AVANZA mirtazapine 45mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mirtazapine

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Mirtazapine

Authorization status:

Registered

Patient Information leaflet

AVANZA
®
_Mirtazapine 30mg and 45mg Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Avanza. 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 Avanza
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 AVANZA IS USED
FOR
Avanza 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.
Avanza is not addictive.
BEFORE YOU TAKE
AVANZA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AVANZA:
•
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 AVANZA IF YOU ARE
TAKING ANOTHER MEDICINE FOR
DEPRESSION CALLED A MONOAMINE
OXIDASE INHIBITOR (MAOI) OR HAVE
B

Summary of Product characteristics

S-CCDS-MK8246-ALL-122018
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
AVANZA
® (MIRTAZAPINE)
1
NAME OF THE MEDICINE
Mirtazapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 30 mg tablets contain 30 mg mirtazapine and the 45 mg strength
contains 45 mg of
mirtazapine.
List of excipients with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Avanza 30 mg tablets are oval, biconvex, red-brown, scored and marked
with ‘Organon’ or
‘MSD’ on one side, and on the other side with the (code ) on both
sides of the score. The
tablet can be divided into equal halves.
Avanza 45 mg tablets are white tablets (code
).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression including relapse prevention.
4.2
DOSE 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 Avanza to this
category of patients (refer
to Section 5.2 Pharmacokinetic Properties).
Mirtazapine has a half-life of 20-40 hours and therefore Avanza is
suitable for once-a-day
administration. It should be taken preferably as a single night-time
dose before going to bed.
Avanza may also be given in sub-doses equally divided over the day
(once in the morning and
once at night-time).
Treatment should preferably be continued until the patient has been
completely symptom-free
for 4-6 months. After this, treatment can be gradually discont