Clopizam

Leaflet accompanying the packaging: patient information

Clopizam, 25 mg, tablets

Clopizam, 50 mg, tablets

Clopizam, 100 mg, tablets

Clopizam, 200 mg, tablets

Clozapine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 did not respond to these medicines or experienced severe side effects that did not respond to treatment.

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 any of the above points apply to the patient, they should not take Clopizam. They should consult their 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, tell your doctorif the patient has or has 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, tell your doctor immediately if:

the patient:

• experiences cold symptoms, fever, flu-like symptoms, sore throat, or other signs of infection.The doctor may order urgent blood tests to check if these symptoms are caused by taking Clopizam.
• experiences sudden 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.
• experiences rapid and irregular heart rhythm, 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.
• experiences nausea, vomiting, and (or) loss of appetite- the doctor will assess liver function.
• experiences severe constipation- the doctor will provide treatment to avoid further complications.
• experiences constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea.Consultation with a doctor is necessary.

Control tests and blood tests

Before starting this medicine, the doctor will conduct an 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, Clopizam treatment should be stopped immediately. The white blood cell count should return to normal.
• Blood tests should be performed for 4 weeks after stopping Clopizam treatment.

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 sugar 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 can 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 the following side effects during clozapine treatment: fainting or feeling "empty" in the head when changing body position, dizziness, rapid heart rate, difficulty urinating, and constipation.

Tell your doctor if you have a condition called dementia.

Clopizam and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription and herbal medicines. It may be necessary to change the dosage of medicines or change medicines.

Do not take Clopizam with medicines that inhibit the proper functioning of the bone marrow and (or) reduce the number of white blood cells produced by the body

such as:

• carbamazepine, a medicine used to treat epilepsy;
• certain antibiotics: chloramphenicol, sulfonamides, such as co-trimoxazole;
• certain painkillers: pyrazolone derivatives, such as phenylbutazone;
• 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.

Tell your 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 rhythm;
• 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. Your doctor or pharmacist has more information about medicines that should be used with caution with Clopizam or should be avoided during Clopizam treatment. Your doctor or pharmacist will inform you if the medicines you are taking belong to these groups - you should discuss this with your doctor or pharmacist.

Clopizam with food, drink, and alcohol

Do not drink alcohol while taking Clopizam.

Tell your doctor if you smoke and inform your doctor how often you drink caffeinated beverages (coffee, tea, cola). Sudden changes in smoking or caffeinated beverage consumption habits can also change the effect of this medicine.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine.

Your doctor will inform you about the benefits and potential risks of taking this medicine during pregnancy. If you become pregnant during Clopizam treatment, tell your doctor immediately.

In newborns whose mothers took clozapine in 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 your child experiences any of these symptoms, contact your doctor.

In some women taking medicines for mental illnesses, irregular periods or absence of periods may occur. When switching from another medicine to Clopizam, normal menstruation may return. Therefore, women of childbearing age should use effective contraception.

Do not breastfeed while taking 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. Do not drive or operate machinery if you experience these symptoms.

Clopizam contains lactose

Clopizam contains lactose. If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking Clopizam.

3. How to take Clopizam

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

If you have any doubts, consult your doctor or pharmacist.

It is very important not to change the dose or stop taking this medicine without consulting your doctor first. Continue treatment for as long as your doctor recommends. For patients 60 years or older, 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 a different strength 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 only facilitates breaking it, making it easier to swallow, and not dividing 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. Swallow the tablet 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 (especially seizures) may increase. 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, it can 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 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. Swallow the tablet 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, feeling "empty" in the head, or confusion, the doctor will stop or delay dose escalation. To avoid these symptoms, the doctor will recommend blood pressure monitoring in the first weeks of treatment.

The effective daily dose is usually between 25 mg and 37.5 mg, taken as a single dose in the evening. Doses above 50 mg per day will only be recommended by the doctor 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, contact a doctor or call emergency services immediately.

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 rhythm, 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. Do not take a double dose to make up for the missed dose.

If the patient forgets to take Clopizam for 48 hours or more, contact a doctor immediately.

Stopping Clopizam treatment

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, they should tell their doctor immediately.

After these symptoms, more severe side effects may occur if the patient does not receive immediate treatment. The symptoms of the underlying disease may return. It is recommended to gradually reduce the dose by 12.5 mg over one to two 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 two days ago, the starting dose will be 12.5 mg.

If you have any further doubts about taking this medicine, consult your 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, tell your doctor immediately if you experience any of the following symptoms:

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

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

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

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

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

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

Rare(may affect up to 1 in 1,000 people):

• infection symptoms, 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 low blood pressure (circulatory collapse).
• difficulty swallowing (which can cause food to enter the airways).
• if you experience nausea, vomitingand (or) loss of appetite- the doctor will assess liver function.
• weight gain or onset of obesity.
• 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 rhythm, 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 more than 4 hours, immediate treatment may be necessary to avoid further complications.
• sudden bleeding or bruising, which can be symptoms of a low platelet count.
• symptoms of uncontrolled blood sugar levels, such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation, or confusion.
• abdominal pain, cramps, bloating, vomiting, constipation, and difficulty passing gas, which can be symptoms of intestinal obstruction.
• loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and general feeling of being unwell. These symptoms may indicate developing liver failure, which can lead to fulminant liver necrosis.
• nausea, vomiting, fatigue, weight loss, which can be symptoms 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 upper abdomen), shortness of breath, excessive sweating, weakness, feeling of "emptiness" in the head, nausea, vomiting, and palpitations (symptoms of a heart attack), which can lead to death - in this case, contact a doctor immediately.
• 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 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 heart function.
• symptoms of low blood pressure, such as dizziness, dizziness, fainting, blurred vision, excessive fatigue, cold and sweaty 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 (symptom of kidney failure).
• allergic reaction (swelling mainly of the face, mucous membranes of the mouth and throat, as well as the tongue, which may be accompanied by itching or pain).
• loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and general feeling of being unwell. These symptoms may indicate liver failure, which can cause scarring of liver tissue, leading to liver failure, including liver failure and a life-threatening condition (which can lead to death), 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 (stomach and (or) intestinal ulcers), which can lead to death.
• severe abdominal pain worsening with movement, nausea, vomiting, including bloody vomiting (or coffee grounds-like vomit); the abdomen becomes hard, and tenderness spreads from the perforation site throughout the abdomen; fever and (or) chills (perforation of the stomach and (or) intestines or bowel rupture), which can lead to death.
• constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. These symptoms may indicate acute colonic distension (acute intestinal distension) or bowel infarction/necrosis, which can lead to death. Consultation with a doctor is necessary.
• piercing chest pain with shortness of breath, with or without cough.
• significant increase or onset of muscle weakness, muscle cramps, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). Consultation with a doctor is necessary.
• piercing chest pain or abdominal pain, with or without shortness of breath or fever.
• During clozapine treatment, exceptionally 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 may occur, as well as flu-like symptoms. DRESS symptoms usually appear about 2-6 weeks (possibly up to 8 weeks) after starting treatment.

If any of the above conditions apply to you, tell your doctor before taking the next Clopizam dose.

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, high count of a specific type of white blood cell (eosinophilia), weight gain, blurred vision, headache, trembling, stiffness, restlessness, seizures, sudden muscle contractions, involuntary movements, difficulty starting movement, difficulty remaining still, changes in ECG, high blood pressure, fainting or feeling "empty" 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, excessive 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, blood clots in the lungs (pulmonary embolism), liver inflammation, liver disease causing yellowing of the skin and eyes and dark urine, as well as itching, increased activity of an 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/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 muscle 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, sudden, uncontrolled increase in blood pressure (pseudo-phaochromocytoma syndrome), uncontrolled twisting of the body to one side (pleurothotonus), ejaculation disorders in men (semen does not come out of the body but instead goes into the bladder - dry orgasm or retrograde ejaculation), rash, purple-red spots on the skin, fever, or itching due to blood vessel inflammation, intestinal inflammation with diarrhea, abdominal pain, fever, change in skin color, rash on the face in a butterfly shape, 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 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Clopizam

• There are no special precautions for storing the medicine.
• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the blister and carton after: EXP. The expiration date refers to the last day of the specified month.
• Do not use the medicine if the packaging is damaged or shows signs of tampering.
• Medicines should not be disposed of via wastewater or household waste. Ask your 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 pack contains

Clopizam, 25 mg: round, uncoated tablets with a diameter of about 6 mm, light yellow to yellow in color, with a dividing line and embossing "FC" and "1" on one side of the dividing 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 embossing "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 dividing line and embossing "FC" and "3" on one side of the dividing 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 dividing line and embossing "F" and "C" on one side and a triple dividing 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 dividing line on the tablet only facilitates breaking it, making it easier to swallow, and not dividing 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