NEMACTIL 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Nemactil 10 mg Film-Coated Tablets

Periciazine

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Nemactil and what is it used for

Periciazine is an antipsychotic medication that has selective therapeutic activity on character and behavior disorders, regardless of their origin.

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

• Character and behavior disorders (aggressive behavior, psychomotor agitation, negativism, maladjustment to school, professional, social, or hospital environment, etc.) observed in: epilepsy, oligophrenia, neurosis, psychopathy, senile psychosis, alcoholism.
• Acute episodes of neurosis. Obsessive neurosis.
• Acute and chronic psychoses: schizophrenia, chronic delirium.

2. What you need to know before taking Nemactil

Do not take Nemactil

• if you are allergic to periciazine, phenothiazines, or any of the other components of this medication (listed in section 6).
• if you have a risk of increased intraocular pressure (glaucoma).
• if you have a risk of urinary retention due to problems in the urethra or prostate.
• if you have Parkinson's disease.
• if you are taking medications for Parkinson's disease.
• if you have had agranulocytosis or porphyria (blood diseases).
• in combination with levodopa (medication for the treatment of Parkinson's disease), guanethidine (medication for the treatment of hypertension), or sultopride (medication for the treatment of behavioral disorders) (see "Use of other medications").
• if you consume alcohol (see "Use of other medications").
• if you are under 3 years old.
• if you are under 1 year old, as products containing phenothiazines are related to sudden infant death syndrome.

Warnings and precautions

• if your body temperature increases inexplicably, consult your doctor immediately, due to the risk of developing a syndrome called malignant neuroleptic syndrome, described during treatment with this type of medication, whose effects include pallor, increased body temperature, nervous system disorders, altered consciousness, and muscle rigidity. If you experience sweating or your blood pressure becomes unstable, you may be developing symptoms that indicate the onset of malignant neuroleptic syndrome. Although there are patients who may have a predisposition to suffer from this syndrome with this type of medication, there are risk factors such as dehydration or brain damage.
• if you have risk factors for suffering a stroke.

• if you have severe heart and/or circulatory problems, as some heart medications (such as quinidine and its derivatives) can increase heart rate or decrease blood pressure if you are being treated with Nemactil. If you have heart problems or your heart beats more slowly, 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 disorder, your doctor should check the levels of the medication in your blood to prevent accumulation in your body.
• if you have epilepsy. It may increase the risk of seizures, so your doctor will subject you to special control with an electroencephalogram. If you have any seizures, you will need to discontinue treatment.
• if your treatment is prolonged, your doctor may recommend an eye exam and blood test.
• this type of medication can potentiate the appearance of cardiac rhythm disorders (prolongation of the QT interval) that can be serious (torsades de pointes) and cause death. Therefore, your doctor will perform the necessary checks to exclude possible risk factors before starting treatment and, if necessary, during treatment.
• Nemactil is not recommended in children under 3 years old. The oral solution can be used in children under 6 years old only in exceptional situations in specialized units. When administered to children of these ages, strict medical surveillance of adverse reactions, mainly neurological, is recommended. An annual clinical examination is recommended to evaluate the child's learning abilities, due to the cognitive impact and the need to regularly adapt the dose depending on the child's clinical condition.

In elderly patients, as they are more likely to suffer from drowsiness and dizziness when standing up due to a decrease in blood pressure. They may also suffer from extrapyramidal reactions, constipation (paralytic ileus), or an increase in prostate size (prostatic hypertrophy).

• you should avoid exposure to the sun.
• in elderly patients with psychosis related to dementia, who are being treated with antipsychotics (possibility of presenting a higher risk of death).
• if you have risk factors for suffering from thromboembolism (blood clot formation) (see "Possible side effects").
• if you have diabetes mellitus or risk factors for developing it, as if you take Nemactil, you should properly control your blood glucose levels.

• if you have a swollen abdomen or abdominal pain, it may be the onset of a disease called paralytic ileus, which requires urgent medical treatment.

• if you have a fever, sore throat, or any other infection, consult your doctor, who will check your blood cell levels. If the levels change abruptly, you should stop taking Nemactil.

Pregnancy and Breastfeeding

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

Pregnancy

Nemactil should be avoided during pregnancy.

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

The following symptoms have been reported in newborns of mothers treated with Nemactil during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or muscle weakness, drowsiness, agitation, breathing problems, reduced heart rate or rapid heart rate, abdominal distension, constipation, and difficulty starting breastfeeding. If your baby develops any of these symptoms, you should 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 Using Machines

Due to the risk of drowsiness during the day, do not drive or use machines, especially at the beginning of treatment.

Important Information about Some of the Components of Nemactil

Nemactil contains Gluten

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

One tablet does not contain more than 9.8 micrograms of gluten. If you are allergic to wheat (different from celiac disease), you should not take this medication.

Other Medications and Nemactil

Taking Nemactil with other medications, inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Like other medications used in the treatment of psychoses, if Nemactil and levodopa (medication used for the treatment of Parkinson's disease) are administered together, the effect of these medications may be canceled. If you have Parkinson's disease, your doctor should prescribe the lowest possible dose of both medications. In case of movement disorders, your doctor will not prescribe levodopa or will replace it with another medication.

During treatment, avoid alcoholic beverages and medications that contain alcohol. The effect of alcohol potentiates sedation.

The concomitant administration of Nemactil with guanethidine (medication for the treatment of hypertension) produces a decrease in the effect of this medication.

The administration of Nemactil with other medications used to decrease blood pressure (antihypertensives) increases the effect of these and the risk of decreased blood pressure when standing up, which can cause dizziness.

The concomitant administration with antacids (salts, oxides, and hydroxides of aluminum, magnesium, and calcium) produces a decrease in the absorption of Nemactil. Therefore, it is recommended to take them at least two hours apart.

Medications that act on the brain, such as tranquilizers, morphine derivatives (medications for the treatment of pain and cough), barbiturates, medications for the treatment of allergies, sleep inducers, antidepressants, medications for the treatment of anxiety, clonidine, and related substances (medications for the treatment of hypertension, headache, or drug withdrawal), methadone, and thalidomide, enhance the effect of Nemactil. You should be cautious when driving or using machines.

Medications for the treatment of depression (such as imipramine), medications for the treatment of allergies that act on the brain, tranquilizers, medications for the treatment of Parkinson's disease, and antispasmodics, when administered concomitantly with Nemactil, increase the appearance of the following adverse reactions: urinary retention, constipation, and dry mouth.

If you are taking lithium, the combined use of the two medications may increase the risk of cardiac rhythm disorders (prolongation of the QT interval) and symptoms that suggest an inexplicable increase in body temperature (malignant neuroleptic syndrome) or lithium intoxication. It is recommended that your doctor closely monitor you if you are taking these two medications, especially at the start of treatment.

If you are taking medications 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 medication and need to be treated with a neuroleptic, you should discontinue Parkinson's disease therapy, as the concomitant administration of these medications increases psychotic symptoms and cannot exert their effect.

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

• Some medications used for the treatment of cardiac arrhythmias: quinidine, procainamide, amiodarone, mibefradil.
• Some medications used for different types of infections: erythromycin, cotrimoxazole, trimethoprim-sulfamethoxazole, azithromycin, ketoconazole, pentamidine.
• Medications that act on gastrointestinal motility: cisapride.
• Some medications used for allergies: terfenadine.
• Some medications for the treatment of high cholesterol: probucol.
• Some medications for the treatment of psychosis: haloperidol, sultopride, and other phenothiazines.
• Some medications for the treatment of depression: tricyclic and tetracyclic antidepressants.
• Other medications: organophosphates (for the treatment of certain types of cancer) and vasopressin (for the treatment of severe blood pressure drops).

as it may increase the risk of cardiac rhythm disorders.

There is a possible interaction between CYP2D6 inhibitors, such as phenothiazines (including periciazine), and CYP2D6 substrates. The concomitant administration of Nemactil with amitriptyline/amitriptyline oxide may produce an increase in amitriptyline/amitriptyline oxide plasma concentrations. If you are being treated with these medications, your doctor will monitor you for adverse reactions.

Taking Nemactil with Food and Drinks

Alcoholic beverages should not be consumed during treatment with Nemactil, as the effect of alcohol potentiates sedation.

3. How to Take Nemactil

Follow your doctor's instructions for taking Nemactil exactly. If you have any doubts, 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 essential to monitor your blood pressure due to the risk of it dropping when standing up.

Remember to take your medication.

The usual doses may vary depending on the indications and the patient's age. The daily dose will be divided into 2-3 doses:

• in patients with character and behavior disorders: the recommended dose for adults is 10 to 60 mg per day. The recommended dose for the elderly is 5 to 15 mg per day. The dose in children will be 1 mg per year of age (see "Special warnings and precautions for use").
• in patients with neurosis: the recommended dose is 50 to 250 mg per day.
• in patients with psychosis: the recommended dose is 50 to 200 mg per day.

Never change the dose your doctor has prescribed for you. If you think the effect of Nemactil is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Nemactil. Do not discontinue treatment before.

If you take more Nemactil than you should:

Consult your doctor immediately or go to the nearest hospital. The symptoms of a Nemactil overdose can be severe parkinsonian syndrome, prolonged sleep and inactivity (lethargy), difficulty speaking (dysarthria), altered movements (ataxia), stupor, coma, convulsions; dilation of the eye pupil (mydriasis); cardiovascular symptoms, such as decreased blood pressure (hypotension), increased heart rate (ventricular tachycardia), and irregular heartbeats (arrhythmias); respiratory depression; decreased body temperature (hypothermia). Although there is no specific antidote, in case of acute overdose, it is recommended to treat the symptoms and administer medications that restore cardiac activity intravenously.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Nemactil

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

4. Possible Adverse Effects

Like all medicines, Nemactil can cause adverse effects, although not all people suffer from them.

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

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

Disorders of the Blood and Lymphatic System

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

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

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

Endocrine Disorders

Frequency not known: absence of menstrual period (amenorrhea), unusual milk secretion (galactorrhea), excessive breast volume in men (gynecomastia), difficulty regulating body temperature, lack of sexual desire, impotence, and weight gain.

Metabolic and Nutritional Disorders

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

Psychiatric Disorders

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

Nervous System Disorders

At high doses

Frequency not known: early (incoordination or difficulty moving, characterized by contraction of the muscles of the neck, eye, mouth,...) or late dyskinesias.

Extrapyramidal syndrome (absence or decrease of movement, need to move constantly, muscle contraction, motor excitement).

Frequency not known: sedation or somnolence, especially at the start of treatment.

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

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

Ocular Disorders

Decrease in eye muscle tension.

Frequency not known: pigmentary retinopathy (increase in retinal pigment).

Cardiac Disorders

Frequency not known: you may have a predisposition to the appearance of cardiac rhythm alterations. There are isolated cases of fatal outcome associated with cardiac alterations (see "Be especially careful with Nemactil") or without apparent explanation in patients receiving this type of medication.

Vascular Disorders

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

Decrease in blood pressure when standing up (especially susceptible are elderly patients and those with decreased blood volume (volume depletion).

Hepatobiliary Disorders

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

Disorders of the Skin and Subcutaneous Tissue

Frequency not known: increased sensitivity of the skin to the sun and allergy.

Disorders of the Reproductive System and Breast

Very rare cases of erection without sexual desire (priapism) have been reported in patients treated with Nemactil.

Complementary Examinations

Positive result in the determination of antinuclear antibodies of lupus erythematosus without symptoms.

Pregnancy, Puerperium, and Perinatal Diseases

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Nemactil

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

Do not store at a temperature above 25°C.

Do not use Nemactil after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Nemactil

• The active ingredient is periciazine. Each tablet contains 10 mg of periciazine.
• The other components are: wheat starch (contains gluten), calcium phosphate, magnesium stearate. Varnish: hypromellose, polyoxyethylene glycol 20,000, demineralized water, and 96º alcohol.

Appearance of the Product and Content of the Packaging

Each package contains 50 tablets.

Marketing Authorization Holder and Manufacturer

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 prospectus was approved in May 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/