Package Insert: Information for the Patient

Clozapina Stada 100 mg Tablets EFG

Read this package insert carefully before starting to take 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 or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they 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 Stada is clozapine, which belongs to a group of medications called antipsychotics (medications used to treat specific mental disorders such as psychosis).

Clozapine is used to treat patients with schizophrenia when the use of other medications has not been effective. Schizophrenia is a mental disorder that involves disturbances in thought, emotional reactions, and behavioral disturbances. You can only use this medication if you have already tried at least two other neuroleptic medications, including one of the new atypical neuroleptics for treating schizophrenia, and these medications do not respond, or cause severe adverse reactions that cannot be treated.

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

Do not take Clozapina Stada if you:

• are allergic to clozapine or any of the other components of this medication (listed in section 6).
• cannot have blood tests performed periodically.
• have been informed 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.
• previously had to stop taking clozapine because it caused severe adverse reactions (e.g. agranulocytosis or heart problems).
• are being or have been treated with long-acting depot injections of antipsychotics.
• have or have had bone marrow disease.
• have uncontrolled epilepsy (seizures or attacks).
• have severe mental disorders caused by alcohol or other medications (e.g. narcotics).
• have loss of consciousness and severe drowsiness.
• have circulatory collapse that may occur as a result of severe shock.
• have severe kidney disease.
• have myocarditis (inflammation of the heart muscle).
• have any other severe heart disease.
• have symptoms of active liver disease such as jaundice (yellowing of the skin and eyes, feeling unwell, and loss of appetite).
• have any other severe liver disease.
• have paralytic ileus (intestinal obstruction, your intestine does not function correctly and you have severe constipation).
• are taking any medication that prevents your bone marrow from functioning correctly.
• are taking 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 adverse reactions that may be life-threatening.

Inform your doctor before starting treatment with clozapine if you have or have had any of the following circumstances:

• coagulation disorders or a family history of coagulation disorders, as this type of medication has been associated with blood clot formation.
• high eye pressure (glaucoma).
• diabetes. In patients with or without a medical 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).
• controlled epilepsy.
• intestinal diseases.
• abdominal surgery.
• a heart condition 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.

Inform your doctor immediately before taking the next clozapine tablet if:

• you have signs of a 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 a sudden increase in body temperature, muscle stiffness that may lead to altered consciousness (neuroleptic malignant syndrome), as this may be a severe adverse reaction that requires immediate treatment.
• you have a rapid and irregular heartbeat, 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 queasy), vomiting (feeling dizzy), and/or loss of appetite. Your doctor will need to examine your liver.
• you have severe constipation. Your doctor will need to treat you to prevent other complications.
• you experience constipation, abdominal pain, abdominal sensitivity, fever, abdominal distension, and/or bloody diarrhea. Your doctor will need to examine you.

Medical examinations and blood tests

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

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

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

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 experience liver problems, you will have periodic liver function tests during treatment with clozapina.

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

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

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

If you are to undergo surgery or are unable to walk for a prolonged period, inform your doctor that you are taking clozapina. You may be at risk of developing thrombosis (blood clot in a vein).

Children and adolescents under 16 years

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

Use in elderly patients (60 years and older)

Elderly patients (60 years and older) may be more susceptible to the following adverse effects during treatment with clozapina:

• debility or mild headache after changing position
• dizziness
• rapid heartbeat
• urinary retention
• constipation

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

Other medications and Clozapina Stada

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

Do not take clozapina 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.
• specific antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
• specific pain medications: analgesics in the pyrazolone group such as phenylbutazone.
• penicillamine, a medication used to treat rheumatoid arthritis.
• cytotoxic agents, medications used in chemotherapy.
• long-acting depot injections of antipsychotics.

These medications increase your risk of developing agranulocytosis (severe decrease in white blood cells in your blood).

The use of clozapina with other medications may affect the correct action of clozapina 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 to treat colds and allergies, such as hay fever.
• anticholinergic medications, used to relieve stomach cramps, 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 heartbeat.
• 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 protease inhibitors, used to treat HIV/AIDS).
• atropine, a medication that may be used in eye drops or cough and cold preparations.
• adrenaline, a medication used in emergency situations.
• hormonal 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 clozapina. They also know if the medications you are taking belong to any of the groups listed above.

Inform them.

Taking Clozapina Stada with food and drinks

Do not drink alcohol during treatment with clozapina.

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 clozapina.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

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 whose mothers took clozapina in the last trimester (the last three months of pregnancy):

• shivering
• muscle stiffness and/or weakness
• drowsiness
• agitation
• breathing problems
• difficulty feeding

If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding

Do not breastfeed your baby during treatment with clozapina. Clozapine, the active substance in this medication, may pass into breast milk and affect your baby.

Fertility

Some women taking certain medications for mental illnesses may experience irregular or absent menstrual periods. If this has happened to you, your menstrual periods will return to normal when your medication is replaced with clozapina. This means you should use effective contraception.

Driving and operating machinery

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

Clozapina may cause symptoms such as drowsiness, dizziness, or visual disturbances and may impair your reaction time. These effects, as well as the underlying illness, may make it difficult for you 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.

Clozapina Stada contains lactose

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with them 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 the administration instructions exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is essential that you do not change your dose or stop taking clozapine without first asking your doctor.

Continue taking clozapine for the time your doctor has indicated. If you are 60 years old or older, your doctor may start your treatment with a lower dose and gradually increase it more slowly, as you may be more susceptible to developing unexpected adverse reactions. (See section 2 "What you need to know before starting to take Clozapina Stada").

If you cannot achieve the prescribed dose with this tablet presentation, other presentations of this medication are available to achieve the prescribed dose.

Administration form

Oral.

Swallow the tablet with water.

Treatment of schizophrenia

Unless your doctor prescribes another dose, 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. If you tolerate it well, your doctor will gradually increase the dose in increments of 25 or 50 mg over 2 to 3 weeks to reach a daily dose of 300 mg. You may need to continue increasing the dose in increments of 50 or 100 mg twice a week, or preferably once a week.

The usual 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 should take a portion 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 your treatment with clozapine is working well for some time, your doctor will try to switch you to lower doses. You will need to take clozapine for at least 6 months.

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

Unless your doctor prescribes another dose, the usual initial dose of clozapine is 12.5 mg (half of a 25 mg tablet) at night.

Your doctor will gradually increase the dose in increments 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 Clozapina Stada than you should

If you think you have taken more clozapine than you should, or if someone has taken some of your tablets, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Symptoms of overdose are:

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

If you forgot to take Clozapina Stada

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. Contact your doctor as soon as possible if you have stopped taking clozapine for more than 48 hours.

If you interrupt treatment with Clozapina Stada

Do not stop treatment with clozapine 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 your daily dose in increments 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 should examine you.

If your doctor decides to restart treatment with clozapine and your last dose of clozapine was more than two days ago, you 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, clozapine may cause side effects, although not everyone will experience them.

Some side effects may 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 (affects more than 1 in 10 people)

• Severe constipation. Your doctor will need to treat it to prevent other complications.
• Rapid heart rate.

Common (affects up to 1 in 10 people)

• Signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. An urgent blood test will be required 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 people)

• A sudden 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 falls.

Very rare (affects up to 1 in 1,000 people)

• Signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, or 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 lead to inhaling food).
• Nausea (feeling sick), vomiting (being sick), and/or loss of appetite. Your doctor will need to confirm liver function.
• Signs of obesity or increased obesity.
• Apnea with or without snoring during sleep.

Very rare (affects up to 1 in 1,000 patients) or extremely rare (affects up to 1 in 10,000 people)

-Rapid and irregular heart rate, even at rest, palpitations, breathing difficulties, chest pain, or unusual fatigue. Your doctor will need to perform a heart check and, if necessary, immediately refer you to a cardiologist.

Extremely rare (affects up to 1 in 10,000 people)

• Persistent and painful erections of the penis. This is known as priapism. If you have an erection that lasts more than 4 hours, you may need immediate medical treatment to prevent further complications.
• Spontaneous bleeding or bruising, which may 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, bloated abdomen, vomiting, constipation, and lack of gas passage, which may be signs and symptoms of intestinal obstruction.
• Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. These symptoms may indicate that you are starting to develop liver disease 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):

• Severe 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 "prickling," "accelerated," or "agitated" manner (palpitations).
• Irregular and rapid 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, 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 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).
• Abundant sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
• Drastic decrease in urine production (signs of kidney failure).
• Severe allergic reaction (swelling mainly in the face, mouth, and throat, as well as the tongue, which may cause itching or be painful).
• Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. This may indicate possible liver damage that leads to the replacement of normal liver tissue with scar tissue, resulting in liver function loss, including those 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.
• 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; bloating, acid reflux, nausea, or vomiting, early feeling of fullness (intestinal ulceration of the stomach and/or intestines), which may lead to death.
• Severe abdominal pain intensified by movement, nausea, vomiting, even vomiting blood (or liquid that looks like ground coffee); the abdomen becomes rigid with sensitivity (rebound) that extends from the perforation site through the abdomen; fever and/or chills (intestinal perforation of the stomach and/or intestines or intestinal rupture) that may lead to death.
• Constipation, abdominal pain, abdominal sensitivity, fever, bloating, bloody diarrhea. This may be a symptom of possible megacolon (intestinal expansion) or ischemia/intestinal infarction/necrosis, which may lead to death. Your doctor will need to examine you.
• Appearance or increase in muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle damage (rhabdomyolysis). Your doctor will need to examine you.
• Severe chest or abdominal pain with difficulty breathing 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, as well as flu-like symptoms. 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 (affects more than 1 in 10 people)

Drowsiness, dizziness, increased saliva production.

Common (affects up to 1 in 10 people)

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 people)

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

Rare (affects up to 1 in 1,000 people)

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 that causes yellowing of the skin/dark urine/itching, elevated levels in the blood of an enzyme called creatine phosphokinase.

Extremely rare (affects up to 1 in 10,000 people)

Increased platelet count in the blood with possible blood vessel coagulation, involuntary movements of the mouth/lips and tongue, 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 (frequency cannot be estimated from available data)

Changes in brain wave recordings (electroencephalogram/EEG), diarrhea, stomach discomfort, burning, stomach discomfort after eating, 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 (pleurototonus), sexual dysfunction, in which semen enters the bladder instead of being ejaculated 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 that causes diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), restless legs syndrome (irresistible impulse 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 has been reported compared to those not taking them.

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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 medication.

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

Do not use clozapina after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C.

Container: the period of validity after the first opening is 9 months.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Clozapina Stada Composition

The active ingredient is clozapine

Each tablet contains 100 mg of clozapine.

The other components are: lactose monohydrate, cornstarch, povidone, anhydrous colloidal silica, talc, and magnesium stearate.

Appearance of the product and contents of the packaging

Yellowish pale film-coated tablets, round, flat, with beveled edges, engraved with “C” and “Z” on either side of the groove on one face and “100” on the other face. The tablets measure approximately 10 mm. The tablet can be divided into equal doses.

Blister packs:20, 30, 40, 50, and 100 tablets.

Single-dose pre-cut blister packs:20 x 1, 30 x 1, 40 x 1, 50 x 1, and 100 x 1 tablets.

Bottle: 30 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Responsible for Manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Clozapin AL 100 mg Tabletten

Spain:Clozapina STADA 100 mg tablets EFG

France::CLOZAPINE EG LABO 100 mg, scored tablet

Hungary::Clozapine Stada 100 mg tabletta

Last review date of this leaflet:June 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/