NEULEPTIL 10 mg Tablet

Зміст інструкції

1. Neuleptil 10 mg tablets, 2 g/100 ml oral drops, solution
   1. What is Neuleptil and what is it 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

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

periciazina
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or 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 you take 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 is Neuleptil and what is it used for

Neuleptil contains the active substance periciazine which belongs to the class of antipsychotic
phenothiazine medicines, medicines that act on personality disorders and behavioral disorders.
Neuleptil is used to treat:

• behavioral disorders during mental illnesses (psychoses and neuroses),
• personality disorders in adults and children,
• states of mental and physical excitement.

2. What you need to know before taking Neuleptil

DO NOT take Neuleptil

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

Warnings and precautions
Consult your doctor or pharmacist before taking Neuleptil.
Pay particular attention with Neuleptil:

• if you or someone in your family has or has had heart and blood vessel diseases or disturbances of the electrical activity of the heart (prolongation of the QT interval on the electrocardiogram);
• if you are taking other medicines for the treatment of mental disorders. The doctor will tell you which medicines you can take to avoid unwanted effects (see section “Other medicines and Neuleptil”);
• if you have Parkinson's disease, other diseases similar to Parkinson's disease or motor disorders, because medicines like Neuleptil can increase muscle stiffness;
• if you have a pheochromocytoma (a particular tumor of the adrenal gland);
• if you have a severe heart valve disease (mitral insufficiency), because you may experience a reduction in blood pressure;
• if you are at risk for cerebrovascular events (stroke);
• if you suffer from dementia
• if you or someone in your family has or has had thrombosis (formation of blood clots in blood vessels), as this medicine can cause the formation of thrombi;
• if you have previously experienced an excessive sensitivity to medicines similar to Neuleptil (phenothiazines).

If you experience these symptoms during treatment with this medicine, contact your doctor immediately:
or very high fever,
or muscle stiffness,
or reduction or absence of movements (akinesia),
or irregular blood pressure,
or sweating,
or rapid or irregular heartbeat (tachycardia, arrhythmias),
or loss of consciousness (which can progress to stupor and coma).
These could be symptoms of a serious condition called Neuroleptic Malignant Syndrome.
For those who engage in sports, the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the concentration limits indicated by some sports federations.

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

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

• medicines that can change the levels of salts in the body.
• medicines that can cause alterations in the electrical activity of the heart (prolongation of the QT interval), as simultaneous administration can cause heart rhythm disturbances.

Neuleptil can increase the effect of the medicines listed below. If you take Neuleptil with these medicines, their dose will need to be adjusted:

• opioids (similar to morphine),
• antihistamines (for allergies),
• analgesics (to relieve pain),
• barbiturates (for epilepsy),
• other psychotropic drugs.

Neuleptil can reduce the effect of medicines for treating seizures: if you are taking these medicines, it may be necessary to increase their dose. Tell your doctor that you are taking these medicines.
Therapy with medicines like Neuleptil increases sensitivity to atropine and organophosphorus insecticides.

Neuleptil with alcohol
Therapy with medicines like Neuleptil increases sensitivity to alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Neuleptil should only be used during pregnancy in cases of actual necessity and under the direct control of the doctor.
Newborns born to mothers who have taken medicines like Neuleptil during the last 3 months of pregnancy have shown the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, respiratory problems and difficulty taking food.
If your baby will need to be carefully monitored if they have taken this medicine.

Driving and using machines
Neuleptil can alter the state of alertness, the speed of reflexes and can modify reaction times, therefore it can alter the ability to drive vehicles and use machinery.

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

Neuleptil 2 g/100 ml oral drops, solution contains sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine. It may be harmful to your 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, 3.7 ml of wine per dose.
It may be harmful to alcoholics.
To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people affected by liver disease or epilepsy.

3. How to take Neuleptil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you how much Neuleptil you need to take and the interval between administrations, based on your
clinical condition.

Use in psychiatry
Use in adults
The recommended average daily dose is 20-30 mg.
The dose may be increased, depending on the severity of the cases, up to 50-70 mg by a gradual increase
of 10 mg per day.
Use in children
The recommended average daily dose ranges from 5 to 10 mg per day, with a maximum of 10 mg per day.
Use in elderly patients
The recommended initial dose is 5 mg per day, which may be gradually increased up to 15 mg per
day, exceptionally up to 20-30 mg per day.

Use in internal medicine
Use in adults
The recommended average daily dose is 5-20 mg. Do not increase the dose further.
Use in children
The dose is assessed based on the child's body weight. The recommended dose is 0.25 mg per kg of body
weight without exceeding 5 mg per day (i.e. 1 drop every 2 kg of weight up to a maximum of 10 drops).
The maintenance dose is 2.5-5 mg per day.
Use in elderly patients
The recommended initial dose is 5 mg per day. Do not exceed 10 mg.

Instructions for use
Neuleptil 2 g/100 ml drops oral solution

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

If necessary, you can initially give a few light taps on the bottle with your finger.

WARNING: The bottle is equipped with a child-resistant closure.
To open: press
the overcap and unscrew

To close: screw
pressing the overcap

If you take more Neuleptil than you should
In case of accidental ingestion or use of an excessive dose of this medicine, immediately
inform your doctor or go to the nearest hospital.

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

If you stop taking Neuleptil
Do not suddenly stop treatment. Your doctor will tell you how to do it.
If you have any doubts about the use of this medicine, ask 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:

• uncontrolled movements of voluntary or involuntary muscles (neurological manifestations of the extrapyramidal type with dyskinetic symptoms).
• heart disorders and cardiac rhythm abnormalities (prolongation of the QT interval, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.
• very rare cases of sudden death;
• very rare cases of uncontrolled movements (persistent tardive dyskinesia) that occur towards the end of treatment or after its discontinuation and with very high doses of phenothiazines. these initially occur especially at the level of the tongue, lips, nose, cheeks.
• exceptionally allergic reactions with effects on the skin (erythema, itching, urticaria, eczema, localized swelling, sensitivity to sunlight, exfoliative dermatitis);
• very rarely allergic reactions with asthma crises;
• menstrual cycle alteration;
• enlargement of the breasts in males (gynecomastia);
• spontaneous leakage from the nipple of secretions (galactorrhea);
• mild insomnia;
• state of excitement;
• low blood pressure;
• fast heartbeat;
• dry mouth;
• nasal congestion;
• constipation;
• blurred vision;
• urination disorders;
• ejaculation disorders in men;
• rarely alterations affecting the liver with yellowing of the skin, mucous membranes and eye (jaundice);
• rarely alterations in blood parameters with reduction in the 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 can reach the lungs through the blood vessels (pulmonary embolism) and cause chest pain and difficulty breathing.
• Newborns born to mothers who have taken medicines like Neuleptil have shown tremor, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding (neonatal withdrawal syndrome and extrapyramidal symptoms). If any of these symptoms occur, consult a doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature 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 which is stated on the packaging after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Neuleptil contains
Neuleptil 10 mg tablets

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

Neuleptil 2 g/100 ml oral drops, solution

• The active ingredient is periciazine. 1 ml of solution contains 20 mg of periciazine.
• The other ingredients 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 Authorisation 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