APO-MIRTAZAPINE mirtazapine 30 mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

mirtazapine, Quantity: 30 mg

Dostupné z:

Arrotex Pharmaceuticals Pty Ltd

INN (Medzinárodný Name):

Mirtazapine

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: microcrystalline cellulose; hypromellose; titanium dioxide; croscarmellose sodium; magnesium stearate; macrogol 8000; iron oxide red; iron oxide yellow; hyprolose; lactose monohydrate

Spôsob podávania:

Oral

Počet v balení:

30 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Treatment of major depression including relapse prevention

Prehľad produktov:

Visual Identification: Light pink, oval shaped, scored, film coated tablets, imprinted "APO" on one side and "MI" bisect "30" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2007-08-14

Príbalový leták

APO-MIRTAZAPINE
_Contains the active ingredient mirtazapine_
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
The name of your medicine is APO-
Mirtazapine. It contains the active
ingredient mirtazapine.
It is used to treat and prevent the
reoccurrence of depression.
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
affects your whole body and can
cause emotional and physical
symptoms, such as feeling low in
spirit, loss of interest in activities,
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.
Mirtazapine 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.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN_
This medicine must not be used in
children or adolescents under 18
years of age.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
mirtazapine
•
any of the ingredients listed at the
end of this leaflet
Some of the

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION
APO-MIRTAZAPINE (MIRTAZAPINE) TABLETS
NAME OF THE MEDICINE
Mirtazapine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15, 30 or 45 mg mirtazapine (as mirtazapine
hemihydrate).
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
APO-MIRTAZAPINE 15 MG TABLETS
Pale Yellow, oval shaped, scored, film coated tablets, imprinted
“APO” on one side and “MI”
bisect “15” on the other side.
APO-MIRTAZAPINE 30 MG TABLETS
Light pink, oval shaped, scored, film coated tablets, imprinted
“APO” on one side and “MI”
bisect “30” on the other side.
APO-MIRTAZAPINE 45 MG TABLETS
White to off-white, oval shaped, unscored, film coated tablets,
imprinted “APO” on one side
and “MI-45” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Mirtazapine Tablets are intended for oral administration.
Mirtazapine should be taken orally, if necessary with fluid, and
swallowed without chewing.
DOSAGE
ADULTS – Treatment should begin with 15 mg daily. The dosage
generally needs to be
increased to obtain an optimal clinical response. The effective daily
dose is usually between
30 and 45 mg but responses have been observed at 60 mg per day.
ELDERLY – The recommended dose is the same as that for adults. In
elderly patients an increase
in dosing should be done under close supervision to elicit a
satisfactory and safe response.
The clearance of mirtazapine may be decreased in patients with renal
or hepatic insufficiency.
This should be taken into account when prescribing mirtazapine to this
category of patients
(see section 5.2 PHARMACOKINETIC PROPERTIES).
Mirtazapine has a half-life of 20–40 hours and therefore mirtazapine
is suitable for once-a-day
administration. It should be taken preferably as a single night-time
dose before going to bed.
Mirtazapine may also be gi