Clopixol 200 mg/ml Solution for Injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

ZUCLOPENTHIXOL DECANOATE

Fáanlegur frá:

Lundbeck ( Ireland ) Limited

ATC númer:

N05AF; N05AF05

INN (Alþjóðlegt nafn):

ZUCLOPENTHIXOL DECANOATE

Skammtar:

200 milligram(s)/millilitre

Lyfjaform:

Solution for injection

Lækningarsvæði:

Thioxanthene derivatives; zuclopenthixol

Leyfisstaða:

Marketed

Leyfisdagur:

1977-06-13

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 Clopixol is and what it is used for
2.
What you need to know before
you use Clopixol
3. How to use Clopixol
4. Possible side effects
5. How to store Clopixol
6. Contents of the pack and other information
1.
WHAT CLOPIXOL IS AND WHAT IT IS USED FOR
Clopixol contains the active substance zuclopenthixol.
Clopixol 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 is used for the treatment of schizophrenia and other related
psychoses.
Ask your doctor if you have any questions about why Clopixol has been
prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CLOPIXOL
DO NOT USE CLOPIXOL
•
if you are allergic to zuclopenthixol or any of the other ingredients
of this medicine (listed
in section 6). Consult your doctor if you think you might be
•
if you have a reduced level of alertness due to the consumption of
alcohol or drugs such as
opiates (e.g. morphine) and barbiturates
•
if you are an older person who suffers from confusion
•
if you are receiving emergency treatment to support your blood
circulation
•
if you are a child.
WARNINGS AND PRECAUTIONS
Talk to doctor or pharmacist before taking Clopixol if yo

Vara einkenni

Health Products Regulatory Authority
28 February 2023
CRN00DDXV
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopixol 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 200 mg zuclopenthixol decanoate
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 management of schizophrenia and allied psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dosage should be adjusted according to the severity of the
patient's symptoms. The usual dose range is 200-400 mg every
two to four weeks depending on the response of the individual patient.
If volumes larger than 2-3 ml of the 200 mg/ml solution are required,
the more concentrated solution (zuclopenthixol
decanoate 500 mg/ml) should be preferred.
The maximum recommended dose is 600 mg weekly. Patients who have not
previously received depot neuroleptics are usually
started on an initial dose of 100 mg.
A few patients may need higher doses or shorter intervals between
doses. Injection volumes exceeding 2 ml should be
distributed between two injection sites (administration on both
injection sites in total should not exceed 600mg).
When changing the medication from oral zuclopenthixol or
zuclopenthixol acetate i.m. to maintenance treatment with
zuclopenthixol decanoate the following guidelines should be used:
_1) Change from oral zuclopenthixol to zuclopenthixol decanoate_
x mg p.o. daily corresponds to 8x mg decanoate every two weeks.
x mg p.o. daily corresponds to 16x mg decanoate every four weeks.
Numerical example:
10 mg p.o. daily corresponds to 80 mg decanoate every two weeks.
10 mg p.o. daily corresponds to 160 mg decanoate every four weeks.
Oral zuclopenthixol should be continued during the first week after
the first injection but in diminishing dosage.
_2) Change from zuclopenthixol acetate to zuclopenthixol decanoate_
C