Mirtazapine 45mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Mirtazapine

可用日期:

Genus Pharmaceuticals Ltd

ATC代码:

N06AX11

INN（国际名称）:

Mirtazapine

剂量:

45mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04030400

资料单张

Myriad Pro
9 pt
9 pt
Mirtazapine_45mg_15mg_30mg_all
Leaflet
1941517
1936886
1941517
N/A
Aurobindo Pharma Ltd
(Unit-III : Hyderabad - IN)
P1521870
21870
N/A
102854961/0020
3
United Kingdom
Leaflet KLD 280 x 480 mm (60 x 35 mm)
N/A
1
280 x 480 mm
BLACK
1 / 2
N/A
v3/Jul 2017
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23:00
18 Sep 19
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mirtazapine is and what it is used for
2.
What you need to know before you take Mirtazapine
3.
How to take Mirtazapine
4.
Possible side effects
5.
How to store Mirtazapine
6.
Contents of the pack and other information
1. WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called ANTIDEPRESSANTS.
Mirtazapine is used to treat depressive illness in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIRTAZAPINE
DO NOT TAKE MIRTAZAPINE:
•
if you are ALLERGIC to mirtazapine or any of the other ingredients of
this medicine (listed in section 6)
if you are taking or have recen

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mirtazapine 45mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 45mg of mirtazapine
Excipient with known effects: Lactose monohydrate.
Each tablet contains 305.4mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, 14.5 x 7.5 mm oval, biconvex, film-coated tablets. Marked with
I on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of episodes of major depression.
Mirtazapine 45mg Tablets are indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The effective daily dose is usually between 15 and 45mg; the starting
dose is 15
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.
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 populationMirtazapine 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 <40ml/min). This should
be taken
into account when prescribing Mirtazapine 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 to
this category of patients, particularly with severe hepatic
impairment, as patients
with