Posaconazole Abdi

Leaflet accompanying the packaging: information for the user

Posaconazole Abdi 100 mg gastro-resistant tablets

Posaconazole

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Posaconazole Abdi 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 stopping the growth of fungi that can cause infections in humans.

Posaconazole Abdi may be used in adults to treat the following fungal infections when other antifungal medicines cannot be used or have not worked:

• 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 medicines have had to be stopped;
• 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;
• 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 medicines have had to be stopped;

The medicine may also be used to prevent fungal infections in adults 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 Abdi

When not to take Posaconazole Abdi:

• 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.

Do not take Posaconazole Abdi if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Abdi.

More information on this is given below in the section "Posaconazole Abdi and other medicines".

Warnings and precautions

Before taking Posaconazole Abdi, 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 necessary 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 weakened heart muscle or heart failure;
• if you have significant slowing of the 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 (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 Abdi.

If you experience severe diarrhea or vomiting while taking Posaconazole Abdi, contact your doctor, pharmacist, or nurse immediately, as this may reduce the effectiveness of the medicine. More information on this is given in section 4.

Children

Posaconazole Abdi should not be used in children (under 18 years of age).

Posaconazole Abdi 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 Abdi 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 Abdi may increase the levels of these medicines in your blood, which may lead to serious changes in heart rhythm.

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Abdi may increase the levels of these medicines in your blood, which may lead to significant reduction of 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.

If any of the above applies to you, do not take Posaconazole Abdi. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Abdi.

Other medicines

Check the list of medicines above that should not be taken with Posaconazole Abdi. In addition to the medicines listed above, taking other medicines with Posaconazole Abdi may increase the risk of heart rhythm disturbances, which may be further increased if these medicines are taken together with Posaconazole Abdi. Tell your doctor about all medicines you are taking (prescription and non-prescription). Certain medicines may increase the levels of Posaconazole Abdi in your blood, which may increase the risk of side effects.

The following medicines may decrease the levels of Posaconazole Abdi 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 prevent or treat seizures, including phenytoin, carbamazepine, phenobarbital, or primidone;
• efavirenz and fosamprenavir (used to treat HIV infection).

Posaconazole Abdi may increase the levels of certain medicines in your blood, which may increase the risk of side effects, including:

• vincristine, vinblastine, and other vinca alkaloids (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 (such as 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).

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

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, tell your doctor before taking Posaconazole Abdi. Do not take Posaconazole Abdi during pregnancy unless your doctor advises you to. Women of childbearing age should use effective contraception while taking this medicine. If you become pregnant while taking Posaconazole Abdi, tell your doctor immediately.

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

Driving and using machines

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

Information about some of the ingredients of Posaconazole Abdi

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

Posaconazole Abdi contains 80.0 mg of lactose monohydrate per tablet. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Posaconazole Abdi

Do not take Posaconazole Abdi tablets as a substitute for Posaconazole Abdi oral suspension without consulting your doctor or pharmacist, as this may lead to lack of effectiveness 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 (three 100 mg tablets) twice a day on the first day, and then 300 mg (three 100 mg tablets) once a day. The duration of treatment may depend on the type of infection and may be adjusted individually by your doctor. Do not change the dose or treatment schedule without consulting your doctor.

How to take the medicine

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

Taking more Posaconazole Abdi than prescribed

If you think you have taken too much Posaconazole Abdi, contact your doctor or go to the hospital immediately.

Missing a dose of Posaconazole Abdi

• 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 dosing 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 Abdi 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 upset, loss of appetite, unusual tiredness 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 sensations of 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 neutrophil count (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 headaches, feeling tired or dizzy, 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 infection;
• increased eosinophil count (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, as seen on an electrocardiogram (ECG), irregular heartbeat, slow or fast heart rate, high or low blood pressure;
• low blood pressure;
• pancreatitis, which may cause severe stomach pain;
• infarction of the spleen (splenic infarction) - 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, stabbing chest pain 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 pain, arm or leg pain;
• fluid retention (edema);
• menstrual disorders (abnormal vaginal bleeding);
• difficulty sleeping (insomnia);
• partial or complete 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.

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, sudden, uncontrolled movements of the limbs, especially the arms;
• stroke - symptoms include pain, weakness, numbness, or tingling of the limbs, or difficulty speaking;
• appearance of a blind spot or dark spot in the field of vision;
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disturbances that may cause sudden death;
• presence of blood clots in the deep veins of the legs (deep vein thrombosis) - symptoms include severe pain or swelling of the legs;
• 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. Symptoms include bloating, vomiting, severe constipation, loss of appetite, and abdominal 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) as seen in blood tests;
• large purple spots under the skin (thrombocytopenic purpura);
• swelling of the face or tongue;
• depression;
• double vision;
• chest pain;
• adrenal problems, which may cause weakness, fatigue, loss of appetite, or changes in skin color;
• pituitary problems, which may cause decreased levels of certain hormones in the blood that affect the function of male or female sex organs;
• hearing problems.

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

• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (as seen in blood tests)
• some patients have also reported feeling disoriented after taking Posaconazole Abdi.

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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported 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, e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posaconazole Abdi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack after EXP. The expiry date refers to the last day of the month stated.
• 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 Abdi contains

The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.

The other ingredients are: hypromellose acetate succinate, hypromellose, cornstarch, colloidal anhydrous silica, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, low-substituted, magnesium stearate, polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172)

What Posaconazole Abdi looks like and contents of the pack

Posaconazole Abdi is a gastro-resistant, film-coated, yellow, capsule-shaped tablet, approximately 19.9 mm in length, with "P100" engraved on one side, packaged in blisters in cardboard boxes containing 24 or 96 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Abdi Farma, Unipessoal Lda

Quinta da Fonte, Rua dos Malhões

Edifício D. Pedro I

2770-071 Paço de Arcos

Portugal

Importer

Interpharma Services Ltd.

43A Cherni Vrach Blvd.,

1407 Sofia,

Bulgaria

Importer for Germany

HEUMANN PHARMA GmbH & Co. Generica KG

Südwestpark 50 · 90449 Nürnberg

Interpharma Services Ltd.

43A Cherni Vrach Blvd.,

1407 Sofia,

Bulgaria

Date of last revision of the leaflet: 11.08.2021