Mirtazapine 15mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Mirtazapine

Inapatikana kutoka:

Relonchem Ltd

ATC kanuni:

N06AX11

INN (Jina la Kimataifa):

Mirtazapine

Kipimo:

15mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030400; GTIN: 05055144202037

Taarifa za kipeperushi

COUNTRY
MANUFACTURER
SOFTWARE
ARTIST
ARTWORK LEGEND
PRODUCT NAME
PRODUCT LICENCE NO.
COMPONENT
DIMENSION
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
MIRTAZAPINE 15/30/45 MG FILM-COATED TABLETS
PL 20395-0095-0096-0097
PIL
148 x 535 mm
15/30/45 mg
-
Humanist 531 BT (Min 9.8 pt), Arial Narrow (9 pt)
NA
Comments Received from Shivaraj on 27.08.2020.as observed “18”
retyped to 18 years under
children and adolscents section.
UK (English)
Indoco
Adobe illustrator CC
Gurukiran
NO. OF COLORS
01
██
Black
██ Dieline
1.6
VERSION
XXXXXX
DATE
27.08.2020
_1. _
_WHAT MIRTAZAPINE TABLETS ARE AND WHAT IT IS _
_USED FOR_
Mirtazapine Film-coated Tablets contains active
substance Mirtazapine.
Which is one of a group of medicines called
anti-depressants.
Mirtazapine Tablets are used to treat depressive
illness in adults.
Mirtazapine Tablets will take 1 to 2 weeks before it
starts working. After 2 to 4 weeks you may start
feeling better.
You must talk to your doctor if you do not feel better
or if you feel worse after 2 to 4 weeks.
More information is in section 3 heading 'When can
you expect to start feeling better".
_2. _
_WHAT YOU NEED TO KNOW BEFORE YOU TAKE _
_MIRTAZAPINE TABLETS_
DO NOT TAKE MIRTAZAPINE TABLETS:
•
if you are ALLERGIC (hypersensitive) to Mirtazapine
(listed in section 6) or any of the other ingredients
of Mirtazapine Tablets. If so, you must talk to your
doctor as soon as you can before taking
Mirtazapine Tablets.
•
if you are taking or have recently taken (within
the last two weeks) medicines called monoamine
oxidase inhibitors (MAOI’s).
•
if you have ever developed a severe skin rash or
skin peeling, blistering and/or mouth sores after
taking Mirtazapine Tablets or other medicinal
products.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Mirtazapine Tablets.
CHILDREN AND ADOLESCENTS
Mirtazapine Tablets should not normally be used for
children and adolescents under 18 years because
efficacy was not demonstrated. Also, you should
know that patients under 18

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 15 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
15mg: Each tablet contains 15 mg mirtazapine.
Excipient with known effects:
Lactose monohydrate: 99.0 mg
Sunset Yellow FCF (E110): 0.021 mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Mirtazapine 15 mg Tablets are yellow, oblong and biconvex tablets with
a score line
on one side.
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 15 and 45 mg; the starting
dose is
15 or 30 mg. 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.
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.
Children and adolescents under the age of 18 years
Mirtazapine Tablets should not be used in children and adolescents
under the
age of 18 years 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 account when prescribing Mirtazapine Tablets to this
category of
patients (see section 4.4).
Hepatic impairment
The clearance of mirtazapine may be decreased in patients with hepatic
impairment. This should be taken into account when prescribing
Mirtazapine
Tablets
to
this
category
of
patients,
particularly
with
severe
hepatic
impairment,
as
patie