CLOZAPINE STADA 25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Clozapine Stada 25 mg Tablets EFG

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

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

Contents of the Package Leaflet

1. What is Clozapine Stada and what is it used for
2. What you need to know before you take Clozapine Stada
3. How to take Clozapine Stada
4. Possible side effects
5. Storing Clozapine Stada
6. Package Contents and Further Information

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

The active substance of Clozapine Stada is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders such as psychosis).

Clozapine is used to treat patients with schizophrenia when other medicines have not worked. Schizophrenia is a mental illness that involves disorders of thought, emotional reactions, and behavioral disorders. You can only use this medicine if you have already tried at least two other neuroleptic medicines, including one of the new atypical neuroleptics to treat schizophrenia, and these medicines have not responded, or have caused severe adverse reactions that cannot be treated.

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

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

Do not take Clozapine Stada if you:

• are allergic to clozapine or any of the other components of this medicine (listed in section 6).
• will not be able to have regular blood tests.
• have been informed that you have a low white blood cell count (e.g., leucopenia or agranulocitosis), especially if it has been caused by other medicines. This does not apply if you have had a low white blood cell count caused by previous chemotherapy.
• have previously had to stop using clozapine because it caused you severe adverse reactions (e.g., agranulocitosis or heart problems).
• are being or have been treated with long-acting depot injections of antipsychotics.
• have or have had a bone marrow disease.
• have uncontrolled epilepsy (seizures or attacks).
• have had severe mental disorders caused by alcoholic beverages or other medicines (e.g., narcotics).
• have loss of consciousness and strong drowsiness.
• have circulatory collapse that can occur as a result of severe shock.
• have any 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 work properly, and you have severe constipation).
• use any medicine that prevents your bone marrow from working properly.
• use any medicine that reduces the number of white blood cells in your blood.

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

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

Warnings and Precautions

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

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

• blood clots or a family history of blood clots, as this type of medicine has been associated with the formation of blood clots.
• high eye pressure (glaucoma).
• diabetes. In patients with or without a medical history of diabetes mellitus (see section 4), elevated blood glucose levels have occurred (sometimes considerably).
• prostate problems or difficulty urinating.
• any heart, kidney, or liver disease.
• chronic constipation or are taking medicines that cause constipation (such as anticholinergics).
• controlled epilepsy.
• large intestine diseases.
• abdominal surgery.
• a heart disease or family history of abnormal heart conduction called "prolongation of the QT interval".
• risk of having a stroke, for example, if you have very high blood pressure, cardiovascular problems, or problems in the blood vessels of the brain.

Tell 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 medicine.
• you have a sudden increase in body temperature, muscle stiffness that can lead to altered consciousness (neuroleptic malignant syndrome), as it may be a severe adverse reaction that requires immediate treatment.
• you have a rapid and irregular heartbeat, even when you are at rest, palpitations, breathing problems, chest pain, or unusual tiredness. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
• you have nausea (feeling sick), vomiting (being sick), 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 avoid other complications.
• you experience constipation, abdominal pain, abdominal tenderness, fever, abdominal distension, and/or bloody diarrhea. Your doctor will need to examine you.

Medical Exams and Blood Tests

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

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

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

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

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

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

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

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

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

Children and Adolescents Under 16 Years

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

Use in Elderly Patients (60 Years and Older)

Patient over 60 years may be more susceptible to the following adverse effects during treatment with clozapine:

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

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

Other Medicines and Clozapine Stada

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

Do not take clozapine with other medicines that prevent the proper functioning of the bone marrow and/or reduce the number of blood cells produced by the body, such as:

• carbamazepine, a medicine used in epilepsy.
• certain antibiotics: chloramphenicol, sulfonamides such as cotrimoxazole.
• certain painkillers: analgesics of the pyrazolone group such as phenylbutazone.
• penicillamine, a medicine used to treat rheumatic joint inflammation.
• cytotoxic agents, medicines used in chemotherapy.
• long-acting depot injections of antipsychotic medicines.

These medicines increase your risk of developing agranulocitosis (a deficit of white blood cells in the blood).

Taking clozapine at the same time as other medicines can affect the proper action of clozapine and/or the other medicines. Tell your doctor if you intend to take, are taking (even if treatment is about to finish), or have recently stopped taking any of the following medicines:

• medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline.
• other antipsychotic medicines used to treat mental illnesses, such as perazine.
• benzodiazepines and other medicines used to treat anxiety or sleep disorders.
• narcotics and other medicines that can affect your breathing.
• medicines used to control epilepsy, such as phenytoin and valproic acid.
• medicines used to treat high or low blood pressure, such as adrenaline and noradrenaline.
• warfarin, a medicine used to prevent blood clotting.
• antihistamines, medicines used for colds and allergies, such as hay fever.
• anticholinergic medicines, used to relieve stomach cramps, spasms, and dizziness.
• medicines used to treat Parkinson's disease.
• digoxin, a medicine used to treat heart problems.
• medicines used to treat rapid or irregular heartbeat.
• some medicines used to treat stomach ulcers, such as omeprazole or cimetidine.
• some antibiotics, such as erythromycin and rifampicin.
• some medicines used to treat fungal (such as ketoconazole) or viral infections (such as protease inhibitors used to treat AIDS).
• atropine, a medicine that may be used in some eye drops or in preparations for cough and cold.
• adrenaline, a medicine used in emergency situations.
• hormonal contraceptives (birth control pills).

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

Discuss it with them.

Taking Clozapine Stada with Food and Drinks

During treatment with clozapine, do not drink alcohol.

Tell your doctor if you smoke and how often you consume caffeine-containing beverages (coffee, tea, cola). A sudden change in your smoking habits or consumption of caffeine-containing beverages can also change the effects of clozapine.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

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 clozapine.

The following symptoms may occur in newborn babies of mothers who have used clozapine in the last trimester (the last three months of pregnancy):

• shaking
• 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

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

Fertility

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

Driving and Using Machines

Clozapine can cause tiredness, drowsiness, and seizures, especially at the start of treatment. Therefore, you should avoid driving or operating machinery while you have these symptoms.

Clozapine can cause symptoms such as drowsiness, dizziness, or vision changes and reduce your reaction ability. These effects, as well as the disease itself, can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Clozapine Stada Contains Lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to Take Clozapina Stada

To minimize the risk of experiencing epileptic seizures, drowsiness, or hypotension, it is necessary for your doctor to gradually increase the dose. Follow your doctor's administration instructions exactly. If in doubt, consult your doctor or pharmacist again.

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

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

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

Method of administration

Oral route.

Swallow the tablet with water.

Treatment of schizophrenia

Unless your doctor prescribes a different dose, 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. If you tolerate it well, your doctor will gradually increase the dose in amounts of 25 or 50 mg over 2 to 3 weeks until reaching 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 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 can take it as a single dose at night. Once clozapine treatment is working well for you over time, your doctor will try treatment with 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 a different dose, the normal initial dose of clozapine is 12.5 mg (half of a 25 mg tablet) at night.

Your doctor will slowly increase the dose in amounts 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 increments 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. The dose can only be increased to more than 50 mg per day in exceptional cases. The maximum dose is 100 mg per day. Always take the minimum dose that is effective for you.

If you take more Clozapina Stada than you should

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

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

The symptoms of overdose are:

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

If you forget to take Clozapina Stada

If you forget to take a dose, take the missed dose as soon as possible. If it is close to the time for the next dose, do not take the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose. 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 interrupt treatment with clozapine without asking your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea (feeling dizzy), vomiting (being dizzy), and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms can be followed by more severe ones unless you are treated immediately. Your initial symptoms may recur. If you need to interrupt treatment, it is recommended to gradually decrease the dose in amounts of 12.5 mg over a period of 1 to 2 weeks.

Your doctor will give you instructions on how to reduce your daily dose. If you need to interrupt your treatment suddenly, your doctor should examine you.

If your doctor decides to restart treatment with clozapine and your last dose of clozapine was 2 days or more ago, you should start with the initial dose of 12.5 mg.

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

4. Possible adverse effects

Like all medications, clozapine can cause adverse effects, although not everyone experiences them.

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

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

Very common (affect more than 1 in 10 people)

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

Common (affect up to 1 in 10 people)

• Cold symptoms, fever, flu-like symptoms, sore throat, or any other infection. An urgent blood test will be necessary to check if your symptoms are related to your medication.

• Seizures.
  • Sudden fainting or loss of consciousness with muscle weakness (syncope).

Uncommon (affect 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 can be a serious adverse effect that requires immediate treatment.
• Mild headache, dizziness, or weakness when standing up from a sitting or lying position, as it can increase the risk of falls.

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

• Signs of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing (noisy breathing).
• Burning pain in the upper abdomen that radiates to the back, accompanied by nausea and vomiting due to pancreas inflammation.
• Fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse).
• Difficulty swallowing (which can cause food inhalation).
• Nausea (feeling sick), vomiting (being sick), and/or loss of appetite. Your doctor will need to confirm your liver function.
• Signs of obesity or increased obesity.
• Interruption of breathing with or without snoring during sleep.

Rare (affect up to 1 in 1,000 patients) or very rare (affect up to 1 in 10,000 people)

• Rapid and irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unusual fatigue. Your doctor should check your heart and, if necessary, immediately refer you to a cardiologist.

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

• Prolonged and painful erections of the penis. This is called priapism. If you have an erection that lasts more than 4 hours, you may need immediate medical treatment to avoid additional 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, frequent urination, disorientation, or confusion).
• Abdominal pain, cramps, bloated abdomen, vomiting, constipation, and lack of gas passage, which can be signs and symptoms of intestinal obstruction.
• Lack of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. These symptoms can be indicative of possible liver damage that can progress to sudden liver necrosis.
• Nausea, vomiting, fatigue, weight loss, which can be symptoms of kidney inflammation.

Unknown (frequency cannot be estimated from available data)

• 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 can be fatal. Seek immediate emergency medical treatment.
• Chest pressure, heaviness, oppression, constriction, burning, or suffocation (signs of insufficient blood and oxygen flow to the heart), which can be fatal. Your doctor should evaluate your heart function.
• Intermittent sensation in the chest, feeling "stabbing", "racing", or "agitated" (palpitations).
• Rapid and irregular heartbeats (atrial fibrillation). There may be 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, cool and moist skin, or nausea.
• Signs of blood clots in the veins, especially in the legs (symptoms including swelling, pain, and redness in the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing.
• Confirmed or suspected infection, accompanied by fever or low body temperature, abnormal rapid breathing, rapid heartbeat, altered reaction capacity, and consciousness, decreased blood pressure (sepsis).
• Excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
• Drastic decrease in urine production (signs of kidney failure).
• Allergic reaction (swelling mainly in the face, mouth, and throat, as well as on the tongue, which can be itchy or painful).
• Lack of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and discomfort. This can be indicative of possible liver damage that can progress to liver necrosis, including those events that lead to life-threatening consequences, such as liver failure (which can lead to death), liver damage (damage to liver cells, bile duct in the liver, or both), and liver transplant.
• Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; black, tarry stools or stools with blood; bloating, heartburn, nausea, or vomiting, early feeling of fullness (intestinal stomach and/or intestinal ulceration), which can lead to death.
• Severe abdominal pain intensified by movement, nausea, vomiting, even vomiting blood (or liquid that looks like coffee grounds); the abdomen becomes rigid with sensitivity (rebound) that extends from the point of perforation throughout the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) which can lead to death.
• Constipation, abdominal pain, abdominal sensitivity, fever, bloating, diarrhea with blood. This can be a symptom of possible megacolon (expansion of the intestines) or intestinal ischemia/infarction/necrosis, which can lead to death. Your doctor will need to examine you.
• Appearance or increase of muscle weakness, muscle spasms, muscle pain. This can indicate possible muscle damage (rhabdomyolysis). Your doctor will need to examine you.
• Acute chest or abdominal pain with difficulty breathing, with or without cough or fever.
• During the use of clozapine, extremely severe and serious skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS). The adverse skin reaction can appear as a rash with or without blisters. There can be skin irritation, edema, and fever, and symptoms similar to those of the flu. The symptoms of DRESS syndrome usually appear approximately 2 to 6 weeks (possibly up to 8 weeks) after starting treatment.

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

Other adverse effects:

Very common (affect more than 1 in 10 people)

Drowsiness, dizziness, increased saliva production.

Common (affect up to 1 in 10 people)

High levels of white blood cells in the blood (leukocytosis), high levels of a certain type of white blood cells in the blood (eosinophilia), weight gain, blurred vision, headache, tremors, rigidity, restlessness, agitation, seizures, sudden movements, abnormal movements, inability to initiate movement, inability to remain still, changes in the electrocardiogram (ECG) test of the heart, high blood pressure, weakness or mild headache after changing position, nausea (feeling dizzy), vomiting (being dizzy), loss of appetite, dry mouth, minor anomalies in liver function tests, loss of bladder control, difficulty urinating, fatigue, fever, increased sweating, elevated body temperature, speech disorders (e.g., slurred words).

Uncommon (affect up to 1 in 100 people)

Deficit of white blood cells in the blood (agranulocytosis), speech disorder (e.g., stuttering).

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

High levels of red blood cells in the blood (anemia), restlessness, agitation, confusion, delirium, irregular heartbeat, inflammation of the heart muscle (myocarditis) or the membrane surrounding the heart muscle (pericarditis), fluid accumulation around the heart (pericardial effusion), high blood sugar levels, diabetes mellitus, blood clotting in the lungs (thromboembolism), liver inflammation (hepatitis), liver disease that causes yellowing of the skin/dark urine/itching, elevated levels in the blood of an enzyme called creatine phosphokinase.

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

Increased number of platelets in the blood with possible blood vessel clotting, uncontrolled movements of the mouth/tongue and lips, obsessive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, swelling of the face (due to inflammation of the salivary glands), difficulty breathing, very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cardiac arrest (cardiac arrest), sudden unexpected death.

Unknown (frequency cannot be estimated from available data)

Changes in brain wave recording (electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden and uncontrollable increase in blood pressure (pseudopheochromocytoma), involuntary contraction that causes the body to curve to one side (pleurothotonos), ejaculation disorder, in which semen enters the bladder instead of being ejaculated through the penis (dry orgasm or retrograde ejaculation), rash, purple spots, fever or itching due to inflammation of the blood vessels, colon inflammation that causes diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by uncomfortable sensations during rest periods, especially in the afternoon or evening, and which is temporarily relieved by movement).

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

Reporting adverse effects

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

5. Conservation of Clozapina Stada

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

Do not use clozapine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C.

Bottle: the validity period after the first opening is 9 months.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Clozapina Stada Composition

The active ingredient is clozapine.

Each tablet contains 25 mg of clozapine.

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

Appearance of the Product and Packaging Contents

Pale yellow, round, flat tablets with beveled edges, scored with "C" and "Z" on either side of the notch on one face and "25" on the other face. The tablets measure approximately 6.35 mm. The tablet can be divided into equal doses.

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

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

Bottle: 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

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

Germany: Clozapin AL 25 mg Tabletten

Spain: Clozapina STADA 25 mg tablets EFG

France: CLOZAPINE EG LABO 25 mg, scored tablet

Hungary: Clozapine Stada 25 mg tablet

Date of the Last Revision of this Leaflet:June 2022

Detailed 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/