Olanzapine Accord 5mg film-coated Tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

OLANZAPINE

متاح من:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC رمز:

N05AH03

INN (الاسم الدولي):

OLANZAPINE 5 mg

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

OLANZAPINE 5 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

PSYCHOLEPTICS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2012-04-04

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE ACCORD 2.5 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 5 MG FILM-COATED TABLETS OLANZAPINE ACCORD 7.5 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 10 MG FILM-COATED TABLETS
OLANZAPINE ACCORD 15 MG FILM-COATED 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, please 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 or
nurse. This includes
any possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1. What Olanzapine Accord is and what it is used for
2. What you need to know before you take Olanzapine Accord
3. How to take Olanzapine Accord
4. Possible side effects
5. How to store Olanzapine Accord
6. Contents of the pack and other information
1. WHAT OLANZAPINE ACCORD IS AND WHAT IT IS USED FOR
Olanzapine Accord contains the active substance olanzapine. Olanzapine
tablets 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withdrawn.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 Accord 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 ACCORD
DO NOT TAKE OLANZAPINE ACCORD
•
If you are allergic (hypersensitive) to olanzapine or any of the other
ingredients of this medici

خصائص المنتج

Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Accord 2.5 mg film-coated tablets
Olanzapine Accord 5 mg film-coated tablets
Olanzapine Accord 7.5 mg film-coated tablets
Olanzapine Accord 10 mg film-coated tablets
Olanzapine Accord 15 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
For 2.5 mg:
Each film-coated tablet contains 2.5 mg of Olanzapine. Excipient
with known effect: Lactose 58.61 mg
For 5 mg:
Each film-coated tablet contains 5 mg of Olanzapine. Excipient
with known effect: Lactose 56.24 mg
For 7.5 mg:
Each film-coated tablet contains 7.5 mg of Olanzapine. Excipient
with known effect: Lactose 84.36 mg
For 10 mg:
Each film-coated tablet contains 10mg of Olanzapine. Excipient
with known effect: Lactose 112.48 mg
For 15 mg:
Each film-coated tablet contains 15 mg of Olanzapine. Excipient
with known effect: Lactose 168.72 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
For 2.5 mg:
White to off white round, biconvex, film-coated tablets of 5.6 mm,
plain on both sides.
For 5 mg:
White to off white round biconvex, film coated tablets of 6.4 mm,
debossed with ‘O1’
on one side and plain on other side.
Page 2 of 20
For 7.5mg:
White to off white round biconvex, film coated tablets of 7.2 mm,
debossed with ‘O2’
on one side and plain on other side.
For 10 mg:
White to off white round biconvex, film coated tablets of 8.0 mm,
debossed with ‘O3’
on one side and plain on other side.
For 15 mg:
Light blue coloured, round, biconvex, film coated tablets of 8.8 mm,
plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Olanzapine Accord is indicated for the treatment of schizophrenia.
Olanzapine Accord is effective in maintaining the clinical improvement
during continuation
therapy in patients who have shown an initial treatment response.
Olanzapine Accord is
indicated for the treatment of moderate to severe manic episode.
In patients whose manic episode has responded to Olanzapine Accord
treatment, Olanzapine
Acc