Olanzapine Aurobindo 10mg orodispersible Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

OLANZAPINE

Tillgänglig från:

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

ATC-kod:

N05AH03

INN (International namn):

OLANZAPINE 10 mg

Läkemedelsform:

ORODISPERSIBLE TABLET

Sammansättning:

OLANZAPINE 10 mg

Receptbelagda typ:

POM

Terapiområde:

PSYCHOLEPTICS

Bemyndigande status:

Authorised

Tillstånd datum:

2013-02-19

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE
USER
OLANZAPINE AUROBINDO 5 MG ORODISPERSIBLE TABLETS
OLANZAPINE AUROBINDO 10 MG ORODISPERSIBLE TABLETS
OLANZAPINE AUROBINDO 15 MG ORODISPERSIBLE TABLETS
OLANZAPINE AUROBINDO 20 MG ORODISPERSIBLE TABLETS
olanzapine
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 Olanzapine Aurobindo is and what it is used for
2.
What you need to know before you take Olanzapine Aurobindo
3.
How to take Olanzapine Aurobindo
4.
Possible side effects
5.
How to store Olanzapine Aurobindo
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE AUROBINDO IS AND WHAT IT IS USED FOR
Olanzapine Aurobindo belongs to a group of medicines called
antipsychotics and is used to treat the
following conditions:
•
Schizophrenia, a disease with symptoms such as hearing, seeing or
sensing things which are not
there, mistaken beliefs, unusual suspiciousness, and becoming
withdrawn. People with this
disease may also feel depressed, anxious or tense.
•
Moderate to severe manic episodes, a condition with symptoms of
excitement or euphoria.
Olanzapine has been shown to prevent recurrence of these symptoms in
patients with bipolar
disorder whose manic episode has responded to olanzapine treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE AUROBINDO
DO NOT TAKE OLANZAPINE AUROBINDO
•
If you are allergic to olanzapine or any of the other ingredients of
this medicine (listed in section 6).
An allergic reaction may be recognised as a rash, itching, a swollen
face, swollen lips or

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Aurobindo 5 mg orodispersible tablets
Olanzapine Aurobindo 10 mg orodispersible tablets
Olanzapine Aurobindo 15 mg orodispersible tablets
Olanzapine Aurobindo 20 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 5 mg olanzapine.
Each orodispersible tablet contains 10 mg olanzapine.
Each orodispersible tablet contains 15 mg olanzapine.
Each orodispersible tablet contains 20 mg olanzapine.
EXCIPIENTS WITH KNOWN EFFECT:
_5 mg _
Each orodispersible tablet contains
0.50 mg aspartame.
_10 mg _
Each orodispersible tablet contains 1
.00 mg aspartame.
_15 mg _
Each orodispersible tablet contains 1
.50 mg aspartame.
_20 mg _
Each orodispersible tablet contains 2
.00 mg aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
_Olanzapine Aurobindo 5 mg orodispersible _
_tablets _
Yellow coloured, circular [diameter 5.7 mm], flat faced beveled edge
tablets debossed with
‘C’ on one side and ‘51’ on the other side.
_Olanzapine Aurobindo 10 mg orodispersible _
_tablets _
Yellow coloured, circular [diameter 7 mm], flat faced beveled edge
tablets debossed with ‘C’
on one side and ‘52’ on the other side.
_Olanzapine Aurobindo 15 mg orodispersible _
_tablets _
Yellow coloured, circular [diameter 8.2 mm], flat faced beveled edge
tablets debossed with
‘C’ on one side and ‘53’ on the other side.
_Olanzapine Aurobindo 20 mg orodispersible _
_tablets _
Yellow coloured, circular [diameter 9 mm], flat faced beveled edge
tablets debossed with ‘C’
on one side and ‘54’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults_
Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during
continuation therapy in
patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to severe manic
episod