Package leaflet: Information for the patient

Clozapine Hasco, 25 mg, tablets
Clozapine Hasco, 100 mg, tablets
Clozapinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Clozapine Hasco is and what it is used for
Important information before taking Clozapine Hasco
How to take Clozapine Hasco
Possible side effects
How to store Clozapine Hasco
Contents of the pack and other information

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

The active substance in Clozapine Hasco is clozapine, which belongs to a group of medicines called neuroleptics (medicines used to treat specific mental disorders, such as psychoses).
Clozapine Hasco is used to treat patients with schizophrenia who have not responded to treatment with other medicines.
Schizophrenia is a mental illness causing disturbances in thinking, emotions, and behaviour.
Clozapine Hasco should only be used in patients who have already been treated with at least two different antipsychotic medicines, including one from the group of new atypical antipsychotics indicated for the treatment of schizophrenia, and who did not respond to these medicines or experienced severe adverse effects that could not be managed.
Clozapine Hasco is also used to treat severe disturbances in thinking, emotions, and behaviour in patients with Parkinson's disease who do not respond to treatment with other medicines.

2. Important information before using Clozapine Hasco

When not to use Clozapine Hasco

if the patient has a known allergy (hypersensitivity) to clozapine or to any of the other ingredients of this medicine (listed in section 6),
if regular blood tests cannot be performed for the patient,
if the patient has ever had a low white blood cell count (e.g. leukopenia or agranulocytosis), particularly if it was caused by medications, except for cases of low white blood cell count related to previous chemotherapy,
if the patient has previously discontinued treatment with Clozapine Hasco due to severe adverse reactions (e.g. agranulocytosis or heart disorders),
if the patient is or has been treated with long-acting injectable antipsychotic medicines (depot),
if the patient has or has had impaired bone marrow function,
if the patient has uncontrolled epilepsy (seizures or convulsions of any type),
if the patient has acute psychiatric disorders caused by alcohol or drugs (e.g. narcotics),
if the patient has reduced consciousness and marked drowsiness,
if the patient has circulatory collapse, which may result from severe shock,
if the patient has severe kidney function disorders,
if the patient has myocarditis (inflammation of the heart muscle),
if the patient has other severe heart diseases,
if the patient shows 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 patient's intestine does not function properly and the patient has severe constipation),
if the patient is taking any medicines that suppress normal bone marrow function,
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, inform the doctor and do not use Clozapine Hasco.
Clozapine Hasco must not be used in patients who are unconscious or in a coma.

Warnings and precautions
Before starting treatment with Clozapine Hasco, discuss this with the doctor or pharmacist.
The safety issues mentioned in this section are very important. The patient must pay special attention to them in order to minimize the risk of severe, life-threatening adverse reactions.
Before the patient starts treatment with Clozapine Hasco, the patient should inform the doctor if any of the following apply, either to the patient or to someone in their family:

blood clots, because medicines such as this have been associated with clot formation,
glaucoma (increased pressure in the eye),
diabetes (elevated, sometimes significantly, blood glucose levels, occurring in patients with or without a history of diabetes),
problems with the prostate gland or difficulty urinating,
heart, kidney, or liver diseases,
chronic constipation or use of medicines causing constipation (such as anticholinergic drugs),
galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome,
controlled epilepsy,
diseases of the large intestine,
previous abdominal surgeries,
or in family history, heart disorders or abnormal heart conduction known as "QT prolongation",
risk of stroke, e.g. if the patient has high blood pressure, cardiovascular problems, or cerebrovascular disorders,
severe skin rash, skin peeling, blisters and (or) mouth ulcers after taking Clozapine Hasco. This medicine may cause severe skin reactions. If any symptoms related to severe skin reactions occur, discontinue clozapine and contact the doctor immediately.

Inform the doctor immediately before taking the next dose of Clozapine Hasco if the patient:

develops symptoms of cold, fever, flu-like symptoms, sore throat, or any infection. The doctor may recommend urgent blood count testing if these symptoms are related to this medicine,
experiences sudden high temperature and muscle stiffness, which may lead to loss of consciousness (symptoms of neuroleptic malignant syndrome), a serious adverse reaction requiring immediate treatment,
has rapid or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check heart function and, if necessary, refer the patient urgently to a cardiologist,
has nausea, vomiting, and (or) loss of appetite. The doctor will check liver function,
has constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. Medical consultation is required,
develops symptoms of appendicitis. These may include: severe and worsening abdominal pain starting around the navel and moving to the lower right abdomen, worsening with movement, coughing, or pressure on the area. Other possible symptoms include constipation, abdominal bloating, malaise, mild fever, vomiting, loss of appetite, or diarrhea. Immediate medical examination is necessary.

Regular medical check-ups and blood tests
Before starting treatment with Clozapine Hasco, the doctor will take a medical history 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 are essential before starting treatment, during treatment, and after stopping Clozapine Hasco.

The doctor will inform the patient exactly when and where to have the tests performed. Clozapine Hasco may only be used if the patient's blood count results are normal.
Clozapine Hasco may cause a significant decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can detect the risk of developing agranulocytosis (see section 4).
Blood tests should be performed weekly for the first 18 weeks of treatment. Then, for the following 34 weeks, tests should be performed at least once a month.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then
if no decrease in white blood cell count has been detected, once a year.
If a decrease in white blood cell count occurs, Clozapine Hasco must be discontinued immediately. The white blood cell count should return to normal values.
Blood tests should continue for an additional 4 weeks after stopping Clozapine Hasco, in cases of complete treatment discontinuation for hematological reasons (e.g. agranulocytosis) or if monitoring has been for <2 years or in cases of a history of neutropenia that did not lead to treatment discontinuation. The doctor will also perform a medical examination before starting treatment with Clozapine Hasco. The doctor may order an electrocardiogram (ECG) to check heart function if necessary for the patient or if the patient has specific concerns. If the patient has liver function disorders, regular liver function tests will be performed throughout treatment with Clozapine Hasco.

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If the patient has high blood sugar (glucose) levels (diabetes), the doctor may order regular blood glucose tests.
Clozapine Hasco may cause changes in blood lipid levels. Clozapine Hasco may cause weight gain. The doctor may monitor the patient's body weight and blood lipid levels.
If the patient currently has or develops dizziness, lightheadedness, or fainting while taking Clozapine Hasco, the patient should change position carefully from sitting or lying down, as these symptoms may increase the risk of falls.
If the patient needs to undergo surgery or for other reasons will be immobilized for a prolonged period, discuss the use of Clozapine Hasco with the doctor. There is a risk of venous thrombosis (blood clotting in veins).

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

Elderly patients (aged 60 years and above)
In elderly patients (aged 60 years and above), the following adverse reactions may occur more frequently during treatment with Clozapine Hasco: fainting or lightheadedness upon changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation.
Inform the doctor if the patient has a condition called dementia.

Clozapine Hasco and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Dose adjustments or changes in medication may be necessary.
Do not use Clozapine Hasco together with medicines that suppress normal bone marrow function 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-derived analgesics such as phenylbutazone or metamizole;
penicillamine, a medicine used, among others, in the treatment of rheumatoid arthritis;
cytotoxic agents, medicines used in chemotherapy;
antipsychotic medicines in depot injection form. These medicines increase the risk of developing agranulocytosis (lack of white blood cells).

Using Clozapine Hasco together with other medicines may affect the action of Clozapine Hasco and (or) other medicines. Inform the doctor if the patient plans to take, is currently taking (even if treatment is ending), or has 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 respiratory function
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 certain eye drops, cold remedies, or antitussives
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 cautiously with Clozapine Hasco or avoided during treatment with Clozapine Hasco, and knows whether a medicine belongs to the mentioned groups. Ask them for advice.

Clozapine Hasco with food and drink
Do not drink alcohol while taking Clozapine Hasco.
Inform the doctor if the patient smokes and how often they consume drinks containing caffeine (coffee, tea, cola). Sudden changes in smoking habits or consumption of caffeine-containing drinks may also alter the effects of Clozapine Hasco.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult the doctor before using this medicine. The doctor will discuss the benefits and possible risks of using the medicine during pregnancy. Inform the doctor immediately if the patient becomes pregnant while being treated with Clozapine Hasco.
Newborns of mothers who took antipsychotic medicines during the third trimester of pregnancy (last three months) may experience the following symptoms: tremor, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the baby develops these symptoms, contact the doctor.
Some women taking medicines used to treat mental illnesses have irregular or absent menstrual periods. As a result of switching from another treatment to Clozapine Hasco, normal menstruation may return. Therefore, women of childbearing age should use effective contraceptive methods.
Do not breastfeed while being treated with Clozapine Hasco. Clozapine, the active substance in Clozapine Hasco, may pass into breast milk and affect the baby.

Driving and operating machinery
Clozapine Hasco may cause fatigue, drowsiness, and seizures, especially during the initial period of treatment. Do not drive motor vehicles or operate machinery if the above symptoms occur.

Clozapine Hasco contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
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3. How to use Clozapine Hasco

This medicine should always be taken exactly as prescribed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
To minimise the risk of low blood pressure, seizures, and drowsiness, your doctor must gradually
increase the dose of this medicine.
It is very important not to change the dose or stop taking Clozapine Hasco without first discussing it
with your doctor. You should continue treatment for as long as your doctor recommends. For patients
aged 60 years or older, your doctor may start treatment with a lower dose and increase it gradually,
as they are more likely to experience certain adverse effects (see section 2, "Important information
before taking Clozapine Hasco").
If the prescribed dose cannot be achieved with the available strength of this medicine, another
strength of this medicine is available on the market which will allow you to achieve the required
dose.
Treatment of schizophrenia
The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice daily on the first day, followed
by 25 mg once or twice daily on the second day. Swallow the tablet with water. If the treatment is
well tolerated, your doctor may then gradually increase the daily dose by 25 mg to 50 mg over 2-3
weeks, aiming for a target dose of up to 300 mg per day. Thereafter, if necessary, the daily dose
may be further increased by 50 mg to 100 mg every 3 to 4 days, or preferably once a week.
The effective daily dose is usually between 200 mg and 450 mg, divided into several individual
doses. Some patients may require higher doses. The maximum recommended daily dose is 900 mg.
At daily doses above 450 mg, certain adverse effects (particularly seizures) may become more
pronounced. The lowest effective dose for the patient should always be used. Most patients take
part of the dose in the morning and part in the evening. Your doctor will explain exactly how the
daily dose should be divided. If the daily dose is only 200 mg, the patient may take it as a single dose
in the evening. If the patient has been taking Clozapine Hasco for some time with good effect, the
doctor may consider reducing the dose. The patient should continue taking Clozapine Hasco for at
least 6 months.
Treatment of severe disturbances of thought, emotion, and behaviour in patients with Parkinson’s
disease
The usual starting dose is 12.5 mg (half a 25 mg tablet) taken in the evening. Swallow the tablet with
water. Your doctor will then gradually increase the dose by 12.5 mg, no more than twice a week, until
a maximum daily dose of 50 mg is reached by the end of the second week. If the patient experiences
fainting, dizziness, or confusion, dose escalation should be delayed or paused. To avoid such
symptoms, the patient's blood pressure should be monitored during the first weeks of treatment.
The effective daily dose is usually 25 mg to 37.5 mg, taken as a single evening dose. Doses higher
than 50 mg per day should only be used in exceptional cases. The maximum daily dose is 100 mg.
The lowest effective dose should always be used.
The tablet may be divided into equal doses.
Taking more Clozapine Hasco than prescribed
If you take more Clozapine Hasco than prescribed, or if someone else takes the medicine, contact
your doctor immediately or go to the nearest hospital.
Symptoms of overdose include: drowsiness, fatigue, lack of energy, loss of consciousness, coma,
confusion (disorientation), hallucinations, agitation, delirium, muscle stiffness, hand tremors,
seizures (convulsions), excessive salivation, dilated pupils, blurred vision, hypotension, collapse,
fast or irregular heartbeat, shallow breathing, or difficulty breathing.
If you miss a dose of Clozapine Hasco
If you miss a dose, take it as soon as possible. However, do not take the medicine if it is almost time
for the next dose. In that case, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have forgotten to take the medicine for 48 hours or longer, contact your doctor immediately.
Stopping Clozapine Hasco
Do not stop taking Clozapine Hasco without consulting your doctor, as withdrawal reactions may
occur. These include: sweating, headache, nausea, vomiting, and diarrhoea.
If any of these symptoms occur, inform your doctor immediately. Following these symptoms,
more serious adverse effects may occur if the patient does not receive immediate treatment.
Symptoms of the illness may return. To discontinue treatment, a gradual reduction of the dose by
12.5 mg over one to two weeks is recommended. If immediate discontinuation of Clozapine Hasco
is necessary, consult your doctor. If your doctor decides to restart treatment with Clozapine Hasco
and the last dose was taken more than two days earlier, the starting dose will be 12.5 mg.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention.
You should immediately tell the doctor before taking the next dose of Clozapine Hasco if the
patient experiences any of the following symptoms:
Very common (affects more than 1 in 10 people):

severe constipation. The doctor will initiate treatment to prevent further complications,
fast heartbeat.

Common (affects less than 1 in 10 people):

symptoms of a cold, fever, flu-like symptoms, sore throat or other infections. Blood tests should be urgently performed to determine whether symptoms are related to the medicine,
seizures,
sudden fainting or sudden loss of consciousness with muscle weakness (fainting).

Uncommon (affects less than 1 in 100 people):

sudden increase in body temperature, muscle stiffness, which may lead to loss of consciousness (neuroleptic malignant syndrome), as this may indicate serious adverse reactions requiring immediate treatment,

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dizziness or fainting upon changing position from lying down to standing, as this may increase the risk of falling.

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

respiratory tract infection symptoms or pneumonia, such as fever, cough, difficulty breathing, wheezing,
severe, burning pain in the upper abdomen spreading to the back, accompanied by nausea and vomiting due to pancreatitis,
fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse),
difficulty swallowing (may lead to food aspiration),
nausea, vomiting and (or) loss of appetite. The doctor will check liver function,
occurrence or worsening of existing obesity,
sleep apnea with or without snoring.

Rare (affects less than 1 in 1,000 people) or very rare (may affect 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 heart function and, if necessary, immediately refer the patient to a cardiologist.

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

prolonged, painful erection of the penis, called priapism. If the erection lasts longer than 4 hours, immediate treatment may be required to prevent further complications,
sudden bleeding or appearance of bruises, which may be signs of reduced platelet count,
symptoms caused by uncontrolled blood sugar levels (such as nausea or vomiting, abdominal pain, excessive thirst, frequent urination, disorientation or confusion),
abdominal pain, cramps, bloating, vomiting, constipation and difficulty passing gas, which may indicate intestinal obstruction,
loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness and general malaise. These symptoms may indicate developing liver failure, which may lead to fulminant hepatic necrosis,
nausea, vomiting, fatigue, weight loss, which may be symptoms of kidney inflammation.

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

pressure-like chest pain, feeling of tightness in the chest, pressure or sudden 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 heart attack) – life-threatening symptoms. In such cases, seek medical attention immediately,
chest tightness, feeling of heaviness, pressure, sudden severe pain, burning sensation or feeling of suffocation (symptoms of inadequate blood and oxygen supply to the heart muscle) – life-threatening symptoms. The doctor will check the patient's heart function,
sensation 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. Medical consultation is necessary,
symptoms of low blood pressure, such as dizziness, vertigo, fainting, blurred vision, excessive fatigue, cold and clammy skin or nausea,
symptoms indicating blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties, 8 / 12
confirmed or diagnosed infection with accompanying fever or abnormally low body temperature, abnormally rapid breathing, rapid heartbeat, changes in reaction speed and awareness, low blood pressure (sepsis),
excessive sweating, headache, nausea, vomiting and diarrhea (symptoms of cholinergic syndrome),
significantly reduced urine output (symptom of kidney failure),
hypersensitivity reaction (swelling mainly of the face, lips and throat, as well as the tongue, which may cause itching and be painful),
loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness and general malaise. Symptoms may indicate liver failure, which leads to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including life-threatening liver failure, liver damage (liver cell damage, bile duct damage, or both), liver transplantation,
burning pain in the upper abdomen, especially between meals, early in the morning or after drinking acidic beverages; tarry, black or bloody stools; bloating, heartburn, nausea or vomiting, rapid feeling of fullness during meals (peptic ulcer of the intestine and/or stomach) – life-threatening symptoms,
severe abdominal pain worsened by movement; nausea, vomiting, including vomiting blood (or coffee-ground-like fluid); abdominal rigidity with rebound tenderness (after pressure release) spreading peripherally from the site of perforation; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) – life-threatening symptoms,
constipation, abdominal pain, tenderness on abdominal palpation, fever, bloating, bloody diarrhea. These symptoms may indicate acute colonic dilation (acute intestinal dilation) or intestinal infarction/ischemia/necrosis – life-threatening symptoms. Medical consultation is necessary,
appendicitis,
dull chest pain with shortness of breath, with or without cough,
increase or onset of muscle weakness, muscle cramps, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). Medical consultation is necessary,
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 discomfort during rest, especially in the evening or at night, with temporary relief during movement),
very severe and serious skin reactions, such as drug rash with eosinophilia (increased number of a certain type of white blood cells) and systemic symptoms (DRESS syndrome). Skin-related adverse reactions may occur with or without blisters. Skin irritation, swelling, fever and flu-like symptoms may occur. DRESS syndrome symptoms usually appear about 2–6 weeks after starting the medicine,
blood cancer (hematological malignancy). A slightly increased risk of blood cancer has been observed in patients treated with clozapine, especially with longer treatment duration. Symptoms may include:
- unexplained fever,
- enlarged lymph nodes,
- recurrent infections during treatment,
- weight loss,
- excessive fatigue,
- skin redness,
- night sweats,
- easy bruising or bleeding.

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If any of the above points apply to the patient, inform the doctor before administering 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 (leukocytosis), high count of a certain type of white blood cells (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, motor restlessness, convulsions, muscle twitching, involuntary movements, inability to perform movements, inability to remain still, changes in ECG recording, hypertension, fainting or feeling of emptiness in the head upon changing position, nausea, vomiting, loss of appetite, dryness of the oral mucosa, abnormal liver function test results, 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):
Absence of white blood cells in the blood (agranulocytosis), speech disorders (e.g. stuttering).
Rare (affects less than 1 in 1,000 people):
Low red blood cell count (anemia), motor restlessness, agitation, confusion, delirium, arrhythmia, myocarditis or pericarditis, pericardial effusion, increased blood glucose concentration, diabetes, pulmonary embolism (venous thromboembolic disease), hepatitis, jaundice (liver disease causing: yellowing of the skin, dark urine color, itching), pancreatitis leading to severe abdominal pain, increased blood levels of an enzyme called creatine kinase.
Very rare (affects less than 1 in 10,000 people):
Increased platelet count with possible blood clotting in blood vessels, uncontrolled movements of lips/tongue and limbs, intrusive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, parotid gland swelling (salivary gland enlargement), 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, stomach discomfort, heartburn, stomach discomfort after eating, feeling of muscle weakness, muscle cramps, muscle pain, nasal congestion, nocturnal enuresis, sudden, uncontrolled rise in blood pressure (pseudo-pheochromocytoma syndrome), uncontrolled body bending 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-red spots, fever or itching due to vasculitis, colitis causing diarrhea, abdominal pain, fever, skin color changes, butterfly-shaped facial rash, joint pain, muscle pain, fever and fatigue (lupus erythematosus).
In elderly patients with dementia treated with antipsychotic medicines, there is a slightly increased risk of death compared to patients not taking antipsychotic medicines.
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Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Clozapine Hasco

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Clozapine Hasco contains
Clozapine Hasco 25 mg, tablets

The active substance is clozapine. One tablet contains 25 mg of clozapine.
The other ingredients (excipients) are: monohydrate lactose, pregelatinized corn starch, povidone K-17, talc, magnesium stearate, anhydrous colloidal silicon dioxide.

Clozapine Hasco 100 mg, tablets

The active substance is clozapine. One tablet contains 100 mg of clozapine.
The other ingredients (excipients) are: monohydrate lactose, pregelatinized corn starch, povidone K-17, talc, magnesium stearate, anhydrous colloidal silicon dioxide.

What Clozapine Hasco looks like and contents of the pack
Tablets containing 25 mg of clozapine are yellow, round, flat tablets with bevelled edges, uniform surface, and a division line on one side.
Tablets containing 100 mg of clozapine are yellow, round, biconvex tablets with uniform surface and a division line on one side.
Packs: PVC/PVDC/Aluminium blisters in a cardboard box. The pack contains 50, 100, 150 or 200 tablets.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
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Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]
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Clozapine hasco