Posaconazole Teva

Package Leaflet: Information for the Patient

Posaconazole Teva, 100 mg, Gastro-Resistant Tablets

Posaconazole

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

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

Posaconazole Teva 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. It works by killing or stopping the growth of fungi that cause infections. Posaconazole Teva can be used in adults to treat fungal infections caused by fungi of the genus Aspergillus. Posaconazole Teva can be used in adults and children aged 2 years and above, weighing over 40 kg, to treat the following types of fungal infections:

• fungal infections caused by fungi of the genus Aspergillus(aspergillosis), if there has been no improvement after treatment with amphotericin B or itraconazole, or if these treatments have had to be stopped;
• fungal infections caused by fungi of the genus Fusarium, if there has been no improvement after treatment with amphotericin B or if amphotericin B has had to be stopped;
• fungal infections that cause diseases such as chromoblastomycosis and mycetoma, if there has been no improvement after treatment with itraconazole or if itraconazole has had to be stopped;
• fungal infections caused by fungi of the genus Coccidioides, if there has been no improvement after treatment with amphotericin B, itraconazole, or fluconazole, or if these treatments have had to be stopped.

This medicine can also be used to prevent fungal infections in adults and children aged 2 years and above, weighing 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 taking high-dose immunosuppressive therapy after hematopoietic stem cell transplantation.

2. Important information before taking Posaconazole Teva

When not to take Posaconazole Teva:

• if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6);
• if you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, or statins such as simvastatin, atorvastatin, or lovastatin;
• if you have 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 Teva if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Teva. For more information, see the section "Posaconazole Teva and other medicines" below.

Warnings and precautions

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

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

If any of the above applies to you (or if you are unsure), consult your doctor, pharmacist, or nurse before taking Posaconazole Teva. If you experience severe diarrhea or vomiting while taking Posaconazole Teva, consult your doctor, pharmacist, or nurse immediately, as this may reduce the effectiveness of the medicine. For more information, see section 4.

Children and adolescents

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

Posaconazole Teva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Do not take Posaconazole Teva 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 disturbances). Posaconazole Teva may increase the levels of these medicines in your blood, leading to serious heart rhythm disturbances.
• any medicines containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Teva may increase the levels of these medicines in your blood, which may lead to reduced blood flow to your fingers or toes and cause damage to them;
• "statins" such as simvastatin, atorvastatin, or lovastatin, used to lower high cholesterol levels;
• venetoclax used to treat certain types of cancer.

If any of the above applies to you, do not take Posaconazole Teva. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Teva. Other medicines: You should be aware of the list of medicines that should not be taken with Posaconazole Teva, listed above. In addition to these medicines, taking other medicines with Posaconazole Teva may increase the risk of heart rhythm disturbances. You should inform your doctor about all medicines you are taking (prescription and non-prescription). Certain medicines may increase the levels of Posaconazole Teva in your blood, which may increase the risk of side effects (e.g., clarithromycin, erythromycin used to treat certain infections). The following medicines may decrease the levels of Posaconazole Teva in your blood, which may reduce its effectiveness:

• rifabutin and rifampicin (used to treat certain infections). Patients taking rifabutin should have blood tests and be aware of possible side effects of rifabutin;
• certain medicines used to treat or prevent seizures, including phenytoin, carbamazepine, phenobarbital, or primidone;
• efavirenz and fosamprenavir used to treat HIV infection.

Posaconazole Teva may increase the levels of certain medicines in your blood, which may increase the risk of side effects. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer);
• venetoclax (used to treat cancer);
• cyclosporine (used after organ transplantation);
• tacrolimus and sirolimus (used after organ transplantation);
• rifabutin (used to treat certain infections);
• HIV protease inhibitors (including lopinavir and atazanavir when taken with ritonavir);
• midazolam, triazolam, alprazolam, or other "benzodiazepines" (used as sedatives or muscle relaxants);
• diltiazem, verapamil, nifedipine, 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 blood cancers).

If any of the above applies to you (or if you are unsure), consult your doctor or pharmacist before taking Posaconazole Teva.

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 Teva during pregnancy unless your doctor has told you to. Women of childbearing age should use effective contraception while taking this medicine. If you become pregnant while taking Posaconazole Teva, tell your doctor immediately. You should not breastfeed while taking Posaconazole Teva, as small amounts of the medicine may pass into breast milk.

Driving and using machines

While taking Posaconazole Teva, you may experience dizziness, drowsiness, or blurred vision, which may affect your ability to drive or use machines. If this happens, do not drive or use machines and consult your doctor.

Posaconazole Teva contains sodium

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

3. How to take Posaconazole Teva

Do not take Posaconazole Teva tablets as a substitute for posaconazole oral suspension without consulting your doctor or pharmacist, as this may lead to reduced efficacy or increased risk of side effects. Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

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, and then 300 mg of posaconazole (three 100 mg gastro-resistant tablets) once a day. 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 of the medicine or the treatment schedule without consulting your doctor first.

How to take the medicine

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

If you take more Posaconazole Teva than you should

If you think you have taken too much of this medicine, contact your doctor or go to the hospital immediately.

If you forget to take Posaconazole Teva

• 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 continue with your regular schedule. Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, Posaconazole Teva 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, diarrhea;
• symptoms of liver failure - these include yellowing of the skin or whites of the eyes, dark urine, or pale stools, unexplained nausea, stomach pain, loss of appetite, unusual tiredness or weakness, or abnormal liver enzyme levels 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 sensation in the skin, 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 upset stomach, gas, dry mouth, taste disturbances;
• heartburn (a burning sensation in the chest and throat);
• low levels of neutrophils, a type of white blood cell, which may increase the risk of infection;
• fever;
• feeling weak, dizzy, tired, or sleepy;
• rash;
• itching;
• constipation;
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anemia - symptoms include headache, feeling tired or dizzy, shortness of breath, or pale skin, and low hemoglobin levels in blood tests;
• low levels of platelets in the blood, which may increase the risk of bleeding;
• low levels of white blood cells, which may increase the risk of infection;
• high levels of eosinophils, a type of white blood cell, which may be associated with inflammation;
• inflammation of blood vessels;
• heart rhythm disturbances;
• seizures;
• nerve damage (neuropathy);
• abnormal heart rhythm, irregular heartbeat, slow or fast heart rate, high or low blood pressure;
• low blood pressure;
• inflammation of the pancreas, which may cause severe stomach pain;
• infarction of the spleen (splenic infarction), which may cause severe stomach pain;
• severe kidney problems - symptoms include reduced or increased urine output, or changes in urine color;
• high levels of creatinine in the blood;
• cough, hiccups;
• nosebleeds;
• sharp and severe chest pain when breathing in (pleuritic pain);
• enlarged lymph nodes (lymphadenopathy);
• reduced sensation, especially skin sensation;
• 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 pain, arm and leg pain;
• fluid retention (edema);
• menstrual disorders (abnormal vaginal bleeding);
• difficulty sleeping (insomnia);
• complete or partial loss of speech;
• mouth swelling;
• vivid dreams or sleep problems;
• coordination or balance problems;
• inflammation of mucous membranes;
• 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;
• skin inflammation or redness, small blood spots under the skin;
• some patients have also reported feeling disoriented after taking posaconazole.

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 blood vessels of the lungs (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 peeling of the skin;
• psychiatric disorders, such as hearing voices or seeing things that are not there;
• fainting;
• problems with thinking or speaking, uncontrolled movements of the limbs, especially the hands;
• stroke - symptoms include pain, weakness, numbness, or tingling of the limbs, and blurred vision;
• appearance of a defect or blind spot in the field of vision;
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disturbances that can cause sudden death;
• presence of blood clots in the deep veins of the legs (deep vein thrombosis) - symptoms include severe leg pain or swelling;
• presence of 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;
• blockage of the intestines, especially the small intestine. Blockage prevents the movement of intestinal contents into the large intestine (colon). Symptoms include bloating, vomiting, severe constipation, loss of appetite, and intestinal cramps;
• hemolytic-uremic syndrome, in which red blood cells are broken down (hemolysis). This may be accompanied by kidney failure;
• pancytopenia, a decrease in the number of all blood cells (white blood cells, red blood cells, and platelets) in blood tests;
• large purple spots under the skin (thrombocytopenic purpura);
• swelling of the face or tongue;
• depression;
• double vision;
• chest pain;
• adrenal gland problems, which may cause weakness, fatigue, loss of appetite, or changes in skin color;
• pituitary gland problems, which may cause low levels of certain hormones in the blood that affect the function of male or female reproductive organs;
• hearing problems;
• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (seen in blood tests).

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this medicine. You can also report side effects to the representative of the marketing authorization holder.

5. How to store Posaconazole Teva

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP. The expiry date refers to the last day of that 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Posaconazole Teva contains

The active substance is posaconazole. 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, hydroxypropyl cellulose, propyl gallate, microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, sodium stearyl fumarate (see section 2 Posaconazole Teva contains sodium), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

What Posaconazole Teva looks like and contents of the pack

Posaconazole Teva 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 cartons, in blisters of 24 or 96, in single-dose blisters of 24x1 or 96x1, and in bottles of 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands. Manufacturer: Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, Cyprus. Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków.

For more information about this medicine and its authorized names in the European Economic Area, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

Date of last revision of the package leaflet: September 2022