CLOZAPINE AUROVITAS 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Clozapine Aurovitas 100 mg Tablets EFG

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

The active substance of 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 you think, feel, and behave. You should only use this medicine if you have already tried at least two other antipsychotic medicines, including one of the new atypical antipsychotics to treat schizophrenia, and these medicines did not work, or caused you severe side effects that cannot be treated.

Clozapine is also indicated for treating severe thought disorders, emotional reactions, and behavioral disorders that occur in Parkinson's disease, when other treatments have not been effective.

2. What you need to know before you take Clozapine Aurovitas

Do not take Clozapine Aurovitas if:

• You are allergic to clozapine or any of the other ingredients of clozapine (listed in section 6).

• You have ever been told that you have a low white blood cell count (e.g., leucopenia 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 have previously had to stop using clozapine because it caused you severe side effects (e.g., agranulocytosis or heart problems).
• You are being or have been treated with long-acting depot injections of antipsychotics.
• You have or have had a bone marrow disease.
• You have uncontrolled epilepsy (seizures or fits).
• You have had severe mental disorders caused by alcohol or other medicines (e.g., narcotics).
• You have episodes of loss of consciousness and strong drowsiness.
• You have circulatory collapse that can occur as a result of severe shock.
• You have severe kidney disease.
• You have myocarditis (inflammation of the heart muscle).
• You have any other severe 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 severe liver disease.
• You have paralytic ileus (your intestine does not work properly and you have severe constipation).
• You use any medicine that prevents your bone marrow from working properly.
• You use any medicine that reduces the number of white blood cells in your blood.

Tell your doctor and do not take clozapine if any of the above applies to you.

Clozapine should not be given to anyone who is unconscious or in a coma.

Warnings and precautions

The safety measures mentioned in this section are very important. You must comply with them to minimize the risk of severe side effects that can be life-threatening.

Before starting treatment with Clozapine Aurovitas,tell 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 the formation of blood clots.
• Glaucoma (high eye pressure).
• Diabetes. In patients with or without a medical history of diabetes mellitus (see section 4), high blood sugar levels have occurred (sometimes considerably).
• 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.
• Intestinal diseases.
• Abdominal surgery.
• A heart disease or family history of abnormal heart conduction called "prolongation of the QT interval".
• Risk of stroke, for example, if you have high blood pressure, cardiovascular problems, or problems in the blood vessels of the brain.

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

• You have signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You should have an urgent blood test to see if these symptoms are related to the medicine.
• You have a sudden increase in body temperature, muscle stiffnessthat can lead to loss of consciousness (neuroleptic malignant syndrome), as it may be a severe side effect that requires immediate treatment.
• You have rapid and irregular heartbeat, even when you are at rest, palpitations, breathing problems, chest pain, or unusual tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
• You have nausea, vomitingand/or loss of appetite. Your doctor should examine your liver.
• You have severe constipation. Your doctor should treat you to avoid other complications.
• You experience constipation, abdominal pain, abdominal tenderness, fever, abdominal distension, and/or bloody diarrhea. Your doctor will need to examine you.

Medical examinations and blood tests

Before starting treatment with clozapine, your doctor will ask you about your medical history and perform a blood test to ensure that your white blood cell count is normal. It is essential to know this, as you need white blood cells to fight infections.

Make sure you have regular blood tests before, during, and after finishing treatment with clozapine.

• Your doctor will inform you exactly when and where these tests will be performed. You can only take clozapine if you have a normal blood count.
• Clozapine can cause a severe decrease in your white blood cell count (agranulocytosis). Only with regular blood tests can your doctor know if you are at risk of developing agranulocytosis.
• This test should be done weekly during the first 18 weeks of treatment with clozapine and then at least once a month.
• If there is a decrease in the number of white blood cells, you should stop treatment with clozapine immediately. Your white blood cells should return to normal values.
• Blood tests should be performed during 4 weeks after finishing treatment with clozapine.

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 it is necessary for you or if you have a special concern.

If you have liver disorders, you will have periodic liver function tests throughout treatment with clozapine.

If you have high blood sugar levels (diabetes), your doctor may perform periodic checks of your blood sugar levels.

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

If you feel dizzy, lightheaded, or lose consciousness, or clozapine makes you feel this way, be careful when getting up from a sitting or lying position, as this can increase the risk of falls.

If you need to have surgery or if for any reason you cannot walk for a long period, tell your doctor that you are taking clozapine. You may be at risk of having a blood clot (thrombosis).

Children and adolescents under 16 years

If you are under 16 years old, you should not take clozapine, as there is not enough information available for its use in this age group.

Older people (60 years and over)

Older people (60 years and over) may be more likely to experience the following side effects during treatment with clozapine: weakness or dizziness after changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.

Tell your doctor or pharmacist if you suffer from a disease called dementia.

Other medicines and Clozapine Aurovitas

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

Do not take Clozapine Aurovitas with other medicines that prevent your bone marrow from working properly and/or decrease the number of blood cells produced by your body,such as:

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

These medicines increase your risk of developing agranulocytosis (low white blood cell count).

Taking clozapine at the same time as other medicines may affect the correct action of clozapine and/or the other medicines. Tell your doctor if you intend to take, are taking (even if treatment is about to finish), 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 can 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 rapid 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 (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infections).
• Atropine, a medicine that may be used in some eye drops or in preparations for cough and cold.
• 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 administered with caution or should be avoided while taking clozapine. They also know if the medicines you are taking belong to any of the groups listed above. Discuss this with them.

Taking Clozapine Aurovitas with food and drinks

During treatment with clozapine, do not drink alcohol.

Tell your doctor if you smoke and how often you take drinks containing caffeine (coffee, tea, cola). Suddenly changing your smoking habits or taking drinks containing caffeine can also change 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. Immediately inform your doctor if you become pregnant during treatment with clozapine.

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

Some women who take certain medicines for mental illnesses have irregular periods or do not have periods. If this has happened to you, your periods will return to normal when your medication is replaced with clozapine. This means you should use effective contraceptives.

During treatment with clozapine, you should not breastfeed your baby. Clozapine, the active substance of Clozapine Aurovitas, can pass into breast milk and affect your baby.

Driving and using machines

Clozapine can cause tiredness, drowsiness, and seizures, especially at the start of treatment. You should not drive or use machines while you have these symptoms.

Clozapine Aurovitas contains lactose

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

3. How to take Clozapina Aurovitas

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

To reduce the risk of suffering from hypotension, seizures, and somnolence, it is necessary for your doctor to gradually increase the dose. Follow the administration instructions for clozapine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential that you do not change the dose or stop taking clozapine without asking your doctor first. Continue taking the tablets for the time indicated by the doctor.

If you are a patient over 60 years old, your doctor may start treatment with a lower dose and increase it more gradually, as you may be more susceptible to developing some unexpected adverse reactions (see section 2 "What you need to know before taking Clozapina Aurovitas").

If you cannot achieve the prescribed dose with this tablet presentation, other presentations of this medication 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 the dose in amounts of 25-50 mg over the next 2-3 weeks until reaching a daily dose of 300 mg. After that, it may be necessary to increase the daily dose in amounts of 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 need higher doses. Doses of up to 900 mg per day are allowed. At daily doses above 450 mg, adverse reactions (particularly seizures) may increase. Always take the minimum dose that is effective for you. Most patients should take part of the dose in the morning and another 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 can take it as a single dose at night. Once the treatment with clozapine is working well for some time, your doctor may try to reduce the 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 initial 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 in amounts of 12.5 mg, with a maximum of two increases per week, until reaching a maximum dose of 50 mg at the end of the second week. Dose increments should be stopped or postponed if you feel weak, dizzy, or confused. To avoid these symptoms, your blood pressure will be measured 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. It can only be increased to doses above 50 mg per day in exceptional cases. The maximum dose is 100 mg per day. Always take the minimum dose that is effective for you.

If you take more Clozapina Aurovitas than you should

If you think you have taken more clozapine than you should, or if someone has taken any of your tablets, inform your doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of overdose are:

Somnolence, fatigue, lack of energy, unconsciousness, coma, confusion, hallucinations, agitation, incoherent speech, numbness in the limbs, tremors in the hands, seizures, increased saliva production, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow or difficult breathing.

If you forget to take Clozapina Aurovitas

If you forget to take a dose, take the missed dose as soon as possible. If it is almost time for the 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 the missed dose. If you have stopped taking clozapine for two or more days, consult your doctor.

If you interrupt treatment with Clozapina Aurovitas

Do not interrupt treatment with clozapine without asking your doctor, as you may have withdrawal symptoms.

These symptoms include sweating, headache, nausea, vomiting, and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms can be followed by more severe ones unless treated immediately. Your initial symptoms may recur. If you need to interrupt treatment, it is recommended to gradually decrease the dose in amounts of 12.5 mg over a period of 1 to 2 weeks. Your doctor will give you instructions on how to reduce your daily dose. If you need to interrupt your treatment with clozapine suddenly, your doctor will review you. If your doctor decides to restart treatment with clozapine and your last dose was two days or more ago, you will need to start again with the initial dose of 12.5 mg.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

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

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

Very common: may affect more than 1 in 10 people

• Severe constipation. Your doctor should treat you to avoid other complications.
• Rapid heartbeat.

Common: may affect up to 1 in 10 people

• Signs of cold, fever, flu-like symptoms, sore throat, or any other infection. An urgent blood test will be necessary to check if the symptoms you have are related to your medication.
• Seizures.
• Sudden loss of consciousness or fainting with muscle weakness (syncope).

Uncommon: may affect up to 1 in 100 people

• A sudden increase in body temperature, muscle stiffness that can lead to loss of consciousness (neuroleptic malignant syndrome), as it can be a serious adverse effect that requires immediate treatment.
• Dizziness, dizziness, or fainting when standing up from a sitting or lying position, as it can increase the risk of falls.

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 pain, burning sensation in the upper abdomen that spreads to the back accompanied by nausea and vomiting due to pancreas inflammation.
• Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
• Difficulty swallowing (which can cause food aspiration).
• Nausea, vomitingand/or loss of appetite. Your doctor will need to review your liver.
• Signs of obesity or increased obesity.
• Interruption of breathing with or without snoring during sleep.

Rare: may affect up to 1 in 1,000 peopleor very rare: may affect up to 1 in 10,000 people

• Rapid and irregular heartbeat, even at rest, palpitations, breathing problems, chest painor unexplained fatigue. 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

• Prolonged and painful erections, if you are a man. This is called priapism. If you have an erection that lasts more than four hours, you may need immediate medical treatment to avoid additional 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, frequent urination, disorientation, or confusion).
• Abdominal pain, cramps, bloated abdomen, vomiting, constipation, and inability to pass gas, which can be signs and symptoms of intestinal obstruction.
• Lack of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. These symptoms can be indicative of a liver disorder that can progress to sudden liver necrosis.
• Nausea, vomiting, fatigue, weight loss, which can be symptoms of kidney inflammation.

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

• Chest pain, feeling 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) that can cause death. Seek immediate emergency medical treatment.

• Pressure in the chest, feeling of heaviness, pressure, tightness, burning, or suffocation (signs of insufficient blood and oxygen flow to the heart) that can cause death. Your doctor should evaluate your heart function.
• Intermittent sensation in the chest of "stabbing", "pounding", 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 review your heart.
• Symptoms of low blood pressure such as dizziness, dizziness, fainting, blurred vision, unusual fatigue, cool and moist skin, or nausea.
• Signs of blood clots in the veins, especially in the legs (symptoms that include swelling, pain, and redness in the legs), which can move through the blood vessels to the lungs causing chest pain and difficulty breathing.
• Confirmed or suspected infection, accompanied by fever or low body temperature, abnormal rapid breathing, rapid heartbeat, altered reaction capacity and consciousness, decreased blood pressure (sepsis).
• Excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
• Drastic decrease in urine production (signs of kidney failure).
• Allergic reaction (swelling mainly in the face, mouth, and throat, as well as on the tongue that can be itchy or painful).

• Lack of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. This can be indicative of possible liver alterations that involve replacement of normal liver tissue with scar tissue leading to loss of liver function, including those hepatic events that lead to life-threatening consequences such as liver failure (which can lead to death), liver damage (damage to liver cells, bile duct in the liver, or both), and liver transplant.
• Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; black, tarry stools or stools with blood; bloating, heartburn, nausea, or vomiting, early feeling of fullness (ulceration of the stomach and/or intestine), which can lead to death.
• Severe abdominal pain intensified by movement, nausea, vomiting, even vomiting blood (or liquid that looks like coffee grounds); the abdomen becomes rigid with sensitivity (rebound) that spreads from the point of perforation throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) that can lead to death.

• Constipation, abdominal pain, abdominal sensitivity, fever, bloating, diarrhea with blood. This can be a symptom of possible megacolon (intestinal dilation) or intestinal ischemia/infarction that can lead to death. Your doctor will need to examine you.
• Sharp chest pain with difficulty breathing with or without cough.
• Appearance or increase of muscle weakness, muscle spasms, muscle pain. This can indicate a possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you.

• Sharp chest pain or abdominal pain with difficulty breathing and with or without cough or fever.
• During the use of clozapine, extremely intense and severe skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS). The adverse skin reaction can appear as rashes with or without blisters. There can be skin irritation, edema, and fever, and symptoms similar to those of the flu. The symptoms of DRESS syndrome 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

Somnolence, dizziness, increased saliva production.

Common: may affect up to 1 in 10 people

High levels of white blood cells in the blood (leukocytosis), high levels of a certain type of white blood cells in the blood (eosinophilia), weight gain, blurred vision, headache, tremors, stiffness, restlessness, seizures, sudden movements, abnormal movements, inability to initiate movement, inability to remain still, changes in the electrocardiogram (ECG) test of the heart, high blood pressure, dizziness or fainting when 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

Low white blood cell count in the blood (agranulocytosis), speech disorder (e.g., stuttering).

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

Low red blood cell count in the blood (anemia), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle (myocarditis) or 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 (pulmonary embolism), liver inflammation (hepatitis), liver disease that causes 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

Increased number of platelets in the blood with possible blood vessel coagulation, uncontrolled movements of the mouth/tongue and limbs, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, swelling in the 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), cardiac arrest, sudden unexpected death.

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

Changes in brain wave recording (electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden and uncontrollable increase in blood pressure (pseudopheochromocytoma), involuntary contraction that causes curvature of the body to one side (pleurothotonus), if you are a man, ejaculation disorder, in which 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 the blood vessels, colon inflammation that causes diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, 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 afternoon or evening, and which is 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 take them.

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 is not listed 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. Storage of Clozapina Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after CAD. The expiry date is the last day of the month indicated.

Store below 30 ºC.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofClozapina Aurovitas

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

Appearance of the Product and Package Contents

.

Uncoated tablets, pale yellow in color, round, flat, beveled, engraved on one face with a "C" and a "Z" with a score line in the middle and "100" on the other face. The tablet can be divided into two equal doses.

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

Package Sizes:

Blister Packs: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 and 100 mg only).

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Clozapin PUREN 100 mg Tabletten

Spain: Clozapina Aurovitas 100 mg tablets EFG

France: Clozapine Arrow 100 mg comprimé sécable

Netherlands: Clozapine Auro 100 mg tabletten

Portugal: Clozapina Aurovitas

Date of the Last Revision of this Leaflet: September 2021

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