REMERON SOLTAB mirtazapine 30mg orally disintegrating tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

mirtazapine

Boleh didapati daripada:

Merck Sharp & Dohme (Australia) Pty Ltd

Status kebenaran:

Registered

Risalah maklumat

REMERON SOLTAB
®
_Mirtazapine 15mg, 30mg and 45mg Orally Disintegrating Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Remeron SolTab. 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 Remeron
SolTab 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 REMERON SOLTAB
IS USED FOR
Remeron SolTab is used in the
treatment of depression
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.
Remeron SolTab is not addictive.
BEFORE YOU TAKE
REMERON SOLTAB
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE REMERON SOLTAB:
•
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 REMERON SOLTAB IF YOU
ARE TAKING ANOTHER MEDICIN

Ciri produk

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Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
REMERON SOLTAB
® (MIRTAZAPINE)
1
NAME OF THE MEDICINE
Mirtazapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
Excipients with known effect: Sugar Spheres NF (25/30 Mesh) PI (4780),
aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Remeron SolTab tablets are round, white, flat faced bevelled-edge
tablets marked with a code
on one side, with a characteristic orange odour.
The codes are:
15 mg (code )
30 mg (code )
45 mg (code )
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of major depression
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 Remeron SolTab to
this category of
patients (refer to Section 5.2 Pharmacokinetic Properties).
Mirtazapine has a half-life of 20-40 hours and therefore Remeron
SolTab is suitable for once-
a-day administration. It should be taken preferably as a single
night-time dose before going to
bed. Remeron SolTab 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 discontinued to
avoid withdrawal
TZ
1
TZ
2
TZ
4
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symptoms