Clopixol Injection

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

ZUCLOPENTHIXOL DECANOATE

Disponibil de la:

Lundbeck Limited

Codul ATC:

N05AF05

INN (nume internaţional):

ZUCLOPENTHIXOL DECANOATE

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

ZUCLOPENTHIXOL DECANOATE 200 mg/ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

PSYCHOLEPTICS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2006-02-14

Prospect

Package leaflet: Information for the patient
CLOPIXOL
® 200 MG/ML SOLUTION FOR INJECTION
ZUCLOPENTHIXOL DECANOATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE CLOPIXOL INJECTION IS GIVEN
3.
HOW CLOPIXOL INJECTION IS GIVEN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CLOPIXOL INJECTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CLOPIXOL INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Clopixol 200 mg/ml solution for injection
(called Clopixol
Injection in this leaflet). Clopixol Injection contains the active
substance zuclopenthixol. It
belongs to a group of medicines known as antipsychotics (also called
neuroleptics).
These medicines act on nerve pathways in specific areas of the brain
and help to correct
certain chemical imbalances in the brain that are causing the symptoms
of your illness.
Clopixol Injection is used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Clopixol Injection for another
purpose. Ask your doctor
if you have any questions about why this medicine has been prescribed
for you.
2.
WHAT YOU NEED TO KNOW BEFORE CLOPIXOL INJECTION IS GIVEN
Clopixol Injection is not given

If you are allergic (hypersensitive) to zuclopenthixol, other
thioxanthene drugs or
antipsychotic drugs or any of the other ingredients of this medicine
(listed in section 6).
Tell your doctor if you think you might be

If you are feeling less a

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clopixol 200 mg/ml solution for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zuclopenthixol decanoate 200 mg/ml.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish oil, practically free from particles.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The maintenance treatment of schizophrenia and paranoid psychoses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Dosage and dosage interval should be adjusted according to the
patient’s symptoms
and response to treatment.
The usual dosage range of zuclopenthixol decanoate is 200 - 500 mg
every one to
four weeks, depending on response, but some patients may require up to
600 mg per
week. The maximum single dose at any one time is 600 mg. For example,
1200 mg
every 2 weeks should not be given. In patients who have not previously
received
depot antipsychotics, treatment is usually started with a small dose
(e.g. 100 mg) to
assess tolerance. An interval, of at least one week should be allowed
before the
second injection is given at a dose consistent with the patient’s
condition.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high
enough dosage. Once stabilised lower maintenance doses may be
considered, but
must be sufficient to prevent relapse.
Injection volumes of greater than 2 ml should be distributed between
two injection
sites.
_Older patients _
In accordance with standard medical practice initial dosage may need
to be reduced to
a quarter or half the normal starting dose in the frail or older
patients.
_Paediatric population _
Clopixol is not recommended for use in children due to lack of
clinical experience.
_Patients with renal impairment _
Clopixol can be given in usual doses to patients with reduced renal
function. Where
there is renal failure dosage should be reduced to half the normal
dosage.
_Patients with hepatic impairment _
Use with caution in patients with liver diseas