Posaconazole Fresenius Kabi

Package leaflet: Information for the user

Posaconazole Fresenius Kabi gastro-resistant tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Posaconazole Fresenius Kabi is and what it is used for
2. What you need to know before taking Posaconazole Fresenius Kabi
3. How to take Posaconazole Fresenius Kabi
4. Possible side effects
5. How to store Posaconazole Fresenius Kabi
6. Contents of the pack and other information

1. What Posaconazolo Fresenius Kabi is and what it is used for

Posaconazolo Fresenius Kabi contains the active substance posaconazole. It belongs to a group of
medicines called “antifungals”. It is used to prevent and treat many different types of fungal
infections.
This medicine works by killing or stopping the growth of certain types of fungi that can cause
infections.
Posaconazole can be used in adults to treat fungal infections caused by fungi of the Aspergillus
family.
This medicine can be used in adults and children from 2 years of age weighing more than 40 kg to
treat the following types of fungal infections:

• infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines had to be discontinued;
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B, or when treatment with amphotericin B had to be discontinued;
• infections caused by fungi leading to conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole, or when treatment with itraconazole had to be discontinued;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of the following medicines: amphotericin B, itraconazole or fluconazole, or when treatment with these medicines had to be discontinued.

This medicine can also be used to prevent fungal infections in adults and children from 2 years of age and weighing more than 40 kg who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to chemotherapy for “acute myeloid leukaemia” (AML) or “myelodysplastic syndromes” (MDS);
• patients receiving “high-dose immunosuppressive therapy” following “haematopoietic stem cell transplantation” (HSCT).

2. What you need to know before taking Posaconazole Fresenius Kabi

Do not take Posaconazole Fresenius Kabi:

• if you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine containing "ergot alkaloids" such as ergotamine or dihydroergotamine, or a "statin" such as simvastatin, atorvastatin, or lovastatin;
• if you have recently started taking venetoclax or if the dose of venetoclax is being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Fresenius Kabi if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking this medicine.
See below under "Other medicines and Posaconazole Fresenius Kabi" for further information, including details on other medicines that may interact with posaconazole.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole Fresenius Kabi if:

• you have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole, or voriconazole;
• you have or have had liver problems. You may need blood tests while taking this medicine;
• you develop severe diarrhea or vomiting, as these conditions may reduce the effectiveness of this medicine;
• you have an abnormal heart rhythm trace (ECG) showing a condition called prolonged QTc interval;
• you have weakened heart muscle or heart failure;
• you have a very slow heart rate;
• you have a heart rhythm disorder;
• you have any problems with potassium, magnesium, or calcium levels in your blood;
• you are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer);
• you are taking venetoclax (a medicine used to treat cancer).

If you have any of the above conditions (or if you are unsure), consult your doctor, pharmacist, or nurse before taking this medicine.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole Fresenius Kabi, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. See section 4 for more information.

Children
This medicine must not be given to children under 2 years of age.

Other medicines and Posaconazole Fresenius Kabi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Posaconazole Fresenius Kabi if you are 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 mental illnesses);
• halofantrine (used to treat malaria);
• quinidine (used to treat heart rhythm abnormalities);

Posaconazole Fresenius Kabi can increase the amount of these medicines in your blood, which may lead to very serious changes in heart rhythm.

• any medicine containing "ergot alkaloids" such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole Fresenius Kabi can increase the amount of these medicines in your blood, which may lead to a severe reduction in blood flow to the fingers or toes and may damage them;
• a "statin" such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol levels;
• venetoclax, when used at the beginning of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Fresenius Kabi if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Other medicines
Check the list above of medicines that must not be taken while you are taking Posaconazole Fresenius Kabi. In addition to the medicines listed above, there are other medicines that may carry a risk of heart rhythm disturbances, which may be increased when taken with Posaconazole Fresenius Kabi. Make sure you inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of side effects of Posaconazole Fresenius Kabi by increasing the amount of Posaconazole Fresenius Kabi in the blood.

The following medicines may reduce the effectiveness of Posaconazole Fresenius Kabi by decreasing the amount of Posaconazole Fresenius Kabi in the blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already being treated with rifabutin, you will need a blood test and should watch for 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 Fresenius Kabi may likely increase the risk of side effects of certain other medicines by increasing the amount of these medicines in the blood. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat tumors);
• venetoclax (used to treat cancer);
• cyclosporine (used during or after transplantation);
• tacrolimus and sirolimus (used during or after transplantation);
• rifabutin (used to treat certain infections);
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, administered 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 treat high blood sugar levels);
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If you have any of the above conditions (or if you are unsure), consult your doctor or pharmacist before taking Posaconazole Fresenius Kabi.

Posaconazole Fresenius Kabi with food and drinks
Posaconazole Fresenius Kabi 100 mg gastro-resistant tablets can be taken with or without food.
Food does not affect the bioavailability of Posaconazole Fresenius Kabi 100 mg gastro-resistant tablets.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking Posaconazole Fresenius Kabi.
Do not take this medicine during pregnancy unless specifically instructed by your doctor.
If you are a woman of childbearing potential, you must use an effective method of contraception while taking this medicine. Contact your doctor immediately if you become pregnant while being treated with Posaconazole Fresenius Kabi.
Do not breastfeed while taking Posaconazole Fresenius Kabi. This is because small amounts may pass into breast milk.

Driving and using machines
During treatment with Posaconazole Fresenius Kabi, you may experience dizziness, drowsiness, or blurred vision, which could affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use tools or machinery and contact your doctor.

Posaconazole Fresenius Kabi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

Posaconazole Fresenius Kabi contains lactose
Each tablet contains 80.0 mg of lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Posaconazole Fresenius Kabi

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Do not switch from taking posaconazole tablets to posaconazole oral suspension without consulting your doctor or pharmacist, as this may result in reduced effectiveness or an increased risk of adverse reactions.

How much medicine to take
The usual dose is 300 mg (three 100 mg tablets) twice daily on the first day, followed by 300 mg (three 100 mg tablets) once daily thereafter.
The duration of treatment may depend on the type of infection you have and may be individually adjusted by your doctor. Do not adjust the dose on your own or change the treatment regimen without consulting your doctor.

How to take this medicine

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

If you take more Posaconazole Fresenius Kabi than you should
If you think you have taken more than the prescribed amount of Posaconazole Fresenius Kabi, inform a doctor immediately or go to the hospital without delay.

If you forget to take Posaconazole Fresenius Kabi
If you forget to take a dose, take it as soon as you remember.
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 the forgotten dose.

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

4. Possible side effects

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

Serious side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following serious side effects, as you may need urgent medical treatment:

• nausea or vomiting (feeling or state of being unwell), diarrhoea;
• signs of liver problems, including yellowing of the skin or the whites of the eyes, unusually dark-coloured urine, or pale stools, unexplained feeling of being unwell, stomach problems, loss of appetite, or unusual tiredness or weakness, increased liver enzymes detected in blood tests;
• allergic reaction.

Other side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

• changes in blood salt levels detected in blood tests – signs include feeling confused or weak
• abnormal skin sensations such as numbness, tingling, itching, goosebumps, pricking, or burning
• headache
• low blood potassium levels – detected in blood tests
• low magnesium levels – detected in blood tests
• high blood pressure
• loss of appetite, stomach ache, or stomach discomfort, passing wind, dry mouth, taste disturbances
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of “neutrophils”, a type of white blood cell (neutropenia) – this may increase the risk of infections and can be detected in blood tests
• fever
• feeling weak, dizzy, tired, or sleepy
• skin rash
• itching
• constipation
• rectal discomfort.

Uncommon: may affect up to 1 in 100 people

• anaemia – signs include headache, feeling tired or dizzy, shortness of breath, pale appearance, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia) detected in blood tests – this may lead to bleeding
• low levels of “leucocytes”, a type of white blood cell (leucopenia) detected in blood tests – this may increase the risk of infections
• high levels of “eosinophils”, a type of white blood cell (eosinophilia) – this may occur if you have inflammation
• inflammation of blood vessels
• changes in heart rhythm
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm – detected on electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain
• interruption of oxygen supply to the spleen (splenic infarction) – this may cause severe stomach pain
• severe kidney problems – signs include increased or decreased urine production with urine of unusual colour
• high creatinine levels in blood – detected in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• swelling of lymph glands (lymphadenopathy)
• reduced sensation, especially in the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of being unwell
• pain, back pain or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• being completely or partially unable to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of mucous membranes
• stuffy nose
• difficulty breathing
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, cramps, and diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling nervous

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

• pneumonia – signs include shortness of breath and discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering skin rashes and skin peeling
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, jerky movements, especially in the hands that you cannot control
• stroke – signs include pain, weakness, numbness, or tingling in limbs
• having a blind or dark spot in your field of vision
• heart failure or heart attack, which may lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) – signs include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism) – signs include shortness of breath or pain when breathing
• bleeding in the stomach or intestines – signs include vomiting blood or blood in the stools
• blockage in the intestine (intestinal obstruction), especially in the “ileum”. The blockage will prevent intestinal contents from passing to the lower part of the intestine – signs include bloating, vomiting, severe constipation, loss of appetite, and cramps
• “haemolytic uraemic syndrome” when red blood cells break down (haemolysis), a condition that may occur with or without kidney failure
• “pancytopenia”, a low level of all blood cells (red and white blood cells and platelets) detected in blood tests
• widespread purplish discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction – this may cause weakness, tiredness, loss of appetite, skin discolouration
• pituitary gland dysfunction – this may cause low blood levels of certain hormones affecting male or female sexual organ function
• hearing disturbances
• pseudohyperaldosteronism, causing high blood pressure with low potassium levels (detected in blood tests).

Not known: frequency cannot be estimated from the available data

• some patients have also reported feeling confused after taking Posaconazole Fresenius Kabi.

Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posaconazole Fresenius Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after “EXP.”
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Posaconazole Fresenius Kabi contains

• The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are: hypromellose acetate succinate, hypromellose, corn starch, anhydrous colloidal silica, sodium croscarmellose, lactose granulate (spray-dried lactose monohydrate), silicified microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate, partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

Description of the appearance of Posaconazole Fresenius Kabi and package contents
The gastro-resistant tablets of Posaconazole Fresenius Kabi 100 mg are yellow, biconvex, capsule-shaped, approximately 19.9 mm in length, with "P100" engraved on one side of the tablet, and are packaged in blisters within cartons containing 24 or 96 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala – Verona
Responsible manufacturer for batch release:
Interpharma Services Ltd.
43A Cherni Vrach Blvd.,
1407 Sofia
Bulgaria

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: