Olanzapine Accord 7.5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OLANZAPINE

Available from:

Accord Healthcare Limited

ATC code:

N05AH03

INN (International Name):

OLANZAPINE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

OLANZAPINE 7.5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2012-04-04

Patient Information leaflet

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beliefs, unusual suspiciousness, and becoming withdrawn.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 medicine (listed i

Summary of Product characteristics

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.
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 Accord is indicated for the p