Clopine

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Clozapine 200mg;  

Fáanlegur frá:

Douglas Pharmaceuticals Limited

INN (Alþjóðlegt nafn):

Clozapine 200 mg

Skammtar:

200 mg

Lyfjaform:

Tablet

Samsetning:

Active: Clozapine 200mg   Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone Purified water Sodium starch glycolate

Einingar í pakka:

Blister pack, PVC/PVDC/Al, 50 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Taizhou Xingming Pharmaceutical Co., Ltd

Ábendingar:

The use of clozapine is indicated in the treatment of resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to or intolerant of classical antipsychotics. Non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two marketed antipsychotics prescribed for adequate durations. Intolerance is defined as the impossibility of achieving adequate clinical benefit with classical antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Vörulýsing:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP tamper evident and child resistant cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP tamper evident and child resistant cap - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Leyfisdagur:

2003-06-25

Upplýsingar fylgiseðill

CONSUMER MEDICINE INFORMATION
CLOPINE®
_Clozapine _
25, 50, 100 and 200 mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start
taking CLOPINE.
This leaflet answers some common questions
about CLOPINE. It does not contain all the
available information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor
has weighed the risks of you taking CLOPINE
against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT CLOPINE IS USED FOR
CLOPINE tablets belong to the group of medicines
known as antipsychotics. This group of medicines
is mainly used in the treatment of schizophrenia.
Schizophrenia is a mental illness with
disturbances in thinking, feelings and behaviour.
This medicine is only used in patients with
schizophrenia for whom other antipsychotic
medicines have not worked or have caused
severe side effects.
This medicine is thought to work by correcting
the chemical imbalances in the brain, which may
cause mental illness.
Your doctor may have prescribed it for another
reason.
Ask your doctor if you have any questions about
why this medicine has been prescribed for you.
This medicine is available only with a doctor's
prescription.
There is no evidence that this medicine is
addictive.
CLOPINE is not recommended for use in children
or adolescents under the age of 16, as there is
not enough information on its use in that age
group.
BEFORE YOU TAKE CLOPINE
_ _
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY
TO:
•
the active ingredient, clozapine
•
any of the other ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction to this medicine
may include:
•
breathing problems such as shortness of
breath, wheezing, difficulty breathing
•
skin rash, itching or hives
•
swelling of the face, lips, tongue or other
parts

Vara einkenni

1 | P a g e
NEW ZEALAND DATA SHEET
Clopine® can cause agranulocytosis. Its use should be limited to
patients:
-
with schizophrenia who are non-responsive to or intolerant of
classical antipsychotic
agents, or with schizophrenia or schizoaffective disorder who are at
risk of recurrent
suicidal behaviour _(see section 4.1),_
-
who have initially normal leukocyte findings (white blood cell count
(WBC) ≥ 3500/mm
3
(3.5 x 10
9
/L), and absolute neutrophil counts (ANC) ≥ 2000/mm
3
(2.0 x 10
9
/L)),
-
and in whom regular white blood cell counts and absolute neutrophil
counts can be
performed as follows: weekly during the first 18 weeks of therapy, and
at least every 4
weeks
thereafter
throughout
treatment.
Monitoring
must
continue
throughout
treatment and for 4 weeks after complete discontinuation of Clopine
(see section 4.4).
Prescribing physicians should comply fully with the required safety
measures. At each
consultation, a patient receiving Clopine should be reminded to
contact the treating
physician immediately if any kind of infection begins to develop.
Particular attention should
be paid to flu-like complaints such as fever or a sore throat and to
other evidence of
infection, which may be indicative of neutropenia (see section 4.4).
Close monitoring of
bowel
habits
is
also
recommended
for
any
signs
of
constipation
or
gastrointestinal
hypomotility.
Clopine must be prescribed and dispensed in accordance with
appropriate local guidelines.
The following conditions apply to the sale, supply and use of Clopine
in New Zealand under
the consent notice from Medsafe. Douglas draws prescribers, nurses and
patients’ attention
to the following criteria:
Clozapine may only be initiated and prescribed by:
-
Registered medical practitioners as defined in the Health
Practitioners Competence
Assurance Act 2003 who are certified by the Medical Council of New
Zealand as
competent in the scope of practice of psychiatry (i.e. psychiatrist);
-
Medical practitioners employed as registrars in the branch of
psychiatry, or nurse
pra