Paxifar

Leaflet accompanying the packaging: patient information

Paxifar, 25 mg, tablets

Paxifar, 50 mg, tablets

Paxifar, 100 mg, tablets

Paxifar, 200 mg, tablets

Clozapine

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Paxifar and what is it used for
• 2. Important information before taking Paxifar
• 3. How to take Paxifar
• 4. Possible side effects
• 5. How to store Paxifar
• 6. Package contents and other information

1. What is Paxifar and what is it used for

The active substance of Paxifar is clozapine, which belongs to a group of medicines called antipsychotics (medicines used to treat specific mental disorders, such as psychoses). Paxifar is used to treat patients with schizophrenia who do not respond to treatment with other medicines. Schizophrenia is a mental illness that causes disturbances in thinking, emotions, and behavior. Paxifar is recommended only for the treatment of patients who have already taken at least two different antipsychotic medicines, including new atypical antipsychotic medicines indicated for the treatment of schizophrenia, and have not responded to these medicines or have experienced severe side effects that could not be controlled. Paxifar at a strength of 25 mg, 50 mg, and 100 mg is also used to treat severe thought, emotional, and behavioral disorders in patients with Parkinson's disease, when other treatment methods have been ineffective.

2. Important information before taking Paxifar

When not to take Paxifar

except in cases of low white blood cell count in the blood associated with previous chemotherapy;

If any of the above points apply to the patient, they should tell their doctor and not take Paxifar. Paxifar should not be taken by 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 severe side effects that can be life-threatening.

Before the patient starts taking Paxifar, they should tell their doctor if they have or have ever had:

• or if anyone in their family has had blood clots, as medicines like this have been associated with the formation of blood clots;
• glaucoma (increased pressure in the eye);
• diabetes; increased - sometimes significantly - glucose levels in the blood, occurring in patients with diabetes or without diabetes in their medical history (see section 4);
• prostate problems or difficulty urinating;
• heart, kidney, or liver disease;
• chronic constipation or taking medicines that cause constipation (such as anticholinergic medicines);
• controlled epilepsy;
• colon disease;
• abdominal surgery;

The patient should tell their doctor immediately before taking the next Paxifar tablet:

cold, fever, flu-like symptoms, sore throat, or any infection. The doctor may recommend urgent blood tests to check if these symptoms are related to the medicine;sudden increased 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;rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will check the patient's heart function and, if necessary, refer them to a cardiologist immediately;nausea, vomiting, and (or) loss of appetite. The doctor will check the patient's liver function;severe constipation, abdominal pain, abdominal tenderness, fever, bloating, and (or) bloody diarrhea. The doctor will provide treatment to avoid further complications.

Some women taking medicines for mental illnesses have irregular periods or do not have them at all. As a result of switching to Paxifar, normal menstruation may return. Therefore, women of childbearing age should use effective contraception.

Medical check-ups 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 infection.

It is necessary to perform regular blood tests 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 done. Paxifar can only be taken if the patient has a normal white blood cell count.
• Paxifar may cause a significant decrease in the number of white blood cells in the blood (agranulocytosis). Only regular blood tests can confirm that the patient is at risk of developing agranulocytosis.
• Blood tests should be performed once a week for the first 18 weeks of treatment. Then, tests should be performed at least once a month.
• If the patient's white blood cell count decreases, treatment with Paxifar should be stopped immediately. The white blood cell count should return to normal.
• Blood tests should be performed for another 4 weeks after stopping treatment with Paxifar.

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

Patients with liver function disorders

If the patient has liver function disorders, regular liver function tests will be performed throughout the treatment with Paxifar. If the patient has a high blood sugar level (diabetes), the doctor may order regular blood sugar tests.

Paxifar may cause weight gain and changes in lipid levels

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

Paxifar may increase the risk of falls

If Paxifar causes the patient to feel dizzy, lightheaded, or faint, they should be careful when changing position from sitting or lying down, as these symptoms can increase the risk of falls.

Risk of blood clots

If the patient needs to have surgery or is immobilized for a long time, they should discuss taking Paxifar with their doctor. There is a risk of blood clots (thrombosis).

Children and adolescents under 16 years of age

Patients under 16 years of age should not take Paxifar, as there is limited data on the use of the medicine in this age group.

Elderly patients (60 years of age and older)

In elderly patients (60 years of age and older), the following side effects may occur more frequently during treatment with Paxifar: fainting or feeling lightheaded when changing position, dizziness, rapid heartbeat, difficulty urinating, and constipation. The patient should tell their doctor if they have a condition called dementia.

Paxifar and other medicines

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

Do not take Paxifar with medicines that inhibit bone marrow function and (or)

reduce the number of white blood cells produced by the body, such as:

• carbamazepine, a medicine used to treat epilepsy;
• certain antibiotics: chloramphenicol, sulfonamides, such as co-trimoxazole;
• certain painkillers: pyrazolone derivatives, such as phenylbutazone or metamizole;
• penicillamine, a medicine used to treat rheumatoid arthritis;
• cytotoxic agents, medicines used in chemotherapy;
• antipsychotic depot injections with prolonged action. These medicines increase the risk of developing agranulocytosis (lack of white blood cells).

Taking Paxifar with other medicines may affect the action of Paxifar and (or) other medicines

The patient should tell their doctor if they plan to take, are taking (even if the treatment is ending), or have recently stopped taking 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 and sleep disorders;
• opioid medicines and other medicines that may affect breathing;
• 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 some eye drops, cold remedies, and cough medicines;
• adrenaline, a medicine used in emergency situations;
• hormonal contraceptives (birth control pills).

The above list is not exhaustive. The doctor or pharmacist has more information about medicines that should be used with caution with Paxifar or should be avoided during treatment with Paxifar, and they know if the medicine belongs to the listed groups. The patient should ask them about it.

Paxifar with food and drink and alcohol

The patient should not drink alcohol while taking Paxifar. The patient should tell their doctor if they smoke and how often they drink caffeinated beverages (coffee, tea, cola). Sudden changes in smoking or drinking caffeinated beverages can also change the effects of Paxifar.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. The doctor will discuss the benefits and possible risks of taking the medicine during pregnancy. The patient should tell their doctor immediately if they become pregnant while taking Paxifar. In newborns of mothers taking antipsychotic medicines in the last trimester (last three months of pregnancy), the following symptoms may occur: trembling, stiffness, and (or) muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If the baby develops these symptoms, the patient should contact their doctor. Some women taking medicines for mental illnesses have irregular periods or do not have them at all. As a result of switching to Paxifar, normal menstruation may return. Therefore, women of childbearing age should use effective contraception. The patient should not breastfeed while taking Paxifar. Clozapine, the active substance of Paxifar, may pass into breast milk and affect the baby.

Driving and operating machinery

Paxifar may cause drowsiness, sleepiness, and seizures, especially during the initial treatment period. The patient should not drive vehicles or operate machinery if they experience these symptoms.

Paxifar contains lactose monohydrate

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

3. How to take Paxifar

In order to minimize the risk of low blood pressure, seizures, and drowsiness, it is necessary for the doctor to gradually increase the dose of Paxifar. Paxifar should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. It is very important not to change the dose or stop taking Paxifar without consulting the doctor first. The patient should continue treatment for as long as the doctor recommends. In patients over 60 years of age, the doctor may start treatment with smaller doses and gradually increase them, as it is more likely that they will experience certain side 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 a different strength are available.

Treatment of schizophrenia

The usual recommended starting dose is 12.5 mg (half a 25 mg tablet) once or twice a day on the first day, and then 25 mg once or twice a day on the second day. The tablet should be swallowed with water. If the patient tolerates the treatment well, the daily dose can then be gradually increased by 25 mg to 50 mg over 2-3 weeks to achieve a target dose of up to 300 mg per day. Then, if necessary, the daily dose can be further increased by 50 mg to 100 mg at intervals of 3 to 4 days or preferably once a week. The effective daily dose is usually 200 mg or 450 mg, divided into several single doses. Some patients may need higher doses. The maximum daily dose is 900 mg. At doses above 450 mg per day, it is possible to exacerbate some side effects (in particular, seizures). The patient should always take the smallest effective dose of the medicine. Most patients take part of the dose in the morning and part in the evening. The doctor will explain how to divide the daily dose. If the daily dose is 200 mg, the patient can take it as a single dose in the evening. If the patient has been taking Paxifar for some time with good results, the doctor may try to reduce the dose. The patient should take Paxifar for at least 6 months.

Treatment of severe thought, emotional, and behavioral disorders in patients with Parkinson's disease

The usual recommended starting dose is 12.5 mg (half a 25 mg tablet) in the evening. The tablet should be swallowed with water. Then, the doctor will gradually increase the dose by 12.5 mg, no faster than twice a week, to achieve a maximum dose of 50 mg per day within two weeks. If the patient experiences fainting, dizziness, or confusion, the dose increase should be delayed or suspended. To avoid these symptoms, the patient's blood pressure should be checked in the first weeks of treatment. The effective daily dose is usually 25 mg to 37.5 mg, taken as a single dose in the evening. Taking doses higher than 50 mg per day should only be done in exceptional cases. The maximum daily dose is 100 mg. The patient should always take the smallest effective dose of the medicine. In the treatment of psychiatric disorders in Parkinson's disease, only 25 mg, 50 mg, and 100 mg tablets are used.

Taking a higher dose of Paxifar than recommended

If the patient has taken too many tablets, they should contact their doctor or call emergency services immediately. Symptoms of overdose: drowsiness, fatigue, lack of energy, loss of consciousness, coma, confusion (disorientation), hallucinations, agitation, chaotic speech, muscle stiffness, hand tremors, seizures (convulsions), excessive salivation, dilated pupils, blurred vision, low blood pressure, collapse, rapid or irregular heartbeat, shallow or difficult breathing.

Missing a dose of Paxifar

If the patient misses a dose, they should take it as soon as possible. However, they should not take the medicine if it is almost time for the next dose. In this case, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient forgets to take Paxifar for 48 hours or more, they should contact their doctor immediately.

Stopping treatment with Paxifar

The patient should not stop taking Paxifar without consulting their doctor, as withdrawal reactions may occur. These include: 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 disease may return. It is recommended to gradually reduce the dose by 12.5 mg over one to two weeks. The doctor will inform the patient how to reduce the daily dose. If it is necessary to stop taking Paxifar immediately, the patient should consult their doctor. If the doctor decides to restart treatment with Paxifar and the patient has taken the last dose of Paxifar more than two days ago, the starting dose will be 12.5 mg. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Paxifar can cause side effects, although not everybody gets them.

Some side effects can be severe and require medical attention. The patient should tell their doctor immediately before taking the next Paxifar tablet:

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

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

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

• if the patient experiences symptoms of a cold, fever, flu-like symptoms, sore throat, or other infections. The doctor will urgently perform a blood test to check if these symptoms are related to the medicine;
• if the patient experiences seizures;
• if the patient experiences sudden fainting or loss of consciousness with muscle weakness (syncope).

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

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

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

• if the patient has symptoms of a respiratory tract infection or pneumonia, such as fever, cough, difficulty breathing, wheezing;
• if the patient experiences severe, burning pain in the upper abdomen, especially between meals, early in the morning, or after drinking acidic beverages, caused by pancreatitis;
• if the patient experiences fainting and muscle weakness due to significantly low blood pressure (circulatory collapse);
• if the patient experiences difficulty swallowing (which can cause food to enter the airway);
• if the patient experiences nausea, vomiting, and (or) loss of appetite. The doctor will check the patient's liver function;
• if the patient experiences weight gain or exacerbation of existing obesity;
• if the patient experiences sleep apnea with snoring or without snoring.

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

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

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

• if the patient is a man and experiences prolonged, painful erection, known as priapism. If the erection lasts for more than 4 hours, immediate treatment may be necessary to avoid further complications;
• if the patient experiences bleeding or bruising, which can be symptoms of a low platelet count;
• if the patient experiences symptoms of uncontrolled blood sugar levels, such as nausea or vomiting, abdominal pain, excessive thirst, excessive urination, disorientation, or confusion, hyperosmolar coma;
• if the patient experiences abdominal pain, cramps, bloating, vomiting, constipation, and bloody diarrhea, which can be symptoms of intestinal obstruction;
• if the patient experiences loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and malaise. These symptoms may indicate developing liver failure, which can lead to life-threatening liver necrosis;
• if the patient experiences nausea, vomiting, fatigue, weight loss, which can be symptoms of kidney inflammation.

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

• if the patient experiences chest pain, feeling of compression 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 a heart attack). In these cases, the patient should contact their doctor immediately;
• if the patient experiences pressure in the chest, feeling of heaviness, pressure, squeezing, burning, or feeling of suffocation (symptoms of insufficient blood flow and oxygen 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). Occasionally, palpitations, fainting, shortness of breath, or chest discomfort may occur. The patient should consult their doctor;
• if the patient experiences symptoms of low blood pressure, such as dizziness, lightheadedness, fainting, blurred vision, excessive fatigue, cold and clammy skin, or nausea;
• if the patient experiences heart valve problems in the course of clozapine-related cardiomyopathy;
• if the patient experiences symptoms of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing;
• if the patient experiences confirmed or suspected infection with accompanying fever or low body temperature, 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 (symptom of kidney failure);
• if the patient experiences an allergic reaction (swelling, mainly of the face, lips, and tongue, as well as the throat, which can cause itching and be painful);
• if the patient experiences loss of appetite, bloating, abdominal pain, jaundice, severe weakness, and malaise. These symptoms may indicate replacement of normal liver tissue with scar tissue, leading to loss of liver function, including life-threatening liver failure, liver damage (liver cell, bile duct, or both damage), liver transplant;
• if the patient experiences 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, rapid onset of feeling full during eating (ulceration of the intestine and (or) stomach) - life-threatening symptoms;
• if the patient experiences abdominal pain, cramps, vomiting, and bloody diarrhea. These symptoms may indicate acute colon dilation (acute colon dilation) or intestinal infarction/ischemia/necrosis - life-threatening symptoms. The patient should consult their doctor;
• if the patient experiences dull chest pain with shortness of breath, with or without cough;
• if the patient experiences muscle weakness, muscle cramps, muscle pain. These symptoms may indicate muscle disorders (rhabdomyolysis). The patient should consult their doctor;
• if the patient experiences dull chest pain or abdominal pain, with shortness of breath, with or without cough and fever;
• if the patient experiences restless legs syndrome (irresistible urge to move the legs or arms, usually accompanied by a feeling of discomfort during rest, especially in the evening or at night, with temporary relief during movement);
• if the patient experiences very severe and serious skin reactions, such as drug rash with eosinophilia (increased number of a certain type of white blood cell) and systemic symptoms (DRESS syndrome). Skin reactions may occur as a rash with or without blisters. Skin irritation, swelling, fever, and flu-like symptoms may occur. DRESS syndrome symptoms usually occur within 2-6 weeks of starting the medicine. If any of the above points apply to the patient, they should tell their doctor before taking the next Paxifar tablet.

Other side effects:

Very common(affects more than 1 in 10 people):
Drowsiness, non-systemic dizziness, excessive salivation.
Common(may affect up to 1 in 10 people):
High white blood cell count, high eosinophil count, weight gain, blurred vision, headache, tremors, stiffness, restlessness, muscle spasms, seizures, muscle contractions, inability to move, inability to remain still, changes in ECG, high blood pressure, fainting or feeling lightheaded when changing position, nausea, vomiting, loss of appetite, dry mouth, liver function test abnormalities, urinary incontinence, difficulty urinating, fatigue, fever, increased sweating, increased body temperature, speech disorders (e.g., slurred speech).
Uncommon(may affect up to 1 in 100 people):
Low white blood cell count (agranulocytosis), dysthymia (neurotic depression).
Rare(may affect up to 1 in 1,000 people):
Low red blood cell count (anemia), restlessness, agitation, confusion, delirium, arrhythmia, myocarditis or pericarditis, high blood sugar levels, diabetes, pulmonary embolism (venous thromboembolism), liver inflammation, jaundice (liver disease causing yellowing of the skin/ dark urine/itching), pancreatitis leading to severe abdominal pain, increased levels of an enzyme called creatine phosphokinase in the blood, .
Very rare(may affect less than 1 in 10,000 people):
Increased platelet count with possible blood clotting, uncontrolled movements of the lips, tongue, and limbs, obsessive-compulsive symptoms, skin reactions, swelling of the parotid gland (enlargement of the salivary glands), breathing difficulties, very high levels of triglycerides or cholesterol in the blood, heart disease (cardiomyopathy), cardiac arrest, sudden unexplained death.
Frequency not known(frequency cannot be estimated from the available data):
Changes in brain wave tests (electroencephalogram/EEG), diarrhea, discomfort in the stomach, heartburn, discomfort in the stomach after eating, feeling of weakness, muscle cramps, muscle pain, nasal congestion, nocturnal enuresis, sudden, uncontrolled increase in blood pressure (pseudo-pheochromocytoma syndrome), uncontrolled twisting of the body to one side (pleurothotonus), ejaculation disorders in men (semen does not come out of the body but enters the bladder - dry orgasm or retrograde ejaculation), rash, purple spots on the skin, fever or itching due to blood vessel inflammation, colon inflammation with diarrhea, abdominal pain, fever, change in skin color, butterfly-shaped rash on the face, joint pain, muscle pain, fever, and fatigue (lupus erythematosus), withdrawal syndrome in newborns (see section 2 "Pregnancy, breastfeeding, and fertility "),pericarditis.
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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, it will be possible to gather more information on the safety of the medicine.

5. How to store Paxifar

The medicine should be stored in a place that is out of sight and reach of children. Do not take Paxifar after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. There are no special storage instructions for the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Paxifar contains

• The active substance of Paxifar 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.

• The other ingredients are: lactose monohydrate, magnesium stearate, cornstarch, povidone K30, colloidal silica, talc.

What Paxifar looks like and what the pack contains

Paxifar, 25 mg
Light yellow to yellow, round tablets, approximately 6.0 mm in diameter, with "FC" embossed on one side and "1" on either side of the break line and 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, with "FC2" embossed on one side and smooth on the other side.
Paxifar, 100 mg
Light yellow to yellow, round tablets, approximately 10.0 mm in diameter, with "FC" embossed on one side and "3" on either side of the break line and 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 in length and 8.0 mm in width, with "F" and "C" embossed on one side with three break lines and "7" embossed on the other side with three break lines.
The break line on the tablet is only to facilitate breaking and not to divide into equal doses.
Paxifar tablets are packaged in PVC/PVDC/Aluminum blisters placed in a cardboard box.
The pack contains: 30, 50, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500
biofarm@biofarm.pl

Importer

Laboratori Fundació DAU
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Date of last revision of the leaflet: