DEPIXOL Film-coated tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Depixol 3 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 3 mg flupentixol (as 3.504 mg flupentixol dihydrochloride). Excipients with known effect: Lactose monohydrate Sunset yellow (E110) For the full list of excipients, see ...
Pharmaceutical form
Film-coated tablet. Round, slightly biconvex, ochre, film-coated tablet marked FI.
Therapeutic indications
The treatment of schizophrenia and other psychoses.
Posology and method of administration
Posology Adults 1-3 tablets twice daily to a maximum of 18 mg (6 tablets) per day. It is recommended that commencement of treatment and increase in dosage should be carried out under close supervision. ...
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, flupentixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics ...
Fertility, pregnancy and lactation
Pregnancy As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient ...
Effects on ability to drive and use machines
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 or operate machinery until their ...
Undesirable effects
Cases of suicidal ideation and suicidal behaviours have been reported during flupentixol therapy or early after treatment discontinuation (see section 4.4). The majority of undesirable effects are dose ...
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: N05AF01 Flupentixol is a neuroleptic of the thioxanthene series. The antipsychotic effect of neuroleptics is believed to be related to ...
Pharmacokinetic properties
Oral administration to volunteers (8 mg single dose and 1.5 mg/day) and patients (5-60 mg/day) resulted in serum drug concentration curves with a maximum around four hours after administration. Mean biological ...
Preclinical safety data
Reproductive toxicity In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Animal reproduction studies in mice, rats and rabbits have not shown evidence of teratogenic ...
List of excipients
<u>Tablet core:</u> Betadex Lactose monohydrate Maize starch Hydroxypropylcellulose Microcrystalline cellulose Croscarmellose sodium Talc Vegetable oil, hydrogenated Magnesium stearate <u>Coating and colour: ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
White, High Density Polyethylene (HDPE) tablet container with a child-resistant closure and tamper-evident seal; 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, UK
Marketing authorization number(s)
PL 0458/0013R
Date of first authorization / renewal of the authorization
Date of First Authorisation in the UK: 29 January 1987 Renewal of the Authorisation: 09 November 2010
Date of revision of the text
01/2021
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