NOUMED MIRTAZAPINE mirtazapine 45 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mirtazapine, Quantity: 45 mg

Available from:

AVALLON PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; hypromellose; magnesium stearate; lactose monohydrate; titanium dioxide; macrogol 8000; maize starch; colloidal anhydrous silica

Administration route:

Oral

Units in package:

60, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of major depression.

Product summary:

Visual Identification: White, round shape biconvex film-coated tablet; 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:

2018-11-07

Patient Information leaflet

NOUMED MIRTAZAPINE
1
NOUMED MIRTAZAPINE
_mirtazapine tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOUMED
MIRTAZAPINE.
It does not contain all of 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 taking this medicine
against the benefits it is expected to
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 NOUMED
MIRTAZAPINE IS USED
FOR
NOUMED MIRTAZAPINE tablets
contain the active ingredient
mirtazapine.
Mirtazapine helps relieve symptoms
of major depression by correcting
imbalances in brain chemicals that
are involved in controlling moods.
Depression is longer lasting or more
severe than the "low moods" that
everyone has from time to time due
to the stress of everyday life.
Chemical imbalances in parts of the
brain can affect the whole body and
cause emotional and physical
symptoms including being low in
spirit, lacking interest in activities,
inability to enjoy life, poor appetite
or overeating, disturbed sleep or
waking up too early, loss of sex
drive, lack of energy and feelings of
guilt.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
NOUMED MIRTAZAPINE is not
addictive.
DO NOT GIVE THIS MEDICINE TO A CHILD
OR ADOLESCENT.
Its safety and use in patients under 18
years of age have not been
established.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO MIRTAZAPINE OR
TO ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET
UNDER PRODUCT DESCRIPTION.
Some of the symptoms of an allergic
reaction may include shortness of
breath; wheezing or difficulty in
breathing; swelling of the face, lips
t

Summary of Product characteristics

Product Information - Australia
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION – NOUMED
MIRTAZAPINE (MIRTAZAPINE) FILM COATED TABLETS
1.
NAME OF THE MEDICINE
Mirtazapine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 30 mg tablets contain 30 mg of mirtazapine and the 45 mg strength
contain 45 mg of mirtazapine.
Mirtazapine is a white to creamy white crystalline powder, which is
slightly soluble in water.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see _section 6.1 List of excipients_.
3.
PHARMACEUTICAL
FORM
Film coated tablet
Noumed Mirtazapine 30 mg tablets: Beige, round shape biconvex
film-coated tablet with one-sided breakline.
Noumed Mirtazapine 45 mg tablets: White, round shape biconvex
film-coated tablet.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of major depression.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Treatment should begin with 15 mg daily (available in other brands).
The dosage generally needs to be increased
to obtain an optimal clinical response. The effective daily dose is
usually between 30 mg 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 Noumed Mirtazapine to this
category of patients (see _sections 4.4 Special _
_warnings and precautions for use _and _section 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).
Treatment should preferably be continued until the patient has been
completely symptom free for four to si