Zyprexa

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

olanzapine

Διαθέσιμο από:

Eli Lilly Nederland B.V.

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

olanzapine

Θεραπευτική ομάδα:

Psycholeptics

Θεραπευτική περιοχή:

Schizophrenia; Bipolar Disorder

Θεραπευτικές ενδείξεις:

Coated tabletsAdultsOlanzapine 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.InjectionAdultsZyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.

Περίληψη προϊόντος:

Revision: 42

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1996-09-27

Φύλλο οδηγιών χρήσης

60
B. PACKAGE LEAFLET
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYPREXA 2.5 MG COATED TABLETS
ZYPREXA 5 MG COATED TABLETS
ZYPREXA 7.5 MG COATED TABLETS
ZYPREXA 10 MG COATED TABLETS
ZYPREXA 15 MG COATED TABLETS
ZYPREXA 20 MG 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, 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 ZYPREXA is and what it is used for
2.
What you need to know before you take ZYPREXA
3.
How to take ZYPREXA
4.
Possible side effects
5.
How to store ZYPREXA
6.
Contents of the pack and other information
1.
WHAT ZYPREXA IS AND WHAT IT IS USED FOR
ZYPREXA contains the active substance olanzapine. ZYPREXA 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.
ZYPREXA 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 ZYPREXA
_ _
DO NOT TAKE ZYPREXA
•
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

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZYPREXA 2.5 mg coated tablets
ZYPREXA 5 mg coated tablets
ZYPREXA 7.5 mg coated tablets
ZYPREXA 10 mg coated tablets
ZYPREXA 15 mg coated tablets
ZYPREXA 20 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYPREXA 2.5 mg coated tablets
Each coated tablet contains 2.5 mg olanzapine.
Excipient with known effect: Each coated tablet contains 102 mg
lactose monohydrate.
ZYPREXA 5 mg coated tablets
Each coated tablet contains 5 mg olanzapine.
Excipient with known effect: Each coated tablet contains 156 mg
lactose monohydrate.
ZYPREXA 7.5 mg coated tablets
Each coated tablet contains 7.5 mg olanzapine.
Excipient with known effect: Each coated tablet contains 234 mg
lactose monohydrate.
ZYPREXA 10 mg coated tablets
Each coated tablet contains 10 mg olanzapine.
Excipient with known effect: Each coated tablet contains 312 mg
lactose monohydrate.
ZYPREXA 15 mg coated tablets
Each coated tablet contains 15 mg olanzapine.
Excipient with known effect: Each coated tablet contains 178 mg
lactose monohydrate.
ZYPREXA 20 mg coated tablets
Each coated tablet contains 20 mg olanzapine.
Excipient with known effect: Each coated tablet conatins 238 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
ZYPREXA 2.5 mg coated tablets
Round, white, coated tablets
_ _
imprinted with “LILLY” and a numeric identicode “4112”.
ZYPREXA 5 mg coated tablets
Round, white, coated tablets
_ _
imprinted with “LILLY” and a numeric identicode “4115”.
ZYPREXA 7.5 mg coated tablets
Round, white, coated tablets
_ _
imprinted with “LILLY” and a numeric identicode “4116”.
3
ZYPREXA 10 mg coated tablets
Round, white, coated tablets
_ _
imprinted with “LILLY” and a numeric identicode “4117”.
ZYPREXA 15 mg coated tablets
Elliptical, blue, coated tablets
_ _
debossed with “LILLY” and a numeric identicode “4415”.
ZYPREXA 20 mg coated tablets
Pink, elliptical, coated tablets
_