DEANXIT Film-coated tablet Ref.[28299] Active ingredients: Flupentixol Melitracen

Source: Υπουργείο Υγείας (CY)  Publisher: Lundbeck Hellas A.E., Spyrou Kyprianou, 20 CHAPO CENTRAL, 3rd floor P.C 1075, Nicosia, Cyprus

4.1. Therapeutic indications

Anxiety – Depression – Asthenia.

Neurasthenia. Psychogenic depression. Depressive neuroses. Masked depression.
Psychosomatic affections accompanied by anxiety and apathy. Menopausal depressions. Dysphoria and depression in alcoholics and drug-addicts.

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 morning.

In severe cases 1 tablet in the morning and 1 at noon.

Maintenance dose: Usually 1 tablet in the morning.

In cases of insomnia or severe restlessness additional treatment with a sedative in the acute phase is recommended.

Paediatric population

Children and adolescents (<18 years)

Deanxit is not recommended for use in children and adolescents due to lack of data on safety and efficacy.

Reduced renal function

Deanxit can be given in the recommended doses.

Reduced liver function

Deanxit can be given in the recommended doses.

Method of administration

The tablets are swallowed with water.

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, agitation, hallucinations, anticholinergic effects (mydriasis, tachycardia, urinary retention, mucosal dryness, intestinal hypomotility), convulsions, pyrexia, depressed level of consciousness, coma, respiratory depression, cardiac symptoms (arrhythmias (ventricular arrhythmia, torsade de pointes, ventricular fibrillation), cardiac failure, hypotension, cardiogenic shock), metabolic acidosis, hypokalaemia.

Treatment

Admission to hospital (intensive care unit). Treatment is symptomatic and supportive. Gastric aspiration and lavage even in a late stage after oral ingestion and treatment with activated charcoal. Measures to support the respiratory and cardiovascular systems should be instituted. Continuous ECG-monitoring of cardiac function for 3-5 days. Epinephrine (adrenaline) should not be used as further lowering of blood pressure may result. Convulsions may be treated with diazepam and extrapyramidal disorder with biperiden.

Adults have survived consumption of up to 100 tablets (1000 mg melitracen and 50 mg flupentixol) and an almost 3-year old child 27 tablets (270 mg melitracen and 13,5 mg flupentixol).

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.

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