Clozapine Aurovitas 100 mg tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clozapine Aurovitas 100 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Clozapine Aurovitas is and what it is used for
What you need to know before taking Clozapine Aurovitas
How to take Clozapine Aurovitas
Possible side effects
How to store Clozapine Aurovitas
Contents of the pack and other information

1. What Clozapine Aurovitas is and what it is used for

The active substance in Clozapine Aurovitas is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders such as psychosis).

Clozapine is used to treat patients with schizophrenia when other medicines have not worked. Schizophrenia is a mental illness that affects how a person thinks, feels, and behaves. This medicine should only be used if you have already tried at least two other antipsychotic medicines, including one of the newer atypical antipsychotics for treating schizophrenia, and these medicines were ineffective or caused serious adverse reactions that cannot be managed.

Clozapine is also indicated for the treatment of severe disorders of thought, emotional disturbances, and behavioural disorders occurring in Parkinson's disease, when other treatments have not been effective.

2. What you need to know before taking Clozapina Aurovitas

Do not take Clozapina Aurovitas if:

You are allergic to clozapine or to any of the other components of clozapine (listed in section 6).
You have ever been told that you have a low white blood cell count (e.g. leukopenia or agranulocytosis), especially if it was caused by other medicines. This does not apply if you had a low white blood cell count caused by previous chemotherapy.
You previously had to stop using clozapine because it caused you serious adverse reactions (e.g. agranulocytosis or any heart problems).
You are currently being or have been treated with long-acting depot injections of antipsychotics.
You have or have had a bone marrow disorder.
You have uncontrolled epilepsy (seizures or fits).
You have had severe mental disturbances caused by alcohol or other medicines (e.g. narcotics).
You experience episodes of loss of consciousness and intense drowsiness.
You have circulatory collapse that may occur as a result of severe shock.
You have a serious kidney disease.
You have myocarditis (inflammation of the heart muscle).
You have any other serious heart disease.
You have symptoms or active liver disease such as jaundice (yellowing of the skin and eyes, feeling unwell, and loss of appetite).
You have any other serious liver disease.
You have paralytic ileus (your intestine does not function properly and you have severe constipation).
You are taking any medicine that prevents your bone marrow from working properly.
You are taking any medicine that reduces the number of white blood cells in your blood.

Inform your doctor and do not take clozapine if any of the above apply to you.

Clozapine must not be administered to anyone who is unconscious or in a coma.

Warnings and precautions

The safety measures described in this section are very important. You must follow them to minimize the risk of serious adverse reactions that could be life-threatening.

Before starting treatment with Clozapina Aurovitas, inform your doctor if you have or have had:

Blood clots or a family history of blood clots, as this type of medicine has been associated with blood clot formation.
Glaucoma (increased pressure in the eye).
Diabetes. Elevated blood glucose levels (sometimes markedly) have occurred in patients with or without a prior medical history of diabetes mellitus (see section 4).
Prostate problems or difficulty urinating.
Any heart, kidney, or liver disease.
Chronic constipation or if you are taking medicines that cause constipation (such as anticholinergics).
Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Controlled epilepsy.
Diseases of the large intestine.
Abdominal surgery.
A heart condition or family history of abnormal heart conduction known as “QT interval prolongation.”
Risk of stroke, for example, if you have high blood pressure, cardiovascular problems, or blood vessel problems in the brain.
If you have ever had a severe skin rash, skin peeling, blistering, or mouth sores after taking clozapine.
This medicine may cause serious skin reactions. Stop taking clozapine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions.

Before taking your next dose of Clozapina Aurovitas tablets, inform your doctor immediately if:

You have signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. You will need an urgent blood test to determine whether these symptoms are related to the medicine.
You have a sudden increase in body temperature, muscle rigidity that may lead to loss of consciousness (neuroleptic malignant syndrome), as this may be a serious adverse effect requiring immediate treatment.
You have a fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unusual tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
You have nausea, vomiting, and/or loss of appetite. Your doctor should examine your liver.
You have severe constipation. Your doctor should treat you to prevent further complications.
You experience constipation, abdominal pain, abdominal tenderness, fever, abdominal distension, and/or bloody diarrhea. Your doctor will need to examine you.
You develop signs and symptoms of appendicitis; these may include severe abdominal pain that worsens, starts near the navel, spreads to the lower right side, and intensifies with movement, coughing, or pressure on the area. Other signs may include constipation, abdominal swelling, malaise, low-grade fever, vomiting, loss of appetite, or diarrhea. Your doctor should perform an urgent medical examination.

Medical examinations and blood tests

Before starting treatment with clozapine, your doctor will ask about your medical history and perform a blood test to ensure your white blood cell count is normal. This is important because you need white blood cells to fight infections.

Make sure you have blood tests performed regularly before, during, and after stopping clozapine treatment.

Your doctor will inform you exactly when and where these tests will be performed. You may only take clozapine if you have a normal blood count.
Clozapine may cause a severe decrease in white blood cells in your blood (agranulocytosis). Only regular blood tests can allow your doctor to determine if you are at risk of developing agranulocytosis (see section 4).
This blood test must be performed weekly during the first 18 weeks of clozapine treatment, and thereafter at least once a month during the following 34 weeks.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then annually, if no decrease in white blood cell count is detected.
If there is a decrease in the number of white blood cells, you must stop clozapine treatment immediately. Your white blood cell count should return to normal.
Blood tests must be performed for 4 weeks after stopping clozapine treatment, either due to complete discontinuation for hematological reasons (i.e., agranulocytosis), or if monitoring duration is less than 2 years, or if you have a history of neutropenia that did not lead to treatment discontinuation.

Before starting treatment, your doctor will also perform a physical examination. Your doctor may perform an electrocardiogram (ECG) to examine your heart, but only if necessary for you or if you have specific concerns.

If you have liver abnormalities, periodic liver function tests will be performed throughout clozapine treatment.

If you have elevated blood glucose levels (diabetes), your doctor may periodically check your glucose levels.

Clozapine may alter blood lipid levels. Clozapine may cause weight gain. Your doctor may monitor your weight and lipid levels.

If you feel dizzy, lightheaded, or faint, or if clozapine causes these symptoms, be careful when getting up from a sitting or lying position, as this may increase the risk of falls.

If you are scheduled for surgery or for any reason cannot walk for a prolonged period, inform your doctor that you are taking clozapine. You may be at risk of developing thrombosis (blood clot in a vein).

Children and adolescents under 16 years of age

If you are under 16 years of age, you must not take clozapine, as there is insufficient information on its use in this age group.

Elderly patients (60 years of age and older)

Elderly patients (60 years of age and older) may be more likely to experience the following adverse effects during clozapine treatment: weakness or drowsiness after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

Inform your doctor or pharmacist if you have a condition called dementia.

Other medicines and Clozapina Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription or herbal remedies. You may need to take different doses of your medicines or different medicines altogether.

Do not take Clozapina Aurovitas together with other medicines that impair proper bone marrow function and/or reduce the number of blood cells produced by the body, such as:

Carbamazepine, a medicine used for epilepsy.
Certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
Certain pain medicines: analgesics of the pyrazolone group, such as phenylbutazone.
Penicillamine, a medicine used to treat rheumatoid joint inflammation.
Cytotoxic agents, medicines used in chemotherapy.
Long-acting depot injections of antipsychotic medicines.

These medicines increase your risk of developing agranulocytosis (lack of white blood cells).

Taking clozapine together with other medicines may affect the proper action of clozapine and/or the other medicines. Inform your doctor if you intend to take, are currently taking (even if treatment is about to end), or have recently stopped taking any of the following medicines:

Medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
Other antipsychotic medicines used to treat mental illnesses, such as perazine.
Benzodiazepines and other medicines used to treat anxiety or sleep disorders.
Narcotics and other medicines that may affect your breathing.
Medicines used to control epilepsy, such as phenytoin and valproic acid.
Medicines used to treat high or low blood pressure, such as adrenaline and noradrenaline.
Warfarin, a medicine used to prevent blood clotting.
Antihistamines, medicines used for colds and allergies such as allergic rhinitis.
Anticholinergic medicines, used to relieve stomach cramps, spasms, and dizziness.
Medicines used to treat Parkinson's disease.
Digoxin, a medicine used to treat heart problems.
Medicines used to treat fast or irregular heartbeat.
Some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
Some antibiotics, such as erythromycin and rifampicin.
Some medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors, used to treat HIV infection).
Atropine, a medicine that may be used in certain eye drops or cold and cough preparations.
Adrenaline, a medicine used in emergency situations.
Hormonal contraceptives (birth control pills).

This list is not complete. Your doctor and pharmacist have more information about medicines that should be used with caution or avoided while taking clozapine. They also know whether the medicines you are taking belong to any of the groups listed above. Discuss this with them.

Taking Clozapina Aurovitas with food and drinks

Do not drink alcohol during treatment with clozapine.

Inform your doctor if you smoke and how frequently you consume caffeine-containing beverages (coffee, tea, cola drinks). Sudden changes in your smoking habits or caffeine intake may also alter the effects of clozapine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and possible risks of using this medicine during pregnancy. Inform your doctor immediately if you become pregnant during clozapine treatment.

The following symptoms may occur in newborn babies of mothers who used clozapine during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you should contact your doctor.

Some women who take certain medicines for mental illnesses may have irregular or absent menstrual periods. If this has happened to you, your periods may return to normal when your medication is switched to clozapine. This means you should use effective contraception.

During treatment with clozapine, you must not breastfeed your baby. Clozapine, the active substance in Clozapina Aurovitas, may pass into breast milk and affect the baby.

Driving and using machines

Clozapine may cause tiredness, drowsiness, and seizures, especially at the beginning of treatment. You must not drive or operate machinery while experiencing these symptoms.

Clozapina Aurovitas contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Clozapine Aurovitas

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

To reduce the risk of hypotension, seizures, and drowsiness, your doctor must gradually increase your dose. Follow exactly the instructions for taking clozapine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is important that you do not change the dose or stop taking clozapine without first asking your doctor. Continue taking the tablets for as long as your doctor has told you to.

If you are a patient aged 60 years or older, your doctor may start you on a lower dose and increase it more gradually, as you may be more susceptible to developing certain unexpected adverse reactions (see section 2 “What you need to know before starting to take Clozapine Aurovitas”).

If with this tablet formulation you cannot reach the dose prescribed to you, other formulations of this medicine are available to achieve the prescribed dose.

Treatment of schizophrenia

Treatment is started with 12.5 mg (half a 25 mg tablet) once or twice on the first day, followed by 25 mg once or twice on the second day. Swallow the tablet with a glass of water. If you tolerate it well, your doctor will gradually increase your dose by increments of 25–50 mg over the next 2–3 weeks until reaching a dose of 300 mg per day. After that, the daily dose may need to be increased by 50 mg to 100 mg twice a week, or preferably once a week.

The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses per day. Some people may require higher doses. Doses up to 900 mg per day are permitted. At daily doses above 450 mg, adverse reactions (particularly seizures) may increase. Always take the lowest dose that is effective for you. Most patients should take part of the dose in the morning and part at night. Your doctor will tell you exactly how to divide your daily dose. If your daily dose does not exceed 200 mg, you may take it as a single dose at night. Once clozapine treatment is working well for you over a period of time, your doctor may try reducing your dose. You will need to take clozapine for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson’s disease

The usual starting dose of clozapine is 12.5 mg (half a 25 mg tablet) at night. Swallow the tablet with a glass of water. Your doctor will gradually increase the dose by increments of 12.5 mg, with a maximum of two increases per week, until reaching a maximum dose of 50 mg by the end of the second week. Dose increases should be stopped or postponed if you feel weak, dizzy, or confused. To avoid such symptoms, your blood pressure will be monitored during the first weeks of treatment.

The effective daily dose is usually between 25 mg and 37.5 mg, taken as a single dose at night. Doses above 50 mg per day should only be used in exceptional cases. The maximum dose is 100 mg per day. Always take the lowest dose that is effective for you.

If you take more Clozapine Aurovitas than you should

If you think you have taken more clozapine than you should, or if someone else has taken any of your tablets, inform your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

Symptoms of overdose include:

Drowsiness, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, numbness in the limbs, hand tremor, seizures, increased salivation, pupil dilation, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

If you forget to take Clozapine Aurovitas

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose. If you have stopped taking clozapine for two or more days, consult your doctor.

If you stop taking Clozapine Aurovitas

Do not stop clozapine treatment without consulting your doctor, as you may experience withdrawal symptoms.

These symptoms include sweating, headache, nausea, vomiting, and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more severe ones unless treated promptly. Your original symptoms may return. If you need to stop treatment, it is recommended to gradually reduce the dose by 12.5 mg increments over a period of 1 to 2 weeks. Your doctor will advise you on how to reduce your daily dose. If you need to stop clozapine treatment suddenly, your doctor should review your condition. If your doctor decides to restart clozapine treatment and your last dose was two days or more ago, treatment should be restarted at the initial dose of 12.5 mg.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious and require immediate medical attention:

Contact your doctor immediately before taking your next clozapine tablet if you experience any of the following:

Very common: may affect more than 1 in 10 people

Severe constipation. Your doctor should treat this to prevent further complications.
Fast heartbeat.

Common: may affect up to 1 in 10 people

Signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You will need an urgent blood test to check whether your symptoms are related to your medicine.
Seizures.
Sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

Uncommon: may affect up to 1 in 100 people

A sudden increase in body temperature, muscle stiffness that may lead to loss of consciousness (neuroleptic malignant syndrome), as this may be a serious adverse effect requiring immediate treatment.
Dizziness, lightheadedness, or fainting when standing up from a sitting or lying position, as this may increase the risk of falling.

Rare: may affect up to 1 in 1,000 people

Signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, wheezing.
Severe burning-type pain in the upper abdomen spreading to the back, accompanied by nausea and vomiting due to inflammation of the pancreas.
Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
Difficulty swallowing (which may lead to aspiration of food).
Nausea, vomiting, and/or loss of appetite. Your doctor will need to check your liver.
Signs of obesity or worsening obesity.
Interruption of breathing with or without snoring during sleep.

Rare: may affect up to 1 in 1,000 people or Very rare: may affect up to 1 in 10,000 people

Fast and irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

Very rare: may affect up to 1 in 10,000 patients

Persistent, painful erections of the penis, if you are a man. This is called priapism. If you have an erection lasting more than four hours, immediate medical treatment may be needed to avoid further complications.
Spontaneous bleeding or bruising, which could be signs of a decrease in the number of platelets in the blood.
Symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation, or confusion).
Abdominal pain, cramps, bloated abdomen, vomiting, constipation, and inability to pass gas, which may be signs and symptoms of intestinal obstruction.
Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. These symptoms may indicate the onset of a liver disorder that could rapidly progress to liver necrosis.
Nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Frequency not known (cannot be estimated from available data):

Crushing pain in the chest, sensation of pressure, tightness, or constriction in the chest (chest pain may radiate to the left arm, jaw, neck, and upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting, and palpitations (symptoms of a heart attack) which may be fatal. Seek immediate emergency medical treatment.
Chest pressure, sensation of heaviness, tightness, constriction, burning, or suffocation (signs of insufficient blood and oxygen flow to the heart) which may be fatal. Your doctor should evaluate your heart function.
Intermittent sensation in the chest of “stabbing,” “hammering,” or “fluttering” (palpitations).
Rapid and irregular heartbeats (atrial fibrillation). There may be occasional heart palpitations, fainting, difficulty breathing, or chest discomfort. Your doctor will need to check your heart.
Symptoms of low blood pressure such as dizziness, lightheadedness, fainting, blurred vision, unusual fatigue, cold and clammy skin, or nausea.
Signs of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Confirmed or highly suspected infection, accompanied by fever or low body temperature, abnormally rapid breathing, fast heart rate, altered reaction capacity and consciousness, decreased blood pressure (sepsis).
Haematological neoplasia (malignant haematological process).

A small increase in the risk of developing haematological neoplasia has been observed in patients taking clozapine, especially with prolonged treatment.

Symptoms may include:

- fever without focus
- swollen lymph nodes
- persistent infections during treatment
- weight loss
- extreme fatigue
- redness
- night sweats
- easy bleeding or bruising
Excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
Inflammation of the appendix (appendicitis).
Drastic decrease in urine production (signs of kidney failure).
Allergic reaction (swelling mainly in the face, mouth, and throat, as well as the tongue, which may cause itching or be painful).
Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. This may indicate possible liver disorders leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including life-threatening liver events such as liver failure (which may lead to death), liver damage (damage to liver cells, bile ducts in the liver, or both), and liver transplantation.
Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; bloating, heartburn, nausea or vomiting, early satiety (intestinal ulceration of the stomach and/or intestine), which may be fatal.
Severe abdominal pain worsened by movement, nausea, vomiting, even vomiting blood (or fluid resembling ground coffee); the abdomen becomes rigid with rebound tenderness spreading from the site of perforation throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) which may be fatal.
Constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may be a symptom of possible megacolon (intestinal dilation) or intestinal ischaemia/infarction which may be fatal. Your doctor will need to examine you.
Sudden chest pain with difficulty breathing with or without cough.
Onset or worsening of muscle weakness, muscle spasms, muscle pain. This may indicate a possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you.
- Sudden chest pain or abdominal pain with difficulty breathing and with or without cough or fever.
- During use of clozapine, extremely severe and serious skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS). The adverse skin reaction may appear as rashes with or without blisters. Skin irritation, edema, fever, and flu-like symptoms may occur. DRESS syndrome symptoms usually appear approximately 2 to 6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above cases apply to you, inform your doctor immediately before taking the next clozapine tablet.

Other adverse effects

Very common: may affect more than 1 in 10 people

Drowsiness, dizziness, increased saliva production.

Common: may affect up to 1 in 10 people

High levels of white blood cells in the blood (leucocytosis), high levels of a certain type of white blood cells in the blood (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, restlessness, seizures, jerky movements, abnormal movements, inability to initiate movement, inability to remain still, changes in the heart electrocardiogram (ECG) test, high blood pressure, dizziness or fainting upon changing position, nausea, vomiting, loss of appetite, dry mouth, minor abnormalities in liver function tests, loss of bladder control, difficulty urinating, fatigue, fever, increased sweating, elevated body temperature, speech disorders (e.g., difficulty articulating words).

Uncommon: may affect up to 1 in 100 people

Deficiency of white blood cells in the blood (agranulocytosis), speech disorder (e.g., stuttering).

Rare: may affect up to 1 in 1,000 people

Low levels of red blood cells in the blood (anaemia), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), fluid accumulation around the heart (pericardial effusion), high blood sugar levels, diabetes mellitus, blood clots in the lungs (thromboembolism), liver inflammation (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, elevated levels in the blood of an enzyme called creatine phosphokinase.

Very rare: may affect up to 1 in 10,000 patients

Increase in the number of blood platelets with possible blood vessel clotting, uncontrollable movements of the mouth/tongue and limbs, obsessive thoughts and repetitive compulsive behaviours (obsessive-compulsive symptoms), skin reactions, swelling in front of the ear (due to inflammation of the salivary glands), difficulty breathing, very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cessation of heartbeat (cardiac arrest), unexpected sudden death.

Frequency not known (cannot be estimated from available data):

Changes in brain wave recordings (electroencephalogram/EEG), diarrhea, stomach discomfort, burning sensation, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden uncontrolled increase in blood pressure (pseudopheochromocytoma), involuntary contractions causing the body to arch to one side (pleurothotonus), in men, ejaculation disorder where semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), rash, red-purple spots, fever or itching due to inflammation of blood vessels, inflammation of the colon causing diarrhea, abdominal pain, fever, skin color changes, butterfly-shaped facial rash, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by uncomfortable sensations during rest periods, especially in the evening or at night, temporarily relieved by movement).

In elderly patients with dementia, a small increase in the number of deaths has been reported in patients taking antipsychotics compared to those who do not.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Clozapine Aurovitas

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Do not use this medicine if you notice any changes in the appearance of the tablets.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clozapina Aurovitas

The active substance is clozapine. Each tablet contains 100 mg of clozapine.
The other components are: lactose monohydrate, corn starch, povidone (K-30), colloidal anhydrous silica, talc and magnesium stearate.

Nature of the product and pack contents

Uncoated tablets, pale yellow in colour, round, flat, bevelled, marked on one side with a "C" and a "Z" separated by a central groove, and "100" on the other side. The tablet can be divided into two equal doses.

Clozapina Aurovitas 100 mg tablets are available in blisters and high-density polyethylene (HDPE) bottles.

Pack sizes:

Blisters: 7, 14, 20, 28, 30, 40, 50, 60, 90, 100, 250 and 1,000 tablets.

HDPE bottles: 30, 50, 100 and 250 tablets (for 25 mg, 100 mg and 250 mg only).

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Clozapin PUREN 100 mg Tabletten

Spain: Clozapina Aurovitas 100 mg comprimidos EFG

France: Clozapine Arrow 100 mg comprimé sécable

Netherlands: Clozapine Auro 100 mg tabletten

Portugal: Clozapina Aurovitas

Date of the most recent revision of this leaflet: February 2026

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