Citalopram

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Citalopram hydrobromide 24.99mg equivalent to citalopram 20 mg;  ;  

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Citalopram hydrobromide 24.99 mg (equivalent to citalopram 20 mg)

Dosage:

20 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Citalopram hydrobromide 24.99mg equivalent to citalopram 20 mg     Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Purified water Titanium dioxide

Units in package:

Blister pack, PVDC coated PVC/aluminium foil - 28 tablets, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Huahai Pharmaceutical Co Ltd

Therapeutic indications:

Treatment of depressive illness in the initial phase and as maintenance against potential relapse or recurrence.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVDC coated PVC/aluminium foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC coated PVC/aluminium foil - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVDC coated PVC/aluminium foil - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-09-27

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI)
1 | P a g e
CITALOPRAM, TABLETS, FILM-COATED, 20 MG
_Citalopram hydrobromide _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Citalopram,
tablets, film-
coated, 20 mg.
This leaflet answers some common questions about Citalopram, tablets,
film-coated,
20 mg.
It does not contain all the available information. It does not take
the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Citalopram, tablets, film-coated, 20 mg against the benefits they
expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT IT IS USED FOR
Citalopram, tablets, film-coated, 20 mg is used to treat depression.
It belongs to a group of medicines called selective serotonin reuptake
inhibitors
(SSRIs). They are thought to work by their actions on brain chemicals
called amines
which are involved in controlling mood.
Depression is longer lasting or more severe than the "low moods"
everyone has from
time to time due to the stress of everyday life. It is thought to be
caused by a
chemical imbalance in parts of the brain. This imbalance affects your
whole body and
can cause emotional and physical symptoms such as feeling low in
spirit, loss of
interest in activities, being unable to enjoy life, poor appetite or
overeating, disturbed
sleep, often waking up early, loss of sex drive, lack of energy and
feeling guilty over
nothing.
Citalopram, tablets, film-coated, 20 mg corrects this chemical
imbalance and may
help relieve the symptoms of depression.
Your doctor may have prescribed Citalopram, tablets, film-coated, 20
mg for another
reason.
_ _
NEW ZEALAND CONSUMER MEDICINE INFORMATION (CMI)
2 | P a g e
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CITALOPRAM,
TABLETS, FILM-
COATED, 20 MG HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with a

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 27
1.
PRODUCT NAME
Citalopram, tablets, film-coated, 20 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Each film-coated tablet contains 24.99 mg citalopram hydrobromide Ph.
Eur. corresponding
to 20 mg of citalopram base.
Citalopram hydrobromide is a fine white to off-white, crystalline
material.
Sparingly soluble in water, soluble in ethanol (96%), freely soluble
in chloroform and very
slightly soluble in diethyl ether. No polymorphic forms have been
detected.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
The tablets contain lactose monohydrate. Patients with rare hereditary
problems of
galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption
should not receive this medicine (also _refer Section 4.4 Special
warnings and precautions_).
3.
PHARMACEUTICAL FORM
Oral, film-coated tablets Presentation
White to off-white, oval, biconvex, film-coated tablets with
break-line on one side &
‘20’ embossed on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_Adults _
Treatment of depressive illness in the initial phase and as
maintenance against potential
relapse or recurrence.
4.2
Dose and method of administration
The dose may be taken in the morning or evening without regard for
food. As the treatment
result in general can be evaluated only after 2-3 weeks' treatment, a
possible dose increase
in increments of 10mg should take place with intervals of 2-3 weeks.
_Adults _
Should be administered as a single oral dose of 20mg daily. Dependent
on individual patient
response and severity of depression the dose may be increased to a
maximum of 40mg
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 27
daily.
The maximum daily dose of citalopram should not exceed 40mg/day as
doses above
40mg/day are associated with an increased risk of QT prolongation.
A maximum dose of 20mg/day is recommended for patients known to be
CYP2C19 poor
metabolisers o