Olanzapine Aurobindo Pharma 5 mg tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Tilgængelig fra:

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

ATC-kode:

N05AH03

INN (International Name):

OLANZAPINE 5 mg

Lægemiddelform:

TABLET

Sammensætning:

OLANZAPINE 5 mg

Recept type:

POM

Terapeutisk område:

PSYCHOLEPTICS

Autorisation status:

Authorised

Autorisation dato:

2023-07-20

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE AUROBINDO PHARMA 5 MG TABLETS
OLANZAPINE AUROBINDO PHARMA 10 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 Pharma is and what it is used for
2.
What you need to know before you take Olanzapine Aurobindo Pharma
3.
How to take Olanzapine Aurobindo Pharma
4.
Possible side effects
5.
How to store Olanzapine Aurobindo Pharma
6.
Contents of the pack and other information
1.
WHAT OLANZAPINE AUROBINDO PHARMA IS AND WHAT IT IS USED FOR
Olanzapine Aurobindo Pharma contains the active substance olanzapine.
Olanzapine Aurobindo
Pharma 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withdrawn.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 Pharma 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 PHARMA_ _
DO NOT TAKE OLANZAPINE AUROBINDO PHARMA
•
If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this medicine
(listed in section 6). An allergic reaction may be recogn

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Aurobindo
Pharma 5 mg tablets
Olanzapine Aurobindo Pharma 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg olanzapine.
Excipient with known effect
: 90.50 mg lactose monohydrate.
Each tablet contains 10 mg olanzapine.
Excipient with known effect: 181.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Olanzapine Aurobindo Pharma 5 mg Tablets:
_[Size: About 6.5 mm]_
Yellow coloured, circular, biconvex uncoated tablets, debossed with
‘OA’ on one side and ‘5’ on the
other side.
Olanzapine Aurobindo Pharma 10 mg Tablets:
_[Size: About 8 mm]_
Yellow coloured, circular, biconvex uncoated tablets, debossed with
‘OA’ on one side and ‘10’ 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
episode.
In patients whose manic episode has responded to olanzapine treatment,
olanzapine is indicated for the
prevention of recurrence in patients with bipolar disorder (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults _
Schizophrenia: The recommended starting dose for olanzapine is 10
mg/day.
Manic episode: The starting dose is 15 mg as a single daily dose in
monotherapy or 10 mg daily in
combination therapy (see section 5.1).
Preventing recurrence in bipolar disorder: The recommended starting
dose is 10 mg/day. For patients who
have been receiving olanzapine for treatment of manic episode,
continue therapy for preventing
recurrence at the same dose. If a new manic, mixed, or depressive
episode occurs, olanzapine treatment
should be continued (with dose optimisation as needed), with
supplementary therapy to treat mood
sym