the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.
_Paediatric population _
Citalopram should not be used in the treatment of children and
adolescents under the age of
18 years (see section 4.4).
_Adults _
The recommended starting dose is 20 mg 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.
_Elderly patients (>65 years of age) _
For elderly patients the dose should be decreased to half of the
recommended dose, e.g. 10-
20 mg daily. Depending on the individual response of the patient, the
dose can be increased.
The recommended maximum dose for the elderly is 20 mg daily.
_Reduced renal function _
Dosage adjustment is not required if the patient has mild to moderate
renal impairment.
Caution is advised in patients with severe renal impairment
(creatinine clearance less than
30ml/min, see section 5.2).
_Reduced hepatic function _
An initial dose of 10 mg 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 20 mg daily.
Caution and extra
careful dose titration is advised in patients with severely reduced
hep