Clozapine Hasco

Leaflet accompanying the packaging: patient information

Clozapine Hasco, 25 mg, tablets

Clozapine Hasco, 100 mg, tablets

Clozapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The active substance of Clozapine Hasco is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat certain mental disorders, such as psychoses). Clozapine Hasco is used to treat patients with schizophrenia who do not respond to treatment with other medicines. Schizophrenia is a mental illness that causes disturbances in thinking, emotions, and behavior. The use of Clozapine Hasco is recommended only for the treatment of patients who have already taken at least two different antipsychotic medicines, including one from the group of new atypical antipsychotic medicines indicated for the treatment of schizophrenia, and who did not respond to these medicines or experienced severe side effects that could not be controlled. Clozapine Hasco is also used to treat severe thought, emotional, and behavioral disorders in patients with Parkinson's disease who do not respond to treatment with other medicines.

2. Important information before taking Clozapine Hasco

When not to take Clozapine Hasco

• if the patient has been diagnosed with an allergy (hypersensitivity) to clozapine or any of the other ingredients of this medicine (listed in section 6),
• if it is not possible to perform regular blood tests on the patient,
• if the patient has ever had a low white blood cell count in the blood (e.g., leukopenia or agranulocytosis), especially if it was caused by taking medicines, except in cases of low white blood cell count in the blood related to previous chemotherapy,

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• if the patient has previously stopped taking Clozapine Hasco due to severe side effects (e.g., agranulocytosis or heart disorders),
• if the patient is or has been treated with antipsychotic medicines in the form of long-acting injections (depot),
• if the patient has or has had a bone marrow disorder,
• if the patient has uncontrolled epilepsy (seizures or other types of epilepsy),
• if the patient has acute mental disorders caused by alcohol or drugs (e.g., narcotics),
• if the patient has impaired consciousness and increased drowsiness,
• if the patient has circulatory collapse, which may be a consequence of severe shock,
• if the patient has severe kidney dysfunction,
• if the patient has myocarditis,
• if the patient has other severe heart diseases,
• if the patient has symptoms of active liver disease, such as jaundice (yellowing of the skin and whites of the eyes, nausea, loss of appetite),
• if the patient has other severe liver function disorders,
• if the patient has paralytic ileus (the intestine does not work properly and the patient has severe constipation),
• if the patient is taking any medicines that inhibit the proper functioning of the bone marrow,
• if the patient is taking any medicines that reduce the number of white blood cells in the blood.

If any of the above points apply to the patient, they should tell their doctor and not take Clozapine Hasco. Clozapine Hasco should not be taken by patients who are unconscious or in a coma.

Warnings and precautions

Before starting treatment with Clozapine Hasco, the patient should discuss it with their doctor or pharmacist.

The safety issues mentioned in this section are very important. The patient must pay special attention to them to minimize the risk of severe side effects that can be life-threatening.

Before the patient starts treatment with Clozapine Hasco, they should tell their doctor if they have or have had:

• blood clots, as medicines like this one have been associated with the formation of blood clots,
• glaucoma (increased pressure in the eye),
• diabetes (high blood sugar levels, which can occur in patients with diabetes or without diabetes in their medical history),
• prostate problems or difficulty urinating,
• heart, kidney, or liver disease,
• chronic constipation or taking medicines that cause constipation (such as anticholinergic medicines),
• lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome,
• controlled epilepsy,
• colon disease,
• previous abdominal surgery,
• a family history of heart disorders or abnormal heart conduction, known as "QT interval prolongation",
• stroke risk, e.g., if the patient has high blood pressure, cardiovascular problems, or problems with blood vessels in the brain.

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The patient should immediately tell their doctor before taking the next dose of Clozapine Hasco if they:

experience:

• symptoms of a cold, fever, flu-like symptoms, sore throat, or any infection. The doctor may recommend urgent blood tests to check if the symptoms are related to the medicine,
• sudden increased body temperature, muscle stiffness that can lead to loss of consciousness (symptoms of malignant neuroleptic syndrome), which can be a severe side effect requiring immediate treatment,
• experience rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check the patient's heart function and, if necessary, refer them to a cardiologist immediately,
• experience nausea, vomiting, and (or) loss of appetite. The doctor will check the patient's liver function,
• experience constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. The patient should consult their doctor.

Medical check-ups and blood tests

Before starting treatment with Clozapine Hasco, the doctor will conduct a medical interview and order blood tests to confirm a normal white blood cell count. This is important because the patient's body needs white blood cells to fight infections.

Regular blood tests must be performed before starting treatment, during treatment, and after stopping treatment with Clozapine Hasco.

• The doctor will inform the patient exactly when and where to have the blood tests done. Clozapine Hasco can only be taken if the patient has a normal white blood cell count.
• Clozapine Hasco may cause a significant decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can confirm whether the patient is at risk of developing agranulocytosis.
• Blood tests should be performed once a week for the first 18 weeks of treatment. Then, blood tests should be performed at least once a month.
• If the patient's white blood cell count decreases, treatment with Clozapine Hasco should be stopped immediately. The white blood cell count should return to normal.
• Blood tests should be performed for 4 weeks after stopping treatment with Clozapine Hasco. The doctor will also perform a physical examination before starting treatment with Clozapine Hasco. The doctor may order an electrocardiogram (ECG) to check the patient's heart function if necessary. If the patient has liver function disorders, regular liver function tests will be performed throughout the treatment with Clozapine Hasco. If the patient has high blood sugar levels (diabetes), the doctor may order regular blood sugar tests. Clozapine Hasco may cause changes in blood lipid levels. Clozapine Hasco may cause weight gain. The doctor may monitor the patient's weight and blood lipid levels.

If the patient currently experiences or Clozapine Hasco causes the patient to experience dizziness, lightheadedness, or fainting, they should change positions carefully, as these symptoms can increase the risk of falls. If the patient needs to undergo surgery or is immobilized for a longer period, they should discuss the use of Clozapine Hasco with their doctor. There is a risk of thrombosis (blood clotting in the veins).

Children and adolescents under 16 years of age

Clozapine Hasco should not be taken by patients under 16 years of age, as there is limited data on the use of this medicine in this age group.

Elderly patients (65 years of age and older)

In elderly patients (65 years of age and older), the following side effects may occur more frequently during treatment with Clozapine Hasco: fainting or lightheadedness when changing positions, dizziness, rapid heartbeat, difficulty urinating, and constipation. The patient should tell their doctor if they have a condition called dementia.

Clozapine Hasco and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take. It may be necessary to change the dosage of the medicines or change the medicines.

Clozapine Hasco should not be taken with medicines that inhibit the proper functioning of the bone marrow and (or) reduce the number of white blood cells produced by the body, such as:

• carbamazepine, a medicine used to treat epilepsy;
• certain antibiotics: chloramphenicol, sulfonamides, such as co-trimoxazole;
• certain painkillers: pyrazolone derivatives, such as phenylbutazone or metamizole;
• penicillamine, a medicine used to treat rheumatoid arthritis;
• cytotoxic agents, medicines used in chemotherapy;
• antipsychotic medicines in the form of long-acting injections (depot). These medicines increase the risk of developing agranulocytosis (lack of white blood cells).

Taking Clozapine Hasco with other medicines may affect the action of Clozapine Hasco and (or) other medicines. The patient should tell their doctor if they plan to take, are taking (even if the treatment is ending), or have recently stopped taking:

• 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 and sleep disorders
• narcotics and other medicines that may affect breathing
• medicines used to treat epilepsy, such as phenytoin and valproic acid
• medicines used to treat high and low blood pressure (such as adrenaline and noradrenaline)
• warfarin, a medicine used to prevent blood clots
• antihistamines, medicines used to treat colds or allergies, such as hay fever
• anticholinergic medicines, used to relieve stomach cramps and motion sickness
• medicines used to treat Parkinson's disease
• digoxin, a medicine used to treat heart diseases
• medicines used to treat rapid or irregular heartbeat
• certain medicines used to treat stomach ulcers, such as omeprazole or cimetidine
• certain antibiotics, such as erythromycin and rifampicin
• certain medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infection)
• atropine, a medicine that may be an ingredient in some eye drops, cold remedies, and cough medicines
• adrenaline, a medicine used in emergency situations
• hormonal contraceptives (birth control pills) The above list is not exhaustive. The doctor or pharmacist has more information about medicines that should be used with caution with Clozapine Hasco or should be avoided during treatment with Clozapine Hasco, and they know whether the medicine belongs to the mentioned groups. The patient should ask them about it.

Clozapine Hasco with food and drink

The patient should not drink alcohol while taking Clozapine Hasco. The patient should tell their doctor if they smoke and how often they drink beverages containing caffeine (coffee, tea, cola). Sudden changes in smoking or caffeine consumption habits may also change the effects of Clozapine Hasco.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. The doctor will discuss the benefits and possible risks of taking the medicine during pregnancy. The patient should tell their doctor immediately if they become pregnant while taking Clozapine Hasco. In newborns of mothers taking antipsychotic medicines in the last trimester of pregnancy (the last three months of their pregnancy), the following symptoms may occur: trembling, stiffness, and (or) muscle weakness, drowsiness, agitation, feeding problems, and breathing difficulties. If the child develops these symptoms, the patient should contact their doctor. Some women taking antipsychotic medicines have irregular periods or do not have them at all. When switching from another medicine to Clozapine Hasco, the patient's menstrual cycle may return to normal. Therefore, women of childbearing age should use effective contraception. The patient should not breastfeed while taking Clozapine Hasco. Clozapine, the active substance of Clozapine Hasco, may pass into breast milk and affect the baby.

Driving and using machines

Clozapine Hasco may cause drowsiness, dizziness, and seizures, especially during the initial treatment period. The patient should not drive vehicles or operate machines if they experience these symptoms.

Clozapine Hasco contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Clozapine Hasco

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. To minimize the risk of low blood pressure, seizures, and drowsiness, it is necessary for the doctor to gradually increase the dose of the medicine. It is very important not to change the dose or stop taking Clozapine Hasco without consulting the doctor first. The patient should continue treatment for as long as the doctor recommends. In the case of patients aged 60 or older, the doctor may start treatment with a lower dose and gradually increase it, as it is more likely that they will experience certain side effects (see section 2, "Important information before taking Clozapine Hasco"). If the prescribed dose cannot be achieved with this strength of the medicine, another strength of the medicine is available on the market, which will allow the required dose to be achieved.

Treatment of schizophrenia

The recommended initial dose is 12.5 mg (half a 25 mg tablet) once or twice a day on the first day, and then 25 mg once or twice a day on the second day. The tablet should be swallowed with water. If the patient tolerates the treatment well, the doctor may then gradually increase the daily dose by 25 mg to 50 mg over 2-3 weeks to achieve a target dose of 300 mg per day. Then, if necessary, the daily dose can be further increased by 50 mg to 100 mg at intervals of 3 to 4 days or preferably once a week. The effective daily dose is usually between 200 mg and 450 mg, divided into several single doses. Some patients may need higher doses. The maximum daily dose is 900 mg. At doses above 450 mg per day, it is possible to exacerbate some side effects (in particular, seizures). The patient should always take the smallest effective dose of the medicine. Most patients take part of the dose in the morning and part in the evening. The doctor will explain exactly how to divide the daily dose. If the daily dose is only 200 mg, the patient can take it as a single dose in the evening. If the patient has been taking Clozapine Hasco for some time with good results, the doctor may try to reduce the dose. The patient should take Clozapine Hasco for at least 6 months.

Treatment of severe thought, emotional, and behavioral disorders in patients with Parkinson's disease

The recommended initial dose is 12.5 mg (half a 25 mg tablet) in the evening. The tablet should be swallowed with water. Then, the doctor will gradually increase the dose by 12.5 mg, no faster than twice a week, to achieve a maximum dose of 50 mg per day by the end of the second week. If the patient experiences fainting, lightheadedness, or confusion, the dose increase should be delayed or stopped. To avoid these symptoms, the patient's blood pressure should be checked in the first weeks of treatment. The effective daily dose is usually 25 mg to 37.5 mg, taken as a single dose in the evening. The use of doses higher than 50 mg per day should only be done in exceptional cases. The maximum daily dose is 100 mg. The patient should always take the smallest effective dose of the medicine. The tablet can be divided into equal doses.

Taking a higher dose of Clozapine Hasco than recommended

If the patient takes a higher dose of Clozapine Hasco than recommended or takes the medicine by mistake, they should contact their doctor or go to the nearest hospital immediately. Symptoms of overdose include: drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion (disorientation), hallucinations, agitation, delirium, muscle stiffness, tremors, seizures, excessive salivation, dilated pupils, blurred vision, low blood pressure, shock, rapid or irregular heartbeat, shallow breathing or difficulty breathing.

Missing a dose of Clozapine Hasco

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose. Instead, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient forgets to take the medicine for 48 hours or longer, they should contact their doctor immediately.

Stopping treatment with Clozapine Hasco

The patient should not stop taking Clozapine Hasco without consulting their doctor, as withdrawal reactions may occur. These include: sweating, headache, nausea, vomiting, and diarrhea. If the patient experiences any of these symptoms, they should tell their doctor immediately. After these symptoms, more severe side effects may occur if the patient does not receive immediate treatment. The symptoms of the disease may return. To stop treatment, it is recommended to gradually reduce the dose by 12.5 mg over 1 to 2 weeks. If it is necessary to stop treatment with Clozapine Hasco immediately, the patient should consult their doctor. If the doctor decides to restart treatment with Clozapine Hasco and the patient has taken the last dose of Clozapine Hasco more than 2 days ago, the initial dose will be 12.5 mg. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clozapine Hasco can cause side effects, although not everyone will experience them.

Some side effects may be severe and require immediate medical attention.

The patient should tell their doctor immediately before taking the next dose of Clozapine Hasco if they experience any of the following symptoms:

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

• severe constipation. The doctor will provide treatment to prevent further complications,
• rapid heartbeat.

Common(affects less than 1 in 10 people):

• symptoms of a cold, fever, flu-like symptoms, sore throat, or other infections. The doctor will perform urgent blood tests to check if the symptoms are related to the medicine,
• seizures,
• sudden fainting or loss of consciousness with muscle weakness (fainting).

Uncommon(affects less than 1 in 100 people):

• sudden increased body temperature, muscle stiffness that can lead to loss of consciousness (symptoms of malignant neuroleptic syndrome), which can be a severe side effect requiring immediate treatment,
• dizziness or fainting when changing positions, which can increase the risk of falls.

Rare(affects less than 1 in 1,000 people):

• symptoms of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing,
• severe, burning pain in the upper abdomen that radiates to the back, with accompanying nausea and vomiting, caused by pancreatitis,
• fainting and muscle weakness due to significantly low blood pressure (circulatory collapse),
• difficulty swallowing (which can cause food to be inhaled),
• nausea, vomiting, and (or) loss of appetite. The doctor will check the patient's liver function,
• weight gain or increased weight,
• shortness of breath.

Rare(affects less than 1 in 1,000 people) or very rare(affects less than 1 in 10,000 people):

• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check the patient's heart function and, if necessary, refer them to a cardiologist immediately.

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Very rare(affects less than 1 in 10,000 people):

• prolonged, painful erection of the penis, known as priapism. If the erection lasts for more than 4 hours, immediate treatment may be necessary to prevent further complications,
• sudden bleeding or bruising, which can be symptoms of a low platelet count,
• symptoms of uncontrolled blood sugar levels, such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, confusion or disorientation,
• abdominal pain, cramps, bloating, vomiting, constipation, and difficulty passing gas, which can be symptoms of intestinal obstruction,
• loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and general feeling of being unwell. These symptoms may indicate developing liver failure, which can lead to life-threatening liver necrosis,
• nausea, vomiting, fatigue, weight loss, which can be symptoms of kidney inflammation.

Frequency not known(frequency cannot be estimated from the available data):

• chest pain, feeling of tightness in the chest, pressure or severe pain (chest pain that may radiate to the left arm, jaw, neck, and upper abdomen), shortness of breath, sweating, weakness, dizziness, nausea, vomiting, and palpitations (symptoms of a heart attack) - life-threatening symptoms. In these cases, the patient should see a doctor immediately,
• pressure in the chest, feeling of heaviness, pressure, severe pain, or burning (symptoms of insufficient blood flow and oxygen to the heart muscle) - life-threatening symptoms. The doctor will check the patient's heart function,
• feeling of irregular heartbeat: "thumping", "pounding", or "fluttering" in the chest (palpitations),
• rapid and irregular heartbeat (atrial fibrillation). Occasionally, palpitations, fainting, shortness of breath, or chest discomfort may occur. The patient should consult their doctor,
• symptoms of low blood pressure, such as dizziness, lightheadedness, fainting, blurred vision, excessive fatigue, cold and clammy skin, or nausea,
• symptoms of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing,
• confirmed or suspected infection with accompanying fever or low body temperature, rapid breathing, rapid heartbeat, changes in reaction speed and consciousness, low blood pressure (sepsis),
• excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome),
• significant decrease in urine output (symptom of kidney failure),
• allergic reaction (swelling mainly of the face, lips, and throat, as well as the tongue, which can cause itching and be painful),
• loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and general feeling of being unwell. These symptoms may indicate liver failure, which can lead to life-threatening liver necrosis, liver damage (damage to liver cells, bile ducts, or both), liver transplant,
• burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages; black, tarry stools; bloating, heartburn, nausea, or vomiting; rapid onset of fullness during meals (ulceration of the intestine and (or) stomach) - life-threatening symptoms,
• intense abdominal pain worsened by movement; nausea, vomiting, including vomiting blood (or coffee ground-like material); abdominal tenderness with guarding (muscle tension) upon palpation (perforation of the stomach and (or) intestine or rupture of the intestine) - life-threatening symptoms,

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• constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. These symptoms may indicate acute colonic distension (acute colonic distension) or intestinal infarction/ischemia/necrosis - life-threatening symptoms. The patient should consult their doctor,
• dull chest pain with shortness of breath, with or without cough,
• increased or worsening muscle weakness, muscle cramps, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). The patient should consult their doctor,
• dull chest pain or abdominal pain, with shortness of breath, with or without cough and fever,
• restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by a feeling of discomfort, which occurs during rest, especially in the evening or at night, with temporary relief during movement),
• severe and serious skin reactions, such as drug rash with eosinophilia (increased number of a certain type of white blood cell) and systemic symptoms (DRESS syndrome). Skin reactions may occur in the form of a rash with or without blisters. There may be skin irritation, swelling, fever, and flu-like symptoms. Symptoms of DRESS syndrome usually occur within 2-6 weeks of starting the medicine.

If any of the above points apply to the patient, they should tell their doctor before taking the next dose of Clozapine Hasco.

Other side effects:

Very common(affects more than 1 in 10 people):
Drowsiness, dizziness, excessive salivation.
Common(affects less than 1 in 10 people):
High white blood cell count, high eosinophil count, weight gain, blurred vision, headache, tremors, stiffness, restlessness, involuntary movements, inability to perform movements, inability to remain still, changes in ECG, high blood pressure, fainting or lightheadedness when changing positions, nausea, vomiting, loss of appetite, dry mouth, abnormal liver function tests, urinary incontinence, urinary retention, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g., slurred speech).
Uncommon(affects less than 1 in 100 people):
Low white blood cell count, speech disorders (e.g., stuttering).
Rare(affects less than 1 in 1,000 people):
Low red blood cell count, restlessness, agitation, confusion, delirium, arrhythmia, myocarditis or pericarditis, fluid accumulation in the pericardium, high blood sugar levels, diabetes, pulmonary embolism (venous thromboembolism), hepatitis, jaundice (liver disease causing yellowing of the skin, dark urine, itching), pancreatitis leading to severe abdominal pain, increased levels of an enzyme called creatine phosphokinase in the blood.
Very rare(affects less than 1 in 10,000 people):
Increased platelet count with possible blood clotting in blood vessels, uncontrolled movements of the mouth/tongue and limbs, and repetitive thoughts and compulsive actions (obsessive-compulsive symptoms), skin reactions, swelling of the parotid gland (enlargement of the salivary glands), breathing difficulties, very high levels of triglycerides or cholesterol in the blood, heart muscle disease (cardiomyopathy), cardiac arrest, sudden unexplained death.
Frequency not known(frequency cannot be estimated from the available data):
Changes in brain wave tests (electroencephalogram/EEG), diarrhea, discomfort in the stomach, heartburn, discomfort in the stomach after eating, feeling of weakness, muscle cramps, muscle pain, stuffy nose, bedwetting, sudden, uncontrolled increase in blood pressure (pseudo-pheochromocytoma), uncontrolled bending of the body to one side (pleurothotonus), ejaculation disorders in men, during which semen enters the bladder instead of exiting the penis (dry orgasm or retrograde ejaculation), rash, purple spots, fever, or itching due to vasculitis, colon inflammation causing diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), increased risk of death in elderly patients with dementia treated with antipsychotic medicines compared to those not taking antipsychotic medicines.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Clozapine Hasco

There are no special precautions for storing the medicinal product. The medicine should be stored out of sight and reach of children. The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clozapine Hasco contains

• The active substance of Clozapine Hasco is clozapine. One tablet contains 25 mg or 100 mg of clozapine.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K-17, talc, magnesium stearate, colloidal anhydrous silica.

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What Clozapine Hasco looks like and contents of the pack

Tablets containing 25 mg of clozapine are yellow, round, flat tablets with beveled edges, with a uniform surface, and a score line on one side. Tablets containing 100 mg of clozapine are yellow, round, biconvex tablets, with a uniform surface, and a score line on one side. PVC/PVDC/Aluminum blisters in a cardboard box. The pack contains 50, 100, 150, or 200 tablets.

Marketing authorization holder and manufacturer

Hasco-Lek S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E, Poland. Information about the medicine, phone: 22 742 00 22, e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

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