Leponex 200 mg tablets: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Leponex 200mg tablets

clozapine

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

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Leponex is and what it is used for

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

Leponex is used to treat adult patients with schizophrenia when other medications have not worked. Schizophrenia is a mental illness involving disturbances in thought, emotional reactions, and behavioural disorders. You may only use this medicine if you have already tried at least two other neuroleptic medicines, including one of the newer atypical neuroleptics for treating schizophrenia, and these medicines have either been ineffective or have caused serious adverse reactions that cannot be managed.

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

2. What you need to know before taking Leponex

Do not take Leponex if:

you are allergic to clozapine or any of the other ingredients of this medicine (listed in section 6);
regular blood tests cannot be performed;
you have ever been told that you have a low white blood cell count (e.g., leukopenia or agranulocytosis), especially if it was caused by other medicines. This does not apply if you had a low white blood cell count caused by previous chemotherapy;
you previously had to stop taking Leponex due to serious adverse reactions (e.g., agranulocytosis or heart problems);
you are currently or have recently been treated with long-acting depot injections of antipsychotics;
you have or have had 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 experience episodes of loss of consciousness and strong, uncontrollable drowsiness;
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 serious heart condition;
you have signs 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 bowel does not function properly and you have severe constipation);
you are taking any medicine that impairs the normal function of your bone marrow;
you are taking any medicine that reduces the number of white blood cells in your blood.

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

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

Warnings and precautions

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

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

blood clots or a family history of blood clots, as this type of medicine has been associated with blood clot formation;
glaucoma (increased pressure in the eye);
diabetes. Elevated blood glucose levels (sometimes markedly) have occurred in patients with or without a medical history of diabetes mellitus (see section 4);
prostate problems or difficulty urinating;
any heart, kidney, or liver disease;
chronic constipation or are taking medicines that cause constipation (such as anticholinergics);
galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption;
controlled epilepsy;
diseases of the large intestine;
abdominal surgery;
heart disease or a family history of abnormal heart conduction known as “QT interval prolongation”;
risk of stroke, for example, if you have very high blood pressure, cardiovascular problems, or cerebrovascular disease.

Immediately before taking your next Leponex tablet, inform your doctor if:

you have signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You will need an urgent blood test to determine whether these symptoms are related to the medicine;
you have a sudden increase in body temperature and muscle rigidity that may lead to altered consciousness (neuroleptic malignant syndrome), as this may be a serious adverse reaction requiring immediate treatment;
you have rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unusual tiredness. Your doctor should perform a heart check and, if necessary, refer you immediately to a cardiologist;
you have nausea, vomiting, and/or loss of appetite. Your doctor should examine your liver;
you have severe constipation. Your doctor should treat you to prevent further complications;
you experience constipation, abdominal pain, abdominal tenderness, fever, bloating, and/or bloody diarrhoea. Your doctor will need to examine you.

Medical examinations and blood tests

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

Make sure you have regular blood tests before starting treatment, during treatment, and after stopping treatment with Leponex.

Your doctor will inform you exactly when and where these tests will be performed. You may only take Leponex if you have a normal blood count. Leponex can cause a severe decrease in white blood cells (agranulocytosis). Only regular blood tests can allow your doctor to detect whether you are at risk of developing agranulocytosis (see section 4). Blood tests must be performed weekly during the first 18 weeks of treatment and then at least once a month during the following 34 weeks.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then annually, provided no decrease in white blood cells has been detected. If a decrease in white blood cells occurs, treatment with Leponex must be stopped immediately. Your white blood cell count should return to normal. Blood tests must continue for another 4 weeks after stopping Leponex, especially if treatment is completely discontinued for hematological reasons (i.e., agranulocytosis), or if monitoring duration is less than 2 years, or if you have a history of neutropenia that did not lead to discontinuation of treatment.

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 or if you have specific concerns.

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

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

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

If you experience mild headache, dizziness, or weakness, or if Leponex makes you feel this way, be careful when rising from a sitting or lying position, as this may increase the risk of falls.

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

Children and adolescents under 16 years of age

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

Use in elderly patients (60 years and older)

Patients aged 60 years and older may be more susceptible to the following adverse effects during treatment with Leponex: weakness or mild headache after changing position, dizziness, rapid heartbeat, urinary retention, and constipation.

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

Other medicines and Leponex

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines or herbal remedies. You may need to take different doses or different medicines.

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

carbamazepine, a medicine used for epilepsy;
certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole;
certain pain medicines: analgesics of the pyrazolone group, such as phenylbutazone;
penicillamine, a medicine used to treat rheumatoid arthritis;
cytotoxic agents, medicines used in chemotherapy;
long-acting depot injections of antipsychotic medicines.

These medicines increase your risk of developing agranulocytosis (deficiency of white blood cells in the blood).

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

medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline;
other antipsychotic medicines used to treat mental illnesses, such as perazine;
benzodiazepines and other medicines used to treat anxiety or sleep disorders;
narcotics and other medicines that may affect 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 seasonal 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 infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infection);
atropine, a medicine that may be used in certain eye drops or in cough and cold preparations;
adrenaline, a medicine used in emergency situations;
hormonal contraceptives (birth control pills).

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

Taking Leponex with food and drinks

Do not drink alcohol during treatment with Leponex.

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

Pregnancy and breastfeeding

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

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

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

During treatment with Leponex, you must not breastfeed. Clozapine, the active substance in Leponex, may pass into breast milk and harm the baby.

Driving and using machines

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

Leponex contains lactose.

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

3. How to take Leponex

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

To minimize the risk of seizures, drowsiness, or low blood pressure as much as possible, your doctor must gradually increase your dose.

It is important that you do not change the dose or stop taking Leponex without first consulting your doctor. Continue taking Leponex for as long as your doctor has instructed. If you are 60 years of age or older, your doctor may start you on a lower dose and increase it more gradually, as you may be more susceptible to developing certain unexpected adverse reactions (see section 2 “What you need to know before starting to take Leponex”).

If this tablet formulation does not allow you to reach the prescribed dose, other formulations of this medicine are available to achieve the prescribed dose.

Treatment of schizophrenia

Treatment starts 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 well tolerated, your doctor will gradually increase the dose by increments of 25 to 50 mg over 2 to 3 weeks until reaching a dose of 300 mg per day. It may be necessary to continue increasing the dose by increments of 50 to 100 mg twice weekly, or preferably once weekly.

The effective daily dose of clozapine ranges between 200 and 450 mg, divided into several daily doses. Some individuals may require higher doses. Doses up to 900 mg per day are permitted. At daily doses exceeding 450 mg, adverse reactions (particularly seizures) may increase. Always take the lowest dose that is effective for you. Most patients should take part of the dose in the morning and part 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 may take it as a single nightly dose. Once treatment with Leponex has been effective for some time, your doctor may test 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

For dosing in psychotic disorders associated with Parkinson’s disease, more appropriate pharmaceutical formulations are available.

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 slowly increase the dose by increments of 12.5 mg, with a maximum of two increases per week, until reaching 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 monitored during the first weeks of treatment.

The effective daily dose is usually between 25 and 37.5 mg, taken as a single nightly dose.

Doses exceeding 50 mg per day may only be used in exceptional cases. The maximum dose is 100 mg per day. Always take the lowest dose that is effective for you.

Method of administration

Leponex is administered orally.

The tablet may be divided into equal doses.

If you take more Leponex than you should

If you think you have taken more Leponex than you should, or if someone else has taken any of your tablets, contact a doctor immediately or seek emergency medical help. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

Symptoms of overdose include:

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

If you forget to take Leponex

If you forget to take a dose, take it as soon as possible. If it is almost time for your next dose, do not take the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed one. If you have stopped taking Leponex for more than 48 hours, do not restart treatment without first consulting your doctor.

If you stop taking Leponex

Do not stop treatment with Leponex without consulting your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea, vomiting, and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more severe ones unless immediate treatment is received. Your initial symptoms may reappear. If you need to stop treatment, it is recommended to gradually reduce the dose by 12.5 mg increments over a period of 1 to 2 weeks. Your doctor will provide instructions on how to reduce your daily dose. If you must stop treatment suddenly, your doctor should examine you.

If your doctor decides to restart treatment with Leponex and your last dose of Leponex was two days or more ago, treatment should begin again with the initial dose of 12.5 mg.

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

4. Possible adverse effects

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

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

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

Severe constipation. Your doctor will need to treat you to prevent further complications.
Constipation, abdominal pain, abdominal tenderness, fever, feeling bloated, bloody diarrhea. These may indicate possible megacolon (enlargement of the intestine) or intestinal infarction/ischemia/necrosis, which could be fatal. Your doctor will need to examine you.
Abdominal pain, cramps, bloated abdomen, vomiting, constipation, and lack of passage of gas, which may be signs and symptoms of intestinal obstruction.
- Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; feeling bloated, heartburn, nausea or vomiting, early satiety (ulceration of the stomach and/or intestine), which may be fatal.
- Severe abdominal pain worsened by movement, nausea, vomiting, including vomiting blood (or material resembling ground coffee); the abdomen becomes rigid with rebound tenderness spreading from the site of perforation throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or bowel rupture), which may be fatal.
- Low white blood cell count in a blood test (agranulocytosis).
- Signs of cold, fever, flu-like symptoms, sore throat, or any other infection. You will need an urgent blood test to determine whether these symptoms are related to the medicine.
- Confirmed infection or high suspicion of infection, accompanied by fever or abnormally low body temperature, abnormally rapid breathing, rapid heart rate, altered reaction capacity and consciousness, decreased blood pressure (sepsis).
- Signs of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing (noisy breathing).
- Seizures.
- Fast and irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unusual tiredness. Your doctor should perform a heart check and, if necessary, refer you immediately to a cardiologist.
- Crushing chest pain, tightness, pressure, or constriction (chest pain may radiate to the left arm, jaw, neck, or upper abdomen), difficulty breathing, sweating, weakness, dizziness, nausea, vomiting, and palpitations (symptoms of a heart attack), which may be fatal. Seek immediate medical attention for emergency treatment.
- Heart muscle disease (cardiomyopathy), cessation of heartbeat (cardiac arrest).
- Irregular heartbeat, inflammation of the heart muscle (myocarditis) or of the membrane surrounding the heart muscle (pericarditis), fluid accumulation around the heart (pericardial effusion).
- Feeling of pressure, heaviness, tightness, constriction, burning, or suffocation in the chest (signs of insufficient blood and oxygen supply to the heart), which may be fatal. Your doctor should evaluate heart function.
- Intermittent "stabbing," "racing," or "fluttering" sensations in the chest (palpitations).
- Rapid and irregular heartbeats (atrial fibrillation). You may experience occasional palpitations, fainting, difficulty breathing, or chest discomfort. Your doctor should evaluate heart function.
- Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. These may indicate possible liver abnormalities leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including potentially life-threatening liver events such as liver failure (which may be fatal), liver damage (damage to liver cells, bile ducts in the liver, or both), and liver transplantation.
- Sudden increase in body temperature, muscle rigidity that may progress to altered consciousness (neuroleptic malignant syndrome), as this may be a serious adverse effect requiring immediate treatment.

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

Other adverse effects:

Very common (may affect more than 1 in 10 people):

Drowsiness, dizziness, increased saliva production.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

Speech disorders (e.g., stuttering), dizziness, lightheadedness, or fainting when standing up from a sitting or lying position, as this may increase the risk of falls.

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

High levels of red blood cells in the blood (anemia), restlessness, agitation, confusion, delirium, high blood sugar levels, diabetes mellitus, blood clot in the lungs (thromboembolism), 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, severe burning pain in the upper abdomen radiating to the back accompanied by nausea and vomiting due to inflammation of the pancreas, fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse), difficulty swallowing (which may lead to food inhalation), nausea, vomiting, and/or loss of appetite. Your doctor should examine your liver for signs of obesity or worsening obesity, and interrupted breathing with or without snoring during sleep.

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

Increased number of platelets in the blood with possible blood clotting in blood vessels, uncontrolled movements of the mouth/tongue and limbs, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, swelling in front of the ears (due to inflammation of the salivary glands), difficulty breathing, very high levels of triglycerides or cholesterol in the blood, sudden death of unknown cause, painful and persistent erection of the penis, if you are a man. This is called priapism. If you have an erection lasting more than 4 hours, immediate medical treatment may be necessary to prevent further complications, spontaneous bleeding or bruising, which could be signs of a decrease in the number of platelets in the blood, symptoms due to uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation or confusion), nausea, vomiting, fatigue, and weight loss that may be symptoms of kidney inflammation.

Frequency not known (cannot be estimated from available data)

Changes in brain wave recordings (electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, 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 the body to curve to one side (pleurothotonus), ejaculation disorder in men, 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 blood vessels, inflammation of the colon causing diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped facial rash, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by uncomfortable sensations during periods of rest, especially in the afternoon or at night, and temporarily relieved by movement), symptoms of low blood pressure, such as dizziness, lightheadedness, fainting, blurred vision, unusual fatigue, cold and clammy skin, or nausea, signs of blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing, profuse sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome), marked decrease in urine output (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), acute chest pain with difficulty breathing with or without cough, onset or worsening of muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you; acute chest or abdominal pain with difficulty breathing with or without cough or fever; during use of Leponex, extremely severe and serious skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). The adverse skin reaction may appear as rashes with or without blisters. Skin irritation, edema, and fever and flu-like symptoms may occur. DRESS syndrome symptoms usually appear approximately 2 to 6 weeks (possibly up to 8 weeks) after starting treatment.

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Leponex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton following EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Leponex 200 mg tablets

The active substance is clozapine. Each tablet contains 200 mg of clozapine.
The other components are magnesium stearate, anhydrous colloidal silica, povidone K30, talc, corn starch, and lactose monohydrate.

Appearance of the product and contents of the pack

Light yellow, round, biconvex tablet with a cross-shaped score line on both sides and engraved with "V C 7" on one side.

Diameter: approximately 13 mm.

Leponex 200 mg tablets are available in PVC/PE/PVdC-aluminium blisters containing 20, 30, 40, 50 or 100 tablets, or in single-dose perforated PVC/PE/PVdC-aluminium blisters with 20 × 1, 30 × 1, 40 × 1, 50 × 1 and 100 × 1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer responsible for manufacturing

Madaus GmbH
Lütticher Straße 5
53842 Troisdorf, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Belgium: Leponex 200 mg tabletten
Croatia: Leponex 200 mg tablete
Czech Republic: Leponex 200 mg tablety
Finland: Leponex
Germany: Leponex 200 mg Tabletten
Greece: Leponex
Hungary: Leponex 200 mg tabletta
Ireland: Clozaril 200 mg tablets
Luxembourg: Leponex 200 mg comprimés
Spain: Leponex 200 mg comprimidos
Slovenia: Leponex 200 mg tablete

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es/