Neuleptil

Package leaflet: Information for the patient

Neuleptil 10 mg tablets, 2 g/100 ml oral drops, solution

Periciazine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Neuleptil is and what it is used for
2. What you need to know before taking Neuleptil
3. How to take Neuleptil
4. Possible side effects
5. How to store Neuleptil
6. Contents of the pack and other information

1. What Neuleptil is and what it is used for

Neuleptil contains the active substance periciazine, which belongs to the class of antipsychotic medicines known as phenothiazines. These are medicines that act on personality disorders and behavioural disorders.
Neuleptil is used to treat:

• behavioural disorders occurring in mental illnesses (psychoses and neuroses),
• personality disorders in adults and children,
• states of mental and physical agitation.

2. What you should know before taking Neuleptil

DO NOT take Neuleptil

• if you are allergic to periciazine, to medicines of the phenothiazine class, or to any of the other ingredients of this medicine (listed in section 6);
• if you are not in a state of deep unconsciousness (comatose state);
• if you have severe depression;
• if you have problems with blood cell production (hematopoietic disorders);
• if you have liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking Neuleptil.
Pay particular attention when taking Neuleptil:

• if you or a member of your family has or has had heart or blood vessel diseases or disorders of the heart's electrical activity (QT interval prolongation on electrocardiogram);
• if you are taking other medicines for mental disorders. Your doctor will advise you which medicines you can take to avoid side effects (see section “Other medicines and Neuleptil”);
• if you have Parkinson’s disease, other Parkinson-like diseases, or movement disorders, because medicines like Neuleptil may increase muscle stiffness;
• if you have a pheochromocytoma (a specific tumor of the adrenal gland);
• if you have severe heart valve disease (mitral insufficiency), as this may lead to a drop in blood pressure;
• if you are at risk of cerebrovascular events (stroke);
• if you have dementia;
• if you or a member of your family has or has had thrombosis (blood clots in blood vessels), since this medicine may cause blood clot formation;
• if you have previously shown excessive sensitivity to medicines similar to Neuleptil (phenothiazines).

If you experience any of the following symptoms while taking this medicine, contact your doctor immediately:

• very high fever,
• muscle rigidity,
• reduced or absent movements (akinesia),
• irregular blood pressure,
• sweating,
• rapid or irregular heartbeat (tachycardia, arrhythmias),
• loss of consciousness (which may progress to stupor or coma).
  These could be symptoms of a serious condition called Neuroleptic Malignant Syndrome.
  For individuals engaged in sports, the use of medicines containing ethyl alcohol may result in a positive doping test, depending on the alcohol concentration limits set by certain sports federations.

Children and adolescents
The use of Neuleptil in early infancy is not recommended.

Other medicines and Neuleptil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, be cautious if you are taking any of the following medicines:

• medicines that alter the body's electrolyte levels;
• medicines that may cause changes in the heart's electrical activity (QT interval prolongation), as taking them together with Neuleptil may lead to heart rhythm disturbances.

Neuleptil may enhance the effects of the following medicines. If you take Neuleptil together with these medicines, their dosage may need to be adjusted:

• opioids (morphine-like drugs),
• antihistamines (for allergies),
• analgesics (for pain relief),
• barbiturates (for epilepsy),
• other psychotropic drugs.

Neuleptil may reduce the effectiveness of medicines used to treat seizures: if you are taking these medicines, their dose may need to be increased. Inform your doctor that you are taking these medicines.
Treatment with medicines like Neuleptil increases sensitivity to atropine and organophosphorus insecticides.

Neuleptil and alcohol
Treatment with medicines like Neuleptil increases sensitivity to alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Neuleptil should be used during pregnancy only if clearly necessary and under direct medical supervision.
Newborns born to mothers who took medicines like Neuleptil during the last three months of pregnancy have shown the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Your baby should be closely monitored if you have taken this medicine.

Driving and using machines
Neuleptil may impair alertness, reflex response, and reaction times, and therefore may affect your ability to drive or operate machinery.

Neuleptil 10 mg tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Neuleptil 2 g/100 ml oral drops, solution contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. It may be harmful to teeth.

Neuleptil 2 g/100 ml oral drops, solution contains ethyl alcohol
This medicine contains 12.7% vol ethanol (alcohol), e.g., up to 350 mg per dose, equivalent to 8.8 ml of beer or 3.7 ml of wine per dose.
It may be harmful to alcoholics.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.

3. How to take Neuleptil

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you how much Neuleptil to take and how often, depending on your
clinical condition.

Use in psychiatry
Use in adults
The recommended daily dose is 20–30 mg.
Depending on the severity of symptoms, the dose may be increased gradually by 10 mg per day, up to 50–70 mg.

Use in children
The recommended daily dose ranges from 5 to 10 mg, with a maximum of 10 mg per day.

Use in elderly patients
The recommended starting dose is 5 mg per day, which may be gradually increased up to 15 mg per day, and exceptionally up to 20–30 mg per day.

Use in internal medicine
Use in adults
The recommended daily dose is 5–20 mg. Do not increase the dose further.

Use in children
The dose is determined according to the child's body weight. The recommended dose is 0.25 mg per kg of body weight, not exceeding 5 mg per day (i.e., 1 drop per 2 kg of body weight, up to a maximum of 10 drops).
The maintenance dose is 2.5–5 mg per day.

Use in elderly patients
The recommended starting dose is 5 mg per day. Do not exceed 10 mg per day.

Instructions for use

Neuleptil 2 g/100 ml oral drops, solution

• Unscrew the cap,
• hold the bottle upside down.

If necessary, initially tap gently on the bottle with your finger.
WARNING: The bottle has a child-resistant closure.

To open: press down and unscrew
To close: screw on while pressing the overcap

If you take more Neuleptil than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take Neuleptil
Do not take a double dose to make up for the missed dose.

If you stop taking Neuleptil
Do not stop the treatment abruptly. Your doctor will advise you on how to discontinue the treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of Nuleptil or similar medicines:

• involuntary movements of voluntary or involuntary muscles (extrapyramidal neurological manifestations with dyskinetic symptoms).
• heart disorders and abnormalities in heart rhythm (QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.
• very rare cases of sudden death;
• very rare cases of uncontrolled movements (persistent tardive dyskinesia) occurring towards the end of treatment or after its discontinuation and with very high doses of phenothiazines. These initially occur mainly affecting the tongue, lips, nose, and cheeks.
• exceptionally, allergic reactions with effects on the skin (erythema, pruritus, urticaria, eczema, localized swelling, photosensitivity, exfoliative dermatitis);
• very rarely, allergic reactions with asthma attacks;
• menstrual cycle disturbances;
• breast enlargement in males (gynecomastia);
• spontaneous nipple discharge (galactorrhea);
• mild insomnia;
• state of excitement;
• low blood pressure;
• rapid heartbeat;
• dry mouth;
• nasal congestion;
• constipation;
• blurred vision;
• urinary problems;
• ejaculation disorders in men;
• rarely, liver disorders with yellowing of the skin, mucous membranes, and eyes (jaundice);
• rarely, blood abnormalities with reduced number of granulocytes (agranulocytosis) and platelets (thrombocytopenia);
• blood clots in the veins, especially in the legs (deep vein thrombosis), accompanied by swelling, pain, and redness of the legs. These clots may travel through blood vessels to the lungs (pulmonary embolism) and cause chest pain and breathing difficulties.
• Newborns born to mothers who have taken medicines like Neuleptil may show tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding (neonatal withdrawal syndrome and extrapyramidal symptoms). If any of these symptoms occur, contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neuleptil

Keep this medicine out of the sight and reach of children.
Neuleptil 10 mg tablets
Do not store above 25°C.
Neuleptil 2 g/100 ml oral drops, solution
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Neuleptil contains
Neuleptil 10 mg tablets

• The active substance is periciazine. Each tablet contains 10 mg of periciazine.
• The other components are: lactose, starch, precipitated silica, magnesium stearate.

Neuleptil 2 g/100 ml oral drops, solution

• The active substance is periciazine. 1 ml of solution contains 20 mg of periciazine.
• The other components are: sucrose, glycerol, alcohol, E150, tartaric acid, ascorbic acid, peppermint essence, purified water.

Description of the appearance of Neuleptil and contents of the pack
Neuleptil 10 mg tablets
Each pack contains 30 tablets of 10 mg.
Neuleptil 2 g/100 ml oral drops, solution
Each pack contains 1 bottle of 10 ml (1 drop = 0.5 mg)

Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia