Patient Information Leaflet: Leponex 100 mg Tablets

Clozapine

Read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Leponex is and what it is used for

2. What you need to know before taking Leponex

3. How to take Leponex

4. Possible side effects

5. Storage of Leponex

6. Contents of the pack and additional information

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

Leponex is used to treat patients with schizophrenia when the use of other medications has not been effective. Schizophrenia is a mental illness that involves thought disorders, emotional reactions, and behavioral disorders.

Leponex can only be used if you have already tried at least two other neuroleptic medications, including one of the new atypical antipsychotics for treating schizophrenia, and these medications have not responded, or caused severe adverse reactions that cannot be treated.

Leponex 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.

Do not take Leponex if:

• You are allergic (hypersensitive) to clozapine or any of the other components of Leponex (listed in section 6).
• You will not be able to have blood tests periodically.
• 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 Leponex because it caused 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 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 a strong feeling of sleep that is difficult to control.
• 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 (intestinal obstruction, your intestine does not function correctly and you 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 Leponex if any of the above circumstances apply.

Leponex 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 can be life-threatening.

Before starting treatment with Leponex,inform your doctor if you have or have had any of the following circumstances:

• 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 history of diabetes mellitus (see section 4), elevated blood glucose levels (sometimes significantly) have been reported.
• prostate problems or difficulty urinating.
• any heart, kidney, or liver disease.
• chronic constipation or are taking medications that cause constipation (such as anticholinergics).
• galactose intolerance, Lapp-Lactase deficiency, or glucose-galactose malabsorption.
• controlled epilepsy.
• intestinal diseases.
• abdominal surgery.
• a heart condition or family history of abnormal heart conduction called "prolonged QT interval."
• risk of stroke, for example, if you have high blood pressure, cardiovascular problems, or problems with blood vessels in the brain.

Immediately before taking the next dose of Leponex tablets inform your doctor if:

• You have signs offlu, fever, symptoms similar to the flu, 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 a sudden increase in body temperature, muscle stiffness that can lead to altered 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 problems, chest pain, or unusual fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
• You have nausea (feeling of dizziness), vomiting (feeling dizzy)and/orloss of appetite. Your doctor will need to examine your liver.
• You havesevere constipation. Your doctor will need to treat you to prevent other complications.

- 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 Leponex, your doctor will ask you about your medical history and will 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 Leponex.

• Your doctor will inform you exactly when and where these tests will be done. You can only take Leponex if you have a normal blood count.
• Leponex may cause a severe decrease in white blood cells in your blood (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 Leponex and then at least once a month.
• If there is a decrease in the number of white blood cells, you must stop taking Leponex immediately. Your white blood cells should return to normal values.
• Blood tests should be done for 4 weeks after stopping treatment with Leponex.

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

If you have liver damage, you will have periodic tests of liver function during treatment with Leponex.

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

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

If you have mild headache pain, dizziness, or weakness, or if Leponex 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 Leponex. 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 Leponex as there is not enough information available for its use in this age group.

Use in elderly patients (60 years and older)

Elderly patients may be more susceptible to the following side effects during treatment with Leponex: mild headache or dizziness after changing position, dizziness, rapid heart rate, urinary retention, and constipation.

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

Use of Leponex with other medications

Inform your doctor or pharmacist if you are taking, have taken recentlyor may need to take anyother medication, even those purchased without a prescription or herbal treatments. You may need to take different amounts of your medications or different medications.

Do not take Leponex 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 to treat epilepsy.
• Certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
• Certain pain medications: analgesics in 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).

The use of Leponex with other medicationsmay affect the correct action ofLeponex and/or theother medications. Inform your doctor ifyou intend to take, are taking(even if the treatment is about to end) or have recently stoppedany 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 to treat colds and allergies, such as hay fever (seasonal 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 HIV (such as protease inhibitors).
• Atropine, a medication that may be used in some eye drops, or in cough and cold preparations.
• Adrenaline, a medication used in emergency situations.
• Oral contraceptives (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 Leponex. They also know if the medications you are taking belong to any of the groups listed above. Inform them.

Taking Leponex with food and drinks

Do not drink alcohol during treatment with Leponex.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, 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 Leponex.

The following symptoms may appear in newborn babies, from mothers who have used Leponex in the last trimester (the last three months of pregnancy): tremors, muscle stiffness, weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you need to 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 by Leponex. This means you should use effective birth control.

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

Driving and operating machinery

Leponex may cause drowsiness, dizziness, and seizures, especially at the beginning of treatment. Therefore, you should avoid driving or operating machinery while experiencing these symptoms.

Leponex may cause symptoms such as drowsiness, dizziness, or vision disturbances and may reduce your reaction time. These effects, as well as the underlying illness, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Leponexcontains lactose.

If your doctor has informed you that you have intolerance to some sugars, contact your doctor before taking this medication.

To reduce the risk of seizures, drowsiness, or low blood pressure as much as possible, your doctor will need to gradually increase your dose. Follow exactly the administration instructions for Leponex as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

If you are 60 years old or older, your doctor may start you on a lower dose and gradually increase it, as you may be more susceptible to developing unexpected adverse reactions. (See section 2 "What you need to know before starting to take Leponex").

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 the help of a glass of water. If you tolerate it well, your doctor will gradually increase the dose in amounts of 25 or 50 mg over 2 to 3 weeks to reach a daily dose of 300 mg. It may be necessary to continue increasing the dose in amounts of 50 or 100 mg twice a week, or preferably once a week.

The normal daily dose of clozapine is between 200 and 450 mg, divided into several 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 may increase (particularly seizures). Always take the minimum dose that is effective for you. Most patients must take a part of the dose in the morning and another in the evening. 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 Leponex is working well for you for some time, your doctor will try the treatment with lower doses. You will need to take Leponex for at least 6 months.

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

The initial normal dose of clozapine is 12.5 mg (half of a 25 mg tablet) at night. Swallow the tablet with the help of 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 up to 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 measured during the first weeks of treatment.

The effective daily dose is between 25 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 Leponex than you should

If you think you have taken more Leponex than you should, or if someone has taken some of your tablets, inform your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 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 extremities, tremors in the hands, seizures, increased saliva production, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

If you forget to take Leponex

If you forget 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 Leponex for two or more days, do not start treatment without first consulting your doctor.

If you interrupt treatment with Leponex

Do not stop treatment with Leponex without asking your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea (feeling dizzy), vomiting (feeling dizzy), and diarrhea.If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more severe symptoms unless you are 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 suddenly, your doctor will examine you. If your doctor decides to restart treatment with Leponex and your last dose of Leponex was two days or more ago, they should start it 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, Leponex 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 Leponex tablet if you experience any of the following circumstances:

Very common(affects more than 1 in 10 patients):

-Severe constipation. Your doctor will need to treat you to prevent other complications.

- rapid heart rate.

Common(affects up to 1 in 10 patients):

-signs ofcommon cold, fever, flu-like symptoms, sore throat, or any other infection. You will need to have an urgent blood test to check if the symptoms you are experiencing are related to your medication.

-seizures.

- sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

Rare(affects up to 1 in 100 patients):

-rapid increase in body temperature, muscle stiffness that can lead to altered consciousness (neuroleptic malignant syndrome), as it may be a serious side effect that requires immediate treatment.

- mild headache, dizziness, or weakness, when getting up from a sitting or lying position, as it may increase the risk of falling.

Uncommon(affects up to 1 in 1,000 patients):

-signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, and wheezing.

- severe, burning, and intense 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 can cause food inhalation).

- nausea (feeling sick), vomiting (being sick), and/or loss of appetite. Your doctor will need to confirm your liver.

- signs of obesity or weight gain.

- interruptions in breathing with or without snoring during sleep.

-nausea (feeling sick), vomiting (being sick)and/orloss of appetite. Your doctor will need to examine your liver.

Uncommon(affects up to 1 in 1,000 patients)orvery rare(affects up to 1 in 10,000 patients):

-rapid and irregular heart rate, even when at rest,palpitations, breathing difficulties, chest painorunusual fatigue. Your doctor will need to check your heart and, if necessary, immediately refer you to a cardiologist.

Very rare(affects up to 1 in 10,000 patients):

-persistent and painful erections of the penis, if you are a man. If you have an erection that lasts more than four hours, you may need immediate medical treatment to prevent further complications.

-spontaneous bleeding or bruising, which could be signs of a decrease in platelet count 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, swollen abdomen, vomiting, constipation, and lack of gas passage, which may be signs and symptoms of intestinal obstruction.

-loss of appetite, swollen abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. These symptoms may be indicative of liver disease that can progress to sudden liver necrosis.

-nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Unknown(the frequency cannot be estimated from available data):

-crushing chest pain, feeling of oppression, pressure, or constriction (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 cause death. Seek immediate medical treatment.

-pressure in the chest, heaviness, oppression, constriction, burning, or asphyxia (signs of insufficient blood and oxygen flow to the heart), which may cause death. Your doctor will need to evaluate your heart function.

- intermittent chest pain in a "stinging", "accelerated", or "agitated" manner (palpitations).

- rapid and 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 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 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, rapid and abnormal breathing, rapid heart rate, altered reaction and consciousness, decreased blood pressure (sepsis).
• 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 in the tongue that may cause itching or be painful).

-loss of appetite, swollen abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. This may be indicative of possible liver alterations that involve replacing normal liver tissue with scar tissue leading to liver function loss, including those liver events that lead to life-threatening consequences such as liver insufficiency (which may lead to death), liver damage (damage to liver cells, bile ducts in the liver, or both) and liver transplant.

- abdominal pain, cramps, swollen abdomen, vomiting, constipation, and lack of gas passage, which may be signs and symptoms of stomach and/or intestinal ulceration.

- abdominal pain, cramps, swollen abdomen, vomiting, constipation, and lack of gas passage, which may be signs and symptoms of intestinal perforation or intestinal rupture.

- constipation, abdominal pain, abdominal sensitivity, fever, swelling, diarrhea with blood. This may be a symptom of possible megacolon (expansion of the intestines) or ischemia/intestinal infarction/necrosis, which may lead to death. Your doctor will need to examine you.

- appearance or increase of muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle alteration (rhabdomyolysis). Your doctor will need to examine you.

- acute pain in the chest or abdomen with difficulty breathing with or without cough or fever.

During the use of Leponex, severe and intense 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. Skin irritation, swelling, and fever, and symptoms similar to the flu may occur. 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 Leponex tablet.

Other side effects:

Very common(affects more than 1 in 10 patients):

Drowsiness, dizziness, increased saliva production.

Common(affects up to 1 in 10 patients):

High levels of white blood cells 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, agitation, convulsions, involuntary movements, abnormal movements, inability to initiate movement, inability to remain still,changes in the electrocardiogram (ECG) of the heart,high blood pressure, weakness or mild headache after changing position, nausea (feeling sick), vomiting (being sick), 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. slurred words).

Rare(affects up to 1 in 100 patients):

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

Uncommon(affects up to 1 in 1,000 patients):

High 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 clotting in the lungs (pulmonary embolism), inflammation of the liver (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, high levels of a certain enzyme in the blood called creatine phosphokinase.

Very rare(affects up to 1 in 10,000 patients):

Increased platelet count in the blood with possible blood vessel coagulation, involuntary movements of the mouth/tongue/lips, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, facial swelling (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 and unexpected death.

Unknown(the frequency cannot be estimated from available data):

Changes in the 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 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), hives, 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 which temporarily improves with movement).

In elderly patients with dementia, a small increase in the number of cases of death 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use Leponex after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• No special storage conditions are required.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Leponex 100 mg tablets

• The active ingredient is clozapine. Each tablet contains 100 mg of clozapine.
• The other components are magnesium stearate, anhydrous colloidal silica, povidone K30, talc, cornstarch, lactose monohydrate.

Appearance of the product and contents of the package

Leponex tablets are yellow, round, flat, and beveled-edged, coded with “Z/A” with an angular notch on one side and “CLOZ” on the other side.

Leponex tablets are available in PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum blister packs containing 7, 14, 20, 28, 30, 40, 50, 60, 84, 98, 100, 500 (10x50) or 5000 (100x50) tablets; and/or pre-cut single-dose blister packs of PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum containing 7x1, 14x1, 20x1, 28x1, 30x1, 40x1, 50x1, 60x1, 84x1, 98x1, 100x1, 500 (10x50x1) and 5000 (100x50x1) tablets, and in a white plastic bottle containing 100 or 500 tablets.

Only some package sizes may be marketed.

Other presentations:

Leponex 25 mg tablets in a 40-tablet pack.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Mylan Hungary Kft.

Mylan utca 1

Komárom 2900

Hungary

or

McDermott Laboratories Limited

T/A Gerard Laboratories

T/A Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

or

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of theEuropean Economic Area and in the United Kingdom (Northern Ireland)under the following names:

AustriaLeponex 100 mg Tabletten

BelgiumLeponex 100 mg tabletten/Leponex 100 mg Tabletten/Leponex 100 mg comprimés

DenmarkLeponex

FinlandLeponex 100 mg tabletti

FranceLeponex 100 mg comprimé sécable

GermanyLeponex 100 mg Tabletten

GreeceLeponex 100 mgΔισκ?α

IcelandLeponex 100 mg töflur

IrelandClozaril 100 mg tablets

ItalyLeponex 100 mg compresse

LuxembourgLeponex 100 mg

NetherlandsLeponex 100 mg, tabletten

NorwayLeponex 100 mg tabletter

PortugalLeponex 100 mg comprimidos

SpainLeponex 100 mg comprimidos

SwedenLeponex 100 mg tabletter

United Kingdom(Northern Ireland)Clozaril 100 mg tablets

Last review date of this leaflet:August 2019

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