DEANXIT Film-coated tablet
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Deanxit film-coated tablets.
2. Qualitative and quantitative composition
<u>Each tablet contains:</u> Flupentixol 0.5 mg (as 0.584 mg flupentixol dihydrochloride) Melitracen 10 mg (as 11.25 mg melitracen hydrochloride) <u>Excipients with known effect:</u> Lactose monohydrate ...
3. Pharmaceutical form
Film-coated tablets. Round, biconvex, cyclamen, film-coated tablets.
4.1. Therapeutic indications
Anxiety Depression Asthenia. Neurasthenia. Psychogenic depression. Depressive neuroses. Masked depression. Psychosomatic affections accompanied by anxiety and apathy. Menopausal depressions. Dysphoria ...
4.2. Posology and method of administration
Posology Adults Usually 2 tablets daily: morning and noon. In severe cases the morning dose may be increased to 2 tablets. The maximum dose is 4 tablets daily. Older people (>65 years) 1 tablet in the ...
4.3. Contraindications
Hypersensitivity to flupentixol and melitracen 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, ...
4.4. Special warnings and precautions for use
Deanxit should not be administered together with MAOIs (see section 4.3 and section 4.5). Deanxit should be used with caution in patients with organic brain syndrome, convulsion, urinary retention, hyperthyroidism ...
4.5. Interaction with other medicinal products and other forms of interaction
Contraindicated combinations MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of serotonin syndrome (see section 4.3). Inadvisable combinations Sympathomimetic agents: ...
4.6. Fertility, pregnancy and lactation
Pregnancy Deanxit should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Due to the risk of neonatal withdrawal symptoms it ...
4.7. Effects on ability to drive and use machines
Deanxit is a non-sedating drug in the recommended dosage range. However, patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration ...
4.8. Undesirable effects
Clinical trials There are few and mild adverse effects. Insomnia (in 6%) is the most frequent adverse effect. In the listing below the following convention is used: MedDRA system organ class / preferred ...
4.9. Overdose
In cases of overdosage the symptoms of intoxication by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal disorder due to flupentixol occur. Symptoms Somnolence, irritability, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antidepressants – Tricyclic antidepressant (melitracen) and neuroleptic of the thioxanthene group (flupentixol) <b>ATC-code:</b> N06CA02 Deanxit consists of two well known ...
5.2. Pharmacokinetic properties
Flupentixol Flupentixol is a mixture of two geometric isomers, the active cis(Z)-flupentixol and trans(E)-flupentixol, approximately in the ratio of 1:1. Absorption Oral administration results in maximum ...
5.3. Preclinical safety data
Acute toxicity Flupentixol has low acute toxicity, but the acute toxicity of tricyclic antidepressants including melitracen is high. Chronic toxicity In chronic toxicity studies there were no findings ...
6.1. List of excipients
<u>Tablet core:</u> Betadex Lactose monohydrate Maize starch Hydroxypropylcellulose Microcrystalline cellulose Croscarmellose sodium Talc Hydrogenated vegetable oil Magnesium stearate <u>Coating:</u> ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store in the original package.
6.5. Nature and contents of container
50 in blister packs.
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 Hellas A.E., Spyrou Kyprianou, 20 CHAPO CENTRAL, 3rd floor P.C 1075, Nicosia, Cyprus
8. Marketing authorization number(s)
21765
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 31/05/2013 Date of latest renewal: 08/2020
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