Neuleptil 4% (Propericiazine) oral solution 30 ml

Neuleptil 4% is a prescription antipsychotic (neuroleptic) oral solution supplied as a single 30 ml glass bottle with a graduated dropper. Its active substance is propericiazine, a phenothiazine antipsychotic (ATC N05AC01). In France the medicine is subject to prescription (liste I) and is dispensed only against a doctor's prescription. It acts on the brain and must be used under medical supervision, with the dose set individually by the prescribing doctor.

Product overview

• Trade name: Neuleptil 4% (Neuleptil 4 pour cent)
• Active ingredient: propericiazine (propériciazine)
• Strength: 4% — 4 g of propericiazine per 100 ml; 1 ml (40 drops) contains 40 mg, 1 drop contains 1 mg
• Dosage form: oral solution (solution buvable) for oral use
• Pack size: 1 glass bottle of 30 ml with a dropper inside the box
• Marketing authorisation holder: Neuraxpharm France, 44 rue Cambronne, 75015 Paris, France
• Manufacturer: Neuraxpharm Pharmaceuticals, Sant Joan Despí, Spain
• Country: France (French market pack)

What propericiazine is used for

According to the French patient leaflet, Neuleptil is indicated in the treatment of certain behavioural disorders (troubles du comportement). It belongs to the antipsychotic family and acts on the brain; the leaflet describes its use in a condition characterised by symptoms such as hearing, seeing or feeling things that are not there, unusual suspicion, mistaken beliefs, incoherent speech and behaviour, and affective and social withdrawal, where patients may also feel depressed, guilty, anxious or tense. The 4% oral solution is intended for adults and children over 3 years of age.

How to use

Neuleptil is taken by mouth. The dose is variable and must be set by the doctor for each patient; never change it on your own. For the 30 ml bottle the dropper supplied in the box is used: hold it vertically, count the prescribed number of drops into a glass of water and swallow. The 125 ml presentation (not this one) uses a graduated dosing syringe instead. Do not stop or reduce treatment without medical advice; some effects can appear on abrupt withdrawal.

Possible side effects

Common effects described in the leaflet include dizziness when standing up suddenly, dry mouth, difficulty passing urine, constipation, blurred vision or difficulty focusing, drowsiness, anxiety and mood changes, tremor, muscle rigidity and abnormal movements, sexual dysfunction, weight gain, absence of periods, breast enlargement or abnormal milk flow, and changes in blood sugar and body temperature. Rarely: heart-rhythm disturbances, skin allergy, increased skin reaction to sunlight, liver inflammation with yellowing of skin and eyes, and blood clots in the veins — leg swelling, pain or redness that may travel to the lungs with chest pain and breathing difficulty requires immediate medical attention. Exceptionally: a severe fall in white blood cells (agranulocytosis), a neuroleptic-type reaction with fever, heavy sweating, pallor, muscle rigidity and impaired consciousness (stop the medicine and seek emergency care at once), painful prolonged erection, and brownish deposits in the eye. Contact your doctor promptly if fever, pallor, heavy sweating or other signs of infection appear, or if constipation persists with bloating and abdominal pain.

Important precautions

Do not use if you are allergic to propericiazine or any excipient, if you have difficulty passing urine, glaucoma or a risk of it, or a history of a major fall in white blood cells (agranulocytosis), or if you take cabergoline or quinagolide. Tell your doctor before use if you have heart disease, stroke risk factors (smoking, high blood pressure, high blood sugar, cholesterol or fats), liver or kidney disease, convulsions or epilepsy, an enlarged prostate, constipation, or alcohol dependence; caution is needed in elderly patients with dementia and in anyone with a personal or family history of blood clots. The medicine contains sucrose and alcohol — 96.9 mg of alcohol per 40 drops (1 ml). It may cause drowsiness: ask your doctor before driving or operating machinery. Alcohol must be avoided during treatment, and antipsychotics should not be taken together with Parkinson's medicines. If you are pregnant, planning a pregnancy or breastfeeding, talk to your doctor; breastfeeding is not recommended during treatment. Children must be reviewed regularly by the doctor.

Storage

Keep out of the sight and reach of children. Store in a dry place, protected from heat and light. After first opening, keep at a temperature not exceeding 25 °C and use within a maximum of 6 months. Do not use after the expiry date on the box.

Important notice

This is a prescription medicine. The information above is a summary of the French patient leaflet and is provided for reference only: it is not a substitute for the advice of your doctor or pharmacist, and it is not a recommendation to use the product without medical supervision. Product photos are for identification purposes.

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