Clozapine Stada 25 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Clozapine Stada 25 mg tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may 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

1. What Clozapine Stada is and what it is used for
2. What you need to know before taking Clozapine Stada
3. How to take Clozapine Stada
4. Possible side effects
5. How to store Clozapine Stada
6. Contents of the pack and other information

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

The active substance in Clozapina 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 involving disturbances in thinking, emotional responses, and behavioural disorders. You can 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.

Clozapine is also indicated for the treatment of severe disturbances in thinking, emotional responses, and behavioural disorders occurring in Parkinson's disease, when other medicines have not been effective.

2. What you need to know before starting to take Clozapina Stada

Do not take Clozapina Stada if you:

• are allergic to clozapine or to any of the other ingredients of this medicine (listed in section 6).
• cannot have regular blood tests performed.
• have been told you have a low white blood cell count (e.g., leukopenia or agranulocytosis), especially if caused by other medicines. This does not apply if you had a low white blood cell count due to previous chemotherapy.
• previously had to stop taking clozapine because it caused serious adverse reactions (e.g., agranulocytosis or any heart problem).
• are being treated or have been treated with long-acting depot injections of antipsychotics.
• have or have had a bone marrow disorder.
• have uncontrolled epilepsy (seizures or fits).
• have had severe mental disorders caused by alcohol or other medicines (e.g., narcotics).
• have loss of consciousness and marked 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 serious 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 serious liver disease.
• have paralytic ileus (intestinal obstruction, your bowel does not work properly and you have severe constipation).
• are taking any medicine that impairs the function of your bone marrow.
• are taking any medicine that reduces the number of white blood cells in your blood.

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

Clozapine must 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 follow them to minimize the risk of serious adverse reactions that could be life-threatening.

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

• blood clots or a family history of blood clots, as this type of medication has been associated with blood clot formation.
• increased pressure in the eye (glaucoma).
• diabetes. Elevated blood glucose levels (sometimes markedly) have been reported 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 medications that cause constipation (such as anticholinergics).
• 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.

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

• you have signs of a 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 medication.
• you experience a sudden increase in body temperature, muscle stiffness that may progress to altered consciousness (neuroleptic malignant syndrome), as this may be a serious adverse reaction requiring immediate treatment.
• you have a fast 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 (feeling sick), vomiting (being sick), 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, 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 about your medical history and perform a blood test to ensure that 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 clozapine.

• Your doctor will inform you exactly when and where these tests will be performed. You may only take clozapine if you have a normal blood count.
• Clozapine may cause a serious decrease in the number of white blood cells in your blood (agranulocytosis). Only regular blood testing can allow your doctor to determine 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 cell count has been detected.
• If a decrease in white blood cell count occurs, clozapine treatment must be stopped immediately. Your white blood cell count must return to normal levels.
• You should continue to have blood tests for 4 weeks after stopping clozapine treatment, especially if treatment is completely discontinued for hematological reasons (i.e., agranulocytosis), or if monitoring duration has been 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 any specific concerns.

If you have liver problems, periodic liver function tests will be performed throughout clozapine treatment.

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

Clozapine may alter lipid levels in the blood. Clozapine may cause weight gain. Your doctor may monitor your weight and 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 sitting or lying position, as this may increase your risk of falling.

If you need to undergo surgery or for any reason cannot walk for a prolonged period, inform your doctor that you are taking clozapine. You may be at risk of developing 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 clozapine, as there is insufficient information on its use in this age group.

Use in elderly patients (60 years of age and older)

Patients aged 60 years and older may be more susceptible to the following adverse effects during clozapine treatment:

• weakness 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 medicines and Clozapina Stada

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

Do not take clozapine together with other medicines that impair 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 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 clozapine together with other medicines may affect the proper action of clozapine 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 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 fast 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 infections).
• 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 clozapine. They also know whether the medicines you are taking belong to any of the groups listed above.

Discuss this with them.

Taking Clozapina Stada with food and drinks

Do not drink alcohol during treatment with clozapine.

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

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

• tremor
• muscle stiffness and/or weakness
• drowsiness
• agitation
• breathing difficulties
• feeding problems

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

Breastfeeding

You must not breastfeed while taking clozapine. Clozapine, the active substance in this medicine, may pass into breast milk and affect the baby.

Fertility

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

Driving and using machines

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

Clozapine may cause symptoms such as drowsiness, dizziness, or vision disturbances and may reduce reaction time. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

Clozapina Stada contains lactose

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

3. How to take Clozapina Stada

To minimize the risk of seizures, drowsiness, or hypotension, your doctor must gradually increase your dose. Follow your doctor's dosing instructions exactly. If in doubt, consult your doctor or pharmacist again.

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

Continue taking clozapine 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 certain unexpected adverse reactions. (See section 2, "What you need to know before starting Clozapina Stada.")

If you cannot achieve the prescribed dose with this tablet formulation, other formulations of this medicine are available to reach the prescribed dose.

Route of administration

Oral use.

Swallow the tablet with water.

Treatment of schizophrenia

Unless your doctor prescribes a different dose, treatment is initiated 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 well tolerated, your doctor will gradually increase the dose by increments of 25 or 50 mg over 2 to 3 weeks until reaching a dose of 300 mg per day. Further increases may be necessary in increments of 50 or 100 mg twice weekly, or preferably once weekly.

The usual daily dose of clozapine ranges from 200 to 450 mg, divided into several doses per day. 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 effective dose for you. Most patients should take part of the daily dose in the morning and part at night. Your doctor will tell you exactly how to divide your daily dose. If your daily dose does not exceed 200 mg, it may be taken as a single dose at night. Once clozapine treatment is working well for you over a period of time, your doctor may test 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 otherwise prescribed by your doctor, the usual initial dose of clozapine is 12.5 mg (half a 25 mg tablet) at night.

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 delayed 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 ranges from 25 to 37.5 mg, taken as a single nightly dose. Doses exceeding 50 mg per day are only permitted in exceptional cases. The maximum dose is 100 mg per day. Always take the lowest effective dose 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 else has taken any of your tablets, inform your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating 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, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

If you forget to take Clozapina Stada

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and take the next dose at the usual 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 stop taking Clozapina Stada

Do not stop clozapine treatment without consulting your doctor, as you may experience withdrawal symptoms. These symptoms include sweating, headache, nausea (feeling sick), vomiting (being sick), and diarrhea. If you experience any of these symptoms, consult your doctor immediately. These symptoms may be followed by more serious ones unless you are treated promptly. Your original symptoms may also return. If treatment must be discontinued, 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 need to stop treatment suddenly, your doctor should examine you.

If your doctor decides to restart clozapine treatment and your last dose of clozapine was two days or more ago, treatment should be restarted at 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, clozapine may produce adverse effects, although not everyone experiences them.

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

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

Very common (affects more than 1 in 10 people)

• Severe constipation. Your doctor will need to treat this to prevent further complications.
• Fast heartbeat.

Common (affects up to 1 in 10 people)

• Signs of a cold, fever, flu-like symptoms, sore throat, or any other infection. You will need to have an urgent blood test to check whether your symptoms are related to your medication.
• Epileptic seizures.
  • Sudden fainting or sudden loss of consciousness with muscle weakness (syncope).

Uncommon (affects up to 1 in 100 people)

• A 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.
• Mild headache, dizziness, or weakness when rising from a sitting or lying position, as this may increase the risk of falling.

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

• Signs of respiratory tract infection or pneumonia such as fever, cough, difficulty breathing, or wheezing (noisy breathing).
• Severe burning pain in the upper abdomen spreading 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 inhalation of food).
• Nausea (feeling sick), vomiting (being sick), and/or loss of appetite. Your doctor will need to check your liver.
• Signs of obesity or worsening obesity.
• Interruption of breathing with or without snoring during sleep.

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

• Fast and 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.

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

• Persistent and painful erection of the penis. This is called priapism. If you have an erection lasting more than 4 hours, immediate medical treatment may be needed to prevent further complications.
• Spontaneous bleeding or bruising, which could be signs of a reduced 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 failure to pass gas, which may be signs and symptoms of intestinal obstruction.
• Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. These symptoms may indicate the onset of liver disease, which may progress rapidly to liver necrosis.
• Nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

Not known (frequency cannot be estimated from available data):

• Crushing pain in the chest, sensation of pressure, tightness, 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 be fatal. Seek immediate emergency medical treatment.
• Chest pressure, heaviness, tightness, constriction, burning, or suffocation (signs of insufficient blood and oxygen flow to the heart), which may be fatal. Your doctor should evaluate your heart function.
• Intermittent "stabbing," "racing," or "fluttering" sensation in the chest (palpitations).
• Rapid and irregular heartbeats (atrial fibrillation). There may be occasional palpitations, fainting, difficulty breathing, or chest discomfort. Your doctor will need to check your heart.
• 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 the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing.
• Confirmed infection or high suspicion of infection, accompanied by fever or low body temperature, abnormally rapid breathing, fast heart rate, altered reaction capacity and consciousness, and decreased blood pressure (sepsis).
• Excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
• Drastic reduction 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).
• Loss of appetite, bloated abdomen, abdominal pain, yellowing of the skin, severe weakness, and malaise. This may indicate possible liver abnormalities leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including life-threatening liver events such as liver failure (which may lead to death), liver damage (damage to liver cells, bile ducts in the liver, or both), and liver transplantation.
• Burning pain in the upper abdomen, particularly between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; bloating, heartburn, nausea or vomiting, early satiety (intestinal or gastric ulceration), which may be fatal.
• Severe abdominal pain worsened by movement, nausea, vomiting, even vomiting blood (or fluid resembling ground coffee); the abdomen becomes rigid with rebound tenderness spreading from the perforation site across the abdomen; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture), which may be fatal.
• Constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. This may be a symptom of possible megacolon (intestinal dilation) or intestinal ischemia/infarction/necrosis, which may be fatal. Your doctor will need to examine you.
• Onset or worsening of muscle weakness, muscle spasms, muscle pain. This may indicate possible muscle disorder (rhabdomyolysis). Your doctor will need to examine you.
• Sudden chest or abdominal pain with difficulty breathing, with or without cough or fever.
• During clozapine use, extremely severe and serious skin reactions have been reported, such as drug reaction with eosinophilia and systemic symptoms (DRESS). The adverse skin reaction may appear as rashes with or without blisters. Skin irritation, edema, 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.

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

Other adverse 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 (leucocytosis), high levels of a certain type of white blood cells in the blood (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, restlessness, agitation, seizures, jerky movements, abnormal movements, inability to initiate movement, inability to remain still, changes in heart electrocardiogram (ECG) test, 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 speech).

Uncommon (affects up to 1 in 100 people)

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

Rare (affects 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 of the membrane surrounding the heart muscle (pericarditis), fluid accumulation around the heart (pericardial effusion or pericardial discharge), high blood sugar levels, diabetes mellitus, blood clotting in the lungs (thromboembolism), liver inflammation (hepatitis), liver disease causing yellowing of the skin/dark urine/itching, elevated blood levels of an enzyme called creatine phosphokinase.

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

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

Not known (frequency cannot be estimated from available data)

Changes in brain wave recordings (electroencephalogram/EEG), diarrhea, stomach discomfort, burning sensation, stomach discomfort after eating, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden and uncontrolled increase in blood pressure (pseudopheochromocytoma), involuntary contractions causing the body to curve to one side (pleurothotonus), ejaculation disorder, 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, skin color changes, 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 rest periods, especially in the afternoon or at night, temporarily relieved by movement).

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

Reporting of adverse effects

If you experience any type of 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 Clozapine Stada

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

Do not use clozapine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Bottle: the shelf life after first opening is 9 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Clozapina Stada

The active substance is clozapine.

Each tablet contains 25 mg of clozapine.

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

Appearance of the medicinal product and content of the container

Yellowish-white, round, flat tablets with bevelled edges, scored and engraved with "C" and "Z" on either side of the score on one side and "25" on the other side. The tablets measure approximately 6.35 mm. The tablet can be divided into equal doses.

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

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

Bottle: 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 European Economic Area member states under the following names:

Germany: Clozapin AL 25 mg Tabletten

Spain: Clozapina STADA 25 mg comprimidos EFG

France: CLOZAPINE EG LABO 25 mg, comprimé sécable

Hungary: Clozapine Stada 25 mg tabletta

Date of the most recent review of this leaflet: November 2025

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