Package leaflet: Information for the user

Klozapol, 25 mg, tablets
Klozapol, 100 mg, tablets
Clozapinum
Please read all of this leaflet carefully before taking this medicine,
because it contains important information for you.

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

Contents of the leaflet:

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

1. What Klozapol is and what it is used for

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

2. Important information before using Klozapol

When not to use Klozapol

if the patient has hypersensitivity (allergy) to clozapine or to any of the other ingredients of Klozapol (listed in section 6);
if regular blood tests cannot be performed for the patient;
if the patient has ever had low white blood cell count (e.g. leukopenia or agranulocytosis), particularly if it was caused by medications, except for cases of low white blood cell count related to previous chemotherapy;
if the patient previously discontinued Klozapol due to severe adverse reactions (e.g. agranulocytosis or heart disorders);
if the patient has been or is being treated with long-acting (depot) injectable antipsychotic medicines;
if the patient has impaired bone marrow function;
if the patient has uncontrolled epilepsy (seizures or convulsions);
if the patient has acute psychiatric disturbances caused by alcohol or drugs (e.g. narcotics);
if the patient has reduced consciousness and pronounced drowsiness;
if the patient has circulatory collapse, which may result from severe shock;
if the patient has severe kidney function impairment;
if the patient has myocarditis (inflammation of the heart muscle);
if the patient has other severe heart diseases;
if the patient shows symptoms of active liver disease, such as jaundice (yellowing of the skin and whites of the eyes, nausea, loss of appetite);
if the patient has other severe liver function disorders;
if the patient has paralytic ileus (the patient's intestine does not function properly and the patient has severe constipation);
if the patient is taking any medicines that suppress normal bone marrow function;
if the patient is taking any medicines that reduce the number of white blood cells in the blood.

If any of the above points apply to the patient, inform the doctor and do not use Klozapol.
Klozapol must not be used in patients who are unconscious or in coma.
Warnings and precautions
Before starting treatment with Klozapol, discuss this with your doctor or pharmacist.
The safety issues mentioned in this section are very important. The patient
must pay special attention to them in order to minimize the risk of severe,
life-threatening adverse reactions.
Before the patient starts taking Klozapol, they should inform the doctor if any of the
following conditions are present or have occurred in the past:

(or in someone in their family) blood clots, because medicines like this one have been associated with blood clot formation;
glaucoma (increased pressure in the eye);
diabetes (elevated, sometimes significantly, blood sugar (glucose) levels, occurring in patients with or without a history of diabetes) (see section 4);
prostate gland problems or difficulty urinating;
heart, kidney, or liver diseases;
chronic constipation or use of medicines causing constipation (such as anticholinergic medicines);
galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome;
controlled epilepsy;
diseases of the large intestine;
previous abdominal surgeries;
or in family history, heart disorders or abnormal heart conduction known as "QT prolongation";
risk of stroke, e.g. if the patient has high blood pressure, cardiovascular problems, or problems with blood vessels in the brain.

Immediately inform the doctor before taking the next dose of Klozapol if:

The patient develops symptoms of cold, flu, fever, sore throat, or any infection. The doctor may recommend a blood test if these symptoms are related to the medicine.
The patient experiences sudden increase in body temperature, muscle stiffness, which may lead to loss of consciousness (neuroleptic malignant syndrome), a serious adverse reaction requiring immediate treatment.
The patient has rapid or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check heart function and, if necessary, refer the patient immediately to a cardiologist.
The patient experiences nausea, vomiting, and (or) loss of appetite. The doctor will check liver function.
The patient has constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhoea. A medical consultation is required.

Regular medical check-ups and blood tests
Before starting treatment with Klozapol, the doctor will take a medical history and order blood tests to confirm normal white blood cell count. This is important because the patient's body needs white blood cells to fight infections.
Regular blood tests are essential before starting treatment, during treatment, and after stopping Klozapol.

The doctor will inform the patient exactly when and where to have the tests performed. Klozapol may only be used if the patient has normal white blood cell count.
Klozapol may cause a significant decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can detect if the patient is at risk of developing agranulocytosis (see section 4).
Blood tests should be performed weekly for the first 18 weeks of treatment. Then, for the following 34 weeks, tests should be performed at least once a month.
After 12 months of treatment, blood tests should be performed every 12 weeks for one year, and then, if no decrease in white blood cell count has been detected, once a year.
If a decrease in white blood cell count occurs, Klozapol must be discontinued immediately. The white blood cell count should return to normal values.
Blood tests should continue for an additional 4 weeks after stopping Klozapol, especially if treatment was discontinued for hematological reasons (e.g. agranulocytosis), or if monitoring was for less than 2 years, or if there was a history of neutropenia that did not lead to discontinuation of treatment.

The doctor will also perform a medical examination before starting treatment with Klozapol.
The doctor may order an electrocardiogram (ECG) to check heart function, if necessary for the patient or if the patient has specific concerns.
If the patient has liver function disorders, regular liver function tests will be performed throughout the treatment with Klozapol.
If the patient has high blood sugar (glucose) levels (diabetes), the doctor may order regular blood glucose tests.
Klozapol may alter blood lipid levels. Klozapol may cause weight gain. The doctor may monitor the patient's body weight and blood lipid levels.
If the patient currently experiences dizziness, lightheadedness, or fainting, they should change position carefully from sitting or lying down, due to increased risk of falls.
If the patient is to undergo surgery or is immobilized for a prolonged period for other reasons, discuss the use of Klozapol with the doctor. There is a risk of thrombosis (blood clotting in veins).

Children and adolescents under 16 years of age
Patients under 16 years of age should not use Klozapol, as there is limited data on the use of the medicine in this age group.

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

Klozapol and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take (including over-the-counter medicines and herbal remedies). Dose adjustments or different medicines may be necessary.
Do not use Klozapol 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 cotrimoxazole;
certain painkillers: pyrazolone derivatives such as phenylbutazone or metamizole;
penicillamine, a medicine used to treat rheumatoid arthritis;
cytotoxic agents, medicines used in chemotherapy;
antipsychotic medicines in depot injection form.

These medicines increase the risk of developing agranulocytosis (lack of white blood cells).
Taking Klozapol together with other medicines may affect the action of Klozapol and (or) other medicines. Inform the doctor if the patient plans to take, is currently taking (even if treatment is ending), or has recently stopped taking any of the following medicines:

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 and sleep disorders;
narcotics and other medicines that may affect respiratory function;
medicines used to treat epilepsy, such as phenytoin and valproic acid;
medicines used to treat high or low blood pressure, such as adrenaline and noradrenaline;
warfarin, a medicine used to prevent blood clots;
antihistamines, medicines used to treat colds or allergies, such as hay fever;
anticholinergic medicines, used to relieve stomach cramps and motion sickness;
medicines used to treat Parkinson's disease;
digoxin, a medicine used to treat heart conditions;
medicines used to treat rapid or irregular heartbeat;
certain medicines used to treat stomach ulcers, such as omeprazole or cimetidine;
certain antibiotics, such as erythromycin and rifampicin;
certain medicines used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infection);
atropine, a medicine that may be an ingredient in certain eye drops, cold remedies, or cough medicines;
adrenaline, a medicine used in emergency situations;
hormonal contraceptives.

The above list is not complete. The doctor or pharmacist has more information about medicines that should be used cautiously with Klozapol, or avoided during treatment with Klozapol, and knows whether the medicine being used belongs to the mentioned groups. Ask them for advice.

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult the doctor before using this medicine.
The doctor will discuss the benefits and possible risks of using the medicine during pregnancy. Inform the doctor immediately if the patient becomes pregnant while taking Klozapol.
Newborns whose mothers took antipsychotic medicines (e.g. Klozapol) during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the baby develops these symptoms, contact the doctor.
Some women taking medicines used to treat mental illnesses have irregular or absent menstrual periods. As a result of switching from another medicine to Klozapol, normal menstruation may return. Therefore, women of childbearing age should use effective contraceptive methods.
Do not breastfeed while taking Klozapol. Clozapine, the active substance in Klozapol, may pass into breast milk and affect the baby.

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

Klozapol contains lactose and sodium
One tablet contains 18 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Klozapol

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
To minimize the risk of low blood pressure, seizures, and drowsiness, your doctor must increase
the dose gradually.
It is very important not to change the dose or stop taking Klozapol without first consulting your
doctor. Continue treatment for as long as your doctor advises.
For patients aged 60 years or older, your doctor may start treatment with lower doses and
increase them gradually, as they are more likely to experience certain adverse effects (see
section 2 “Important information before taking Klozapol”).
If the prescribed dose cannot be achieved with the available strength of the medicine, another
strength of this medicine is available on the market to achieve the required dose.

Treatment of schizophrenia
The recommended initial dose is 12.5 mg (half a 25 mg tablet) once or twice daily on the first
day, followed by 25 mg once or twice daily on the second day.
Swallow the tablet with water.
If treatment is well tolerated, the daily dose may then be gradually increased by 25 mg to 50 mg
over 2–3 weeks, aiming for a target dose of up to 300 mg per day.
Thereafter, if needed, the daily dose may be further increased by 50 mg to 100 mg at intervals
of every 3 to 4 days, or preferably once weekly.
An effective daily dose is usually 200 mg or 450 mg, divided into several individual doses.
Some patients may require higher doses. The maximum recommended daily dose is 900 mg.
At daily doses exceeding 450 mg, certain adverse effects (especially seizures) may become
more pronounced. Always use 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 explain exactly how to divide
the daily dose. If the dose is 200 mg, it may be taken as a single dose in the evening. If the
patient has been taking Klozapol for some time with good effect, the doctor may consider
reducing the dose. The patient should take Klozapol for at least 6 months.

Treatment of severe disturbances of thought, emotion, and behaviour in patients with Parkinson’s disease
The recommended initial dose is 12.5 mg (half a 25 mg tablet) in the evening.
Swallow the tablet with water. The doctor will then gradually increase the dose by 12.5 mg, no
more frequently than twice a week, until a maximum daily dose of 50 mg is reached by the end
of the second week. If the patient experiences fainting, a feeling of emptiness in the head, or
confusion, dose escalation should be delayed or stopped. To avoid such symptoms, blood
pressure should be monitored during the first weeks of treatment.
An effective daily dose is usually 25 mg to 37.5 mg, taken as a single evening dose. Doses
exceeding 50 mg per day should only be used in exceptional cases. The maximum daily dose
is 100 mg.
Always use the lowest effective dose of the medicine.
Klozapol 25 mg tablets may be divided into equal doses.

Taking more Klozapol than prescribed
If a patient takes more than the prescribed dose or if someone else takes the medicine, contact
a doctor immediately or go to a hospital.
Symptoms of overdose: drowsiness, fatigue, lack of energy, loss of consciousness, coma,
confusion (disorientation), hallucinations, agitation, delirium, muscle stiffness, hand tremor,
seizures (convulsions), excessive salivation, dilated pupils, blurred vision, hypotension, collapse,
rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

Missing a dose of Klozapol
If a dose is missed, take it as soon as possible. However, do not take the medicine if it is almost
time for the next dose. In this case, 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 Klozapol for 48 hours or longer, they should contact their
doctor immediately.

Stopping Klozapol
Do not stop taking Klozapol without consulting your doctor, as withdrawal reactions may occur.
These include: sweating, headache, nausea, vomiting, and diarrhoea. If any of these
symptoms occur, inform your doctor immediately. After these symptoms, more severe
adverse effects may occur if the patient does not receive immediate treatment. Symptoms of
the illness may return. Gradual dose reduction by 12.5 mg over one to two weeks is recommended.
If immediate discontinuation of Klozapol is necessary, consult your doctor. If the doctor decides
to restart Klozapol and the patient last took the medicine 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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention. You must immediately inform the doctor, before taking the next dose of Klozapol, if any of the following symptoms occur in the patient:

Very common (may affect more than 1 in 10 patients):

Severe constipation. The doctor will initiate treatment to prevent further complications.
Increased heart rate.

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

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

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

Sudden increase in body temperature, muscle rigidity, which may lead to loss of consciousness (neuroleptic malignant syndrome); these may be severe adverse reactions requiring immediate treatment.
Dizziness or fainting upon changing position from lying to standing (orthostatic hypotension), risk of falling.

Rare (may affect up to 1 in 1,000 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).
Nausea, vomiting and (or) loss of appetite. The doctor will check liver function.
Development or worsening of existing obesity.
Sleep apnea with or without snoring.

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

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

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

Prolonged, painful erection (priapism) in men. If the erection lasts more than 4 hours, immediate treatment may be required to avoid complications.
Sudden bleeding or appearance of bruises, which may indicate a reduced platelet count.
Symptoms of uncontrolled blood sugar (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 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 (frequency cannot be estimated from available data):

Pressure-like chest pain, tightness in the chest, pressure or sudden severe pain radiating to the left arm, jaw, neck and upper abdomen, shortness of breath, sweating, weakness, dizziness, nausea, vomiting and palpitations (symptoms of a heart attack). In such cases, seek medical attention immediately.
Chest tightness, heaviness, pressure, sudden severe pain, burning or choking sensation (symptoms of insufficient blood and oxygen supply to the heart muscle). The doctor will check the patient's heart function.
Sensation of irregular heartbeat: "pounding", "thumping" or "fluttering" in the chest (palpitations).
Rapid and irregular heartbeat (atrial fibrillation). Palpitations, fainting, shortness of breath or chest discomfort may occasionally occur. Medical consultation is required.
Symptoms of low blood pressure, such as dizziness, lightheadedness, fainting, blurred vision, excessive fatigue, cold and clammy skin or nausea.
Swelling, pain and redness in the leg – symptoms indicating blood clots in veins, especially in the legs. Clots 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, increased heart rate, changes in reaction speed and consciousness, low blood pressure (sepsis).
Excessive sweating, headache, nausea, vomiting and diarrhea (symptoms of cholinergic syndrome).
Markedly reduced urine output (symptom of kidney failure).
Swelling mainly of the face, lips and throat, as well as the tongue, which may cause itching and be painful (hypersensitivity reaction).
Loss of appetite, bloating, abdominal pain, yellowing of the skin, severe weakness and malaise. Symptoms may indicate liver failure (damage to liver cells, bile ducts, or both), even life-threatening.
Constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. These symptoms may indicate acute colonic dilation (acute intestinal dilation) or intestinal infarction/ischemia. Medical consultation is required.
Dull chest pain or abdominal pain with shortness of breath, with or without cough and fever due to inflammation of several serous membranes simultaneously, such as pleura, pericardium and peritoneum (polyserositis).
Increased or new-onset muscle weakness, muscle cramps, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). Medical consultation is required.

Other adverse reactions:
Very common (may affect more than 1 in 10 patients):

Drowsiness, dizziness,
Excessive salivation.

Common (may affect up to 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, muscle jerks (myoclonus), involuntary movements, inability to move, inability to remain still,
Changes in ECG readings,
Hypertension, fainting or feeling of emptiness in the head upon changing position,
Nausea, vomiting, loss of appetite, dryness of the oral mucosa,
Abnormal liver function test results,
Urinary incontinence, urine retention, difficulty urinating,
Fatigue, fever, increased sweating,
Speech disorders (e.g. slurred speech).

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

Absence of white blood cells in the blood (agranulocytosis),
Speech disorders (e.g. stuttering).

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

Low red blood cell count (anemia),
Restlessness, agitation, confusion, delirium,
Arrhythmia, myocarditis or pericarditis, pericardial effusion,
High blood glucose (hyperglycemia), diabetes,
Pulmonary embolism (venous thromboembolic disease),
Hepatitis, liver disease causing yellowing of the skin, dark urine, itching (jaundice),
Increased blood levels of an enzyme called creatine kinase.

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

Increased platelet count with possible blood clotting in blood vessels,
Uncontrollable movements of the mouth, tongue and limbs, intrusive thoughts and compulsive behaviors (obsessive-compulsive symptoms),
Skin reactions, swelling of the parotid gland (salivary gland enlargement),
Breathing difficulties,
Very high blood triglyceride or cholesterol levels,
Heart muscle disease (cardiomyopathy), cardiac arrest, sudden unexplained death.

Frequency unknown (frequency cannot be estimated from available data):

Changes in brain wave recordings (electroencephalogram - EEG),
Diarrhea, stomach discomfort, heartburn, feeling of discomfort in the stomach after a meal,
Feeling of muscle weakness, muscle cramps, muscle pain,
Nasal congestion,
Nocturnal enuresis (bedwetting),
Sudden, uncontrolled increase in blood pressure (pseudo-pheochromocytoma syndrome),
Uncontrollable tilting of the trunk to one side (pleurothotonus),
Ejaculation disorders in men, in which semen enters the bladder instead of being expelled externally (dry orgasm or retrograde ejaculation),
Rash, purple-red spots (hemorrhagic skin lesions), fever or itching due to vasculitis,
Colitis causing diarrhea, abdominal pain,
Fever, skin discoloration, butterfly-shaped rash on the face, joint pain, muscle pain, fatigue with fever (systemic lupus erythematosus),
Restless legs syndrome (irresistible urge to move legs or arms, usually accompanied by unpleasant sensations during rest, especially in the evening or at night, temporarily relieved by movement),
Sudden, severe chest pain or abdominal pain with shortness of breath, with or without cough or fever due to inflammation of several serous membranes simultaneously, such as pleura, pericardium and peritoneum (polyserositis).

In elderly patients with dementia treated with antipsychotic medicines, a slight increase in the risk of death has been reported compared to untreated patients.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Klozapol

Store below 25°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of in wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Klozapol contains

The active substance is clozapine. One tablet contains 25 mg or 100 mg of clozapine.
The other ingredients are: potato starch, monohydrate lactose (18 mg), microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, sodium lauryl sulfate, colloidal anhydrous silica.

What Klozapol looks like and contents of the pack
Klozapol 25 mg tablets – oblong, biconvex tablets, yellowish-cream in colour, with a score line on one side.
Klozapol 100 mg tablets – round, biconvex tablets, yellowish-cream in colour.
Klozapol 25 mg tablets are available in packs containing 50 tablets in blisters made of Aluminium/PVC foil (2 blisters with 25 tablets each) in a cardboard box.
Klozapol 100 mg tablets are available in packs containing 50 tablets in blisters made of Aluminium/PVC foil (2 blisters with 25 tablets each) in a cardboard box.
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38
Hungary
Manufacturer
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás király u. 65
Hungary
For further information, please contact the representative of the marketing authorisation holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00