Posaconazole Zentiva

Leaflet accompanying the packaging: patient information

Posaconazole Zentiva, 100 mg, gastro-resistant tablets

Posaconazolum

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• 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 those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Posaconazole Zentiva and what is it used for

Posaconazole Zentiva contains the active substance posaconazole, which belongs to a group of antifungal medicines. This medicine is used to prevent and treat many types of fungal infections.

This medicine works by killing or inhibiting the growth of certain types of fungi that can cause infections.

Posaconazole Zentiva can be used in adults to treat fungal infections caused by fungi of the genus Aspergillus.

Posaconazole Zentiva can be used in adults and children over 2 years of age with a body weight over 40 kg to treat the following fungal infections:

• fungal infections caused by fungi of the genus Aspergillus(aspergillosis), if no improvement was achieved with antifungal treatment with amphotericin B or itraconazole, or if it was necessary to discontinue these medicines;
• fungal infections caused by fungi of the genus Fusarium, if no improvement was achieved with amphotericin B treatment or if it was necessary to discontinue amphotericin B;
• fungal infections that cause diseases such as chromoblastomycosis and mycetoma (maduromycosis), if no improvement was achieved with itraconazole treatment or if it was necessary to discontinue itraconazole;
• fungal infections caused by fungi of the genus Coccidioides, if no improvement was achieved with amphotericin B, itraconazole, or fluconazole treatment, or if it was necessary to discontinue these medicines.

The medicine can also be used to prevent fungal infections in adults and children over 2 years of age with a body weight over 40 kg who are at high risk of developing such infections, for example:

• in patients whose immune system is weakened due to chemotherapy for acute myeloid leukemia or myelodysplastic syndrome;
• in patients undergoing high-dose immunosuppressive therapy after hematopoietic stem cell transplantation.

2. Important information before taking Posaconazole Zentiva

When not to take Posaconazole Zentiva:

• if the patient is allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, or quinidine;
• if the patient has started treatment with venetoclax or the dose of venetoclax is being slowly increased as part of the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Zentiva if any of the above situations apply to you. In case of doubts, consult a doctor or pharmacist before taking Posaconazole Zentiva.

Warnings and precautions

Before taking Posaconazole Zentiva, discuss with your doctor, pharmacist, or nurse:

• if the patient has had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole;
• if the patient currently has or has had liver disease. During treatment with this medicine, blood tests may be necessary.
• if the patient has severe diarrhea or vomiting, which may reduce the effectiveness of the medicine;
• if the patient has an abnormal heart rhythm, which may be indicated by a prolonged QTc interval on an ECG;
• if the patient has been diagnosed with heart failure or weakened heart muscle;
• if the patient has a significant slowing of the heart rate;
• if the patient has heart rhythm disorders;
• if the patient has abnormal levels of potassium, magnesium, or calcium in the blood;
• if the patient is taking vincristine, vinblastine, or other vinca alkaloids (medicines used to treat cancer);
• if the patient is taking venetoclax (a medicine used to treat cancer).

If any of the above situations apply to you (or in case of doubts), consult a doctor, pharmacist, or nurse before taking Posaconazole Zentiva.

Children

Posaconazole Zentiva should not be given to children under 2 years of age.

Posaconazole Zentiva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Do not take Posaconazole Zentiva if you are taking any of the following medicines:

• terfenadine (used to treat allergies),
• astemizole (used to treat allergies),
• cisapride (used to treat stomach disorders),
• pimozide (used to treat symptoms of Tourette's syndrome and psychiatric disorders),
• halofantrine (used to treat malaria),
• quinidine (used to treat heart rhythm disorders).

Posaconazole Zentiva may increase the levels of these medicines in the blood, which may lead to serious heart rhythm changes:

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole Zentiva may increase the levels of these medicines in the blood, which may lead to a significant reduction in blood flow to the fingers and toes and consequently damage them;
• statins, such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol;
• venetoclax, used to treat a certain type of cancer called chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Zentiva if any of the above situations apply to you. In case of doubts, consult a doctor or pharmacist before taking Posaconazole Zentiva.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Posaconazole Zentiva during pregnancy unless your doctor advises you to.

Women of childbearing age should use effective contraception while taking Posaconazole Zentiva. If you become pregnant while taking Posaconazole Zentiva, contact your doctor immediately.

Do not breastfeed while taking Posaconazole Zentiva, as small amounts of the medicine may pass into breast milk.

Driving and using machines

While taking Posaconazole Zentiva, you may experience symptoms such as dizziness, drowsiness, or blurred vision, which may affect your ability to drive or operate machinery. In this case, do not drive or operate machinery and consult a doctor.

Posaconazole Zentiva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Posaconazole Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

Posaconazole tablets should not be used interchangeably with posaconazole oral suspension without consulting a doctor or pharmacist, as this may lead to a lack of efficacy or increased risk of side effects.

What dose to take

The usual dose is 300 mg of posaconazole (three 100 mg gastro-resistant tablets) twice a day on the first day of treatment, and then 300 mg of posaconazole (three 100 mg gastro-resistant tablets) once a day.

The treatment duration may depend on the type of infection, and your doctor may adjust it individually for each patient. Do not change the dose or treatment schedule without consulting your doctor first.

How to take the medicine

• Swallow the tablet whole with water.
• Do not crush, chew, divide, or dissolve the tablets.
• The tablets can be taken with or without food.

Taking more than the recommended dose of Posaconazole Zentiva

If you have taken more than the recommended dose of Posaconazole Zentiva, contact your doctor or go to the hospital immediately.

Missing a dose of Posaconazole Zentiva

• If you miss a dose, take it as soon as possible.
• However, if it is almost time for the next dose, skip the missed dose and return to your normal dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

Tell your doctor, pharmacist, or nurse immediately if you experience any of the following severe side effects, as you may need urgent medical attention:

• nausea or vomiting (or feeling like vomiting), diarrhea,
• symptoms of liver failure - including yellowing of the skin or whites of the eyes, dark urine, or pale stools, unexplained nausea, stomach upset, loss of appetite, unusual fatigue or weakness, elevated liver enzymes in blood tests;
• allergic reaction.

Other side effects

If you experience any of the following side effects, tell your doctor, pharmacist, or nurse.

Common: may affect up to 1 in 10 people

• changes in blood electrolyte levels, which may cause symptoms such as confusion or weakness;
• abnormal skin sensations, including numbness, tingling, itching, gooseflesh, prickling, or burning;
• headache;
• low potassium levels in the blood;
• low magnesium levels in the blood;
• high blood pressure;
• loss of appetite, stomach pain, or stomach upset, gas, dry mouth, taste disturbances;
• heartburn (a burning sensation in the chest and throat);
• low white blood cell count (neutropenia), which may increase the risk of infections;
• fever;
• weakness, dizziness, fatigue, or drowsiness;
• rash;
• itching;
• constipation;
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anemia - symptoms include headaches, fatigue, dizziness, shortness of breath, or pale skin, and low hemoglobin levels in blood tests;
• low platelet count (thrombocytopenia), which may lead to bleeding;
• low white blood cell count (leukopenia), which may increase the risk of infections;
• increased eosinophil count (eosinophilia), which may be related to inflammation;
• inflammation of blood vessels;
• heart rhythm disorders;
• seizures;
• nerve damage (neuropathy);
• abnormal heart rhythm, irregular heartbeat, slow or fast heart rate, high or low blood pressure;
• low blood pressure;
• pancreatitis, which may cause severe stomach pain;
• splenic infarction (a condition where the spleen does not receive enough blood), which may cause severe stomach pain;
• severe kidney problems - symptoms include decreased or increased urine output, or changes in urine color;
• high creatinine levels in the blood;
• cough, hiccups;
• nosebleeds;
• sharp and severe chest pain that occurs when breathing in (pleuritic pain);
• enlarged lymph nodes (lymphadenopathy);
• numbness or tingling, especially in the skin;
• tremors;
• high or low blood sugar levels;
• blurred vision, sensitivity to light;
• hair loss (alopecia);
• mouth ulcers;
• chills, general feeling of being unwell;
• pain, back pain, or neck and limb pain;
• fluid retention (edema);
• menstrual disorders (abnormal vaginal bleeding);
• difficulty sleeping (insomnia);
• partial or complete loss of speech;
• mouth swelling;
• abnormal dreams or sleep problems;
• feeling disoriented;
• coordination or balance problems;
• mucosal inflammation;
• stuffy nose;
• breathing difficulties;
• chest discomfort;
• bloating;
• mild to severe nausea, vomiting, abdominal cramps, and diarrhea, usually caused by a virus, stomach pain;
• belching;
• restlessness.

Rare: may affect up to 1 in 1000 people

• pneumonia - symptoms include shortness of breath and coughing up discolored sputum;
• high blood pressure in the pulmonary arteries (pulmonary hypertension), which may lead to severe lung and heart damage;
• blood disorders, such as abnormal blood clotting or prolonged bleeding time;
• severe allergic reactions, including widespread blistering and skin peeling;
• psychiatric disorders, such as hearing voices or seeing things that are not there;
• fainting;
• problems with thinking or speaking, sudden, uncontrolled movements of the limbs, especially the arms;
• stroke - symptoms include pain, weakness, numbness, or tingling of the limbs;
• appearance of a hole or blind spot in the field of vision;
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders that can cause sudden death;
• blood clots in the deep veins of the legs (deep vein thrombosis) - symptoms include severe leg pain or swelling;
• blood clots in the lungs (pulmonary embolism) - symptoms include shortness of breath or chest pain when breathing;
• bleeding from the stomach or intestines - symptoms include vomiting blood or black stools;
• intestinal obstruction, especially of the small intestine. Obstruction prevents the movement of intestinal contents into the large intestine. Symptoms include bloating, vomiting, severe constipation, loss of appetite, and intestinal cramps;
• hemolytic-uremic syndrome, a condition where red blood cells are broken down (hemolysis). It may be accompanied by kidney failure;
• pancytopenia, a decrease in the number of all blood cells (white blood cells, red blood cells, and platelets) shown in blood tests;
• large purple spots under the skin (thrombocytopenic purpura);
• facial or tongue swelling;
• depression;
• double vision;
• chest pain;
• adrenal disorders, which may cause weakness, fatigue, loss of appetite, changes in skin color;
• pituitary disorders, which may cause a decrease in hormone levels in the blood that affect the function of male or female sex organs;
• hearing problems.
• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (visible in blood tests).

If you experience any of the above side effects, consult your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects can be reported to the marketing authorization holder or its representative in Poland.

5. How to store Posaconazole Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister/bottle and outer packaging after EXP. The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Posaconazole Zentiva contains

The active substance is posaconazole (Posaconazolum). Each gastro-resistant tablet contains 100 mg of posaconazole.

The other ingredients are: methacrylic acid - ethyl acrylate copolymer (1:1) (type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, silicon dioxide, sodium croscarmellose, sodium stearyl fumarate, polyvinyl alcohol; titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Posaconazole Zentiva looks like and contents of the pack

Posaconazole Zentiva, gastro-resistant tablets are yellow, capsule-shaped, and have "100P" printed on one side and are smooth on the other.

The tablets are packaged in cardboard boxes containing blisters of 24 or 96 tablets or single-dose blisters containing 24 x 1 or 96 x 1 tablets or HDPE bottles containing 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s.

U Kabelovny 130, Dolní Měcholupy

102 37 Prague 10, Czech Republic

Manufacturer/Importer

Delorbis Pharmaceuticals Ltd.

17 Athion Street, Ergates Industrial Area

2643 Ergates Lefkosia, Cyprus

Winthrop Arzneimittel GmbH

Brüningstraße 50

62926 Frankfurt am Main, Germany

Prestige Promotion Verkaufsfoerderung&Werbeservice GmbH

Lindigstraße 6

63801 Kleinostheim

Bavaria, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany, Romania:

Posaconazol Zentiva

France, Poland, Czech Republic, Slovakia, United Kingdom (Northern Ireland):

Posaconazole Zentiva

Italy:

Posaconazolo Zentiva

For more information about this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

tel.: +48 22 375 92 00

Date of last revision of the leaflet:August 2022