Mirtazapine Aurobindo 45mg orodisperible tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

MIRTAZAPINE

Pieejams no:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATĶ kods:

N06AX11

SNN (starptautisko nepatentēto nosaukumu):

MIRTAZAPINE 45 mg

Zāļu forma:

ORODISPERSIBLE TABLET

Kompozīcija:

MIRTAZAPINE 45 mg

Receptes veids:

POM

Ārstniecības joma:

PSYCHOANALEPTICS

Produktu pārskats:

Licence number in the source country: NOT APPLICAPABLE

Autorizācija statuss:

Authorised

Autorizācija datums:

2020-05-05

Lietošanas instrukcija

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MIRTAZAPINE AUROBINDO 15 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE AUROBINDO 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE AUROBINDO 45 MG ORODISPERSIBLE TABLETS
mirtazapine
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,
•
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 Aurobindo is and what it is used for
2.
What you need to know before you take Mirtazapine Aurobindo
3.
How to take Mirtazapine Aurobindo
4.
Possible side effects
5.
How to store Mirtazapine Aurobindo
6.
Contents of the pack and other information
1.
WHAT MIRTAZAPINE AUROBINDO IS AND WHAT IT IS USED FOR
Mirtazapine Aurobindo is one of a group of medicines called
antidepressants.
Mirtazapine Aurobindo is used to treat depressive illness in adults.
Mirtazapine Aurobindo 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 AUROBINDO
_ _
DO NOT TAKE-OR - TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINE AUROBINDO
:
•
if you are
ALLERGIC
to mirtazapine or any of the other ingredients of this medicine
(listed in
section 6). If so, you must talk to your doctor as soon as you can
before taking Mirtazapine
Aurobindo .
•
if you are taking or have recently taken (within the last two weeks)
medicines called
monoamine oxidase inhibitors (MAOIs).
•
If you have ever developed a severe skin rash or sk

Produkta apraksts

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mirtazapine Aurobindo 15mg orodisperible tablets
Mirtazapine Aurobindo 30mg orodisperible tablets
Mirtazapine Aurobindo 45mg orodisperible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mirtazapine Aurobindo 15mg orodisperible tablets contains 15 mg of
mirtazapine.
Mirtazapine Aurobindo 30mg orodisperible tablets contains 30 mg of
mirtazapine.
Mirtazapine Aurobindo 45mg orodisperible tablets contains 45 mg of
mirtazapine.
Excipients with known effect:
Mirtazapine Aurobindo 15mg orodisperible tablets contains 3 mg of
aspartame.
Mirtazapine Aurobindo 30 mg orodisperible tablets contains 6 mg of
aspartame.
Mirtazapine Aurobindo 45 mg orodisperible tablets contains 9 mg of
aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Orodispersible tablet.
Mirtazapine Aurobindo 15 mg orodispersible tablets:
White, round orodispersible tablets debossed with ‘36’ on one side
and ‘A’ on the other side with an
embossed circular edge.
Mirtazapine Aurobindo 30 mg orodispersible tablets:
White, round orodispersible tablets debossed with ‘37’ on one side
and ‘A’ on the other side with an
embossed circular edge.
Mirtazapine Aurobindo 45 mg orodispersible tablets:
White, round orodispersible tablets debossed with ‘38’ on one side
and ‘A’ on the other side with an
embossed circular edge.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mirtazapine is indicated in adults for the 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
Page 2 of 12
dose can be increased up to the maximum dose. If there is no response
within a further 2-4 weeks, then
treatment