FLUANXOL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Fluanxol 0.5 mg film-coated tablets. Fluanxol 1 mg film-coated tablets.

2. Qualitative and quantitative composition

Each 0.5 mg film-coated tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol dihydrochloride). Each 1 mg film-coated tablet contains 1 mg flupentixol (as 1.168 mg flupentixol dihydrochloride). ...

3. Pharmaceutical form

0.5 mg Film-coated tablet: Round, slightly biconvex, yellow, film-coated tablet marked FD. 1 mg Film-coated tablet: Oval, slightly biconvex, yellow, film-coated tablet marked FF.

4.1. Therapeutic indications

Symptomatic treatment of depression (with or without anxiety).

4.2. Posology and method of administration

Posology Adults The standard initial dosage is 1 mg as a single morning dose. After one week the dose may be increased to 2 mg if there is inadequate clinical response. Daily dosage of more than 2 mg should ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe depression requiring ECT or hospitalisation, states of excitement or overactivity, including mania. Circulatory ...

4.4. 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 ...

4.5. Interaction with other medicinal products and other forms of interaction

In common with other similar drugs, flupentixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics and ...

4.6. Fertility, pregnancy and lactation

Pregnancy As the safety of Fluanxol in human pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient ...

4.7. 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 ...

4.8. 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Neuroleptics (antipsychotics) ATC code: N05AF01 The precise pharmacological mode of action of flupentixol has not been determined. It has been postulated that at ...

5.2. Pharmacokinetic properties

Mean oral bioavailability is about 55%. Maximum drug serum concentrations occur about 4 hours after dosing and the biological half-life is about 35 hours. Flupentixol is widely distributed in the body. ...

5.3. 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 ...

6.1. List of excipients

Tablet core: Betadex Lactose monohydrate Maize starch Hydroxypropylcellulose Microcrystalline cellulose Croscarmellose sodium Talc Vegetable oil, hydrogenated Magnesium stearate Coating and colour: ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 60 tablets.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

8. Marketing authorization number(s)

Fluanxol 0.5 mg film-coated tablets: PL 00458/0011R Fluanxol 1 mg film-coated tablets: PL 00458/0037

9. Date of first authorization / renewal of the authorization

Date of First Authorisation in the UK: Fluanxol 0.5 mg film-coated tablets: 25 November 1982 Fluanxol 1 mg film-coated tablets: 23 September 1982 Renewal of the Authorisation: Fluanxol 0.5 ...

10. Date of revision of the text

01/2021

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