Package Leaflet: Information for the User

Nemactil 10 mg Film-Coated Tablets

Periciazine

Read 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. Do not pass it on to others even if their symptoms are the same as yours.It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Nemactil is and what it is used for

2. What you need to know before you take Nemactil

3. How to take Nemactil

4. Possible side effects

5. Storage of Nemactil

6. Contents of the pack and additional information

Periciazine is an antipsychotic medication that possesses selective therapeutic activity over alterations of character and behavior,regardless of their origin.

This medication is indicated for treatment under the prescription of your doctor:

- Character and behavior disorders (aggressive behavior, psychomotor agitation, negativism, maladjustment to school, professional, social, or hospital community, etc.) observed in: epilepsy, mental retardation, neurosis, psychopathies, senile psychoses, alcoholism.

- Acute episodes of neurosis. Obsessive neurosis.

- Acute and chronic psychoses: schizophrenia, chronic delirium.

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 are at risk of developing increased intraocular pressure (glaucoma).
• if you are at risk of urinary retention due to problems with 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 disorders).
• in association with levodopa (medication for the treatment of Parkinson's disease), guanetidine (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 associated with sudden infant death syndrome.

Warnings and precautions

• if your body temperature suddenly increases, consult your doctor immediately, as there is a 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 have sweating or your blood pressure becomes unstable, you may be developing symptoms indicating the onset of malignant neuroleptic syndrome. Although some patients may be predisposed to developing 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 cerebral infarction.

• if you have severe heart and/or circulatory problems, as some heart medications (such as quinidine and its derivatives) may increase heart rate or decrease blood pressure if you are taking Nemactil. If you have heart problems or your heart beats more slowly, your doctor will closely monitor you during treatment.

• if you have low potassium levels in your blood, your doctor will closely monitor you during treatment.
• if you have any liver or kidney disorders, your doctor will control the levels of the medication in your blood to prevent it from accumulating in your body.
• if you have epilepsy. It may increase the risk of developing seizures, so your doctor will closely monitor you and perform an electroencephalogram. If you have any seizures, you will need to stop treatment.
• if your treatment is prolonged, your doctor may recommend an eye examination and a blood test.
• this type of medication may potentiate the development of cardiac rhythm disorders (prolongation of the QT interval) that can be severe (torsades de pointes) and cause death. Therefore, your doctor will perform the necessary controls to exclude possible risk factors before starting treatment and if necessary during treatment.
• Nemactil is not recommended for children under 3 years old. Oral solution can be used in children under 6 years old only in exceptional cases in specialized units. When administered to children of these ages, it is recommended to have strict medical monitoring of adverse reactions, mainly neurological.It is recommended to perform an annual clinical examination to evaluate the child's learning abilities, due to the cognitive impact and the need to regularly adjust the dose based on the child's clinical condition.

In elderly patients, as they are more likely to experiencedrowsiness and dizziness when getting up due to decreased blood pressure. They may also experience extrapyramidal reactions, constipation (paralytic ileus), orprostatic hypertrophy.

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

• if you have a swollen or painful abdomen, it may be the beginning of a disease called paralytic ileus, which needs 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 your levels change suddenly, you will need to stop taking Nemactil.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you 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):shivering, muscle rigidity, or weakness, drowsiness, agitation, breathing problems, reduced heart rate, or rapid heart rate, abdominal distension, constipation, and difficulty starting to breastfeed. If your baby develops any of these symptoms, you should contact your doctor.

Lactation

If you are breastfeeding a baby, 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 contains no more than 9.8 micrograms of gluten. If you are allergic to wheat (other than 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 taken recently, or may need to take any other medication.

Like other medications used to treat psychosis, if Nemactil is administered together with levodopa (medication used to treat Parkinson's disease), the effect of these medications may be canceled out.If you have Parkinson's disease, your doctor will prescribe the lowest possible dose of both medications. If you experience movement disorders, your doctor will not prescribe levodopa or will substitute it with another medication.

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

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

The combined administration of Nemactil with antihypertensive medications increases the effect of these medications and the risk of decreased blood pressure when getting up, which may cause dizziness.

The combined 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, headaches, or drug withdrawal), methadone, and talidomide, potentiate the effect of Nemactil. You should be cautious when driving or using machines.

Medications for the treatment of depression (type imipramine), medications for the treatment of allergies that act on the brain, tranquilizers, medications for the treatment of Parkinson's disease, and spasms, and disopiramida, when administered together 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 developing cardiac rhythm disorders (prolongation of the QT interval) and symptoms suggesting an unexpected increase in your body temperature (malignant neuroleptic syndrome) or lithium intoxication. Your doctor should closely monitor you if you take these two medications, especially at the beginning 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 the Parkinson's disease treatment, as the combined administration of these medications increases psychotic symptoms and cannot exert its effect.

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

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

because it may increase the risk of developing cardiac rhythm disorders.

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

Taking Nemactil with food and drinks

You should not take alcoholic beverages during Nemactil treatment, as the effect of alcohol potentiates sedation.

Follow exactly the administration instructions for Nemactil as indicated 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 essential to monitor your blood pressure due to the risk of it dropping upon rising.

Remember to take your medication.

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 for children will be 1 mg per year of age (see section "Be especially careful with Nemactil").

- 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 that your doctor has prescribed for you. If you estimate that the action 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 your treatment prematurely.

If you take more Nemactil than you should:

Consult your doctor immediately, or go to the nearest hospital. The symptoms of Nemactil overdose may include severe parkinsonian syndrome, prolonged sleep and inactivity (lethargy), difficulty speaking (dysarthria), altered movement (ataxia), stupor, coma, convulsions; dilation of the pupil of the eye (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 the event of acute overdose, it is recommended to treat symptoms and administer cardiac activity-restoring medications intravenously.

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

If you forgot to take Nemactil

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

Like all medicines, Nemactil may cause side effects, although not everyone will experience them.

To classify them, the following definitions of frequency have been used:

Very common (may affect more than one in 10 patients); common (may affect up to one in 10 patients); uncommon (may affect up to one in 100 patients); rare (may affect up to one in 1,000 patients); very rare (may affect up to one in 10,000 patients); frequency not known (cannot be estimated from 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 cell, granulocytes (agranulocytosis).

Thrombocytopenia, which is a decrease in the number of platelets (blood cells that help coagulation) found in a blood test, which may lead to bleeding and bruising (thrombotic 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: amenorrhea (lack of menstrual period), non-habitual milk secretion (galactorrhea), excessive breast volume in men (gynecomastia), difficulty regulating body temperature, lack of sexual desire, impotence, and weight gain.

Metabolism and nutrition 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 or late dystonias (incoordination or difficulty with movements, characterized by contraction of the neck, eye, mouth, etc. muscles) or tardive dyskinesia.

Extrapyramidal syndrome (absence or decrease of movement, need to move constantly, muscle contraction, 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 eye accommodation problems.

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

Eye disorders

Decrease in the tension of the eye muscles.

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

Cardiac disorders

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

Vascular disorders

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

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

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

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

Reproductive and breast disorders

There have been very rare cases of erection in the absence of sexual desire (priapism) 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 reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet.You can also report them directly through theSpanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

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 disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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. Coating: hypromellose, polyoxyethylene 20,000, demineralized water and 96° alcohol.

Appearance of the product and contents of the packaging

Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing:

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid). Spain

This leaflet was approved in May 2023

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