Posaconazole Viatris

Leaflet accompanying the packaging: information for the user

Posaconazole Viatris, 40 mg/ml, oral suspension

Posaconazole

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please 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 any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Posaconazole Viatris 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 fungi that can cause infections in humans.

Posaconazole Viatris may be used in adults to treat the following fungal infections when other antifungal medicines do not work or cannot be taken for a longer period:

• infections caused by species of the genus Aspergillus, which do not respond to antifungal medicines - amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by species of the genus Fusarium, which do not respond to amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by fungi, known as chromoblastomycosis and mycetoma, which do not respond to treatment with itraconazole or when treatment with itraconazole must be discontinued;
• infections caused by fungi known as Coccidioides, which do not respond to one or more of the following medicines - amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines must be discontinued;
• untreated oral and throat thrush (candidiasis) caused by fungi known as Candida.

This medicine may also be used to prevent fungal infections in adults who are at high risk of developing such infections, e.g.,

• 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 Viatris

When not to take Posaconazole Viatris:

• 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 medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, or statins such as simvastatin, atorvastatin, or lovastatin.
• 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 Viatris if any of the above situations apply to the patient. In case of doubts before taking Posaconazole Viatris, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Posaconazole Viatris, 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 in the past. 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's ECG shows heart rhythm disturbances, which indicate a prolonged QTc interval;
• if the patient has been diagnosed with heart failure or weakened heart muscle;
• if the patient has significant bradycardia (slow heart rate);
• if the patient has heart rhythm disturbances;
• 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 the patient (and in case of doubts), before taking Posaconazole Viatris, consult a doctor, pharmacist, or nurse.

Children

Posaconazole Viatris should not be used in children and adolescents (under 17 years of age and younger).

Posaconazole Viatris and other medicines

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

Do not take Posaconazole Viatris 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 disorders),
• pimozide (used to treat symptoms of Tourette's syndrome and mental illnesses),
• halofantrine (used to treat malaria),
• quinidine (used to treat heart rhythm disturbances).

Posaconazole Viatris may increase the levels of these medicines in the blood and consequently cause serious heart rhythm changes;

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

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

Taking Posaconazole Viatris with food and drink

If possible, to improve the absorption of posaconazole, it should be taken during or immediately after a meal or nutritional supplement (see section 3 "How to take Posaconazole Viatris"). There is no data on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

If the patient is pregnant or thinks she may be pregnant, she should inform her doctor before taking Posaconazole Viatris.

Do not take Posaconazole Viatris during pregnancy, unless advised by a doctor.

Women of childbearing age should use effective contraception while taking this medicine. If pregnancy occurs while taking Posaconazole Viatris, the patient should immediately inform her doctor.

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

Driving and using machines

While taking Posaconazole Viatris, the patient may experience dizziness, drowsiness, or blurred vision, which may affect the ability to drive or operate machinery. In such cases, do not drive or operate machinery and consult a doctor.

Posaconazole Viatris contains glucose

Posaconazole Viatris contains approximately 2.11 g of glucose in 5 ml of suspension. In case of confirmed intolerance to some sugars, consult a doctor before taking this medicine. This medicine may be harmful to teeth.

Posaconazole Viatris contains sodium benzoate (E211)

This medicinal product contains 2 mg of sodium benzoate in each ml, which is equivalent to 10 mg in 5 ml of suspension. Sodium benzoate may exacerbate jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

This medicinal product contains less than 1 mmol of sodium (23 mg) in 5 ml, which means it is essentially "sodium-free".

3. How to take Posaconazole Viatris

Posaconazole Viatris oral suspension should not be taken in place of Posaconazole Viatris tablets or Posaconazole Viatris gastro-resistant tablets without consulting a doctor or pharmacist. This may lead to lack of efficacy or increased risk of side effects.

Always take this medicine exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The doctor will monitor the patient's reaction and condition to determine how long to take Posaconazole Viatris and whether the daily dose should be changed.

The table below shows the recommended doses and duration of treatment, which depend on the type of infection and may be adjusted individually by the doctor. Do not adjust the dose or change the prescribed dose without consulting a doctor.

If possible, posaconazole should be taken during or immediately after a meal or nutritional supplement.

Taking a higher dose of Posaconazole Viatris than recommended

In case of taking too much of the medicine, immediately contact a doctor or other healthcare professional.

Missing a dose of Posaconazole Viatris

If a dose is missed, take it as soon as possible, and then continue treatment as scheduled. However, if it is almost time for the next dose, take the dose as scheduled. Do not take a double dose to make up for the missed dose.

In case of further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

Tell a doctor, pharmacist, or nurse immediately if any of the following severe side effects occur, as immediate medical attention may be necessary:

• nausea or vomiting, diarrhea
• symptoms of liver failure - including yellowing of the skin or whites of the eyes, unusually 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

Tell a doctor, pharmacist, or nurse if any of the following side effects occur:

Common: may occur in up to 1 in 10 people

• changes in electrolyte levels in the blood, as shown in blood tests - including feelings of disorientation or weakness
• abnormal skin sensations, including numbness, tingling, itching, gooseflesh, prickling, or burning
• headache
• low potassium levels in the blood, as shown in blood tests
• low magnesium levels in the blood, as 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)
• low neutrophil count, as shown in blood tests (neutropenia), which may increase the risk of infections
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• discomfort in the rectum

Uncommon: may occur in up to 1 in 100 people

• anemia - including symptoms such as headaches, feeling tired or dizzy, shortness of breath or pale skin, and low hemoglobin levels in blood tests
• low platelet count, as shown in blood tests (thrombocytopenia), which may lead to bleeding
• low white blood cell count, as shown in blood tests (leukopenia), which may increase the risk of infections
• increased eosinophil count, as shown in blood tests (eosinophilia), which may be associated with inflammation
• vasculitis (inflammation of blood vessels)
• heart rhythm disturbances
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm, as shown in ECG, palpitations, slow or fast heart rate, high or low blood pressure
• low blood pressure
• pancreatitis, which may cause severe stomach pain
• splenic infarction (death of spleen tissue), which may cause severe stomach pain
• severe kidney problems - including decreased or increased urine output, or changes in urine color
• high creatinine levels in the blood, as shown in blood tests
• cough, hiccups
• nosebleeds
• sharp chest pain when breathing in (pleuritic pain)
• lymphadenopathy (enlarged lymph nodes)
• decreased 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 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
• unusual dreams or sleep problems
• 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 occur in up to 1 in 1000 people

• pneumonia - including symptoms such as 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 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 hands
• stroke - including symptoms such as pain, weakness, numbness, or tingling of the limbs
• 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) - including symptoms such as severe leg pain or swelling
• presence of blood clots in the lungs (pulmonary embolism) - including symptoms such as shortness of breath or chest pain when breathing
• bleeding from the stomach or intestines - including symptoms such as vomiting blood or black stools
• intestinal obstruction, especially of the small intestine. Obstruction prevents the movement of intestinal contents to the lower part of the digestive tract (large intestine). Symptoms may 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, or a decrease in the number of all blood cells (white blood cells, red blood cells, and platelets), as 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 decreased levels of certain hormones 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).

Frequency not known: cannot be estimated from the available data

• some patients have also reported feeling disoriented after taking Posaconazole Viatris.
• skin redness If any of the above side effects occur, consult a doctor, pharmacist, or nurse.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

Side effects can also be reported to the marketing authorization holder.

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

5. How to store Posaconazole Viatris

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month stated.

If after four weeks after opening the bottle some suspension remains, do not use it. Return the bottle containing unused suspension to a pharmacy.

There are no special precautions for storing the medicine. Do not store in a refrigerator or freeze.

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

6. Contents of the packaging and other information

What Posaconazole Viatris contains

• The active substance of the medicine is posaconazole. One ml of oral suspension contains 40 mg of posaconazole.
• The other ingredients are: citric acid monohydrate, anhydrous sodium citrate, sodium benzoate (E 211) (see section 2 "Posaconazole Viatris contains sodium benzoate"), sodium lauryl sulfate, simethicone emulsion 30% (containing: simethicone, methylcellulose, sorbic acid, purified water), xanthan gum, glycerol, liquid glucose, titanium dioxide (E 171), cherry flavor, purified water

The medicine is a white to yellowish oral suspension with a cherry flavor in a brown glass bottle containing 105 ml of suspension, closed with a polyethylene cap with a child-resistant closure. A plastic measuring spoon is attached to each bottle, allowing the measurement of 2.5 ml and 5 ml of oral suspension. The whole thing is in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

DUBLIN

Ireland

Manufacturer

Genepharm S.A.

18th km Marathonos Avenue

15351 Pallini Attiki

Greece

Rafarm SA

Thesi Pousi-Xatzi Agiou Louka

Paiana Attiki

TK 19002, TΘ 37

Greece

To obtain more detailed information, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet:December 2024