MIRTAZAPINE SANDOZ ODT 15 mirtazapine 15 mg orally disintegrating tablets blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

mirtazapine

זמין מ:

Sandoz Pty Ltd

INN (שם בינלאומי):

Mirtazapine

מצב אישור:

Registered

עלון מידע

MIRTAZAPINE SANDOZ
®
ODT
1
MIRTAZAPINE
SANDOZ
® ODT
_mirtazapine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mirtazapine Sandoz
ODT. 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 Mirtazapine
Sandoz ODT 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 MIRTAZAPINE
SANDOZ ODT IS USED
FOR
Mirtazapine Sandoz ODT 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.
Mirtazapine Sandoz ODT is not
addictive.
BEFORE YOU TAKE
MIRTAZAPINE SANDOZ
ODT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MIRTAZAPINE SANDOZ
ODT:
•
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 troub

מאפייני מוצר

201126-mirtazapine sandoz odt-pi
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AUSTRALIAN PRODUCT INFORMATION
MIRTAZAPINE SANDOZ
® ODT (MIRTAZAPINE) ORALLY DISINTEGRATING
TABLETS
1.
NAME OF THE MEDICINE
Mirtazapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine Sandoz
®
ODT 15 orally disintegrating tablet contains 15 mg of mirtazapine.
Each Mirtazapine Sandoz
®
ODT 30 orally disintegrating tablet contains 30 mg of mirtazapine.
Each Mirtazapine Sandoz
®
ODT 45 orally disintegrating tablet contains 45 mg of mirtazapine.
_Excipients with known effect:_
mannitol, aspartame.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Mirtazapine Sandoz ODT 15: White, round tablets debossed with ‘36’
on one side and ‘A’ on
the other side with an embossed circular edge.
Mirtazapine Sandoz ODT 30: White, round tablets debossed with ‘37’
on one side and ‘A’ on
the other side with an embossed circular edge.
Mirtazapine Sandoz ODT 45: White, round tablets debossed with ‘38’
on one side and ‘A’ on
the other side with an embossed circular edge.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
To prevent crushing of the tablet, do not push against a tablet
pocket. Each strip has 10 tablets
separated by perforations. Bend the strip several times along a
perforation, then tear off one
tablet pocket. Carefully peel off the lidding foil, starting in the
corner indicated by the arrow.
Take out the tablet with dry hands and place it on the tongue, where
it will rapidly disintegrate
and can be swallowed with or without water.
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 clo