Paxifar

Package leaflet: Information for the patient

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

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

Table of contents of the leaflet

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

1. What is Paxifar and for what is it used

The active substance in Paxifar is clozapine, which belongs to a group of medicines called neuroleptics (medicines used to treat specific mental disorders such as psychosis).
Paxifar is used to treat patients with schizophrenia who have not responded to treatment with other medicines.
Schizophrenia is a mental illness that causes disturbances in thinking, emotions, and behavior.
Paxifar should only be used in patients who have already been treated with at least two different antipsychotic medicines, including newer atypical antipsychotics indicated for the treatment of schizophrenia, and who did not respond to these treatments or experienced severe adverse reactions that could not be managed.
Paxifar 25 mg, 50 mg, and 100 mg tablets are also used to treat severe disturbances in thinking, emotions, and behavior in patients with Parkinson's disease when other treatment methods have proven ineffective.

2. Important Information Before Using Paxifar

When Not to Use Paxifar

• if the patient has a known allergy (hypersensitivity) to clozapine or to any of the other ingredients of Paxifar (listed in section 6);
• if regular blood tests cannot be performed for the patient;
• if the patient has ever had a low white blood cell count (e.g. leukopenia or agranulocytosis), particularly if it was caused by medications,

except in cases of low white blood cell count related to previous chemotherapy;

• if the patient previously discontinued Paxifar due to severe adverse reactions (e.g. agranulocytosis or heart problems);
• if the patient has been or is currently treated with long-acting (depot) antipsychotic medications administered by injection;
• if the patient has or has had 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. opioids);
• if the patient has reduced consciousness and severe 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 serious heart diseases;
• if the patient shows signs of active liver disease, such as jaundice (yellowing of the skin and whites of the eyes, nausea, and loss of appetite);
• if the patient has other severe liver function disorders;
• if the patient has paralytic ileus (the patient's bowel does not function properly, resulting in severe constipation);
• if the patient is taking any medications that suppress normal bone marrow function;
• if the patient is taking any medications that reduce the number of white blood cells.

If any of the above conditions apply to the patient, inform the doctor and do not use Paxifar.
Paxifar must not be used in patients who are unconscious or in a coma.

Warnings and Precautions
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 serious, life-threatening adverse reactions.
Before starting treatment with Paxifar, the patient should inform the doctor if any of the following conditions are present or have occurred in the past, either in the patient or in their family:

• blood clots, as drugs like this have been associated with clot formation;
• glaucoma (increased pressure in the eye);
• diabetes; elevated - sometimes significantly - blood glucose levels, occurring in patients with or without a history of diabetes (see section 4);
• problems with the prostate gland or difficulty urinating;
• heart, kidney, or liver diseases;
• chronic constipation or use of medications causing constipation (such as anticholinergic drugs);
• controlled epilepsy;
• diseases of the large intestine;
• previous abdominal surgeries;
• heart disorders or abnormal heart conduction, known as "QT prolongation," in the patient or family history;
• if the patient is at risk of stroke, e.g. if they have high blood pressure, cardiovascular problems, or cerebrovascular disorders.

Tell the doctor immediately before taking the next Paxifar tablet:

• if the patient develops symptoms of a cold, fever, flu-like symptoms, sore throat, or any infection. The doctor may recommend urgent blood tests to determine whether these symptoms are related to the medication;
• if the patient develops sudden high temperature or muscle stiffness, which may lead to loss of consciousness (symptoms of neuroleptic malignant syndrome), a serious adverse reaction requiring immediate treatment;
• if the patient experiences rapid or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check heart function and, if necessary, refer the patient urgently to a cardiologist;
• if the patient experiences nausea, vomiting, and (or) loss of appetite. The doctor will check liver function;
• if the patient develops severe constipation, abdominal pain, tenderness, fever, bloating, and (or) bloody diarrhea. The doctor will initiate treatment to prevent further complications.

Some women taking medications used to treat mental illnesses may experience irregular or absent menstrual periods. As a result of switching from another medication to Paxifar, normal menstruation may resume. Therefore, women of reproductive age should use effective contraceptive methods.

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

• The doctor will inform the patient exactly when and where to have the tests performed. Paxifar may only be used if the patient's blood count results are normal.
• Paxifar may cause a significant decrease in white blood cells (agranulocytosis). Only regular blood tests can confirm whether 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 next 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, treatment with Paxifar must be stopped immediately. The white blood cell count should return to normal values.
• Blood tests should continue for an additional 4 weeks after stopping Paxifar, in cases of complete treatment discontinuation due to hematological reasons (e.g. agranulocytosis), or if monitoring has been for less than 2 years, or in cases of a history of neutropenia that did not lead to treatment discontinuation.

The doctor will also perform a physical examination before starting treatment with Paxifar. The doctor may order an electrocardiogram (ECG) to check heart function if necessary for the patient or if the patient has specific concerns.

Patients with Liver Function Disorders
If the patient has impaired liver function, regular liver function tests will be performed throughout the duration of treatment with Paxifar. If the patient has high blood sugar (glucose) levels (diabetes), the doctor may order regular blood glucose monitoring.

Paxifar may cause weight gain and changes in lipid levels
Paxifar may alter lipid levels in the blood. Paxifar may cause weight gain. The doctor may monitor the patient's body weight and blood lipid levels.

Paxifar may increase the risk of falls
If Paxifar causes the patient to feel lightheaded, dizzy, or faint, they should change position carefully from sitting or lying down, as these symptoms may increase the risk of falling.

Risk of Blood Clots
If the patient requires surgery or is immobilized for any other reason for a prolonged period, discuss the use of Paxifar with the doctor. There is a risk of developing thrombosis (blood clotting in veins).

Children and Adolescents Under 16 Years of Age
Patients under 16 years of age should not use Paxifar, as there is limited data on its use in this age group.

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

Paxifar and Other Medications
Tell the doctor or pharmacist about all medications the patient is currently taking, has recently taken, or plans to take, including over-the-counter and herbal remedies. Dose adjustments or changes in medications may be necessary.

Do not use Paxifar together with medications that suppress bone marrow function and (or) reduce the number of white blood cells produced by the body, such as:

• carbamazepine, a medication used to treat epilepsy;
• certain antibiotics: chloramphenicol, sulfonamides such as co-trimoxazole;
• certain painkillers: pyrazolone derivative analgesics such as phenylbutazone or metamizole;
• penicillamine, a medication used, among others, in the treatment of rheumatoid arthritis;
• cytotoxic agents, medications used in chemotherapy;
• long-acting depot antipsychotic injections. These medications increase the risk of developing agranulocytosis (lack of white blood cells).

Taking Paxifar together with other medications may affect the action of Paxifar and (or) other drugs. 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 medications:

• medications 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 medications used to treat anxiety and sleep disorders;

• opioids and other medications that may affect respiratory function;

• medications used to treat epilepsy, such as phenytoin and valproic acid;

• medications used to treat high or low blood pressure (such as adrenaline and noradrenaline);

• warfarin, a medication used to prevent blood clots;

• antihistamines, medications used to treat colds or allergies, such as hay fever;

• anticholinergic medications, used to relieve stomach cramps and motion sickness;

• medications used to treat Parkinson's disease;

• digoxin, a medication used to treat heart conditions;

• medications used to treat rapid or irregular heartbeat;

• certain medications used to treat stomach ulcers, such as omeprazole or cimetidine;

• certain antibiotics, such as erythromycin and rifampicin;

• certain medications used to treat fungal infections (such as ketoconazole) or viral infections (such as protease inhibitors used to treat HIV infection);

• atropine, a medication that may be an ingredient in certain eye drops, cold remedies, or cough suppressants;

• adrenaline, a medication used in emergency situations;

• hormonal contraceptives (birth control pills).

The above list is not exhaustive. The doctor or pharmacist has more information about medications that should be used cautiously with Paxifar or avoided during treatment with Paxifar, and can advise whether a medication belongs to any of these groups. Ask them for advice.

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

Pregnancy, Breastfeeding, and Fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult the doctor before using this medication. The doctor will discuss the benefits and possible risks of using the medication during pregnancy. Inform the doctor immediately if the patient becomes pregnant while taking Paxifar.
Newborns of mothers who took antipsychotic medications during the third trimester of pregnancy (last three months) 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 medications used to treat mental illnesses may have irregular or absent menstrual periods. As a result of switching from another medication to Paxifar, normal menstruation may resume. Therefore, women of reproductive age should use effective contraceptive methods.
Do not breastfeed while taking Paxifar. Clozapine, the active substance in Paxifar, may pass into human milk and affect the infant.

Driving and Operating Machinery
Paxifar may cause fatigue, drowsiness, and seizures, especially during the initial period of treatment. Do not drive or operate machinery if the above symptoms occur.

Paxifar Contains Monohydrate Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult the doctor before taking the medication.

3. How to take Paxifar

To minimize the risk of low blood pressure, seizures, and drowsiness, it is essential that the doctor increases the dose gradually. Paxifar should always be taken exactly as directed by the physician. If in doubt, consult a doctor or pharmacist. It is very important not to change the dose or discontinue treatment with Paxifar without first consulting your doctor. Treatment should be continued for as long as recommended by the doctor. In patients aged 60 years or older, the 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 Paxifar).
If the recommended dose cannot be achieved with a tablet of a given strength, tablets of other strengths are available.

Treatment of schizophrenia
The usual starting dose is 12.5 mg (half a 25 mg tablet) once or twice daily during the first day, followed by 25 mg once or twice daily on the second day. Swallow the tablet with water. If the treatment is well tolerated, 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. Subsequently, if necessary, the daily dose may be further increased by 50 mg to 100 mg 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 (particularly seizures) may become more pronounced. The lowest effective dose for the patient should always be used. Most patients take part of the dose in the morning and part in the evening. The doctor will provide precise instructions on how to divide the daily dose. If the daily dose is 200 mg, it may be taken as a single dose in the evening. If the patient has been taking Paxifar for some time with good effect, the doctor may consider reducing the dose. The patient should continue taking Paxifar for at least 6 months.

Treatment of severe disorders of thought, emotion, and behavior in patients with Parkinson's disease
The usual starting dose is 12.5 mg (half a 25 mg tablet) taken in the evening. Swallow the tablet with water. The doctor will then gradually increase the dose by 12.5 mg, no more than twice weekly, until a maximum daily dose of 50 mg is reached over two weeks. If the patient experiences fainting, a feeling of emptiness in the head, or confusion, dose escalation should be delayed or paused. To avoid such symptoms, blood pressure should be monitored during the first weeks of treatment. The effective daily dose is usually 25 mg to 37.5 mg, taken as a single evening dose. Doses exceeding 50 mg per day should only be used in exceptional cases. The maximum daily dose is 100 mg. The lowest effective dose should always be used.
Only 25 mg, 50 mg, and 100 mg tablets are used in the treatment of psychiatric disorders associated with Parkinson's disease.

Taking more Paxifar than prescribed
If too many tablets have been taken by the patient or someone else, contact a doctor immediately or call emergency services.
Symptoms of overdose:
Drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion (disorientation), hallucinations, agitation, disorganized speech, limb rigidity, hand tremors, epileptic seizures (convulsions), excessive salivation, dilated pupils, blurred vision, hypotension, circulatory collapse, rapid or irregular heartbeat, shallow breathing, or difficulty breathing.

Missed dose of Paxifar
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 that 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 Paxifar for 48 hours or longer, they should contact their doctor immediately.

Stopping treatment with Paxifar
Do not stop taking Paxifar without consulting your doctor, as withdrawal reactions may occur. These include: sweating, headache, nausea, vomiting, and diarrhea. If the patient experiences any of these symptoms, they should inform the doctor immediately.
Following these symptoms, more severe adverse effects may occur if the patient does not receive immediate treatment. Symptoms of the illness may return. A gradual reduction of the dose by 12.5 mg over one to two weeks is recommended. The doctor will advise the patient on how to reduce the daily dose. If immediate discontinuation of Paxifar is necessary, consult the doctor.
If the doctor decides to restart treatment with Paxifar and the patient last took Paxifar more than two days earlier, the starting dose will be 12.5 mg.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require medical attention. You must immediately inform your doctor before taking the next dose of Paxifar:
Very common (may occur in more than 1 in 10 patients):

• if the patient experiences severe constipation. The doctor will initiate treatment to prevent further complications;
• if the patient experiences rapid heartbeat.

Common (may occur in no more than 1 in 10 patients):

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

Uncommon (may occur in no more than 1 in 100 patients):

• if the patient experiences sudden increase in body temperature and muscle stiffness, which may lead to loss of consciousness (neuroleptic malignant syndrome), as this may indicate serious adverse reactions requiring immediate treatment;
• if the patient experiences dizziness or fainting upon changing position from lying down to standing, as this may increase the risk of falling.

Rare (may occur in no more than 1 in 1,000 patients):

• if the patient has symptoms of respiratory infection or pneumonia, such as fever, cough, difficulty breathing, or wheezing;
• if the patient experiences severe, burning pain in the upper abdomen radiating to the back, accompanied by nausea and vomiting due to pancreatitis;
• if the patient experiences fainting and muscle weakness due to a significant drop in blood pressure (circulatory collapse);
• if the patient experiences difficulty swallowing (which may lead to choking);
• if the patient experiences nausea, vomiting, and (or) loss of appetite. The doctor will check liver function;
• if the patient develops or experiences worsening obesity;
• if the patient experiences sleep apnea with or without snoring.

Rare (may occur in no more than 1 in 1,000 patients) or very rare (may affect less than 1 in 10,000 patients):

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

Very rare (may occur in no more than 1 in 10,000 patients):

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

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

• if the patient experiences pressure-like chest pain, tightness in the chest, pressure or squeezing (chest pain that may radiate to the left arm, jaw, neck, and upper abdomen), shortness of breath, sweating, weakness, dizziness, nausea, vomiting, and palpitations (symptoms of heart attack). In such cases, immediate medical attention is required;
• if the patient experiences chest pressure, heaviness, pressure, squeezing, burning, or choking sensation (symptoms of insufficient blood and oxygen flow to the heart muscle). The doctor will check the patient's heart function;
• if the patient experiences irregular heartbeat: "thumping", "pounding", or "fluttering" in the chest (palpitations);
• if the patient experiences rapid and irregular heartbeat (atrial fibrillation). Palpitations, fainting, shortness of breath, or chest discomfort may occasionally occur. Medical consultation is necessary;
• if the patient experiences symptoms of low blood pressure, such as dizziness, vertigo, fainting, blurred vision, excessive fatigue, cold and clammy skin, or nausea;
• if the patient develops mitral valve insufficiency in the course of cardiomyopathy associated with clozapine treatment;
• if the patient experiences symptoms indicating blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties;
• if the patient develops confirmed or suspected infection with accompanying fever or low body temperature, abnormally rapid breathing, rapid heartbeat, changes in reaction speed and consciousness, low blood pressure (sepsis);
• if the patient experiences excessive sweating, headache, nausea, vomiting, and diarrhea (symptoms of cholinergic syndrome);
• if the patient experiences significantly reduced urine output (a sign of kidney failure);
• if the patient experiences hypersensitivity reaction (swelling, mainly of the face, lips, and throat, as well as the tongue, which may cause itching and be painful);
• if the patient experiences loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and general malaise. Symptoms may indicate replacement of normal liver tissue with scar tissue, leading to loss of liver function, including life-threatening liver failure, liver damage (damage to liver cells, bile ducts, or both), liver transplantation;
• if the patient experiences burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages; tarry, black, or bloody stools; bloating, heartburn, nausea, or vomiting, rapid feeling of fullness during meals (peptic ulcer of the intestine and/or stomach) – life-threatening symptoms;
• if the patient experiences intense abdominal pain worsened by movement; nausea, vomiting, including vomiting blood (or coffee-ground-like fluid); abdominal rigidity with rebound tenderness (after releasing pressure) spreading peripherally from the site of perforation; fever and/or chills (perforation of the stomach and/or intestine or intestinal rupture) – life-threatening symptoms;
• if the patient experiences constipation, abdominal pain, abdominal tenderness, fever, bloating, bloody diarrhea. These symptoms may indicate acute colonic distension (acute intestinal distension) or intestinal infarction/ischemia/necrosis – life-threatening symptoms. Medical consultation is necessary;
• if the patient experiences dull chest pain with shortness of breath, with or without cough;
• if the patient develops increased or new-onset muscle weakness, muscle spasms, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). Medical consultation is necessary;
• if the patient develops dull chest pain or abdominal pain with shortness of breath, with or without cough and fever;
• if the patient develops restless legs syndrome (irresistible urge to move legs or arms, usually accompanied by discomfort during rest, especially in the evening or at night, with temporary relief during movement);
• if the patient develops very severe and serious skin reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Skin-related adverse reactions may occur with or without blisters. Skin irritation, swelling, fever, and flu-like symptoms may occur. DRESS syndrome symptoms usually appear approximately 2–6 weeks after starting the medicine. If any of the above points apply to the patient, inform the doctor before taking the next dose of Paxifar.

Other adverse reactions:
Very common (affects more than 1 in 10 patients):
Somnolence, non-positional dizziness, excessive salivation.
Common (may occur in no more than 1 in 10 patients):
High white blood cell count (leukocytosis), high count of a certain type of white blood cells (eosinophilia), weight gain, blurred vision, headache, tremor, stiffness, motor restlessness, convulsions, muscle twitching, involuntary movements, inability to move, inability to remain still, changes in ECG recording, arterial 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, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g., slurred speech).
Uncommon (may occur in no more than 1 in 100 patients):
Absence of white blood cells in the blood (agranulocytosis), dysthymia (neurotic depression).
Rare (may occur in no more than 1 in 1,000 patients):
Low red blood cell count (anemia), motor restlessness, agitation, confusion, delirium, arrhythmia, myocarditis or pericarditis, pericardial effusion, high blood sugar (glucose) levels, diabetes, pulmonary embolism (venous thromboembolic disease), hepatitis, jaundice (liver disease causing yellowing of the skin/dark urine/itching), pancreatitis leading to severe upper abdominal pain, increased blood activity of an enzyme called creatine kinase.
Very rare (may occur in no more than 1 in 10,000 patients):
Increased platelet count with possible blood clotting in blood vessels, uncontrolled movements of lips, tongue, and limbs, obsessive thoughts and compulsive behaviors (obsessive-compulsive symptoms), skin reactions, swelling of the parotid gland (salivary gland enlargement), breathing difficulties, very high triglyceride or cholesterol levels in the blood, heart muscle disease (cardiomyopathy), cardiac arrest, sudden unexplained death.
Frequency not known (frequency cannot be estimated from available data):
Changes in brain wave tests (electroencephalogram/EEG), diarrhea, stomach discomfort, heartburn, postprandial stomach discomfort, muscle weakness, muscle spasms, muscle pain, nasal congestion, nocturnal enuresis, sudden, uncontrolled increase in blood pressure (pseudo-pheochromocytoma syndrome), uncontrolled body twisting to one side (pleurototonus), ejaculation disorders in men (sperm does not exit the body but enters the bladder – dry orgasm or retrograde ejaculation), rash, purple-red skin spots, fever or itching due to vasculitis, colitis with diarrhea, abdominal pain, fever, skin color changes, facial butterfly-shaped rash, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), withdrawal syndrome in newborns (see section 2 “Pregnancy, breastfeeding, and effect on fertility”), serositis.
In elderly patients with dementia treated with antipsychotic medicines, there is a slight increase in the risk of death compared to patients not taking antipsychotic medicines.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Paxifar

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

6. Contents of the pack and other information

What Paxifar contains

• The active substance is clozapine.

Paxifar 25 mg
One tablet contains 25 mg of clozapine.
Paxifar 50 mg
One tablet contains 50 mg of clozapine.
Paxifar 100 mg
One tablet contains 100 mg of clozapine.
Paxifar 200 mg
One tablet contains 200 mg of clozapine.

• Other ingredients: monohydrate lactose, magnesium stearate, corn starch, povidone K30, anhydrous colloidal silicon dioxide, talc.

What Paxifar looks like and contents of the pack
Paxifar 25 mg
Light yellow to yellow, round tablets, approximately 6.0 mm in diameter, embossed on one side with “FC” and “1” on both sides of the break line, smooth on the other side.
The tablet can be divided into equal doses.

Paxifar 50 mg
Light yellow to yellow, round tablets, approximately 8.0 mm in diameter, embossed on one side with “FC2”, smooth on the other side.

Paxifar 100 mg
Light yellow to yellow, round tablets, approximately 10.0 mm in diameter, embossed on one side with “FC” and “3” on both sides of the break line, smooth on the other side.
The tablet can be divided into equal doses.

Paxifar 200 mg
Light yellow to yellow, capsule-shaped tablets, approximately 17.0 mm long and 8.0 mm wide, uncoated tablets, with “F” and “C” engraved on one side with three division lines, and “7” engraved on the other side with three division lines.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure division into equal doses.

Paxifar tablets are packed in PVC/PVDC/Aluminium blisters placed in a cardboard box.
Pack sizes: 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. +48 61 66 51 500
[email protected]

Importer
Laboratori Fundació DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain