Posaconazole zentiva

Package leaflet: Information for the patient

Posaconazole Zentiva, 100 mg, enteric-coated tablets
Posaconazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents

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

Posaconazole Zentiva contains the active substance posaconazole, which belongs to a group of medicines called antifungals. This medicine is used to prevent and treat many types of infections caused by fungi.
It works by killing or inhibiting the growth of certain types of fungi that may cause infections.
Posaconazole Zentiva may be used in adults for the treatment of fungal infections caused by fungi of the genus Aspergillus.
Posaconazole Zentiva may be used in adults and in children aged 2 years and older with body weight above 40 kg for the treatment of the following fungal infections:

• infections caused by fungi of the genus Aspergillus (aspergillosis), when there has been no improvement with antifungal therapy using amphotericin B or itraconazole, or when treatment with these medicines had to be discontinued;
• infections caused by fungi of the genus Fusarium, when there has been no improvement with amphotericin B or when treatment with amphotericin B had to be discontinued;
• fungal infections causing diseases such as chromoblastomycosis and mycetoma (maduromycosis), when there has been no improvement with itraconazole or when treatment with itraconazole had to be discontinued;
• infections caused by fungi of the genus Coccidioides, when there has been no improvement with amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines had to be discontinued.

This medicine may also be used prophylactically to prevent fungal infections in adults and in children aged 2 years and older with body weight above 40 kg who are at high risk of developing such infections, for example:

• in patients whose immune system is weakened due to chemotherapy used for acute myeloid leukemia or myelodysplastic syndrome;
• in patients receiving high-dose immunosuppressive therapy following 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, quinidine, or any other medicine containing ergot alkaloids (such as ergotamine or dihydroergotamine) or statins (simvastatin, atorvastatin or lovastatin),
• if the patient has started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of therapy for chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Zentiva if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Posaconazole Zentiva.
Further information on this, including information about other medicines that may interact with Posaconazole Zentiva, is provided below in the section "Posaconazole Zentiva and other medicines".

Warnings and precautions

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

• if the patient has previously had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole;
• if the patient currently has or has previously had liver problems. Blood tests may be necessary during treatment with this medicine;
• if the patient currently has severe diarrhoea or severe vomiting, which may reduce the effectiveness of this medicine;
• if the patient has ECG abnormalities indicating QTc interval prolongation;
• if the patient has been diagnosed with weakened heart muscle or heart failure;
• if the patient has 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 in cancer treatment);
• if the patient is taking venetoclax (a medicine used in the treatment of cancer).

If any of the above situations apply to the patient (or if in doubt), consult a doctor, pharmacist or nurse before taking Posaconazole Zentiva.
If severe diarrhoea or vomiting (feeling sick) occurs while taking Posaconazole Zentiva, contact a doctor, pharmacist or nurse immediately, as this may impair the proper action of the medicine. Further information on this is provided in section 4.

Children

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

Posaconazole Zentiva and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or might take in the future.

Do not take Posaconazole Zentiva if the patient is taking any of the following medicines:

• terfenadine (used to treat allergies),
• astemizole (used to treat allergies),
• cisapride (used to treat stomach problems),
• 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 blood levels of these medicines, which can lead to very serious heart rhythm disturbances.

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole Zentiva may increase blood levels of these medicines, leading to significantly reduced blood flow to fingers and toes, potentially causing tissue damage;
• statins such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels;
• venetoclax, used at the beginning of treatment for a type of cancer called chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Zentiva if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Other medicines

Please refer to the list above of medicines that must not be taken during treatment with Posaconazole Zentiva. In addition to the medicines listed above, taking other medicines may also carry a risk of heart rhythm disturbances, and this risk may increase if these medicines are taken together with Posaconazole Zentiva. Inform your doctor about all medicines you are taking (both prescription and over-the-counter).

Some medicines may increase the risk of adverse effects of Posaconazole Zentiva by increasing its blood concentration.

The following medicines may reduce the blood concentration of Posaconazole Zentiva and thereby reduce its effectiveness:

• rifabutin and rifampicin (used to treat certain infections). Patients taking rifabutin should have blood tests and monitor for possible adverse effects of rifabutin;
• phenytoin, carbamazepine, phenobarbital or primidone (used for prevention or treatment of seizures);
• efavirenz and fosamprenavir (used to treat HIV infection).

Posaconazole Zentiva may likely increase the risk of adverse effects of certain medicines by increasing their blood concentrations. These include:

• vincristine, vinblastine and other vinca alkaloids (used in cancer treatment);
• venetoclax (used in cancer treatment);
• cyclosporine (used during or after organ transplantation);
• tacrolimus and sirolimus (used during or after organ transplantation);
• rifabutin (used to treat certain infections);
• HIV medicines called protease inhibitors (including lopinavir and atazanavir taken together with ritonavir);
• midazolam, triazolam, alprazolam or other benzodiazepines (used as sedatives or muscle relaxants);
• diltiazem, verapamil, nifedipine, nisoldipine or other calcium channel blockers (used to treat high blood pressure);
• digoxin (used to treat heart failure);
• glipizide or other sulfonylureas (used to lower high blood sugar levels);
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain cancers).

If any of the above situations apply to the patient (or if in doubt), consult a doctor or pharmacist before using Posaconazole Zentiva.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Do not use Posaconazole Zentiva during pregnancy unless specifically advised by a doctor.

Women of childbearing potential should use effective contraception during treatment with Posaconazole Zentiva. If a patient becomes pregnant while taking Posaconazole Zentiva, she should contact her doctor immediately.

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

Driving and operating machinery

While taking Posaconazole Zentiva, symptoms such as dizziness, drowsiness or blurred vision may occur, which could affect the ability to drive or operate machinery. In such a case, do not drive, use tools or operate any 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

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Posaconazole tablets must not be used interchangeably with posaconazole oral suspension
without consulting your doctor or pharmacist. Doing so may result in reduced effectiveness or an increased risk of adverse effects.

What dose should be taken
The usual dose is 300 mg of posaconazole (three 100 mg enteric-coated tablets) taken twice on the first day of treatment, followed by 300 mg of posaconazole (three 100 mg enteric-coated tablets) once daily thereafter.
The duration of treatment may depend on the type of infection, and your doctor may adjust it individually for each patient. Do not change the dose or dosing schedule on your own without first discussing it with your doctor.

How to take the medicine

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

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

If you forget to take Posaconazole Zentiva

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Immediately inform your doctor, pharmacist or nurse if any of the following serious adverse reactions occur,
as immediate medical attention may be required:

• nausea or vomiting (or feeling sick), diarrhoea,
• symptoms of liver failure – these include yellowing of the skin or whites of the eyes (jaundice), abnormally dark urine or pale stools, nausea without apparent cause, stomach discomfort, loss of appetite, unusual tiredness or weakness, increased liver enzyme activity shown in blood tests,
• allergic reaction.

Other adverse reactions
If the patient experiences any of the adverse reactions listed below, inform the doctor,
pharmacist or nurse.
Common: may affect up to 1 in 10 people

• changes in blood electrolyte levels shown in blood tests – symptoms include feeling disoriented or weak;
• abnormal skin sensations, including numbness, tingling, itching, goosebumps, pricking or burning;
• headache;
• low potassium levels shown in blood tests;
• low magnesium levels shown in blood tests;
• high blood pressure;
• loss of appetite, stomach pain or upset, gas, dry mouth, taste disturbances;
• heartburn (a burning sensation in the chest and throat);
• decreased neutrophil count (a type of white blood cell) shown in blood tests (neutropenia), which may increase susceptibility to infections;
• fever;
• feeling weak, dizziness, fatigue or drowsiness;
• rash;
• itching;
• constipation;
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anaemia – symptoms include headaches, feeling tired or dizzy, shortness of breath or pale skin, and low haemoglobin levels shown in blood tests;
• decreased platelet count shown in blood tests (thrombocytopenia), which may lead to bleeding;
• decreased white blood cell count (leukopenia), which may increase susceptibility to infections;
• increased eosinophil count (a type of white blood cell) shown in blood tests (eosinophilia), which may be associated with inflammatory conditions;
• inflammation of blood vessels;
• heart rhythm disorders;
• seizures;
• nerve damage (neuropathy);
• abnormal heart rhythm shown on ECG, palpitations, slow or rapid heartbeat, elevated or low blood pressure;
• low blood pressure;
• pancreatitis, which may cause severe abdominal pain;
• splenic hypoxia (splenic infarction) – this may cause severe abdominal pain;
• serious kidney function disorders – symptoms include reduced or increased urine output, or changes in urine colour;
• high creatinine levels in urine shown in blood tests;
• cough, hiccups;
• nosebleeds;
• severe, sharp chest pain occurring during breathing (pleuritic pain);
• swollen lymph nodes (lymphadenopathy);
• reduced sensation, especially of the skin;
• tremor;
• elevated or reduced blood sugar levels;
• blurred vision, light sensitivity;
• hair loss (alopecia);
• oral ulceration;
• chills, general malaise;
• pain, back or neck pain, pain in arms and legs;
• fluid retention (oedema);
• menstrual disorders (abnormal vaginal bleeding);
• difficulty sleeping (insomnia);
• partial or complete loss of speech ability;
• swelling of the mouth;
• abnormal dreams or sleep problems;
• feeling disoriented;
• coordination or balance disorders;
• mucosal inflammation;
• stuffy nose;
• breathing difficulties;
• chest discomfort;
• bloating;
• mild to severe nausea, vomiting, abdominal cramps and diarrhoea, usually caused by a virus, abdominal pain;
• belching;
• feeling of restlessness.

Rare: may affect up to 1 in 1000 people

• pneumonia – symptoms may include shortness of breath and coughing up discoloured sputum;
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may lead to severe damage to the lungs and heart;
• blood disorders, such as abnormal blood clotting or prolonged bleeding time;
• severe allergic reactions, including widespread blistering rash and skin peeling;
• psychiatric disorders, such as hearing voices and seeing things that are not there;
• fainting;
• problems with thinking or speaking, sudden, uncontrolled limb movements, especially of the hands;
• stroke – symptoms may include pain, weakness, numbness or tingling in limbs;
• appearance of blind spots or dark spots (dark spots) in the visual field;
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders causing sudden death;
• presence of blood clots in the blood vessels of the lower limbs (deep vein thrombosis) – symptoms may include severe leg pain or swelling;
• presence of blood clots in the blood vessels of the lungs (pulmonary embolism) – symptoms may include shortness of breath or pain during breathing;
• bleeding from the stomach or intestines – symptoms may include vomiting blood or presence of blood in stool;
• intestinal obstruction, especially of the small intestine. Obstruction prevents the movement of intestinal contents into the lower part of the digestive tract (large intestine). Symptoms may include bloating, vomiting, severe constipation, loss of appetite and intestinal cramps;
• haemolytic-uraemic syndrome, in which red blood cells break down (haemolysis). This may be accompanied by kidney failure;
• pancytopenia, i.e. decreased number of all blood cells (white and red blood cells and platelets) shown in blood tests;
• large purple bruises under the skin (thrombotic thrombocytopenic purpura);
• swelling of the face or tongue;
• depression;
• double vision;
• chest pain;
• adrenal gland dysfunction, which may cause weakness, fatigue, loss of appetite, changes in skin pigmentation;
• pituitary gland dysfunction, which may cause reduced levels of certain hormones in the blood affecting the function of male or female reproductive organs;
• hearing problems.
• pseudoaldosteronism, which may contribute to high arterial blood pressure with low potassium levels (visible in blood tests).

If any of the above-mentioned adverse reactions occur, consult a
doctor, pharmacist or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. 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 181 C, 02-222 Warsaw, tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows more information to be gathered about the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.

5. How to store Posaconazole Zentiva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/bottle and outer packaging following EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Posaconazole Zentiva contains
The active substance is posaconazole (Posaconazolum). One enteric-coated tablet contains 100 mg of posaconazole.
The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1) (type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, colloidal anhydrous silica, 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 enteric-coated tablets are yellow film-coated, capsule-shaped tablets, embossed on one side with the code "100P", smooth on the other side.
The tablets are packed in cardboard boxes containing blisters of 24 or 96 tablets, or unit 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 Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Germany, Romania: Posaconazol Zentiva
France, Poland, Czech Republic, Slovak Republic, United Kingdom (Northern Ireland): Posaconazole Zentiva
Italy: Posaconazolo Zentiva

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00