Mirtazapine 45mg orodispersible tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Mirtazapine

Доступно од:

Advanz Pharma

АТЦ код:

N06AX11

INN (Међународно име):

Mirtazapine

Дозирање:

45mg

Фармацеутски облик:

Orodispersible tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 04030400; GTIN: 5060064791073

Информативни летак

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

Карактеристике производа

OBJECT 1
MIRTAZAPINE 45 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 08-Sep-2015 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Mirtazapine 45 mg orodispersible tablets.
2. Qualitative and quantitative composition
Each tablet contains 45 mg of mirtazapine.
Excipient: aspartame 18 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Orodispersible tablet
The tablets are white or almost white, 12 mm round, biconvex, uncoated
tablets and marked M4.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of episodes of major depression.
4.2 Posology and method of administration
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 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 section
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 to
this category of patients (se 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, particula