Olanzapin Actavis 5mg orodispersible Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

OLANZAPINE

Διαθέσιμο από:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Φαρμακολογική κατηγορία (ATC):

N05AH03

INN (Διεθνής Όνομα):

OLANZAPINE 5 mg

Φαρμακοτεχνική μορφή:

ORODISPERSIBLE TABLET

Σύνθεση:

OLANZAPINE 5 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

PSYCHOLEPTICS

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2008-11-03

Φύλλο οδηγιών χρήσης

Page 1 of 7
PACKAGE LEAFLET
Page 2 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OLANZAPIN ACTAVIS 5 MG ORODISPERSIBLE TABLET
OLANZAPIN ACTAVIS 10 MG ORODISPERSIBLE TABLET
OLANZAPIN ACTAVIS 15 MG ORODISPERSIBLE TABLET
OLANZAPIN ACTAVIS 20 MG ORODISPERSIBLE TABLET
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withdrawn.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 (hypersensitive) to olanzapine or any of the other
ingredients of this
medicine (listed in section 6). An allergic

Αρχείο Π.Χ.Π.

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapin Actavis 5 mg orodispersible tablets
Olanzapin Actavis 10 mg orodispersible tablets
Olanzapin Actavis 15 mg orodispersible tablets
Olanzapin Actavis 20 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 5 mg, 10 mg, 15 mg or 20 mg
olanzapine.
Excipient with known effect: aspartame (E951) 2.8 mg, 5.6 mg, 8.4 mg
and 11.2 mg, respectively.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
_Olanzapin Actavis 5 mg orodispersible tablet:_
A round, biconvex, yellow tablet, 6 mm in diameter and marked with
“O” on one side, rapid-
dispersing preparation to be placed in the mouth or alternatively to
be dispersed in water or other
suitable beverage for administration.
_Olanzapin Actavis 10 mg orodispersible tablet: _
A round biconvex, yellow tablet 8 mm in diameter and marked with
“O1” on one side, rapid-
dispersing preparation to be placed in the mouth or alternatively to
be dispersed in water or other
suitable beverage for administration.
_Olanzapin Actavis 15 mg orodispersible tablet:_
A round, biconvex, yellow tablet, 9 mm in diameter and marked with
“O2” on one side, rapid-
dispersing preparation to be placed in the mouth or alternatively to
be dispersed in water or other
suitable beverage for administration.
_Olanzapin Actavis 20 mg orodispersible tablet: _
A round, biconvex, yellow tablet, 10 mm in diameter and marked with
“O3” on one side, rapid-
dispersing preparation to be placed in the mouth or alternatively to
be dispersed in water or other
suitable beverage for administration.
_ _
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 indicated for the treatment of mod