Clopizam

Package leaflet: Information for the patient

Clopizam, 25 mg, tablets
Clopizam, 50 mg, tablets
Clopizam, 100 mg, tablets
Clopizam, 200 mg, tablets
Clozapinum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

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

Leaflet contents:

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

1. What Clopizam is and what it is used for

The active substance in Clopizam is clozapine, which belongs to a group of medicines called antipsychotics (neuroleptics). These are medicines used in the treatment of specific mental disorders, such as psychoses.
Clopizam 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.
Clopizam is prescribed only for patients who have already been treated with at least two different antipsychotic medicines, including one from the group of new atypical antipsychotics indicated in the treatment of schizophrenia, and who did not respond to these treatments or experienced severe adverse reactions that could not be managed.
Indication applies only to strengths of 25 mg, 50 mg, and 100 mg
Clopizam is also used to treat severe disturbances in thinking, emotions, and behavior in patients with Parkinson's disease who do not respond to treatment with other medicines.

2. Important information before using Clopizam

When not to use Clopizam:

• if the patient is allergic to the active substance 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 taking medications, except in cases of low white blood cell count due to previous chemotherapy;
• if the patient previously discontinued Clopizam due to severe adverse reactions (e.g. agranulocytosis or heart disorders);
• if the patient has previously been treated with long-acting (depot) antipsychotic medicines administered by injection;
• if the patient has or has ever had bone marrow disease;
• if the patient has uncontrolled epilepsy (seizures or convulsions of any kind);
• if the patient has acute psychiatric disorders caused by alcohol or drugs (or narcotics);
• if the patient has disturbances of 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 has signs of active liver disease (such as jaundice - yellowing of the skin and eyes, nausea, loss of appetite);
• if the patient has other severe liver function disorders;
• if the patient has paralytic ileus (impaired intestinal function causing 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.

If any of the above points apply to the patient, Clopizam must not be used.
The patient should consult a doctor or pharmacist.
Clopizam must not be used in patients who are unconscious or in a coma.

Warnings and precautions
The safety issues described in this section are very important. The patient must follow them to minimize the risk of severe, life-threatening adverse reactions.

Before starting treatment with Clopizam, tell the doctor if the patient has or has had any of the following conditions:

• blood clots or a family history of blood clots, because medicines like this one may cause blood clots to form;
• glaucoma (increased pressure in the eye);
• diabetes (increased, sometimes significantly elevated, blood glucose levels may occur in patients with or without a history of diabetes) (see section 4.4);
• prostate gland disorders or difficulty in passing urine;
• any heart, kidney, or liver diseases;
• chronic constipation or use of constipating medicines (such as anticholinergic drugs);
• galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome;
• controlled epilepsy;
• diseases of the large intestine;
• abdominal surgery;
• cardiac conduction disorders, known as QT interval prolongation, in the patient or in family history;
• risk of stroke, e.g. due to high blood pressure, cardiovascular disorders, or impaired cerebral circulation.

Before taking the next tablet of Clopizam, immediately inform the doctor if the patient:

• develops symptoms of a cold, fever, flu-like symptoms, sore throat, or other signs of infection. The doctor may recommend urgent blood tests to determine whether these symptoms are caused by Clopizam.
• experiences sudden high body temperature and (or) muscle stiffness, which may lead to loss of consciousness (symptoms of neuroleptic malignant syndrome), a serious adverse reaction requiring immediate treatment.
• experiences rapid and irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue – the doctor will assess heart function and, if necessary, refer the patient immediately to a cardiologist.
• experiences nausea, vomiting, and (or) loss of appetite – the doctor will assess liver function.
• experiences severe constipation – the doctor will initiate treatment to prevent further complications.
• experiences constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhoea. A consultation with a doctor is required.

Monitoring tests and blood tests
Before starting treatment with this medicine, the doctor will take a medical history and order blood tests to confirm that the white blood cell count is normal. This is important because white blood cells are essential for fighting infections.
Regular blood tests are essential before starting treatment, during treatment, and after discontinuation of Clopizam.

• The doctor will inform the patient when and where to have the tests performed. Clopizam may only be used if the patient has a normal white blood cell count.
• This medicine 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 (see section 4).
• During the first 18 weeks of treatment, blood tests should be performed weekly. Then, during 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 cells has been detected, once a year.
• If a decrease in white blood cell count occurs, treatment with clozapine must be stopped immediately. The white blood cell count should return to normal.
• Blood tests should continue for 4 weeks after discontinuation of clozapine treatment, in cases of complete treatment discontinuation due to hematological reasons (e.g. agranulocytosis), or if monitoring has been less than 2 years, or in cases of a history of neutropenia that did not lead to treatment discontinuation.

Before starting treatment, the doctor will also perform a physical examination of the patient. An electrocardiogram (ECG) may be ordered to check heart function, if necessary or if the patient has specific concerns.
If the patient has liver function disorders, regular liver function tests will be performed throughout treatment.
If the patient has high blood sugar (glucose) levels (diabetes), the doctor may order regular blood glucose tests.
This medicine may cause changes in blood lipid levels and weight gain. The doctor may monitor the patient's body weight and blood lipid levels.
If the patient experiences a sensation of "emptiness" in the head, dizziness, or fainting, they should rise carefully from sitting or lying positions, as these symptoms may increase the risk of falls.
If surgery is required or the patient will be immobilized for a prolonged period for other reasons, the use of this medicine should be discussed with the doctor. There is a risk of thrombosis (blood clotting in veins).

Children and adolescents under 16 years of age
Clopizam must not be used in patients under 16 years of age, as there is insufficient data on the use of this medicine in this age group.

Elderly people (60 years and older)
In elderly patients (60 years and older), there is an increased risk of the following adverse reactions during clozapine treatment: fainting or a sensation of "emptiness" in the head upon changing position, dizziness, rapid heartbeat, difficulty in passing urine, and constipation.
Inform the doctor if the patient has a condition known as dementia.

Clopizam and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines and herbal remedies. Dose adjustments or changes in medication may be necessary.
Do not use Clopizam 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 derivative analgesics such as phenylbutazone;
• penicillamine, a medicine used to treat rheumatoid arthritis;
• cytotoxic agents, medicines used in chemotherapy;
• long-acting (depot) antipsychotic medicines administered by injection.

These medicines increase the risk of developing agranulocytosis (lack of white blood cells).
Concomitant use of Clopizam and other medicines may affect the action of Clopizam and (or) the action of these other medicines. Inform the doctor if any of the following medicines are being used:

• medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline;
• other antipsychotics used to treat mental illnesses, such as perazine;
• benzodiazepines and other medicines used to treat anxiety disorders and sleep disturbances;
• opioids and other medicines that may affect breathing;
• medicines used to treat epilepsy, such as phenytoin and valproic acid;
• medicines used to treat high blood pressure;
• medicines used to treat low blood pressure, such as adrenaline and noradrenaline;
• warfarin, a medicine used to prevent blood clots;
• antihistamines 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 peptic ulcer disease, such as omeprazole or cimetidine;
• certain antibiotics, such as erythromycin and rifampicin;
• certain antifungal medicines (such as ketoconazole) or antiviral medicines (such as protease inhibitors used to treat HIV infection);
• atropine, a medicine that may be an ingredient in certain eye drops, cold remedies, or cough medicines;
• adrenaline, a medicine used in life-threatening conditions;
• hormonal contraceptives.

The above list is not complete. The doctor or pharmacist has more information about medicines that should be used cautiously or avoided during treatment with Clopizam. The doctor or pharmacist will inform the patient whether their current medicines belong to these groups – the patient should talk to the doctor or pharmacist.

Clopizam with food, drink, and alcohol
Do not drink alcohol during treatment with Clopizam.
Inform the doctor if the patient smokes tobacco and inform the doctor how often the patient drinks caffeinated beverages (coffee, tea, Coca-Cola). Sudden changes in smoking or caffeine consumption habits may also alter the effect of this medicine.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
The doctor will inform the patient about the benefits and possible risks of using this medicine during pregnancy. Inform the doctor immediately if the patient becomes pregnant during treatment with Clopizam.
Newborns whose mothers took clozapine 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 any of these symptoms occur in the baby, contact the doctor.
Some women taking medicines used to treat mental illnesses may experience irregular or absent menstrual periods. Switching from another treatment to Clopizam may restore regular menstruation. Therefore, women of childbearing age should use effective contraceptive methods.
Do not breastfeed during treatment with this medicine. Clozapine, the active substance in Clopizam, may pass into breast milk and affect the infant.

Driving and operating machinery
This medicine may cause fatigue, drowsiness, and seizures, especially during the initial period of treatment. Do not drive or operate machinery if these symptoms occur.

Clopizam contains lactose
Clopizam contains lactose. If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before using Clopizam.

3. How to take Clopizam

To minimize the risk of low blood pressure, seizures, and drowsiness, your doctor will recommend a gradual increase in the dose of this medicine. This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
It is very important not to change the dose or stop taking this medicine without first consulting your doctor. Treatment should be continued for as long as your doctor recommends. For patients aged 60 years or older, the doctor may start treatment with a lower dose and increase it more slowly, as this group of patients has an increased risk of certain adverse effects (see section 2).
If the recommended dose cannot be achieved with a tablet of a given strength, tablets of other strengths are available.
25 mg tablets: The tablet can be divided into two equal doses.
100 mg tablets: The tablet can be divided into two equal doses.
200 mg tablets: The dividing line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not allow for division into equal doses.

Treatment of schizophrenia
The usual initial dose is 12.5 mg (half of a 25 mg tablet) once or twice daily on the first day, followed by 25 mg once or twice daily on the second day. The tablet should be swallowed with water. If the medicine is well tolerated, the doctor will then recommend gradually increasing the daily dose by 25 mg to 50 mg over 2–3 weeks, aiming for a daily dose of up to 300 mg. Subsequently, if necessary, the doctor may further increase the daily dose by 50 mg to 100 mg at intervals of 3 to 4 days, or preferably once a week.
The effective daily dose usually ranges from 200 mg to 450 mg, administered in several divided doses. Higher doses may be required for some patients. The maximum recommended daily dose is 900 mg. Doses exceeding 450 mg daily may increase the risk of adverse effects (especially seizures). The doctor will always prescribe the lowest effective dose for the patient. Most patients take part of the dose in the morning and part in the evening. Your doctor will clearly explain how to divide the daily dose. If the daily dose is 200 mg, it may be taken as a single dose in the evening. If the patient has been taking Clopizam for some time with good results, the doctor may consider reducing the dose. This medicine should be taken for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson's disease – applies only to strengths 25 mg, 50 mg, and 100 mg
The usual initial dose is 12.5 mg (half of a 25 mg tablet), taken in the evening. The tablet should be swallowed with water. The doctor will then recommend gradually increasing the daily dose by 12.5 mg, no more frequently than twice a week, to reach a maximum dose of 50 mg daily by the end of the second week. If the patient experiences fainting, a feeling of "emptiness" in the head, or confusion, the doctor will stop or delay increasing the dose. To avoid such symptoms, the doctor will recommend monitoring blood pressure during the first weeks of treatment.
The effective daily dose is usually between 25 mg and 37.5 mg, taken as a single evening dose. Doses exceeding 50 mg daily will be prescribed by the doctor only in exceptional cases. The maximum daily dose is 100 mg. The doctor will always prescribe the lowest effective dose for the patient.

Taking more Clopizam than prescribed
If too many tablets have been taken by the patient or if anyone else has taken any number of tablets, contact a doctor immediately or call emergency services.
Symptoms of overdose: drowsiness, fatigue, lack of energy, coma, confusion (disorientation), hallucinations, agitation, incoherent speech, limb stiffness, hand tremors, seizures, excessive salivation, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow breathing or difficulty breathing.

Missed dose of Clopizam
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, do not take the missed dose; take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If the patient has forgotten to take Clopizam for 48 hours or longer, contact the doctor immediately.

Stopping Clopizam
Do not stop taking Clopizam without consulting your doctor, as withdrawal symptoms may occur. These include: excessive sweating, headache, nausea, vomiting, and diarrhea. If the patient experiences any of these symptoms, inform the doctor immediately. More severe adverse effects may follow if the patient does not receive immediate treatment. Symptoms of the underlying disease may return. It is recommended to gradually reduce the dose by 12.5 mg over one to two weeks if discontinuation of the medicine is necessary. Your doctor will advise how to reduce the daily dose. If immediate discontinuation of Clopizam is required, the doctor will monitor the patient's condition. If the doctor decides to restart clozapine treatment and the patient last took Clopizam more than two days earlier, the initial 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious and require immediate medical attention.
If any of the following symptoms occur in the patient, tell the doctor immediately before taking the next dose of Clopizam:

Very common (may affect at least 1 in 10 patients):

• Severe constipation – the doctor will initiate treatment to prevent further complications.
• Rapid heartbeat.

Common (may affect less than 1 in 10 patients):

• Symptoms of cold, fever, flu-like symptoms, sore throat, or other signs of infection. The doctor may recommend urgent blood tests to determine whether these symptoms are caused by Clopizam treatment.
• Seizures.
• Sudden collapse or sudden loss of consciousness with muscle weakness (fainting).

Uncommon (may affect less than 1 in 100 patients):

• Sudden increase in body temperature, muscle rigidity, which may lead to loss of consciousness (neuroleptic malignant syndrome), as this may indicate serious adverse reactions requiring immediate treatment.
• Dizziness or fainting upon changing position from lying to standing, as this may increase the risk of falls.

Rare (may affect less than 1 in 1000 patients):

• Symptoms of respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing.
• Severe, burning pain in the upper abdomen radiating 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).
• If the patient experiences nausea, vomiting and (or) loss of appetite – the doctor will assess liver function.
• Development or worsening of existing obesity.
• Sleep apnea with or without snoring.

Rare (may affect less than 1 in 1000 patients) or very rare (may affect less than 1 in 10,000 patients):

• Rapid and irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue – the doctor will assess heart function and, if necessary, refer the patient immediately to a cardiologist.

Very rare (may affect less than 1 in 10,000 patients):

• Prolonged, painful penile erection, known as priapism, if the patient is male. If erection lasts longer than 4 hours, immediate treatment may be required to prevent further complications.
• Sudden bleeding or appearance of bruises, which may indicate 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 malaise. These symptoms may indicate developing liver failure, which may lead to fulminant hepatic necrosis.
• Nausea, vomiting, fatigue, weight loss, which may indicate kidney inflammation.

Frequency unknown (cannot be estimated from available data):

• Crushing chest pain, sensation of pressure in the chest, tightness or sudden severe pain (chest pain radiating to the left arm, jaw, neck, or upper abdomen), shortness of breath, profuse sweating, weakness, feeling of "emptiness" in the head, nausea, vomiting, and palpitations (symptoms of myocardial infarction), which may lead to death – in such case, seek immediate medical attention.
• Chest tightness, heaviness, pressure, sudden severe pain, burning, or choking sensation (symptoms of insufficient blood and oxygen supply to the heart muscle), which may lead to death – the doctor will assess the patient's heart function.
• Sensation of irregular heartbeat: "pounding", "racing", or "fluttering" in the chest (palpitations).
• Rapid and irregular heartbeat (atrial fibrillation). Occasionally, palpitations, fainting, shortness of breath, or chest discomfort may occur – the doctor will assess the patient's heart function.
• 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 veins, particularly in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties.
• Confirmed or suspected infection with accompanying fever or abnormally low body temperature, abnormally rapid breathing, rapid heartbeat, changes in reaction speed and consciousness, low blood pressure (sepsis).
• Profuse sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome).
• Marked reduction in urine output (symptom of kidney failure).
• Allergic reaction (swelling mainly of the face, oral mucosa, throat, and tongue, accompanied by itching or pain).
• Loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness, and malaise. Symptoms may indicate liver failure, leading to replacement of normal liver tissue with scar tissue, resulting in loss of liver function, including liver failure and life-threatening condition (potentially fatal), 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, early satiety (gastric and/or intestinal ulceration), which may lead to death.
• Severe abdominal pain worsening with movement, nausea, vomiting, including bloody vomiting (or coffee-ground-like fluid); abdomen becomes rigid, tenderness spreads from the perforation site along the abdomen; fever and/or chills (perforation of stomach and/or intestine or bowel rupture), which may lead to death.
• Constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. These symptoms may indicate acute colonic dilation (acute intestinal distension) or intestinal infarction/ischemia/necrosis, which may lead to death. Medical consultation is required.
• Piercing 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 required.
• Piercing chest or abdominal pain, with shortness of breath, with or without cough, fever, or both.
• During clozapine treatment, exceptionally severe and serious skin reactions have been reported, such as drug rash with eosinophilia and systemic symptoms (DRESS). Adverse skin reactions may present with or without rash and blisters. Skin irritation, swelling, fever, and flu-like symptoms may occur. DRESS symptoms usually appear approximately 2–6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above conditions affect the patient, inform the doctor immediately before taking the next dose of Clopizam.

Other adverse reactions:
Very common (may affect at least 1 in 10 patients):
Drowsiness, dizziness, excessive salivation.

Common (may affect less than 1 in 10 patients):
High white blood cell count (leukocytosis), high count of a specific type of white blood cells (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, motor restlessness, seizures, sudden muscle spasms, abnormal movements, inability to initiate movement, inability to remain still, changes in ECG, hypertension, fainting or feeling of "emptiness" in the head upon changing body position, nausea, vomiting, loss of appetite, dry mouth, minor abnormalities in liver function tests, urinary incontinence, urine retention, difficulty urinating, fatigue, fever, excessive sweating, increased body temperature, speech disorders (e.g. slurred speech).

Uncommon (may affect less than 1 in 100 patients):
Absence of white blood cells in blood (agranulocytosis), speech disorders (e.g. stuttering).

Rare (may affect less than 1 in 1000 patients):
Low red blood cell count (anemia), motor restlessness, agitation, confusion, delirium, cardiac rhythm disorders, myocarditis or pericarditis (inflammation of the heart muscle or the membrane surrounding the heart), fluid accumulation around the heart (pericardial effusion), high blood sugar levels, diabetes, pulmonary embolism (thromboembolic disease), hepatitis, liver disease causing yellowing of the skin and dark urine with itching, increased blood levels of an enzyme called creatine phosphokinase.

Very rare (may affect less than 1 in 10,000 patients):
Increased platelet count with possible blood clots in blood vessels, uncontrolled movements of lips/tongue and limbs, intrusive thoughts and repetitive compulsive behaviors (obsessive-compulsive symptoms), skin reactions, salivary gland swelling (enlargement of salivary glands), breathing difficulties, very high blood triglyceride or cholesterol levels, heart muscle disease (cardiomyopathy), cardiac arrest, sudden unexplained death.

Frequency unknown (cannot be estimated from available data):
Changes in brain wave tests (electroencephalogram/EEG), diarrhea, discomfort in the stomach, including after meals, heartburn, sensation of muscle weakness, muscle cramps, muscle pain, nasal congestion, nocturnal enuresis, sudden, uncontrolled increase in blood pressure (pseudo-pheochromocytoma syndrome), uncontrolled body twisting to one side (pleurothotonus), ejaculation disorders in men (semen does not exit the body but enters the bladder – dry orgasm or retrograde ejaculation), rash, purple-red skin spots, fever or itching due to vasculitis, inflammation of the large intestine with 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 legs or arms, usually accompanied by discomfort during rest, especially in the evening or at night, with temporary relief during movement).

In elderly patients with dementia treated with antipsychotic medicines, there is a slightly increased risk of death compared to patients not taking antipsychotic medicines.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Clopizam

• No special storage requirements apply for this medicine.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton following: EXP. The expiry date refers to the last day of the specified month.
• Do not use the medicine if the packaging is damaged or if there are signs suggesting the medicine may be counterfeit.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Clopizam contains

• The active substance is clozapine. Each tablet contains 25 mg, 50 mg, 100 mg, or 200 mg of clozapine.
• The other ingredients are: monohydrate lactose, corn starch, povidone K30, anhydrous colloidal silicon dioxide, magnesium stearate, and talc.

What Clopizam looks like and contents of the pack
Clopizam 25 mg: round, uncoated tablets with a diameter of approximately 6 mm, pale yellow to yellow in colour, with a division line and embossing "FC" and "1" on one side of the division line and smooth on the other side.
Clopizam 50 mg: round, uncoated tablets with a diameter of approximately 8 mm, pale yellow to yellow in colour, with embossing "FC" and "2" on one side and smooth on the other side.
Clopizam 100 mg: round, uncoated tablets with a diameter of approximately 10 mm, pale yellow to yellow in colour, with a division line and embossing "FC" and "3" on one side of the division line and smooth on the other side.
Clopizam 200 mg: uncoated, capsule-shaped tablets, approximately 17 mm in length and 8 mm in thickness, pale yellow to yellow in colour, with a triple division line and embossing "F" and "C" on one side, and a triple division line and embossing "7" on the other side.
25 mg tablets: The tablet can be divided into two equal doses.
100 mg tablets: The tablet can be divided into two equal doses.
200 mg tablets: The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, not for dividing it into equal doses.

Clopizam is available in aluminium/PVC/PVDC blisters, packed in cardboard boxes containing:
25 mg: 7, 14, 28, 30, 40, 50, 100 or 500 tablets
50 mg: 28, 30, 40, 50 or 100 tablets
100 mg: 14, 28, 30, 40, 50, 60, 84, 100 or 500 tablets
200 mg: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Laboratori Fundacio DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, 32009
Greece

This medicinal product is authorised for sale in the European Economic Area under the following names: