MIRTAZAPINE SANDOZ mirtazapine 30mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mirtazapine, Quantity: 30 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Mirtazapine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 8000; hyprolose; iron oxide yellow; colloidal anhydrous silica; iron oxide red; iron oxide black; hypromellose; magnesium stearate; titanium dioxide; maize starch; lactose monohydrate

Administration route:

Oral

Units in package:

30, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression.

Product summary:

Visual Identification: Beige, film-coated tablets, round, biconvex, one sided score,notch; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-06-19

Patient Information leaflet

MIRTAZAPINE SANDOZ
®
1
MIRTAZAPINE SANDOZ
®
_mirtazapine tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Mirtazapine Sandoz.
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 MIRTAZAPINE
SANDOZ IS USED
FOR
This medicine is used to treat
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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE
MIRTAZAPINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE:
•
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 difficulty breathing.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING ANOTHER MEDICINE

Summary of Product characteristics

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Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
MIRTAZAPINE SANDOZ
® (MIRTAZAPINE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Mirtazapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 15 mg tablets contain 15 mg mirtazapine, the 30 mg tablets contain
30 mg mirtazapine and
the 45 mg strength contains 45 mg of mirtazapine.
_Excipients with known effect:_
Sugars (as lactose monohydrate).
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Mirtazapine Sandoz 15 mg tablets: Yellow, film-coated tablets, round,
biconvex, one sided
score notch.
_ _
Mirtazapine Sandoz 30 mg tablets: Beige, film-coated tablets, round,
biconvex, one sided score
notch.
_ _
Mirtazapine Sandoz 45 mg tablets: White, film-coated tablets,
circular, biconvex.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of major depression.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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.
METHOD OF ADMINISTRATION
The tablets should be taken orally, if necessary with fluid, and
swallowed without chewing.
DOSAGE ADJUSTMENT IN:

Renal/hepatic impairment
The clearance of mirtazapine may be decreased in patients with renal
or hepatic insufficiency.
This should be taken into account when prescribing Mirtazapine Sandoz
to this category of
patients (see Sections 4.4 Special warnings and precautions for use
and 5.2 Pharmacokinetic
properties).
Mirtazapine has a half-life of 20 to 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
morning and once at night-time).
220714-Mirtazapine Sandoz-pi
Page 2 of 19
Treatment should preferably be continued until the patient