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

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

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

Prieinama:

Sandoz Pty Ltd

INN (Tarptautinis Pavadinimas):

Citalopram

Vaisto forma:

Tablet, film coated

Sudėtis:

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

Vartojimo būdas:

Oral

Vienetai pakuotėje:

28 tablets

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Treatment of major depression.

Produkto santrauka:

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

Autorizacija statusas:

Registered

Leidimo data:

2004-06-08

Pakuotės lapelis

Citalopram Sandoz®
1
CITALOPRAM SANDOZ
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CITALOPRAM SANDOZ?
Citalopram Sandoz contains the active ingredient citalopram.
Citalopram Sandoz is used to treat depression.
For more information, see Section 1. Why am I using Citalopram Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CITALOPRAM SANDOZ?
Do not use Citalopram Sandoz if you have ever had an allergic reaction
to citalopram or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Citalopram Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Citalopram Sandoz and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE CITALOPRAM SANDOZ?
•
Your doctor will decide what dose you will receive.
•
The standard dose for adults for this medicine is between 20 mg and 40
mg (one to two tablets) per day.
More instructions can be found in Section 4. How do I use Citalopram
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CITALOPRAM SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Citalopram Sandoz.
•
If you become pregnant while taking Citalopram Sandoz, tell your
doctor immediately.
•
Tell your doctor immediately if you have thoughts about killing
yourself
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly or lower the dosage without
telling your doctor.
•
Do not give the tablets to anyone else, even if they have the same
condition as you.
•
Do not let yourself run out of medicine over the weekend or on
holidays.
DRIVING OR USING
MAC

Prekės savybės

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Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION
CITALOPRAM SANDOZ
® (CITALOPRAM HYDROBROMIDE) TABLETS
1
NAME OF THE MEDICINE
Citalopram hydrobromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Citalopram Sandoz 20 mg tablets contains 20 mg citalopram (as
hydrobromide).
Each Citalopram Sandoz 40 mg tablets contains 40 mg citalopram (as
hydrobromide).
_List of excipients with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Citalopram Sandoz 20 mg tablets - oval, white, biconvex film-coated
tablets with a score notch
on one side, and embossed C 20.
Citalopram Sandoz 40 mg tablets - oval, white, biconvex film-coated
tablets with a one-sided
notch and embossment C 40.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_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.
_DURATION OF TREATMENT _
In treating depression, a treatment period of at least six months is
usually necessary to provide
adequate maintenance against the potential for relapse.
_WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF SSRI _
Abrupt discontinuation should be avoided. When stopping treatment with
citalopram the dose
should be gradually reduced over a period of a least one to two weeks
in order to reduce the
risk of withdrawal reactions (see Section 4.4 Special warnings and
precautions for use). If
intolerable symptoms occur following a decrease in the dose or upon
discontinuation of
treatment, then resuming the previously prescribed dose may be
considered. Subsequently, the
physician may continue decreasing the dose, but at a more gradual
rate.
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METHOD