Olanzapine Aurobindo 2.5mg tablets

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

OLANZAPINE

Beszerezhető a:

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

ATC-kód:

N05AH03

INN (nemzetközi neve):

OLANZAPINE 2.5 mg

Gyógyszerészeti forma:

TABLET

Összetétel:

OLANZAPINE 2.5 mg

Recept típusa:

POM

Terápiás terület:

PSYCHOLEPTICS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2015-07-21

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE AUROBINDO 2.5 MG TABLETS
OLANZAPINE AUROBINDO 5 MG TABLETS
OLANZAPINE AUROBINDO 7.5 MG TABLETS
OLANZAPINE AUROBINDO 10 MG TABLETS
OLANZAPINE AUROBINDO 15 MG TABLETS
OLANZAPINE AUROBINDO 20 MG 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 contains the active substance olanzapine.
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withdrawn.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 Aurobindo 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 (hypersensitive) to olanzapine or any of the other
ingredients of this medicine
(l

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Aurobindo 2.5 mg tablets
Olanzapine Aurobindo 5 mg tablets
Olanzapine Aurobindo 7.5 mg tablets
Olanzapine Aurobindo 10 mg tablets
Olanzapine Aurobindo 15 mg tablets
Olanzapine Aurobindo 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg olanzapine.
Excipient with known effect
: 45.25 mg lactose monohydrate.
Each tablet contains 5 mg olanzapine.
Excipient with known effect
: 90.50 mg lactose monohydrate.
Each tablet contains 7.5 mg olanzapine.
Excipient with known effect
: 135.75 mg lactose monohydrate.
Each tablet contains 10 mg olanzapine.
Excipient with known effect
: 181.00 mg lactose monohydrate.
Each tablet contains 15 mg olanzapine.
Excipient with known effect
: 271.50 mg lactose monohydrate.
Each tablet contains 20 mg olanzapine.
Excipient with known effect
: 362.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Olanzapine Aurobindo 2.5mg Tablets:
Yellow coloured, circular (5.2 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘2.5’ on the other side
Olanzapine Aurobindo 5mg Tablets:
Yellow coloured, circular (6.5 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘5’ on the other side
Olanzapine Aurobindo 7.5mg Tablets:
Yellow coloured, circular (7.5 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘7.5’ on the other side
Olanzapine Aurobindo 10mg Tablets:
Yellow coloured, circular (8.0 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘10’ on the other side
Olanzapine Aurobindo 15mg Tablets:
Yellow coloured, circular (9.0 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘15’ on the other side
Olanzapine Aurobindo 20 mg Tablets:
Yellow coloured, circular (10.5 mm in diameter), biconvex uncoated
tablets, debossed with ‘OA’ on
one side and ‘20’ on