Olanzapin Actavis 15mg film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

OLANZAPINE

Διαθέσιμο από:

Actavis Group PTC ehf

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

OLANZAPINE

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

OLANZAPINE 15 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

PSYCHOLEPTICS

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-03-20

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPIN ACTAVIS 2.5 MG FILM-COATED TABLETS
OLANZAPIN ACTAVIS 5 MG FILM-COATED TABLETS
OLANZAPIN ACTAVIS 7.5 MG FILM-COATED TABLETS
OLANZAPIN ACTAVIS 10 MG FILM-COATED TABLETS
OLANZAPIN ACTAVIS 15 MG FILM-COATED TABLETS
OLANZAPIN ACTAVIS 20 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, 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 Olanzapin Actavis is and what it is used for
2.
What you need to know before you take Olanzapin Actavis
3.
How to take Olanzapin Actavis
4.
Possible side effects
5.
How to store Olanzapin Actavis
6.
Contents of the pack and other information
1.
WHAT OLANZAPIN ACTAVIS IS AND WHAT IT IS USED FOR
Olanzapin Actavis contains the active substance olanzapine. Olanzapin
Actavis 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mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.
Olanzapin Actavis 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 OLANZAPIN ACTAVIS
DO NOT TAKE OLANZAPIN ACTAVIS
-
if you are allergic to olanzapine or any of the other ingredients of
this medicine (listed

Αρχείο Π.Χ.Π.

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapin Actavis 2.5 mg film-coated tablets
Olanzapin Actavis 5 mg film-coated tablets
Olanzapin Actavis 7.5 mg film-coated tablets
Olanzapin Actavis 10 mg film-coated tablets
Olanzapin Actavis 15 mg film-coated tablets
Olanzapin Actavis 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
and 20 mg olanzapine.
Excipients with known effect:
2.5 mg film-coated tablet contains 58.3 mg lactose anhydrous.
5 mg film-coated tablet contains 116.6 mg lactose anhydrous.
7.5 mg film-coated tablet contains 174.9 mg lactose anhydrous.
10 mg film-coated tablet contains 233.2 mg lactose anhydrous.
15 mg film-coated tablet contains 228.2 mg lactose anhydrous.
20 mg film-coated tablet contains 304.3 mg lactose anhydrous.
Contains soya lechitin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Film-coated tablet 2.5 mg:
Round, biconvex, white film-coated tablet 6 mm in diameter, marked
with “O” on one side.
Film-coated tablet 5 mg:
Round, biconvex, white film-coated tablet 8 mm in diameter, marked
with “O1” on one side.
Film-coated tablet 7.5 mg:
Round, biconvex, white film-coated tablet 9 mm in diameter, marked
with “O2” on one side.
Film-coated tablet 10 mg:
Round, biconvex, white film-coated tablet 10 mm in diameter, marked
with “O3” on one side.
Film-coated tablet 15 mg:
Oval, biconvex, light blue film-coated tablet 7.35 x 13.35 mm in
diameter, marked with “O” on one
side.
Film-coated tablet 20 mg:
Oval, biconvex, light pink film-coated tablet 7.5 x 14.5 mm in
diameter, marked with “O” on one
side.
Page 2 of 17
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 indica