Clopixol-Acuphase

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ZUCLOPENTHIXOL ACETATE

Available from:

Lundbeck Limited 2nd Floor, Building 3 Abbey View, Everard Close, St Albans ALI 2PS, United Kingdom

ATC code:

N05AF05

INN (International Name):

ZUCLOPENTHIXOL ACETATE 50 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ZUCLOPENTHIXOL ACETATE 50 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-02-14

Patient Information leaflet

Page 1 of 9
Package leaflet: Information for the patient
CLOPIXOL-ACUPHASE® 50 MG/ML SOLUTION FOR INJECTION
ZUCLOPENTHIXOL ACETATE
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
•
f you get any side effects talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT CLOPIXOL-ACUPHASE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE CLOPIXOL-ACUPHASE IS GIVEN
3. HOW CLOPIXOL-ACUPHASE IS GIVEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CLOPIXOL-ACUPHASE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CLOPIXOL-ACUPHASE IS AND WHAT IT IS USED FOR
THE NAME OF YOUR MEDICINE IS CLOPIXOL-ACUPHASE 50 MG/ML SOLUTION FOR
INJECTION
(CALLED CLOPIXOL-ACUPHASE IN THIS LEAFLET). CLOPIXOL-ACUPHASE CONTAINS
THE ACTIVE
SUBSTANCE ZUCLOPENTHIXOL. CLOPIXOL-ACUPHASE 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-Acuphase is used for the initial treatment of short-term
psychoses including
mania or increases in the severity of existing psychoses.
2. WHAT YOU NEED TO KNOW BEFORE CLOPIXOL-ACUPHASE IS GIVEN
CLOPIXOL-ACUPHASE 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 alert than usual, or are drowsy or sleepy or
have serious
problems with your blood circulation
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before Clopixol-Acuphase is
given to you:
Page 2 of 9
•
If you hav

Summary of Product characteristics

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clopixol-Acuphase 50 mg/ml solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zuclopenthixol acetate 50 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
For the initial treatment of acute psychoses including mania and
exacerbation of
chronic psychoses, particularly where a duration of effect of 2-3 days
is desirable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
Dosage should be adjusted according to the severity of the patient's
illness.
The usual dosage is 50-150 mg (1-3 ml), repeated if necessary after 2
or 3 days.
Some patients may need an additional injection between 1 and 2 days
after the first
injection.
Clopixol-Acuphase is not intended for long-term use and duration of
treatment should
not be more than two weeks. The maximum accumulated dosage should not
exceed
400 mg and the number of injections should not exceed four.
_Older patients _
The dosage may need to be reduced in older patients owing to reduced
rates of
metabolism and elimination. Maximum dosage per injection should be 100
mg.
_Paediatric population _
Clopixol-Acuphase is not recommended for use in children due to lack
of clinical
experience.
_Patients with renal impairment _
Page 2 of 10
Clopixol-Acuphase 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 hepatic disease (see section 4.4).
Patients with
compromised hepatic function should receive half the recommended
dosages.
Serum-level monitoring is advised.
Maintenance Therapy
Clopixol-Acuphase is not intended for long-term use.
A single injection of Clopixol-Acuphase has an onset of sedative
action shortly after
injection and an antipsychotic action persist