Zalasta

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

olanzapine

Available from:

Krka

ATC code:

N05AH03

INN (International Name):

olanzapine

Therapeutic group:

Psycholeptics

Therapeutic area:

Schizophrenia; Bipolar Disorder

Therapeutic indications:

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.

Product summary:

Revision: 20

Authorization status:

Authorised

Authorization date:

2007-09-27

Patient Information leaflet

78
B. PACKAGE LEAFLET
79
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZALASTA 2.5 MG TABLETS
ZALASTA 5 MG TABLETS
ZALASTA 7.5 MG TABLETS
ZALASTA 10 MG TABLETS
ZALASTA 15 MG TABLETS
ZALASTA 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.
IN THIS LEAFLET:
1.
What Zalasta is and what it is used for
2.
What you need to know before you take Zalasta
3.
How to take Zalasta
4.
Possible side effects
5.
How to store Zalasta
6.
Contents of the pack and other information
1.
WHAT ZALASTA IS AND WHAT IT IS USED FOR
Zalasta contains the active substance olanzapine. Zalasta 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withdrawn.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.
Zalasta 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 ZALASTA
DO NOT TAKE ZALASTA
-
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 recognised
as a rash, itching, a
swollen face, swollen lips or shortness of breath. If this has
happened to you, tell your
doctor.
-
If you have been previ

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zalasta 2.5 mg tablets
Zalasta 5 mg tablets
Zalasta 7.5 mg tablets
Zalasta 10 mg tablets
Zalasta 15 mg tablets
Zalasta 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zalasta 2.5 mg tablets
Each tablet contains 2.5 mg olanzapine.
Zalasta 5 mg tablets
Each tablet contains 5 mg olanzapine.
Zalasta 7.5 mg tablets
Each tablet contains 7.5 mg olanzapine.
Zalasta 10 mg tablets
Each tablet contains 10 mg olanzapine.
Zalasta 15 mg tablets
Each tablet contains 15 mg olanzapine.
Zalasta 20 mg tablets
Each tablet contains 20 mg olanzapine.
Excipient with known effect
Zalasta 2.5 mg tablets
Each tablet contains 40.4 mg lactose.
Zalasta 5 mg tablets
Each tablet contains 80.9 mg lactose.
Zalasta 7.5 mg tablets
Each tablet contains 121.3 mg lactose.
Zalasta 10 mg tablets
Each tablet contains 161.8 mg lactose.
Zalasta 15 mg tablets
Each tablet contains 242.7 mg lactose.
Zalasta 20 mg tablets
Each tablet contains 323.5 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
3
Zalasta 2.5 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots.
Zalasta 5 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “5”.
Zalasta 7.5 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “7.5”.
Zalasta 10 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “10”.
Zalasta 15 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “15”.
Zalasta 20 mg tablets
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots
and an inscription “20”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults_
Olanzap