CLOPIXOL Film-coated tablet (2022)
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Περιεχόμενα
Name of the medicinal product
Clopixol 2 mg film-coated tablets. Clopixol 10 mg film-coated tablets. Clopixol 25 mg film-coated tablets.
Qualitative and quantitative composition
<u>2 mg film-coated tablets:</u> Each tablet contains 2 mg zuclopenthixol (as dihydrochloride). <u>10 mg film-coated tablets:</u> Each tablet contains 10 mg zuclopenthixol (as dihydrochloride). <u>25 mg ...
Pharmaceutical form
Film-coated tablet. <u>2 mg:</u> Round, biconvex, pale red, film-coated tablet. <u>10 mg:</u> Round, biconvex, light red-brown, film-coated tablet. <u>25 mg:</u> Round, biconvex, red-brown, film-coated ...
Therapeutic indications
The treatment of psychoses, especially schizophrenia.
Posology and method of administration
Posology Adults The dosage range is 4-150 mg/day in divided doses. The usual initial dose is 20-30 mg/day (sometimes with higher dosage requirements in acute cases), increasing as necessary. The usual ...
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 ...
Special warnings and precautions for use
Caution should be exercised in patients having: liver disease; cardiac disease, or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy, e.g. alcohol ...
Interaction with other medicinal products and other forms of interaction
In common with other antipsychotics, zuclopenthixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Zuclopenthixol may potentiate the effects of general anaesthetics ...
Fertility, pregnancy and lactation
Pregnancy Zuclopenthixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Neonates exposed to antipsychotics (including ...
Effects on ability to drive and use machines
Zuclopenthixol is a sedative drug. Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive ...
Undesirable effects
The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment. Extrapyramidal reactions may ...
Overdose
Overdosage may cause somnolence, or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper- or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Neuroleptics (antipsychotics) <b>ATC Code:</b> N05AF05 Mechanism of action The action of zuclopenthixol, as with other antipsychotics is mediated through dopamine receptor ...
Pharmacokinetic properties
Zuclopenthixol given orally in man is relatively quickly absorbed and maximum serum concentrations are reached in 3-6 hours. There is good correlation between the dose of zuclopenthixol and the concentrations ...
Preclinical safety data
Reproductive toxicity Impaired mating performance and reduced conception rates were observed in rats treated with zuclopenthixol at doses equal to the maximum recommend human dose of 50 mg on a mg/m² basis. ...
List of excipients
Potato starch Lactose Microcrystalline cellulose Copolyvidone Glycerol Talc Castor oil hydrogenated Magnesium stearate Methylhydroxypropyl cellulose Macrogol Titanium dioxide (E171) Red iron oxide (E172) ...
Incompatibilities
None known.
Shelf life
Clopixol Tablets are stable for 2 years. Each container has an expiry date.
Special precautions for storage
<u>Clopixol Tablets 2 mg:</u> Store in the original container in order to protect from light. <u>Clopixol tablets 10 mg, 25 mg:</u> This medicinal product does not require any special storage conditions. ...
Nature and contents of container
Grey polypropylene container (with desiccant capsule for 2 mg strength) or Glass bottle or White HDPE container with LDPE twist-off cap including desiccant Pack size: 100 tablets.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Lundbeck Limited, Iveco House,, Station Road, Watford, Hertfordshire, WD17 1ET, United Kingdom
Marketing authorization number(s)
2 mg tablets: PL 00458/0027 10 mg tablets: PL 00458/0028 25 mg tablets: PL 00458/0029
Date of first authorization / renewal of the authorization
Date of First Authorisation in the UK: 17 March 1982 Renewal of the Authorisation: 3 July 2008
Date of revision of the text
June 2022
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