APX-MIRTAZAPINE mirtazapine 45 mg tablets blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

mirtazapine, Quantity: 45 mg

متاح من:

Arrotex Pharmaceuticals Pty Ltd

INN (الاسم الدولي):

Mirtazapine

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: lactose monohydrate; hyprolose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose

طريقة التعاطي:

Oral

الوحدات في الحزمة:

60, 30

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

Treatment of major depression including relapse prevention.

ملخص المنتج:

Visual Identification: White, biconvex, capsule shaped film coated tablets with '10' debossed on one side and 'A' debossed on the other side..; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Registered

تاريخ الترخيص:

2012-01-25

نشرة المعلومات

APX-MIRTAZAPINE CMI
1
APX-MIRTAZAPINE
_Mirtazapine 15 mg, 30mg, 45 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APX-Mirtazapine. 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 APX-
Mirtazapine 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 APX-MIRTAZAPINE IS
USED FOR
APX-Mirtazapine is used in the
treatment of depression including
relapse prevention.
Depression is longer lasting or more
severe than "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.
This medicine corrects this chemical
imbalance and may help relieve the
symptoms of depression.
Your doctor, however, may prescribe
it for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
APX-Mirtazapine is not addictive.
BEFORE YOU TAKE
APX-MIRTAZAPINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE APX-MIRTAZAPINE:
•
IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING MIRTAZAPINE
•
IF YOU ARE ALLERGIC TO ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, mouth, throat or other parts of
the body, shortness of breath,
wheezing or trouble breathing.
DO NOT TAKE APX-MIRTAZAPINE IF

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION – APX-MIRTAZAPINE (MIRTAZAPINE) TABLETS
1
NAME OF THE MEDICINE
The name of the medicine is mirtazapine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mitazapine 15 mg , 30 mg or 45 mg
Excipients of known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APX-MIRTAZAPINE 15 mg: Yellow, biconvex capsule shaped, film coated
tablets with a score line in
between 0 and 8 debossed on one side and ‘A’ on the other side.
APX-MIRTAZAPINE 30 mg: Reddish Brown, biconvex capsule shaped, film
coated tablets with a score
line in between 0 and 9 debossed on one side and ‘A’ on the other
side.
APX-MIRTAZAPINE 45 mg: White, biconvex capsule shaped film coated
tablets with ‘10’ debossed
on one side and ‘A’ on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention
4.2
D
OSE AND METHOD OF ADMINISTRATION
The tablets should be taken orally, if necessary with fluid, and
swallowed without chewing.
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 (refer
to
section 5.2
P
HARMACOKINETIC
P
ROPERTIES
).
2
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 given in sub-doses equally divided over the
day (once in the mornin