Clopixol 10mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zuclopenthixol hydrochloride

Available from:

Lundbeck ( Ireland ) Limited

ATC code:

N05AF; N05AF05

INN (International Name):

Zuclopenthixol hydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Thioxanthene derivatives; zuclopenthixol

Authorization status:

Marketed

Authorization date:

1982-11-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOPIXOL 10 MG FILM-COATED TABLETS.
(ZUCLOPENTHIXOL DIHYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 take Clopixol
3. How to take 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 TAKE CLOPIXOL
DO NOT TAKE 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 any cause (this
includes reduced alertness after 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

if you are unconscious (

Summary of Product characteristics

Health Products Regulatory Authority
31 July 2020
CRN009V3Y
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clopixol 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg zuclopenthixol (as 11.82 mg zuclopenthixol
dihydrochloride).
Excipients with known effect
Each tablet contains 21.6 mg lactose monohydrate and 0.72 mg
hydrogenated castor oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, biconvex, light red-brown, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The treatment of psychoses, especially schizophrenia, particularly in
patients who are agitated or aggressive.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dose is 20-30 mg/day, increasing as necessary to a maximum
of 150 mg/day, in divided doses. The usual
maintenance dose in chronic schizophrenia is 20-50 mg/day in divided
doses. Lower doses may be appropriate depending on
individual patient response.
_Older people_
Older people should receive dosages in the lower end of the dosage
range.
_Children_
Clopixol is not recommended for use in children due to lack of
clinical experience.
_Reduced renal function_
Clopixol can be given in usual doses to patients with reduced renal
function.
_Reduced hepatic function _
Dose reduction (relative to the degree of hepatic impairment) should
be considered. If possible, where assay facilities exist
dosage should be adjusted according to serum levels.
Method of administration
The tablets are swallowed with water
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.

Circulatory collapse

Depressed level of consciousness due to any cause (e.g. intoxication
with alcohol, barbiturates or opiates)

Coma

Use in children
Health Products Regulatory Authority
31 July 2020
CRN009V3Y
Page 2 of 9

Use in senile confusional states
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Extrapyr