CLOPIXOL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
11-07-2018
Summary of Product characteristics
(SPC)
27-05-2017
Active ingredient:
ZUCLOPENTHIXOL DIHYDROCHLORIDE
Available from:
Lundbeck Limited
ATC code:
N05AF05
INN (International Name):
ZUCLOPENTHIXOL DIHYDROCHLORIDE
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
zuclopenthixol
Authorization status:
Marketed
Authorization date:
1982-11-01
Patient Information leaflet
• Medicines known as neuromuscular blocking agents (e.g.
suxamethonium) as concomitant treatment with Clopixol may
prolong the effect of neuromuscular blocking agents
• Adrenergic medicines (e.g. atenolol) as concomitant treatment with
Clopixol may reduce the effect of adrenergic medicines)
The following medicines should not be taken with Clopixol:
• Medicines for heart rhythm problems such as medicines used to
treat irregular heartbeats (e.g. quinidine, amiodarone, sotalol,
dofetilide), certain antibiotics (erythromycin, gatifloxacin,
moxifloxacin), certain antihistamines (e.g. astemizole, terfenadine),
and other medicines such as cisapride and lithium
• Other antipsychotic medicines (e.g. thioridazine)
Clopixol with food, drink and alcohol
Clopixol can be taken with or without food.
Clopixol may increase the sedative effects of alcohol making you more
drowsy. It is recommended not to drink alcohol during treatment with
Clopixol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or
are
planning to have a baby, ask your doctor for advice before taking this
medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor.
Clopixol should not be used during pregnancy, unless clearly
necessary.
The following symptoms may occur in newborn babies of mothers that
have used Clopixol in the last trimester (last three months of their
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.
Breast-feeding
If you are breast-feeding, ask your doctor for advice. You should not
use
Clopixol when breast-feeding, as small amounts of the medicine can
pass into the breast milk.
Fertility
Animal studies have shown that Clopixol affects fertility. Please ask
your
doctor for advice.
Driving and using machines
There is a risk of feeling drowsy and dizzy when using Clopixol,
especially
in the beginning
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Summary of Product characteristics
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
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