Clopixol Acuphase 100mg/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zuclopenthixol acetate

Available from:

Lundbeck Ltd

ATC code:

N05AF05

INN (International Name):

Zuclopenthixol acetate

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5702157108275

Patient Information leaflet

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
•
If 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:
•
If you have a heart condition, in

Summary of Product characteristics

OBJECT 1
CLOPIXOL ACUPHASE INJECTION
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
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_
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 af