Nemactil 10 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nemactil 10 mg film-coated tablets

Periciazine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Nemactil is and what it is used for

Periciazine is an antipsychotic drug with selective therapeutic activity on disturbances of character and behavior, regardless of their origin.

Always under the prescription of your doctor, this medicine is indicated for the treatment of:

• Disorders of character and behavior (aggressive behavior, psychomotor agitation, negativism, maladjustment to school, professional, social, or hospital community settings, etc.) observed in: epilepsy, oligophrenia, neuroses, psychopathies, senile psychoses, alcoholism.
• Acute episodes of neuroses. Obsessive neuroses.
• Acute and chronic psychoses: schizophrenias, chronic delusions.

2. What you need to know before taking Nemactil

Do not take Nemactil

• if you are allergic to periciazine, to phenothiazines, or to any of the other components of this medicine (listed in section 6).
• if you are at risk of increased intraocular pressure (glaucoma).
• if you are at risk of urinary retention due to urethral or prostate problems.
• if you suffer from Parkinson's disease.
• if you are taking medicines for Parkinson's disease.
• if you have previously had agranulocytosis or porphyria (blood disorders).
• in combination with levodopa (a medicine used to treat Parkinson's disease), guanethidine (a medicine used to treat hypertension), or sultopride (a medicine used to treat behavioral disorders) (see "Other medicines and Nemactil").
• if you consume alcohol (see "Other medicines and Nemactil").
• if you are under 3 years of age.
• if you are under 1 year of age, as products containing phenothiazines have been associated with sudden infant death syndrome.

Warnings and precautions

• If your body temperature rises inexplicably, consult your doctor immediately due to the risk of developing a condition called neuroleptic malignant syndrome, which has been reported during treatment with this type of medicine. Symptoms include pallor, increased body temperature, nervous system disorders, altered consciousness, and muscle rigidity. If you experience sweating or unstable blood pressure, you may be developing symptoms indicating the onset of neuroleptic malignant syndrome. Although some patients may be predisposed to this syndrome with such medicines, risk factors include dehydration or brain damage.
• if you have risk factors for suffering a stroke.
• if you have serious heart and/or circulatory problems, as some heart medications (such as quinidine and its derivatives) may increase heart rate or lower your blood pressure when taken with Nemactil. If you have heart problems or a slow heartbeat, your doctor should monitor you closely during treatment.
• if you have low potassium levels in your blood, your doctor should monitor you closely during treatment.
• if you have any liver or kidney disorders, your doctor should monitor blood levels of the medicine to prevent accumulation in your body.
• if you have epilepsy. This medicine may increase the risk of seizures, so your doctor will monitor you closely, possibly performing an electroencephalogram. If you experience any epileptic seizures, treatment must be discontinued.
• if your treatment is prolonged, your doctor may recommend an eye examination and blood tests.
• this type of medicine may increase the risk of cardiac rhythm disturbances (QT interval prolongation), which can become severe (torsades de pointes) and potentially fatal. Therefore, your doctor will perform necessary checks to rule out possible risk factors before starting treatment and, if needed, during treatment.
• Nemactil is not recommended for children under 3 years of age. The oral solution may be used in children under 6 years only in exceptional circumstances and in specialized units. When administered to children in these age groups, strict medical monitoring for adverse reactions, particularly neurological ones, is recommended. An annual clinical assessment to evaluate the child's learning abilities is recommended due to potential cognitive impact and the need to regularly adjust the dose according to the child's clinical condition.

In elderly patients, there is a higher likelihood of experiencing drowsiness and dizziness upon standing due to a drop in blood pressure. They may also experience extrapyramidal reactions, constipation (paralytic ileus), or enlargement of the prostate (prostatic hypertrophy).

• You should avoid exposure to sunlight.
• In elderly patients with psychosis associated with dementia, treatment with antipsychotics may be associated with an increased risk of death.
• if you have risk factors for thromboembolism (blood clot formation) (see "Possible side effects").
• if you have diabetes mellitus or risk factors for developing it, as you should carefully monitor your blood glucose levels while taking Nemactil.
• if you experience abdominal swelling or pain, this could be the beginning of a condition called paralytic ileus, which requires urgent medical treatment.
• if you develop fever, sore throat, or any other infection, contact your doctor, who will monitor your blood cell levels. If levels change abruptly, you must stop taking Nemactil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Pregnancy

Nemactil should be avoided during pregnancy.

Consult your doctor before using this medicine if you are pregnant, planning to become pregnant, or think you may be pregnant.

The following symptoms have been reported in newborns whose mothers were treated with Nemactil during the third trimester of pregnancy (last three months): tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, reduced or rapid heart rate, abdominal distension, constipation, and difficulty initiating breastfeeding. If your baby develops any of these symptoms, contact your doctor.

Breastfeeding

If you are breastfeeding, you should not take Nemactil, as it is not known whether Nemactil passes into breast milk.

Driving and use of machines

Due to the risk of daytime drowsiness, do not drive or operate machinery, especially at the beginning of treatment.

Important information about some of the components of Nemactil

Nemactil contains gluten

This medicine contains very low levels of gluten (derived from wheat starch), and it is highly unlikely to cause problems if you have celiac disease.

One tablet contains no more than 9.8 micrograms of gluten. If you are allergic to wheat (other than celiac disease), you should not take this medicine.

Other medicines and Nemactil

Taking Nemactil with other medicines: inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

As with other medicines used to treat psychosis, if Nemactil is taken together with levodopa (a medicine used to treat Parkinson's disease), the effects of these medicines may cancel each other out. If you have Parkinson's disease, your doctor should prescribe the lowest possible dose of both medicines. If movement disorders occur, your doctor will not prescribe levodopa or will replace it with another medicine.

During treatment, avoid alcoholic beverages and medicines containing alcohol. Alcohol enhances sedation.

Concurrent administration of Nemactil with guanethidine (a medicine used to treat high blood pressure) reduces the effect of guanethidine.

Taking Nemactil together with other medicines used to lower blood pressure (antihypertensives) increases their effect and the risk of low blood pressure upon standing, which may cause dizziness.

Concurrent use with antacids (salts, oxides, and hydroxides of aluminum, magnesium, and calcium) reduces the absorption of Nemactil. Therefore, it is recommended to take them at least two hours apart.

Medicines acting on the brain such as: tranquilizers, morphine derivatives (medicines for pain and cough), barbiturates, antihistamines, sleep-inducing medicines, antidepressants, anxiolytics, clonidine and related substances (medicines for hypertension, headache, or drug withdrawal), methadone, and thalidomide, enhance the effect of Nemactil. Exercise caution when driving or operating machinery.

Medicines for depression (such as imipramine), antihistamines acting on the brain, tranquilizers, medicines for Parkinson's disease and spasms, and disopyramide, when taken with Nemactil, may increase the occurrence of adverse reactions such as urinary retention, constipation, and dry mouth.

If you are taking lithium, using both medicines together may increase the risk of cardiac rhythm disturbances (QT interval prolongation) and symptoms suggesting unexplained rise in body temperature (neuroleptic malignant syndrome) or lithium intoxication. Close monitoring by your doctor is recommended, especially at the beginning of treatment.

If you are taking medicines for Parkinson's disease (amantadine, apomorphine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole), you should not take neuroleptics. If you are being treated for Parkinson's disease with a dopaminergic medicine and require treatment with a neuroleptic, you must discontinue Parkinson's therapy, as combining these medicines worsens psychotic symptoms and prevents their intended effect.

You should inform your doctor if you are taking any of the following medicines:

• Some medicines used to treat cardiac arrhythmias: quinidine, procainamide, amiodarone, mibefradil.
• Some medicines used for various infections: erythromycin, cotrimoxazole, trimethoprim-sulfamethoxazole, azithromycin, ketoconazole, pentamidine.
• Medicines affecting gastrointestinal motility: cisapride.
• Some medicines used for allergies: terfenadine.
• Some medicines used to treat high cholesterol: probucol.
• Some medicines used to treat psychosis: haloperidol, sultopride, and other phenothiazines.
• Some medicines used to treat depression: tricyclic and tetracyclic antidepressants.
• Other medicines: organophosphates (used to treat certain types of cancer) and vasopressin (used to treat severe drops in blood pressure).

as they may increase the risk of cardiac rhythm disturbances.

There is a potential interaction between CYP2D6 inhibitors, such as phenothiazines (including periciazine), and CYP2D6 substrates. Concurrent administration of Nemactil with amitriptyline/amitriptyline N-oxide may increase plasma concentrations of amitriptyline/amitriptyline N-oxide. If you are taking these medicines, your doctor will monitor you for adverse reactions.

Taking Nemactil with food and drinks

Do not consume alcoholic beverages during treatment with Nemactil, as alcohol enhances sedation.

3. How to take Nemactil

Follow exactly the administration instructions for Nemactil as given by your doctor. If in doubt, consult your doctor or pharmacist.

When starting to take Nemactil, you should remain lying down for the hour following each dose. If your dose is high, it is important to monitor your blood pressure due to the risk of it dropping when you stand up.

Remember to take your medication.

Usual doses may vary depending on the indications and the patient's age. The daily dose should be divided into 2–3 doses:

• in patients with behavioral and personality disorders: the recommended dose for adults is 10 to 60 mg daily. The recommended dose for elderly patients is 5 to 15 mg daily. The dose for children should be 1 mg per year of age (see section “Take special care with Nemactil”).
• in patients with neurosis: the recommended dose is 50 to 250 mg daily.
• in patients with psychosis: the recommended dose is 50 to 200 mg daily.

Never change the dose prescribed by your doctor on your own. If you feel that the effect of Nemactil is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine how long your treatment with Nemactil should last. Do not stop treatment prematurely.

If you take more Nemactil than you should:

Contact your doctor immediately or go to the nearest hospital. Symptoms of Nemactil poisoning may include severe parkinsonism, prolonged drowsiness and inactivity (lethargy), difficulty speaking (dysarthria), impaired movement (ataxia), stupor, coma, seizures; dilation of the pupil of the eye (mydriasis); cardiovascular symptoms such as decreased blood pressure (hypotension), increased heart rate (ventricular tachycardia), and irregular heartbeat (arrhythmias); respiratory depression; and decreased body temperature (hypothermia). Although there is no specific antidote, in cases of acute poisoning, symptomatic treatment and intravenous administration of drugs that restore cardiac function are recommended.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Nemactil

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, Nemactil may cause adverse effects, although not everyone experiences them.

For classification purposes, the following frequency definitions have been used:

Very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Frequency not known: decrease in the number of white blood cells (leucopenia) or decrease in a type of white blood cells, granulocytes (agranulocytosis).

Thrombocytopenia, which is a decrease in the number of platelets (blood cells that help with clotting) detected in a blood test, which may lead to bleeding and bruising (thrombocytopenic purpura).

Eosinophilia, which is an increase in the number of eosinophils (a type of white blood cell) detected in a blood test.

Endocrine disorders

Frequency not known: absence of menstrual periods (amenorrhea), abnormal milk secretion (galactorrhea), excessive breast development in men (gynecomastia), difficulty regulating body temperature, loss of sexual desire, impotence, and weight gain.

Metabolism and nutrition disorders

Frequency not known: impaired glucose tolerance and high blood glucose levels (hyperglycemia).

Psychiatric disorders

Frequency not known: indifference, anxiety reactions, mood changes, agitation.

Nervous system disorders

At high doses

Frequency not known: early (early dyskinesias characterized by incoordination or difficulty of movement, including muscle contractions of the neck, eyes, mouth, etc.) or late dyskinesias.

Extrapyramidal syndrome (absence or reduction of movement, constant need to move, muscle contractions, motor excitement).

Frequency not known: sedation or drowsiness, especially at the beginning of treatment.

Frequency not known: dry mouth, constipation, paralytic ileus, risk of urinary retention, and ocular accommodation problems.

Frequency not known: neuroleptic malignant syndrome (muscle rigidity, increased body temperature, and nervous system disturbances).

Eye disorders

Decreased eye muscle tone.

Frequency not known: pigmentary retinopathy (increased pigment in the retina).

Cardiac disorders

Frequency not known: you may be predisposed to cardiac rhythm disturbances. Isolated cases with fatal outcome associated with cardiac abnormalities (see “Take special care with Nemactil”) or without apparent explanation have been reported in patients receiving this type of medication.

Vascular disorders

Formation of blood clots (venous thromboembolism) which may affect the lungs (pulmonary embolism), sometimes fatal, and cases of deep vein thrombosis.

Decrease in blood pressure upon standing (orthostatic hypotension), particularly in elderly patients and those with reduced blood volume (volume depletion).

Hepatobiliary disorders

Yellowing of the eyes and skin (cholestatic jaundice) and liver damage (cholestatic or mixed) very rarely reported in patients treated with Nemactil.

Skin and subcutaneous tissue disorders

Frequency not known: increased skin sensitivity to sunlight and allergic reactions.

Reproductive system and breast disorders

Very rare cases of erection in the absence of sexual desire (priapism) have been reported in patients treated with Nemactil.

Investigations

Positive antinuclear antibody test for systemic lupus erythematosus without symptoms.

Pregnancy, puerperium and perinatal conditions

Frequency not known: withdrawal symptoms in newborns.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nemactil

Keep this medicine out of the reach and sight of children.

Do not store above 25°C.

Do not use Nemactil after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nemactil

• The active substance is periciazine. Each tablet contains 10 mg of periciazine.
• The other components are: wheat starch (contains gluten), calcium hydrogen phosphate, magnesium stearate. Coating: hypromellose, polyethylene glycol 20,000, deionized water and 96º alcohol.

Appearance of the product and contents of the pack

Each pack contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid). Spain

This leaflet was approved in May 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/