Melperon (Melperon)

Instructions for use: Melperon (Melperon)

Brief reference information compiled from official German sources (Gelbe Liste, Fachinfo, Apotheken Umschau). It does not replace a doctor’s consultation or the package insert. This is a prescription medicine — use it only as directed by a doctor.

Active substance

melperone hydrochloride (Melperonhydrochlorid) — an antipsychotic of the butyrophenone group with a sedative action

Available forms

• Film-coated tablets: 10 mg, 25 mg, 50 mg and 100 mg (Melperon-ratiopharm, Melperon-neuraxpharm, Melperon-1A Pharma, Melperon STADA, Melperon Aristo, etc.)
• Oral solution 25 mg/5 ml (Lösung zum Einnehmen), as well as the stronger solution Melperon-neuraxpharm forte

Indications

• Sleep disturbances, primarily in elderly (geriatric) and psychiatric patients — including in dementia and alcohol dependence
• States of confusion (Verwirrtheitszustände) in the elderly, in dementia and mental illnesses
• Psychomotor restlessness and states of agitation (Unruhe- und Erregungszustände)
• Agitation and restlessness in psychoses, organic dementia, intellectual disability and alcohol-related illness
• Psychoneuroses with anxiety and tension — when tranquillisers cannot be used because of intolerance or risk of dependence

How to take

• The dose is selected by the doctor individually — according to age, body weight and severity of the condition; the principle: the minimum effective dose for the shortest possible course
• Mild calming and anti-anxiety effect: usually 25–75 mg per day
• For sleep disturbances, the doctor may prescribe a higher dose in the evening (to enhance the sedative effect)
• Restlessness and confusion: starting with 50–100 mg/day, if necessary gradually up to 200 mg/day
• Severe agitation with aggression, delusions, hallucinations: up to 400 mg/day (only as prescribed by a doctor)
• The daily dose is divided into several intakes; the tablets are washed down with water — but not coffee, tea or milk (they impair absorption)
• For the elderly, a low dose is often sufficient — dose with caution

Contraindications

• Allergy to melperone, other butyrophenones or excipients
• Acute poisoning and depression of consciousness caused by alcohol, hypnotics, analgesics or psychotropic agents
• Severe hepatic insufficiency
• A history of neuroleptic malignant syndrome
• Children under 12 years
• Pregnancy and breastfeeding (use is not recommended)
• Caution: heart diseases, QT-interval prolongation, potassium deficiency, bradycardia, Parkinson’s disease, very low blood pressure, as well as concurrent use of other medicines that prolong the QT interval or cause potassium deficiency (see interactions)

Possible side effects

• Fatigue and drowsiness, especially at the start of treatment
• Decreased blood pressure (including on standing up) and rapid heartbeat
• QT-interval prolongation, in rare cases — serious cardiac arrhythmias
• Extrapyramidal disorders: tremor, rigidity, akathisia (restlessness) — more often at high doses
• Transient increase in liver enzymes, bile stasis
• Allergic skin reactions (rash)
• Weight gain, headache, dry mouth, constipation and menstrual cycle disturbances are possible

Special precautions

• Prescription medicine (rezeptpflichtig) — dispensed only as prescribed by a doctor
• This is an antipsychotic, not an ordinary sleeping pill: it is not intended for treating mild insomnia in young and generally healthy people — it is used for sleep disturbances in the elderly, in dementia and mental disorders
• In the elderly with dementia, antipsychotics are associated with a small increase in mortality and the risk of stroke — use with particular caution and under a doctor’s supervision
• During treatment, avoid alcohol; the medicine reduces reaction speed — limit driving, especially in the first days
• Do not take it together with coffee, tea and milk — poorly soluble compounds form and the effect weakens

Sources: www.gelbe-liste.de, www.gelbe-liste.de, www.apotheken-umschau.de, www.apotheken-umschau.de