BLOOMS THE CHEMIST MIRTAZAPINE 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

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:

2022-12-23

Patient Information leaflet

Blooms The Chemist Mirtazapine
1
BLOOMS THE CHEMIST MIRTAZAPINE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BLOOMS THE CHEMIST MIRTAZAPINE?
Blooms The Chemist Mirtazapine contains the active ingredient
mirtazapine. Blooms The Chemist Mirtazapine is used to treat
depression.
For more information, see Section 1. Why am I using Blooms The Chemist
Mirtazapine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BLOOMS THE CHEMIST MIRTAZAPINE?
Do not use if you have ever had an allergic reaction to Blooms The
Chemist Mirtazapine or any of the ingredients listed at the
end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Blooms The Chemist Mirtazapine?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Blooms The Chemist Mirtazapine and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BLOOMS THE CHEMIST MIRTAZAPINE?
•
The usual starting dose is 15 mg per day. Your doctor may slowly
increase this dose depending on how you respond to
Blooms The Chemist Mirtazapine.
•
The effective dose for most people is usually between 30 mg and 45 mg
per day.
More instructions can be found in Section 4. How do I use Blooms The
Chemist Mirtazapine?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BLOOMS THE CHEMIST MIRTAZAPINE?
THINGS YOU
SHOULD DO
•
Remind
any
doctor,
dentist,
or
pharmacist
you
visit
that you
are
using Blooms
The
Chemist
Mirtazapine.
•
If you have any suicidal thoughts or other mental/mood changes, tell
your doctor immediately or go
to the nearest hospital for treatment.
•
Tell your doctor if you feel the tablets are not helping your
condition.
THINGS YOU
SH

Summary of Product characteristics

221223-Blooms The Chemist Mirtazapine-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
BLOOMS THE CHEMIST MIRTAZAPINE (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:_
Contains sugars as lactose.
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Blooms The Chemist Mirtazapine 15 mg tablets: Yellow, film-coated
tablets, round, biconvex,
one sided score notch.
_ _
Blooms The Chemist Mirtazapine 30 mg tablets: Beige, film-coated
tablets, round, biconvex,
one sided score notch.
_ _
Blooms The Chemist Mirtazapine 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 Blooms The Chemist
Mirtazapine 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).
221223-Blooms The Chemist Mirtazapi