Mirtazapine 30mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Mirtazapine

Boleh didapati daripada:

Genesis Pharmaceuticals Ltd

Kod ATC:

N06AX11

INN (Nama Antarabangsa):

Mirtazapine

Dos:

30mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030400; GTIN: 5060014442536

Risalah maklumat

NO GOOD FOR COLOR PROOF
TEXT BODY: _Font _- Helvetica
_Min. size_ - 9 pt
Notes
Black
Keylines
Pantone:
Colours
240x400mm
Size
MIRTAZAPINE OLS 30mg
FILM-COATED TABLETS
(Package leaflet EN)
Description
Customer
2018-04-11
Date
Grasshopper Sistemas de Informação
[e-mail]
www.gsiportugal.com
AW.CRC.164.03.V08
Code
IN THIS LEAFLET
1.
What Mirtazapine Tablets is and what it is used for
2.
What you need to know before you take Mirtazapine Tablets
3.
How to take Mirtazapine Tablets
4.
Possible side effects
5.
How to store Mirtazapine Tablets
6.
Contents of the pack and other information
1. WHAT MIRTAZAPINE TABLETS IS AND WHAT IT IS USED
FOR
Mirtazapine 30mg Tablets contain the active substance, mirtazapine.
Mirtazapine is one of a group of medicines called antidepressants.
Depression is linked to a shortage of substances which carry messages
in
the brain (including serotonin and noradrenaline). Mirtazapine helps
to
relieve the shortage of these 'brain messages'. Common signs of
depression
include feelings of worthlessness or deep sadness; difficulty with
everyday
tasks; sleeping too much or not being able to sleep; feeling anxious;
and
changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep
better. It is
important to take your medicine every day and not to stop taking it
unless
your doctor tells you to. If you do, your symptoms may come back.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MIRTAZAPINE TABLETS
DO NOT TAKE MIRTAZAPINE 30MG TABLETS:
Ÿ
if you are allergic to mirtazapine or any of the other ingredients of
Mirtazapine 30mg Tablets
Ÿ
if you are taking or have recently taken (within the last two weeks)
medicines called monoamine oxidase inhibitors (MAOIs)
WARNINGS AND PRECAUTIONS
CHILDREN AND ADOLESCENTS
Mirtazapine 30mg Tablets should normally not be used for children and
adolescents under 18 years because efficacy was not demonstrated.
Patients under 18 have an increased risk of side effects such as
suicide
attempt, suicidal thoughts and hostility (predominantly aggres

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine 30mg film-coated tablet contains 30mg of mirtazapine.
Excipient with known effect:
Each Mirtazapine 30mg film-coated tablet contains 203.6mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet, film coated.
Brownish, scored on both sides, oval, biconvex, film-coated tablets.
Marked with “I”
on one side. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The effective daily dose is usually between 15mg and 45mg; the
starting dose
is 15mg or 30mg. Mirtazapine begins to 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 weeks, then treatment should be stopped.
Patients with depression should be treated for a sufficient period of
at least 6
months to ensure that they are free from symptoms.
It is recommended to discontinue treatment with mirtazapine gradually
to
avoid withdrawal symptoms (see section 4.4).
_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.
_Paediatric population _
Mirtazapine tablets should not be used in children and adolescents
under the
age of 18 years (see section 4.4) as efficacy was not demonstrated in
two
short-term clinical trials (see section 5.1) and because of safety
concerns (see
sections 4.4, 4.8 and 5.1)..
_Renal impairment _
The clearance of mirtazapine may be decreased in patients with
moderate to
severe renal impairment (creatinine clearance <40 ml/min). This should
be
taken into a