Mirtazapine (Noumed)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Mirtazapine 30mg

Available from:

Noumed Pharmaceuticals Limited

Dosage:

30 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Mirtazapine 30mg Excipient: Colloidal silicon dioxide Hyprolose   Hypromellose   Iron oxide black Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Purified water Titanium dioxide

Prescription type:

Prescription

Therapeutic indications:

Episodes of major depression.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC white opaque film and Al foil with VMCH coating in carton (UK pack) - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVC/PVDC white opaque film and Al foil with VMCH coating in carton (NZ pack) - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

2021-01-29

Patient Information leaflet

New Zealand Consumer Medicine Information
1
MIRTAZAPINE (NOUMED)
_MIRTAZAPINE PH. EUR. _
Mirtazapine (Noumed), film-coated tablets, 30 mg & 45 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Mirtazapine
(Noumed).
This leaflet answers some common questions about Mirtazapine (Noumed).
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 using
Mirtazapine (Noumed) against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT MIRTAZAPINE (NOUMED) IS USED FOR
Mirtazapine (Noumed) 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 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 may help relieve the symptoms of depression.
ASK YOUR PRESCRIBER IF YOU HAVE ANY QUESTIONS ABOUT WHY MIRTAZAPINE
HAS BEEN
PRESCRIBED FOR YOU.
Your prescriber may have prescribed it for another reason. This
medicine is available
only with a prescriber’s prescription. This medicine is not
addictive.
BEFORE YOU USE MIRTAZAPINE (NOUMED)
New Zealand Consumer Medicine Information
2
_WHEN YOU MUST NOT USE IT _
Do not take mirtazapine if you are allergic to:
•
Mirtazapine
•
other medicines containing mirtazapine
•
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 bod

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 11
1
PRODUCT NAME
Mirtazapine (Noumed), film-coated tablets 30 mg & 45 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
Mirtazapine (Noumed) 30 mg - Each tablet contains 30 mg Mirtazapine
Mirtazapine (Noumed) 45 mg - Each tablet contains 45 mg Mirtazapine
_Excipients: _
For full list of excipients, see section 6.1.
Tablets contain lactose.
3
PHARMACEUTICAL FORM
Tablet, film-coated.
Presentation
30 mg
Reddish brown, biconvex capsule shaped film-coated tablets with score
line on one side and
30 debossed on the other side.
This tablet can be halved to give a 15 mg dose.
45 mg
White, biconvex, capsule shaped film-coated tablets. Plain on one side
and 45 debossed on
other side.
This tablet cannot be halved.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Episodes of major depression.
4.2
Dose and method of administration
Administration
The tablets should be taken orally, if necessary, with fluid, and
swallowed without chewing.
The clearance of mirtazapine may be decreased in patients with renal
or hepatic insufficiency.
This should be taken into account when prescribing mirtazapine to this
category of patients.
Mirtazapine has a half-life of 20-40 hours and, therefore, Mirtazapine
(Noumed) is suitable for
once-a-day administration. It should be taken preferably as a single
night-time dose before
going to bed. Mirtazapine (Noumed) 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.
Mirtazapine begins to
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 11
exert its effect in general after 1-2 weeks of treatment. Treatment
with an adequate dose
should result in a positive response within 2-4 weeks. With an
insufficient response, the dose
can be increased up to the maximum dose. If there is no response
within a further 2-4 week