APO-CITALOPRAM citalopram 20 mg ( as hydrobromide) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide, Quantity: 49.98 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

citalopram hydrobromide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; lactose monohydrate; macrogol 400; microcrystalline cellulose; hypromellose; purified talc; titanium dioxide; purified water; maize starch; pregelatinised maize starch

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression

Product summary:

Visual Identification: APO-Citalopram 40 mg tablets are white to off white, oval, biconvex, film coated tablets with '40' embossed on one side and 'SL' embossed on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-10-09

Patient Information leaflet

APO-CITALOPRAM TABLETS
1
APO-CITALOPRAM
TABLETS
_Contains the active ingredient citalopram (as citalopram
hydrobromide) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-Citalopram contains the active
ingredient citalopram (as citalopram
hydrobromide).
It is used to treat depression.
Citalopram belongs to a group of
antidepressant medicines called
Selective Serotonin Reuptake
Inhibitors (SSRIs). Citalopram and
other SSRIs are thought to help by
increasing the amount of serotonin in
your brain.
Depression is longer lasting and/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 corrects this chemical
imbalance and may help relieve the
symptoms of depression.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
There is no evidence that this
medicine is addictive.
However, if you suddenly stop taking
it, you may get side effects.
This medicine is available only with
a doctor's prescription.
D

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- CITALOPRAM (CITALOPRAM HYDROBROMIDE)
TABLETS
1
NAME OF THE MEDICINE
Citalopram hydrobromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-CITALOPRAM 20 MG:
Each tablet contains 20 mg of citalopram, as the active ingredient.
APO-CITALOPRAM 40 MG:
Each tablet contains 40 mg of citalopram, as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-CITALOPRAM 20 MG:
White to off-white, oval, biconvex, film-coated tablets, with BL
embossed on one side and '20'
on the other.
APO-CITALOPRAM 40 MG:
White to off-white, oval, biconvex, film coated tablets with '40'
embossed on one and 'BL'
embossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
Citalopram tablets are intended for oral administration.
DOSAGE
Citalopram should be administered as a single daily dose. The dose may
be taken in the
morning or evening without regard for food.
ADULTS
The starting dose is 20 mg/day. The dose can be increased in
increments of 10 mg until
satisfactory clinical response is achieved. The maximum dose is 40
mg/day. As the treatment
2
result in general can be evaluated only after 2–3 weeks' treatment,
a possible dose increase
should take place with intervals of 2–3 weeks.
ELDERLY PATIENTS
The starting dose is 10 mg/day. The dose can be increased by 10 mg to
a maximum of
20 mg/day. As the treatment result in general can be evaluated only
after 2–3 weeks'
treatment, a possible dose increase should take place after an
interval of 2–3 weeks.
CHILDREN AND ADOLESCENTS (< 18 YEARS OF AGE)
The efficacy and safety of citalopram for the treatment of major
depressive disorder have not
been established in children and adolescents under the age of 18
years.
Consequently, citalopram should not be used in children and
adolescents less than 18 years
of age.
HEPATIC IMPAIRMENT
An initial dose of 10 mg daily for