MIRTAZAPINE AUROBINDO 45 Milligram Orodispersible Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MIRTAZAPINE

Available from:

Aurobindo Pharma Limited

ATC code:

N06AX11

INN (International Name):

MIRTAZAPINE

Dosage:

45 Milligram

Pharmaceutical form:

Orodispersible Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antidepressants

Authorization status:

Authorised

Authorization date:

2008-04-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
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 USING 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 of the side effects talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leafletSee 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 tablets 
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 MIRTAZAPINE AUROBINDO  

  if you are ALLERGIC to mirtazapine or any of the
other ingredients of this

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirtazapine Aurobindo 45 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Mirtazapine Aurobindo 45 mg orodispersible tablet contains 45 mg
of mirtazapine.
Excipients with known effect:
Each Mirtazapine Aurobindo 45 mg orodispersible tablet contains 9 mg
aspartame.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White, round (diameter 9.5 mm) 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 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).
Older people
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.
Renal impairment
The clearance of mirtazapine may be decreased in patients withmoderate
to severe renal impairment (creatinine
clearance <40 ml/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