Clozapine Orifarm 25 mg Tablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

klozapin

Dostupné z:

Orifarm AB

ATC kód:

N05AH02

INN (Medzinárodný Name):

clozapine

Dávkovanie:

25 mg

Forma lieku:

Tablett

Zloženie:

laktosmonohydrat Hjälpämne; klozapin 25 mg Aktiv substans

Typ predpisu:

Receptbelagt

Stav Autorizácia:

Avregistrerad

Dátum Autorizácia:

2017-02-22

Príbalový leták

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLOZAPINE ACTAVIS 25 MG TABLETS 100 MG TABLETS
clozapine
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 is Clozapine Actavis and what it is used for
2.
What you need to know before you take Clozapine Actavis
3.
How to take Clozapine Actavis
4.
Possible side effects
5.
How to store Clozapine Actavis
6.
Contents of the pack and other information
1.
WHAT CLOZAPINE ACTAVIS IS AND WHAT IT IS USED FOR
The active ingredient of Clozapine Actavis is clozapine which belongs
to a group of medicines called
antipsychotics (medicines that are used to treat specific mental
disorders such as psychosis).
Clozapine Actavis is used to treat people with schizophrenia in whom
other medicines have not worked.
Schizophrenia is a mental illness which affects how you think, feel
and behave. You should only use this
medicine if you have already tried at least two other antipsychotic
medicines, including one of the newer
atypical antipsychotics, to treat schizophrenia, and these medicines
did not work, or caused severe side
effects that cannot be treated.
Clozapine Actavis is also used to treat severe disturbances in the
thoughts, emotions and behaviour of people
with Parkinson’s disease in whom other medicines have not worked.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOZAPINE ACTAVIS
DO NOT TAKE CLOZAPINE ACTAVIS IF YOU
-
are allergic to clozapine or any of the other ingredients of this
medicine (listed in section 6).
-
are not able to have regular blood

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Clozapine Actavis 25 mg tablets
Clozapine Actavis 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg clozapine.
Excipient with known effect: lactose monohydrate 48 mg per tablet
Each tablet contains 100 mg clozapine
Excipient with known effect: lactose monohydrate 192 mg
per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clozapine Actavis can cause agranulocytosis. Its use should be limited
to patients:
-
with schizophrenia who are non-responsive to or intolerant of
antipsychotic medication, or
with psychosis in Parkinson’s disease when other treatment
strategies have failed (see
section 4.1).
-
who have initially normal leukocyte findings (white blood cell count
≥3500/mm
3
(3.5x10
9
/l),
and ANC ≥2000/mm
3
( 2.0x10
9
/l)), and
-
in whom regular white blood cell (WBC) counts and absolute neutrophil
counts (ANC) can
be performed as follows: weekly during the first 18 weeks of
treatment, and at least every
4 weeks thereafter throughout treatment. Monitoring must continue
throughout treatment
and for 4 weeks after complete discontinuation of Clozapine Actavis
(see section 4.4.).
Prescribing physicians must comply fully with the required safety
measures. At each consultation,
a patient receiving Clozapine Actavis must be reminded to contact the
treating physician
immediately if any kind of infection begins to develop. Particular
attention must be paid to flulike
complaints such as fever or sore throat and to other evidence of
infection, which may be indicative
of neutropenia (see section 4.4.).
Clozapine Actavis must be dispensed under strict medical supervision
in accordance with official
recommendations (see section 4.4.).
MYOCARDITIS
Clozapine is associated with an increased risk of myocarditis which
has, in rare cases, been fatal.
The increased risk of myocarditis is greatest in the first 2 months of
treatment. Fatal cases of
cardiomyopathy have also been reported rarel