Package Insert: Information for the Patient

Clozapina Aurovitas 100 mg Tablets EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Clozapina Aurovitas is clozapine, which belongs to a group of medications called antipsychotics (medications used to treat specific mental disorders such as psychosis).

Clozapine is used for the treatment of patients with schizophrenia when the use of other medications has not been effective. Schizophrenia is a mental illness that affects how one thinks, feels, and behaves. This medication should only be used if at least two other antipsychotic medications, including one of the new atypical antipsychotics for treating schizophrenia, have been tried and were not effective, or caused severe adverse reactions that could not be treated.

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

Do not take Clozapina Aurovitas if:

• You are allergic to clozapine or 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. leucopenia or agranulocytosis), especially if it was caused by other medications. This does not apply if you had a low white blood cell count caused by previous chemotherapy.
• You previously had to stop taking clozapine because it caused severe side effects (e.g. agranulocytosis or some heart problems).
• You are being or have been treated with long-acting depot injections of antipsychotics.
• You have or have had bone marrow disease.
• You have uncontrolled epilepsy (seizures or attacks).
• You have had severe mental disorders caused by alcohol or other medications (e.g. narcotics).
• You have episodes of loss of consciousness and strong feeling of sleep.
• You have circulatory collapse that may 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 function correctly and have severe constipation).
• You are using any medication that prevents your bone marrow from functioning correctly.
• You are using any medication that reduces the number of white blood cells in your blood.

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

Clozapine should not be administered 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 may 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 medication has been associated with blood clot formation.
• Glaucoma (elevated eye pressure).
• Diabetes. In patients with or without a medical history of diabetes mellitus (see section 4), high blood glucose levels (sometimes significantly) have been given.
• Prostate problems or difficulty urinating.
• Any heart, kidney, or liver disease.
• Chronic constipation or if you are taking medications that cause constipation (such as anticholinergics).
• Intolerance to galactose, 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 with blood vessels in the brain.

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

• You have signs ofcommon cold, fever, flu-like symptoms, sore throat, or any other infection. You will need to have an urgent blood test to see if these symptoms are related to the medication.
• You have asudden increase in body temperature, muscle stiffnessthat may lead to loss of consciousness (neuroleptic malignant syndrome), as this may be a severe side effect that requires immediate treatment.
• You haverapid and irregular heart rate, even when at rest,palpitations, breathing difficulties, chest pain, or unusual fatigue. Your doctor will examine your heart and, if necessary, refer you to a cardiologist immediately.
• You have nausea, vomitingand/orloss of appetite. Your doctor will examine your liver.
• You havesevere constipation. Your doctor will treat you to prevent other complications.
• You experienceconstipation, abdominal pain,abdominal sensitivity, fever, abdominal distensionand/ordiarrhea with blood. Your doctor will need to examine you.

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 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 stopping treatment with clozapine.

• Your doctor will inform you exactly when and where these tests will be done. You can only take clozapine if you have a normal blood count.
• Clozapine can cause a severe decrease in white blood cells (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 taking clozapine immediately. Your white blood cells should return to normal values.
• Regular blood tests should be done for 4 weeks after stopping 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 necessary for you or if you have a specific concern.

If you have liver abnormalities, you will have periodic liver function tests during treatment with clozapine.

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

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

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

If you need to undergo surgery or are unable to walk for a long period, inform your doctor that you are taking clozapine. You may be at risk of developing blood clots (blood clots in a vein).

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 adults (60 years and older)

Older adults (60 years and older) may be more prone to the following side effects during treatment with clozapine: weakness or dizziness after changing position, dizziness, rapid heart rate, difficulty urinating, and constipation.

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

Other medications and Clozapina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes those obtained without a prescription or herbal treatments. You may need to take different amounts of your medications or different medications.

Do not take Clozapina Aurovitas with other medications that prevent the correct functioning of the bone marrow and/or reduce the number of blood cells produced by the body,such as:

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

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

Taking clozapine at the same time as other medications may affect the correct action of clozapine and/or the other medications. Inform your doctor if you intend to take, are taking (even if the treatment is about to end) or have recently stopped taking any of the following medications:

• Medications used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
• Other antipsychotic medications used to treat mental illnesses, such as perazine.
• Benzodiazepines and other medications used to treat anxiety or sleep disorders.
• Narcotics and other medications that can affect your breathing.
• Medications used to control epilepsy such as phenytoin and valproic acid.
• Medications used to treat high or low blood pressure, such as adrenaline and noradrenaline.
• Warfarin, a medication used to prevent blood clotting.
• Antihistamines, medications used for colds and allergies such as allergic rhinitis.

• Anticholinergic medications, used to relieve stomach upset, spasms, and dizziness.
• Medications used to treat Parkinson's disease.
• Digoxin, a medication used to treat heart problems.
• Medications used to treat rapid or irregular heart rate.
• Some medications used to treat stomach ulcers, such as omeprazole or cimetidine.
• Some antibiotics, such as erythromycin and rifampicin.
• Some medications used to treat fungal or viral infections (such as ketoconazole or protease inhibitors used to treat HIV infections).
• Atropine, a medication that may be used in some eye drops, or in preparations for coughs and colds.
• Adrenaline, a medication used in emergency situations.
• Contraceptive hormones (birth control pills).

This list is not exhaustive. Your doctor and pharmacist have more information about medications that should be taken with caution or avoided while taking clozapine. They also know if the medications you are taking belong to any of the listed groups. Inform them.

Taking Clozapina Aurovitas with food and drinks

Do not drink alcohol during treatment with clozapine.

Inform your doctor if you smoke and how often you take beverages containing caffeine (coffee, tea, cola). Sudden changes in your smoking or caffeine habits may also change the effects of clozapine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication. Your doctor will discuss the benefits and potential risks of using this medication during pregnancy. Inform your doctor immediately if you become pregnant during treatment with clozapina.

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

Some women taking certain medications for mental illnesses have irregular or no menstrual periods. If this has happened to you, your menstrual periods will return to normal when your medication is replaced with clozapine. This means you should use effective birth control.

Do not breastfeed your baby during treatment with clozapine. Clozapine, the active ingredient in Clozapina Aurovitas, may pass into breast milk and affect the baby.

Driving and using machines

Clozapine may cause drowsiness, dizziness, and seizures, especially at the beginning of treatment. Do not drive or use machines while experiencing these symptoms.

Clozapina Aurovitas contains lactose

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

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

To reduce the risk of hypotension, convulsions, and somnolence, your doctor should gradually increase the dose. Follow exactly the administration instructions of clozapine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential not to change the dose or stop taking clozapine without asking your doctor first. Continue taking the tablets for the time your doctor has indicated.

If you are a patient 60 years of age or older, your doctor may start treatment with a lower dose and gradually increase your dose, as you may be more susceptible to developing some unexpected adverse reactions (see section 2 "What you need to know before starting to take Clozapine 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 begins with 12.5 mg (half of 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 to reach 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 permitted. At daily doses above 450 mg, adverse reactions may increase (particularly convulsions). Always take the minimum dose that is effective for you. Most patients should take part of the daily dose in the morning and the other 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 you over some time, your doctor may try to reduce 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 initial dose of clozapine is 12.5 mg (half of 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, to reach 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 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. Only in exceptional cases can doses above 50 mg per day be increased. The maximum dose is 100 mg per day. Always take the minimum 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 has taken one of your tablets, inform your doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

The symptoms of overdose are:

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

If you forgot to take Clozapine Aurovitas

If you forgot to take a dose, take the missed dose as soon as possible. If there is little time left for the next dose, do not take the missed dose and take the next dose at the time it is due. Do not take a double dose to compensate for the missed dose. If you have stopped taking clozapine for two or more days, consult your doctor.

If you interrupt treatment with Clozapine Aurovitas

Do not stop treatment with clozapine without asking 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 symptoms unless treated immediately. Your initial symptoms may recur. If you need to interrupt treatment, it is recommended to gradually reduce 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 need to review you. If your doctor decides to restart treatment with clozapine and your last dose was two days or more ago, they should start with the initial dose of 12.5 mg.

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

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

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

Inform 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 will need to treat it to prevent other complications.
• Fast heart rate.

Common: may affect up to 1 in 10 people

• Signs ofcommon cold, fever, flu-like symptoms, sore throat, or any other infection. A blood test will be required to check if the symptoms you are experiencing are related to your medication.
• Convulsions.
• Sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

Rare: 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 may be a serious side effect that requires immediate treatment.
• Dizziness, drowsiness, or fainting, when getting up from a sitting or lying position, as it may increase the risk of falling.

Very 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 pain in the upper abdomen that radiates to the back, accompanied by nausea and vomiting due to pancreatitis.
• Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
• Difficulty swallowing (which may cause aspiration of food).
• Nausea, vomitingand/orloss of appetite. Your doctor will need to check your liver.
• Signs of obesity or weight gain.
• Apnea with or without snoring during sleep.

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

• Fast and irregular heart rate, even when at rest,palpitations, breathing difficulties, chest painorunexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you immediately to a cardiologist.

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

• Long-lasting and painful erections of the penis, 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 prevent further complications.
• Bleeding or spontaneous bruising, which could be signs of a drop in platelet count in the blood.
• Symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, frequent urination, disorientation, or confusion).
• Severe abdominal pain, nausea, vomiting, constipation, and inability to pass gas, which may be signs and symptoms of intestinal obstruction.
• Loss of appetite, abdominal swelling, abdominal pain, yellowing of the skin, intense weakness, and discomfort. These symptoms may indicate that you are starting to develop a liver disorder that can progress to sudden liver necrosis.
• Nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Unknown frequency (cannot be estimated from available data):

• Pressure in the chest, feeling of oppression, pressure, 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 may cause death. Seek immediate medical treatment.

• Pressure in the chest, feeling of heaviness, oppression, constriction, burning, or asphyxia (signs of insufficient blood and oxygen flow to the heart) that may cause death. Your doctor will need to evaluate your heart function.
• Intermittent chest pain sensation of "stabbing", "beating", or "fluttering" (palpitations).
• Irregular heartbeats (atrial fibrillation). You may experience 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, fainting, blurred vision, unusual fatigue, cold and clammy 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 may travel 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 breathing, rapid heart rate, 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 the tongue, which may cause itching or be painful).

• Loss of appetite, abdominal swelling, abdominal pain, yellowing of the skin, severe weakness, and discomfort. This may be indicative of possible liver damage that can lead to liver failure, including those events that can lead to life-threatening consequences such as liver insufficiency, liver damage (damage to liver cells, bile ducts in the liver, or both), and liver transplant.
• Severe, burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; black, tar-like, or bloody stools; swelling, acid reflux, nausea, or vomiting, early feeling of fullness (intestinal ulceration of the stomach and/or intestine), which may 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 extends from the perforation point through the abdomen; fever and/or chills (intestinal perforation of the stomach and/or intestine or intestinal rupture) that may lead to death.

-Constipation, abdominal pain, abdominal sensitivity, fever, swelling, diarrhea with blood.This may be a symptom of possible megacolon (intestinal dilation) or ischemia/intestinal infarction that may lead to death.Your doctor will need to examine you.

-Acute chest pain with difficulty breathing with or without coughing.

-Appearance or increase in muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle damage (rhabdomyolysis). Your doctor will need to examine you.

• Acute chest pain or abdominal pain with difficulty breathing and with or without coughing or fever.
• During clozapine use, severe and life-threatening skin reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported. The skin reaction may appear as rashes with or without blisters. You may experience skin irritation, swelling, and fever, and symptoms similar to the flu. DRESS 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 side 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 white blood cell count in the blood (leukocytosis), high levels of a specific type of white blood cell in the blood (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, restlessness, convulsions, involuntary movements, abnormal movements, inability to initiate movement, inability to remain still, changes in the electrocardiogram (ECG) of the heart, high blood pressure, dizziness or fainting after 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).

Rare: may affect up to 1 in 100 people

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

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

Low red blood cell count in the blood (anemia), restlessness, agitation, confusion, delirium, irregular heart rate, inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), accumulation of fluid around the heart (pericardial effusion), high blood sugar levels, diabetes mellitus, blood clots in the lungs (pulmonary embolism), inflammation of the liver (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

Increased platelet count in the blood with possible blood vessel clotting, involuntary 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 triglyceride or cholesterol levels in the blood, heart muscle disease (cardiomyopathy), cardiac arrest, sudden unexpected death.

Unknown frequency (cannot be estimated from available data):

Changes in brain wave recording (electroencephalogram/EEG), diarrhea, stomach discomfort, burning, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), involuntary contraction causing curvature of the body to one side (pleurototonos), if you are a man, sexual dysfunction, in which semen enters the bladder instead of ejaculating 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, 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 periods of rest, especially in the afternoon or at night, and temporarily relieved by movement).

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

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofClozapina Aurovitas

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

Appearance of the product and contents of the package

.

Uncoated tablets, pale yellow in color, round, flat, bisected, engraved on one face with a “C” and a “Z” with a groove 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 blisters 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).

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Generiques – Lyon

26 avenue Tony Garnier,

Lyon, 69007

France

O

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 with the following names:

Germany:Clozapin PUREN 100 mg Tabletten

Spain:Clozapina Aurovitas 100 mg tablets EFG

France:Clozapine Arrow 100 mg scored tablet

Netherlands:Clozapine Auro 100 mg tablets

Portugal:Clozapina Aurovitas

Last review date of this leaflet: September 2021

For more detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)