Remirta 45mg orodispersible Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIRTAZAPINE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

N06AX11

INN (International Name):

MIRTAZAPINE 45 mg

Pharmaceutical form:

ORODISPERSIBLE TABLET

Composition:

MIRTAZAPINE 45 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Withdrawn

Authorization date:

2007-08-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMIRTA
15
MG
ORODISPERSIBLE
TABLETS
REMIRTA
30
MG
ORODISPERSIBLE
TABLETS
REMIRTA
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Remirta is and what it is used for
2.
What you need to know before you take Remirta
3.
How to take Remirta
4.
Possible side effects
5.
How to store Remirta
6.
Contents of the pack and other information
1.
WHAT REMIRTA IS AND WHAT IT IS USED FOR
Remirta is one of a group of medicines called
ANTIDEPRESSANTS
. Remirta is used to treat depressive illness
in adults.
Remirta 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
REMIRTA DO NOT TAKE REMIRTA
-
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 Remirta.
-
if you are taking or have recently taken (within the last two weeks)
medicines
called monoamine oxidase inhibitors (MAO-Is).
-
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WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Remirta
DO NOT TAKE - OR - TELL YOUR DOCTOR BEFORE TAKING Remirta:
IF YOU HAVE EVER DEVELOPED A SEVERE SKIN RASH OR SKIN PEELING,
BLISTE

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Remirta 15 mg orodispersible
tablets
Remirta 30 mg orodispersible
tablets
Remirta 45 mg orodispersible
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Remirta 15 mg orodispersible tablet contains 15 mg of
mirtazapine.
Each Remirta 30 mg orodispersible tablet contains 30 mg of
mirtazapine.
Each Remirta 45 mg orodispersible tablet contains 45 mg of
mirtazapine.
Excipient(s) with known effect
Each Remirta 15 mg orodispersible tablet contains 6 mg aspartame, 41
µg glucose and less than
0.04 µg sulphite.
Each Remirta 30 mg orodispersible tablet contains 12 mg aspartame, 82
µg glucose and less than
0.08 µg sulphite.
Each Remirta 45 mg orodispersible tablet contains 18 mg aspartame, 123
µg glucose and less than
0.12 µg sulphite.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
15 mg tablets: White or off-white, round, 8 mm in diameter, biconvex,
uncoated tablet
marked with M1.
30 mg tablets: White or off-white, round, 10 mm in diameter, biconvex,
uncoated tablet
marked with M2.
45 mg tablets: White or off-white, round, 12 mm in diameter, biconvex,
uncoated tablet
marked with M4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Remirta is indicated in adults for the treatment of episodes of major
depression.
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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 mir