NOUMED CITALOPRAM citalopram (as hydrobromide) 20mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

citalopram hydrobromide, Quantity: 24.99 mg (Equivalent: citalopram, Qty 20 mg)

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; microcrystalline cellulose; glycerol; hypromellose; titanium dioxide; lactose monohydrate; sodium starch glycollate; magnesium stearate; copovidone; purified talc; macrogol 6000

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression.

Product summary:

Visual Identification: White, oblong, biconvex, film-coated tablets, scored on one side and embossed 'C20'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-02-26

Patient Information leaflet

NOUMED CITALOPRAM
1
NOUMED CITALOPRAM
_citalopram hydrobromide tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Noumed Citalopram.
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 NOUMED
CITALOPRAM IS
USED FOR
This medicine is used for the
treatment of depression.
It contains the active ingredient
citalopram hydrobromide.
Citalopram hydrobromide 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
sexual drive, lack of energy and
feeling guilty over nothing.
Noumed 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 it
for another reason.
This medicine is available only with
a doctor's prescription.
Noumed Citalopram is not addictive.
However, if you suddenly stop taking
it, you may get side effects.
TELL YOUR DOCTOR IF YOU GET ANY SIDE
EFFECTS AFTER STOPPING NOUMED
CITALOPRAM.
BEFORE YOU TAKE
NOUMED
CITALOPRAM
_

Summary of Product characteristics

Product Information - Australia
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION – NOUMED
CITALOPRAM
(CITALOPRAM)
1. NAME OF THE MEDICINE
Citalopram hydrobromide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Noumed Citalopram tablet contain 20 mg or 40 mg citalopram (as
hydrobromide).
Excipients with known effect: lactose monohydrate
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Noumed Citalopram 20 mg tablets - oval, white, biconvex film-coated
tablets with a score notch on one side, and
embossed C 20.
Noumed Citalopram 40 mg tablets - oval, white, biconvex film-coated
tablets with a one-sided notch and
embossment C 40.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of major depression.
4.2 DOSE AND METHOD OF ADMINISTRATION
Noumed 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
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 safety and efficacy of citalopram for the treatment of major
depressive disorder have not been established in
this population. Citalopram should not be used in children and
adolescents under the age of 18 years.
REDUCED HEPATIC FUNCTION
The maximum recommended dose is 20 mg/day.
REDUCED RENAL FUNCTION
Dosage adjustment is not necessary in patients with mild or moderate
renal impairment. No information is available
on treatment of patients with severely reduced