Merbaril Tablets Orodispersible Tablet 25mg

Land: Malta

Språk: engelska

Källa: Malta Medicines Authority

Aktiva substanser:

CLOZAPINE

Tillgänglig från:

Synthon BV Microweg 22, 6545 CM Nijmegen, Netherlands

ATC-kod:

N05AH02

INN (International namn):

CLOZAPINE 25 mg

Läkemedelsform:

ORODISPERSIBLE TABLET

Sammansättning:

CLOZAPINE 25 mg

Receptbelagda typ:

POM

Terapiområde:

PSYCHOLEPTICS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2019-01-09

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MERBARIL 12.5 MG TABLETS
MERBARIL 25 MG TABLETS
MERBARIL 50 MG TABLETS
MERBARIL 100 MG TABLETS
MERBARIL 200 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 Merbaril is and what it is used for
2.
What you need to know before you take Merbaril Tablets
3.
How to take Merbaril Tablets
4.
Possible side effects
5.
How to store Merbaril Tablets
6.
Contents of the pack and other information
1
WHAT MERBARIL TABLETS IS AND WHAT IT IS USED FOR
Merbaril Tablets contains the active substance clozapine.
Merbaril Tablets belongs to a group of medicines called antipsychotics
(medicines that are used to
treat specific mental disorders such as psychosis).
Merbaril Tablets 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.
Merbaril Tablets 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 MERBARIL TABLETS
DO NOT TAKE MERBARIL TABLETS
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-
if you are allergic (hypersensitive) to clozapine or any of the other
i

Produktens egenskaper

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CLOZAPINE 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 (SEE
SECTION 4.4).
PRESCRIBING PHYSICIANS MUST COMPLY FULLY WITH THE REQUIRED SAFETY
MEASURES. AT EACH
CONSULTATION, A PATIENT RECEIVING CLOZAPINE MUST BE REMINDED TO
CONTACT THE TREATING PHYSICIAN
IMMEDIATELY IF ANY KIND OF INFECTION BEGINS TO DEVELOP. PARTICULAR
ATTENTION MUST BE PAID TO FLU-
LIKE COMPLAINTS SUCH AS FEVER OR SORE THROAT AND TO OTHER EVIDENCE OF
INFECTION, WHICH MAY BE
INDICATIVE OF NEUTROPENIA (SEE SECTION 4.4).
CLOZAPINE 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 RARELY (SEE SECTION 4.4).
MYOCARDITIS OR CARDIOMYOPATHY SHOULD BE SUSPECTED IN PATIENTS WHO
EXPERIENCE PERSISTENT
TACHYCARDIA AT REST, ESPECIALLY IN THE FIRST 2 MONTHS OF TREATMENT,
AND/OR PALPITATIONS,
ARRHYTHMIAS, CHEST PAIN AND OTHER SIGNS AND SYMPTOMS OF HEART FAILURE
(E.G. UNEXPLAINED FATIGUE,
DYSPNOEA, TACHYPNOEA) OR SYMPTOMS THAT MIMIC MYOCARDIAL INFARCTION
(SEE SECTION 4.4).
IF MYOCARDITIS OR CARDIOMYOPATHY ARE SUSPECTED, CLOZAPINE TREATMENT
SHOULD BE PROMPTLY
STOPPE