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SPC, UK: CLOPIXOL Film-coated tablets (2016)

Αναφορές

Βιβλιογραφική αναφορά

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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

2 mg film-coated tablets: Each tablet contains 2 mg zuclopenthixol (as dihydrochloride). 10 mg film-coated tablets: Each tablet contains 10 mg zuclopenthixol (as dihydrochloride). 25 mg film-coated tablets: ...

Pharmaceutical form

Film-coated tablet. 2 mg: Round, biconvex, pale red, film-coated tablet. 10 mg: Round, biconvex, light red-brown, film-coated tablet. 25 mg: Round, biconvex, red-brown, film-coated tablet.

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

Pharmacotherapeutic group: Neuroleptics (antipsychotics) ATC Code: N05AF05 Mechanism of action Zuclopenthixol is a potent neuroleptic of the thioxanthene series with a piperazine side-chain. The antipsychotic ...

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

Shelf life: Clopixol Tablets are stable for 2 years. Each container has an expiry date.

Special precautions for storage

Clopixol Tablets 2 mg: Store in the original container in order to protect from light. Clopixol tablets 10 mg, 25 mg: 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, 2nd Floor, Building 3, Abbey View, Everard Close, St Albans, AL1 2PS, United Kingdom

Marketing authorization number(s)

2 mg tablets: PL 0458/0027 10 mg tablets: PL 0458/0028 25 mg tablets: PL 0458/0029

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

December 2016

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