Clopizam

Leaflet accompanying the packaging: patient information

Clopizam, 25 mg, tablets

Clopizam, 50 mg, tablets

Clopizam, 100 mg, tablets

Clopizam, 200 mg, tablets

Clozapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• 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 Clopizam and what is it used for
• 2. Important information before taking Clopizam
• 3. How to take Clopizam
• 4. Possible side effects
• 5. How to store Clopizam
• 6. Package contents and other information

1. What is Clopizam and what is it used for

The active substance of Clopizam is clozapine, which belongs to a group of medicines called antipsychotics (neuroleptics). These are medicines used to treat 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 disorders of thought, emotion, and behavior.

Clopizam is given only to 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 treated.

Indication only for 25 mg, 50 mg, and 100 mg strengths

Clopizam 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 Clopizam

When not to take Clopizam:

• if the patient is allergic to the active substance 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 due to previous chemotherapy;
• if the patient has previously stopped taking Clopizam due to severe side effects (e.g., agranulocytosis or heart disorders);
• if the patient is or has been treated with depot antipsychotic medicines given by injection;
• if the patient has or has had bone marrow disease;
• if the patient has uncontrolled epilepsy (seizures or other types of epilepsy);
• if the patient has acute mental disorders caused by alcohol or drugs (or narcotics);
• if the patient has disorders of consciousness and increased drowsiness;
• if the patient has circulatory collapse, which may be the result of severe shock;
• if the patient has severe kidney function disorders;
• 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 eyes, nausea, loss of appetite);
• if the patient has other severe liver function disorders;
• if the patient has paralytic ileus (intestinal function is impaired, causing severe constipation);
• if the patient is taking any medicines that inhibit the normal function 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 not take Clopizam, and should consult a doctor or pharmacist.

Clopizam should not be taken by patients who are unconscious or in a coma.

Warnings and precautions

Safety issues described in this section are very important. The patient must follow them to minimize the risk of severe side effects that can be life-threatening.

Before starting Clopizam, the patient should tell their doctorif they have or have had any of the following conditions:

• -blood clots or a family history of blood clots, as medicines like this can cause blood clots;
• -glaucoma (increased pressure in the eye);
• -diabetes (increased, sometimes significantly, glucose levels in the blood may occur in patients with diabetes or without diabetes in their medical history) (see section 4.4);
• -prostate disorders or difficulty urinating;
• -any heart, kidney, or liver disease;
• -chronic constipation or taking medicines that cause constipation (such as anticholinergic medicines);
• -lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome;
• -controlled epilepsy;
• -intestinal diseases;
• -abdominal surgery;
• -conduction disorders in the heart, called QT interval prolongation in the patient or family history;
• -risk of stroke, e.g., due to high blood pressure, cardiovascular disorders, or cerebral circulation disorders.

Before taking the next Clopizam tablet, the patient should immediately tell their doctor if:

they experience:

• symptoms of a cold, fever, flu-like symptoms, sore throat, or other signs of infection.The doctor may recommend urgent blood tests to check if these symptoms are caused by taking Clopizam.
• they experiencesudden increased body temperature and (or) muscle stiffness, which can lead to loss of consciousness (symptoms of malignant neuroleptic syndrome), which can be a severe side effect requiring immediate treatment.
• they experiencerapid and irregular heart rate, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue- the doctor will assess heart function and, if necessary, refer the patient to a cardiologist immediately.
• they experiencenausea, vomiting, and (or) loss of appetite - the doctor will assess liver function.
• they experiencesevere constipation - the doctor will provide treatment to prevent further complications.
• they experienceconstipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. A consultation with a doctor is necessary.

Control tests and blood tests

Before starting this medicine, the doctor will conduct a medical interview with the patient and order blood tests to confirm that the white blood cell count is normal. This is important because white blood cells are necessary to fight infections.

It is necessary to perform regular blood tests before starting treatment, during treatment, and after stopping treatment with Clopizam.

• -The doctor will inform the patient when and where to have the tests done. Clopizam can only be taken 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.
• During the first 18 weeks of treatment, blood tests should be performed once a week. Then, tests should be performed at least once a month.
• If a decrease in white blood cell count occurs, treatment with clozapine 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.

Before starting treatment, the doctor will also perform a physical examination of the patient. The doctor may order an electrocardiogram (ECG) 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 the treatment period.

If the patient has high blood sugar 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 weight and blood lipid levels.

If the patient currently experiences or if this medicine causes a feeling of "emptiness" in the head, dizziness, or fainting, they should get up carefully from a sitting or lying position, as these symptoms may increase the risk of falls.

If surgery is necessary or the patient will be immobilized for a longer period for other reasons, they should consult their doctor about taking this medicine. There is a risk of thrombosis (blood clotting in the veins).

Children and adolescents under 16 years of age

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

Elderly patients (60 years and older)

In elderly patients (60 years and older), there is an increased risk of certain side effects during clozapine treatment: fainting or a feeling of "emptiness" in the head when changing body position, dizziness, rapid heart rate, difficulty urinating, and constipation.

The patient should tell their doctor if they have a condition called dementia.

Clopizam and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including over-the-counter medicines and herbal medicines. It may be necessary to change the dosage of medicines or change medicines.

Clopizam should not be taken with medicines that inhibit the normal function 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;
• penicillamine, a medicine used to treat rheumatoid arthritis;
• cytotoxic agents, medicines used in chemotherapy;
• depot antipsychotic medicines given 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 medicines.

The patient should tell their doctor about taking any of the following medicines:

• medicines used to treat depression, such as lithium, fluvoxamine, tricyclic antidepressants, MAO inhibitors, citalopram, paroxetine, fluoxetine, and sertraline;
• other antipsychotic medicines used to treat mental illnesses, such as perazine;
• benzodiazepines and other medicines used to treat anxiety disorders and sleep disorders;
• 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 heart rate;
• 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 preparations, and cough medicines;
• adrenaline, a medicine used in life-threatening situations;
• hormonal contraceptives.

The above list is not exhaustive. The doctor or pharmacist has more information about medicines that should be used with caution with Clopizam or should be avoided during treatment with Clopizam. The doctor or pharmacist will inform the patient if the medicines they are taking belong to the listed groups - the patient should discuss this with their doctor or pharmacist.

Clopizam with food, drink, and alcohol

The patient should not drink alcohol while taking Clopizam.

The patient should tell their doctor if they smoke and inform their doctor how often they drink beverages containing caffeine (coffee, tea, cola). Sudden changes in smoking habits or caffeine consumption can also change the effect of this medicine.

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

The doctor will inform the patient about the benefits and potential risks of taking this medicine during pregnancy. The patient should immediately tell their doctor if they become pregnant while being treated with Clopizam.

In newborns whose mothers took clozapine during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur: trembling, stiffness, and (or) muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the baby experiences any of these symptoms, the patient should contact their doctor.

In some women taking medicines for mental illnesses, irregular periods or lack of periods may occur. As a result of switching from another treatment to Clopizam, normal menstruation may return. Therefore, women of childbearing age should use effective contraception.

The patient should not breastfeed while being treated with this medicine. Clozapine, the active substance of Clopizam, may pass into breast milk and affect the baby.

Driving and using machines

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

Clopizam contains lactose

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

3. How to take Clopizam

To minimize the risk of low blood pressure, seizures, and drowsiness, the doctor will recommend gradual dose escalation of the medicine. This medicine should always be taken as directed by the doctor.

In case of doubts, the patient should consult their doctor or pharmacist.

It is very important not to change the dose or stop taking this medicine without consulting the doctor first. The patient should continue treatment for as long as the doctor recommends. For patients over 60 years old, the doctor may start treatment with a lower dose and increase it more slowly, as this age group is at increased risk of certain side 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 score line on the tablet only facilitates breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Treatment of schizophrenia

The usual starting 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 medicine is well tolerated, the doctor will then recommend gradual dose escalation to 300 mg per day over 2-3 weeks, to achieve a daily dose of 200-450 mg, divided into several doses. In some patients, higher doses may be necessary. The maximum daily dose is 900 mg. If the daily dose exceeds 450 mg, the risk of side effects may increase (especially seizures). The doctor will always recommend the smallest effective dose for the patient. Most patients take part of the dose in the morning and part in the evening. The doctor will explain how to divide the daily dose. If the daily dose is 200 mg, the patient can take it in a single dose in the evening. If the patient has been taking Clopizam for some time with good results, the doctor may try to reduce the dose. This medicine should be taken for at least 6 months.

Treatment of severe thought disorders in patients with Parkinson's disease - only for 25 mg, 50 mg, and 100 mg strengths

The usual starting dose is 12.5 mg (half a 25 mg tablet), taken in the evening. The tablet should be swallowed with water. The doctor will then recommend gradual dose escalation by 12.5 mg, no more 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, a feeling of "emptiness" in the head, or confusion, the doctor will stop or delay dose escalation. To avoid these symptoms, the doctor will recommend blood pressure monitoring during the first weeks of treatment.

The effective daily dose is usually between 25 mg and 37.5 mg, taken in a single dose in the evening. Doses above 50 mg per day will be recommended by the doctor only in exceptional cases. The maximum daily dose is 100 mg. The doctor will always recommend the smallest effective dose for the patient.

Overdose of Clopizam

If the patient has taken too many tablets or someone else has taken any number of tablets, they should immediately contact a doctor or call an emergency number.

Overdose symptoms: drowsiness, fatigue, lack of energy, coma, confusion (disorientation), hallucinations, agitation, incoherent speech, stiffness of limbs, trembling of hands, seizures, excessive salivation, dilated pupils, blurred vision, low blood pressure, shock, rapid or irregular heart rate, shallow breathing or difficulty breathing.

Missed dose of Clopizam

If a dose is missed, the patient should take it as soon as possible. However, if it is almost time for the next dose, they should not take the missed dose, and 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 Clopizam for 48 hours or more, they should immediately contact their doctor.

Stopping Clopizam treatment

The patient should not stop taking Clopizam without consulting their doctor, as withdrawal symptoms may occur. These include: increased sweating, headache, nausea, vomiting, and diarrhea.

If the patient experiences any of these symptoms, they should immediately tell their doctor.

After these symptoms, more severe side effects may occur if the patient does not receive immediate treatment. The symptoms of the underlying disease may return. It is recommended to gradually reduce the dose by 12.5 mg over 1-2 weeks if it is necessary to stop the medicine. The doctor will inform the patient how to reduce the daily dose. If it is necessary to stop Clopizam treatment immediately, the doctor will monitor the patient's condition. If the doctor decides to restart clozapine treatment and the patient has taken the last dose of Clopizam more than 2 days ago, the starting 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, Clopizam can cause side effects, although not everybody gets them.

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

Before taking the next Clopizam tablet, the patient should immediately tell their doctor if they experience any of the following symptoms:

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

• severe constipation- the doctor will provide treatment to prevent further complications.
• rapid heart rate.

Common(may affect up to 1 in 10 people):

• symptoms of a cold, fever, flu-like symptoms, sore throat, or other signs of infection.The doctor may recommend urgent blood tests to check if these symptoms are caused by taking Clopizam.
• seizures.
• sudden fainting or loss of consciousness with muscle weakness (syncope).

Uncommon(may affect up to 1 in 100 people):

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

Rare(may affect up to 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 spreading to the back, with accompanying nausea and vomiting, caused by pancreatitis.
• fainting and muscle weakness due to significantly decreased blood pressure (circulatory collapse).
• difficulty swallowing (which can cause food to be inhaled).
• if the patient experiencesnausea, vomitingand (or) loss of appetite- the doctor will assess liver function.
• weight gain or increased weight.
• sleep apnea with snoring or without.

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

• rapid and irregular heart rate, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue- the doctor will assess heart function and, if necessary, refer the patient to a cardiologist immediately.

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

• prolonged, painful erection of the penis, called priapism, if the patient is a man. 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 signs of a decrease in platelet count.
• symptoms caused by 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 signs of intestinal obstruction.
• loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness, and poor health. These symptoms may indicate liver failure, which can lead to liver necrosis.
• nausea, vomiting, fatigue, weight loss, which can be signs of kidney inflammation.

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

• constricting chest pain, feeling of compression in the chest, pressure, or sudden severe pain (chest pain that may radiate to the left arm, jaw, neck, and abdomen), shortness of breath, increased sweating, weakness, feeling of "emptiness" in the head, nausea, vomiting, and palpitations (symptoms of a heart attack), which can lead to death - in such a case, the patient should immediately contact their doctor.
• pressure in the chest, feeling of heaviness, pressure, sudden severe pain, or burning (symptoms of insufficient blood flow and oxygen to the heart muscle), which can lead to death - the doctor will assess 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 doctor will assess the patient's heart function.
• symptoms of low blood pressure, such as dizziness, dizziness, 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 move 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 heart rate, 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 (sign of kidney failure).
• allergic reaction (mainly facial, oral, and pharyngeal edema, as well as tongue edema, which may be accompanied by itching or pain).
• loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness, and poor health. These symptoms may indicate liver failure, which can lead to liver necrosis and liver failure (which can be life-threatening), 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, early feeling of fullness (gastric and (or) duodenal ulcer), which can lead to death.
• severe abdominal pain worsening with movement, nausea, vomiting, including bloody vomiting (or coffee ground-like vomit); abdominal tenderness, which may spread from the perforation site along the abdomen; fever and (or) chills (perforation of the stomach and (or) intestine or intestinal rupture), which can lead to death.
• constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. A consultation with a doctor is necessary.
• stabbing chest pain with shortness of breath, with or without cough.
• significant increase in muscle weakness, muscle cramps, muscle pain, which may indicate muscle disorders (rhabdomyolysis). A consultation with a doctor is necessary.
• stabbing chest pain or abdominal pain, with shortness of breath, with or without cough.
• During clozapine treatment, extremely intense and severe skin reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. Adverse skin reactions may manifest as a rash with blisters or without. Skin irritation, swelling, and fever, as well as flu-like symptoms, may occur. Symptoms of DRESS usually appear after about 2-6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above conditions apply to the patient, they should immediately tell their doctor before taking the next dose of Clopizam.

Other side effects:

Very common(may affect at least 1 in 10 people):
drowsiness, dizziness, excessive salivation.
Common(may affect up to 1 in 10 people):
high white blood cell count (leukocytosis), high count of a specific type of white blood cell (eosinophilia), weight gain, blurred vision, headache, trembling, stiffness, restlessness, seizures, sudden muscle contractions, abnormal movements, inability to start movement, inability to remain still, changes in ECG, high blood pressure, fainting or feeling of "emptiness" in the head when changing body position, nausea, vomiting, loss of appetite, dry mouth, minor liver function abnormalities, urinary incontinence, urinary retention, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g., unclear speech).
Uncommon(may affect up to 1 in 100 people):
low white blood cell count (agranulocytosis), speech disorders (e.g., stuttering).
Rare(may affect up to 1 in 1,000 people):
low red blood cell count (anemia), restlessness, agitation, confusion, delirium, heart rhythm disorders, myocarditis or pericarditis (inflammation of the heart or the membrane surrounding the heart), fluid accumulation around the heart (pericardial effusion), high blood sugar levels, diabetes, pulmonary embolism (blood clot in the lungs), liver inflammation, liver disease causing yellowing of the skin and dark urine, as well as itching, increased activity of the enzyme called creatine phosphokinase in the blood.
Very rare(may affect up to 1 in 10,000 people):
increased platelet count with possible blood clots in the blood vessels, uncontrolled movements of the lips and tongue and limbs, and obsessive-compulsive symptoms (obsessive thoughts and repetitive actions), skin reactions, swelling of the parotid gland (enlargement of the salivary glands), breathing difficulties, very high triglyceride or cholesterol levels in the blood, heart disease (cardiomyopathy), cardiac arrest, sudden unexplained death.
Frequency not known(cannot be estimated from the available data):
changes in brain wave tests (electroencephalogram/EEG), diarrhea, feeling of discomfort in the stomach, including after meals, heartburn, feeling of muscle weakness, muscle cramps, muscle pain, nasal congestion, bedwetting, uncontrolled ejaculation in men (semen does not come out of the body but instead goes into the bladder - dry orgasm or retrograde ejaculation), rash, purple spots on the skin, fever, or itching due to blood vessel inflammation, inflammation of the colon with diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by a feeling of discomfort, especially when resting, 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 side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Clopizam

• There are no special precautions for storing the medicine.
• The medicine should be stored out of sight and reach of children.
• The medicine should not be taken after the expiration date stated on the blister and carton after: EXP. The expiration date refers to the last day of the specified month.
• The medicine should not be taken if the packaging is damaged or shows signs of tampering.
• 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. Package contents and other information

What Clopizam contains

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

What Clopizam looks like and what the package contains

Clopizam, 25 mg: round, uncoated tablets with a diameter of about 6 mm, light yellow to yellow in color, with a score line and the inscription "FC" and "1" on one side of the score line and smooth on the other side.

Clopizam, 50 mg: round, uncoated tablets with a diameter of about 8 mm, light yellow to yellow in color, with the inscription "FC" and "2" on one side and smooth on the other side.

Clopizam, 100 mg: round, uncoated tablets with a diameter of about 10 mm, light yellow to yellow in color, with a score line and the inscription "FC" and "3" on one side of the score line and smooth on the other side.

Clopizam, 200 mg: uncoated, capsule-shaped tablets with a length of about 17 mm and a thickness of 8 mm, light yellow to yellow in color, with a triple score line and the inscription "F" and "C" on one side and a triple score line and the inscription "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 score line on the tablet only facilitates breaking the tablet to make it easier to swallow and not to divide it into equal doses.

Clopizam is available in aluminum/PVC/PVDC blisters in cardboard boxes, packaged in:

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 authorization 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, 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 authorized in the Member States of the European Union

Economic Area under the following names:

Date of last update of the leaflet: September 2024