NEULEPTIL - PACKAGE LEAFLET - LEAFLETS

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Neuleptil - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Periciazina

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

Why is Neuleptil used? What is it for?

Neuleptil contains the active substance periciazin which belongs to the phenothiazine class of antipsychotic medicines, medicines which affect character disorders and behavioral disorders.

Neuleptil is used to treat:

behavioral disorders in the course of mental illness (psychosis and neurosis),
character disorders of adults and children,
states of mental and physical excitement.

Contraindications When Neuleptil should not be used

DO NOT take Neuleptil

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

Precautions for use What you need to know before taking Neuleptil

Talk to your doctor or pharmacist before taking Neuleptil.

Take special care with Neuleptil:

if you or someone in your family have or have had heart and blood vessel disease or disturbances in the electrical activity of the heart (QT prolongation of the electrocardiogram);
if you are taking other medicines to treat mental disorders. Your doctor will tell you which medicines you can take to avoid side effects (see section "Other medicines and Neuleptil");
if you have Parkinson's, other Parkinson's-like diseases or movement disorders, as medicines such as Neuleptil can increase muscle stiffness;
if you have a pheochromocytoma (a particular tumor of the adrenal gland);
if you have severe heart valve disease (mitral insufficiency), as your blood pressure may fall;
if you are at risk for cerebrovascular events (stroke);
if you have dementia
if you or someone in your family have or have had thrombosis (formation of blood clots in the blood vessels), as this medicine can cause blood clots;
if you have had excessive sensitivity to drugs similar to Neuleptil (phenothizins) in the past.

If you experience these symptoms while taking this medicine, contact your doctor immediately:

very high fever, or muscle stiffness,
reduction or absence of movement (akinesia),
blood pressure irregularities,
sweating,
rapid or irregular heartbeat (tachycardia, arrhythmias),
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 carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Children and adolescents

The use of Neuleptil in early childhood is not recommended.

Interactions Which drugs or foods can modify the effect of Neuleptil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 capable of causing alterations in the electrical activity of the heart (prolongation of the QT segment), since taking it at the same time can cause heart rhythm disturbances.

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

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

Neuleptil may reduce the effect of medicines to treat seizures: if you are taking these medicines the dose may need to be increased. Tell your doctor that you are taking these medicines.

Therapy with drugs such as Neuleptil increases sensitivity to atropine and phosphoric insecticides.

Neuleptil with alcohol

Therapy with medicines such as Neuleptil increases the sensitivity to alcohol.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Neuleptil should be used during pregnancy only when clearly needed and under direct medical supervision.

Infants born to mothers who took medicines like Neuleptil during the last 3 months of pregnancy showed the following symptoms: shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and difficulty in eating.

If your child will need to be carefully monitored if they have taken this medicine.

Driving and using machines

Neuleptil can alter alertness, alertness and can change reaction times, therefore it can affect the ability to drive and use machines.

Neuleptil 10 mg tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Neuleptil 2 g / 100 ml oral drops, solution contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It can be bad for your teeth.

Neuleptil 2 g / 100 ml oral drops, solution contains ethyl alcohol

This medicine contains 12.7 vol% ethanol (alcohol), eg. up to 350 mg per serving, equivalent to 8.8 ml of beer, 3.7 ml of wine per serving.

It can be harmful to alcoholics.

To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy.

Dose, Method and Time of Administration How to use Neuleptil: Posology

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Your doctor will tell you how much Neuleptil to take and the interval between doses, depending on your medical condition.

Use in psychiatry

Use in adults

The average recommended daily dose is 20-30 mg. The dose can be increased, according to the severity of the cases, up to 50-70 mg by a progressive increase of 10 mg per day.

Use in children

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

Use in elderly patients

The recommended starting dose is 5 mg per day, which can 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 average recommended daily dose is 5-20 mg. Do not increase the dose any 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 per 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 starting dose is 5 mg per day. Do not exceed 10 mg.

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

Unscrew the cap,
keep the bottle upside down.

If necessary, you can initially tap the bottle lightly with your finger.

ATTENTION: The bottle has a closure that is difficult to open for children.

To open: press the cap and unscrew

To close: screw on by pressing the cap

If you forget to take Neuleptil

Do not take a double dose to make up for a forgotten dose.

If you stop using Neuleptil

Do not stop treatment abruptly. Your doctor will tell you how.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken an overdose of Neuleptil

In case of accidental ingestion or use of an excessive dose of this medicine, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Neuleptil

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 heart rhythm abnormalities (QT 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 interruption and with very high doses of phenothiazines. these initially occur mainly 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 attacks;
alteration of the menstrual cycle;
breast enlargement in males (gynecomastia);
spontaneous discharge from the nipple of secretions (galactorrhea);
mild insomnia;
state of excitement;
low blood pressure;
rapid heartbeat;
dry mouth;
nasal congestion;
constipation;
blurred vision;
trouble urinating;
ejaculation disorders in men;
rarely changes in the liver with yellowing of the skin, mucous membranes and eye (jaundice);
rarely changes 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 in the legs. These clots can travel to the lungs through blood vessels (pulmonary embolism) and cause chest pain and difficulty in breathing.
Infants born to mothers who have taken medicines such as Neuleptil have shown tremor, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and difficulty in eating (neonatal withdrawal syndrome and extrapyramidal symptoms).

If you get any of these symptoms, contact your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.

Expiry and Retention

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 which is stated on the package after EXP. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Neuleptil contains

Neuleptil 10 mg tablets

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

Neuleptil 2 g / 100 ml oral drops, solution

The active ingredient is periciazin. 1 ml of solution contains 20 mg of periciazin.
The other ingredients are: sucrose, glycerol, alcohol, E150, tartaric acid, ascorbic acid, mint essence, purified water.

What Neuleptil looks like 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 10ml (1 drop = 0.5mg)

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Neuleptil can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

NEULEPTIL

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

Neuleptil 10 mg tablets

Each tablet contains active ingredient:

Periciazine 10 mg.

Neuleptil 2g / 100ml oral drops, solution

100 ml of oral drops, solution contains active ingredient:

Periciazina 2 g

(1 drop = 0.5 mg of periciazin).

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Tablets.

Oral drops, solution.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Behavioral disturbances in chronic psychosis and neurosis; character disorders of adults and children, states of psychomotor excitement.

04.2 Posology and method of administration -

The dosage of Neuleptil and the distribution of the dose during the day must be as individual as possible and will be established by the doctor, case by case, according to clinical needs.

The daily dosage should be divided regularly when a mild and constant effect is desired; it must instead be concentrated in the evening administration if a predominantly nocturnal sedative action is desired or to avoid any phenomena of daytime sleepiness.

Never stop treatment abruptly.

In psychiatry - In the adult: the average daily dosage is 20-30 mg; it can be raised, depending on the severity of the cases, up to 50-70 mg by a progressive increase of 10 mg per day.

In the child: 5 to 10 mg per day, with a maximum of 10 mg per day.

In the "elder: start with 5 mg per day and gradually increase up to the useful dose of 15 mg per day, exceptionally up to that of 20-30 mg per day.

In internal medicine - In the adult: The average daily dosage is 5-20 mg and should not usually be elevated further.

In the child: 0.25 mg / kg of body weight without exceeding 5 mg per day (ie 1 drop every 2 kg of weight up to a maximum of 10 drops); keep the dosage at 2.5-5 mg per day.

In the "elder: start therapy with 5 mg per day and do not exceed 10 mg.

04.3 Contraindications -

Comatose states, severe states of depression, hematopoiesis disorders, hepatic affections and hypersensitivity to phenothiazines.

04.4 Special warnings and appropriate precautions for use -

Use with caution in patients with cardiovascular disease or a family history of QT prolongation.

Avoid concomitant therapy with other neuroleptics.

The association with other psychotropic drugs requires particular caution and vigilance on the part of the physician, in order to avoid unexpected undesirable effects from interaction. Please read the section "Interactions" carefully, since the drug interacts with other therapies to which the patient may be subjected. Phenothiazines. may increase the state of muscle stiffness in predisposed individuals, in patients with Parkinson's disease, Parkinson-like forms or other motor disorders. Particular attention should be paid to patients with pheochromocytoma or mitral insufficiency for any hypotensive effects that may occur verify, however, controllable with norepinephrine (not with adrenaline, whose action can be antagonized by phenothiazines).

Use in young children is not recommended.

Patients being treated with neuroleptics should be kept under direct medical supervision, particularly those who have previously exhibited abnormal sensitivity to phenothiazines.

A significant rise in body temperature can be the expression of an idiosyncratic reaction and therefore treatment must be stopped.

Due to possible interactions with other drugs, the patient should advise their doctor of any other drug they are being treated with.

A potentially fatal symptom complex called Neuroleptic Malignant Syndrome has been reported during treatment with antipsychotic drugs. Clinical manifestations of this syndrome are: hyperpyrexia, muscle stiffness, akinesia, vegetative disorders (irregularities in the pulse and blood pressure, sweating, tachycardia, arrhythmias); changes in consciousness which can progress to stupor and coma. The treatment of the S.N.M. it consists in immediately suspending the administration of antipsychotic drugs and other non-essential drugs and in instituting intensive symptomatic therapy (particular care must be taken to reduce hyperthermia and correct dehydration). If the resumption of antipsychotic treatment is deemed essential, the patient should be carefully monitored.

An approximately three-fold increase in the risk of cerebrovascular events was observed in randomized clinical trials versus placebo in a population of patients with dementia treated with some atypical antipsychotics. The mechanism of this increased risk is unknown. An increased risk for other antipsychotics or other patient populations cannot be excluded. Neuleptil should be used with caution in patients with risk factors for stroke.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, these factors must be identified before and during treatment with Neuleptil and in order to take adequate preventive measures.

Neuleptil tablets contain lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Neuleptil drops contains sucrose are therefore not suitable for subjects with hereditary fructose intolerance, glucose / galactose malabsorption syndrome or sucrase-isomaltase deficiency.

04.5 Interactions with other medicinal products and other forms of interaction -

When neuroleptics are given concomitantly with QT-prolonging drugs, the risk of developing cardiac arrhythmias increases.

Do not administer concomitantly with drugs that cause electrolyte disturbances.

Since phenothiazines can accentuate the depressing action on the central nervous system of opiates, antihistamines, analgesics and barbiturates or other psychotropic drugs, the dosage of these drugs, if used concomitantly, will have to be suitably adjusted.

Sensitivity to alcohol, atropine and phosphoric insecticides is accentuated during therapy with phenothiazines.

However, if the patient is being treated concomitantly with an anticonvulsant, a higher dose of this drug may be required.

04.6 Pregnancy and breastfeeding -

In pregnant women, the product should be administered in cases of real need and under direct medical supervision.

Infants exposed to conventional or atypical antipsychotics, including Neuleptil, during the third trimester of pregnancy are at risk for side effects including extrapyramidal or withdrawal symptoms which may vary in severity and duration after birth. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, food intake disturbances. Infants should therefore be closely monitored.

04.7 Effects on ability to drive and use machines -

Like all neuroleptics, periciazin should be used with caution in patients who perform activities in which a continuous state of alertness and alertness such as driving or using machines is required, since, like any other medicament active on the central nervous system, it can modify the reaction times.

04.8 Undesirable effects -

After administration of phenothiazines, extrapyramidal neurological manifestations can be observed, mainly with dyskinetic symptoms, mostly controllable with specific drugs.

The following side effects have been observed with other drugs of the same class: rare cases of QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest. Very rare cases of sudden death.

The occurrence of persistent tardive dyskinesia is very rare, sometimes manifesting itself towards the end of treatment or after its termination and with very high doses of phenothiazines.

A warning symptom appears to be a particular movement of the tongue. It is advisable to observe this symptom, together with the uncontrolled movements of the lips, nose and cheeks, as tardive dyskinesia, unlike other manifestations of parkinsonism, tends to last for a long time, is difficult to reverse and is resistant to normal therapies. Exceptionally, allergic reactions characterized by localized or diffuse skin phenomena have been reported (more rarely these are idiosyncrasies with fever): erythema, itching, urticaria, eczema, localized edema, photosensitization phenomena, exfoliative dermatitis and, very rarely, asthma attacks.

Changes in the menstrual cycle, gynecomastia, galactorrhea, mild insomnia, paradoxical arousal, arterial hypotension, tachycardia, dry mouth, nasal congestion, constipation, blurred vision, urination and ejaculation disturbances in men have been observed. described, following treatment with phenothiazines, changes in the liver with jaundice and in the blood crase with agranulocytosis and thrombocytopenia.

Cases of venous thromboembolism (VTE) have been reported, including cases of pulmonary embolism (PE) and deep vein thrombosis (VTE). The frequency of these events is unknown.

Organic system class: pregnancy, puerperium and perinatal conditions:

Adverse reaction and frequency: neonatal withdrawal syndrome, frequency not known, extrapyramidal symptoms (See section 4.6).

04.9 Overdose -

Gastric lavage should be performed and supportive medications such as norepinephrine (not adrenaline) should be given if necessary.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: antipsychotics.

ATC code: N05AC01.

Neuleptil (periciazine), a derivative of phenothiazine and precisely 3-cyano-10-3 "- (4" "- hydroxypiperidin) -propyl-phenothiazine, is a synthetic neuroleptic, with symptomatic activity on character and behavioral disorders.

The treatment with Neuleptil allows to obtain: a regulating effect of mental processes, with improvement of contact, coordination of thought and capacity for synthesis and criticism; a regulating effect of the will, with regard to emotional and motor reactions, with a reduction in impulsivity and an increase in the power of control with normalization of behavior; a sedative and mood regulating effect, with regularization and improvement of sleep, decrease and disappearance of anxiety and excitement.

05.2 "Pharmacokinetic properties -

The behavior of this drug is not unlike that of other phenothiazines.

Absorption of orally administered phenothiazines is erratic and is changed unpredictably either by food or possibly by administration of antacids.

Being lipophilic drugs and which bind to membranes or plasma proteins, they tend to accumulate in the brain, lungs and other tissues supplied by a high blood flow, easily entering the fetal circulation as well.

The metabolism varies with the age: in the fetus, in the newborn and in the elderly, the metabolic capacity is considerably reduced, while in the child it is even more rapid than in the adult.

Hydrophilic metabolites are eliminated via the kidney and, to some extent, via the biliary route.