Posaconazole viatris

Package leaflet: Information for the user

Posaconazole Viatris, 40 mg/ml, oral suspension
Posaconazolum
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 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 someone else, even if their symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

1. What Posaconazole Viatris is and what it is 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 stopping the growth of fungi that can cause infections
in humans.
Posaconazole Viatris can be used in adults to treat the following fungal infections when other antifungal medicines do not work or cannot be used any longer:

• infections caused by Aspergillus species that do not respond to antifungal medicines – amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by Fusarium species that 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 eumycetoma that do not respond to itraconazole treatment or when itraconazole treatment must be discontinued;
• infections caused by fungi called Coccidioides that 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 infections (known as candidiasis), caused by fungi called Candida.

This medicine may also be used prophylactically 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 leukaemia or myelodysplastic syndrome;
• in patients receiving high-dose immunosuppressive therapy after haematopoietic 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, any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, or statins such as simvastatin, atorvastatin or lovastatin;
• if the patient has just started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of treatment for chronic lymphocytic leukaemia (CLL).

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

Warnings and precautions

Before starting Posaconazole Viatris, discuss this 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 previously had liver problems. Blood tests may be necessary during treatment with this medicine;
• if the patient has severe diarrhoea or severe vomiting, which may reduce the effectiveness of this medicine;
• if the patient’s ECG shows heart rhythm disturbances indicating QTc 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 Viatris.
If severe diarrhoea or severe vomiting occurs while taking Posaconazole Viatris, contact a doctor, pharmacist, or nurse immediately, as this may reduce the effectiveness of the medicine. Further information on this topic is provided in section 4.

Children

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

Posaconazole Viatris and other medicines

Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.

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 gastrointestinal complaints),
• 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 Viatris may increase blood levels of these medicines and consequently cause serious heart rhythm disturbances;

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

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

During treatment, avoid exposure to sunlight. It is important to cover sun-exposed skin areas with protective clothing and use a high sun protection factor (SPF) sunscreen, as increased sensitivity of the skin to UV (ultraviolet) radiation may occur.

Other medicines

Review the above list of medicines that must not be taken during treatment with Posaconazole Viatris. In addition to the medicines listed above, other medicines may carry a risk of heart rhythm disturbances, and this risk may be increased when taken with Posaconazole Viatris. Ensure that your treating doctor is informed about all medicines the patient is taking (both prescription and over-the-counter).

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

The following medicines may reduce the blood levels of Posaconazole Viatris and thereby decrease 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;
• flucloxacillin (an antibiotic used to prevent bacterial infections);
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures);
• efavirenz and fosamprenavir (used to treat HIV infection);
• medicines used to reduce stomach acid secretion, such as cimetidine and ranitidine, or omeprazole and similar medicines known as proton pump inhibitors.

Posaconazole Viatris 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 protease inhibitors (including lopinavir and atazanavir taken 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 blood cancers).

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

Taking Posaconazole Viatris with food and drink

To improve absorption of posaconazole, take it during or immediately after a meal or nutritional supplement (see section 3 “How to take Posaconazole Viatris”). There are no data available on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

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

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

Women of childbearing potential should use effective contraception during treatment with this medicine. If pregnancy occurs while taking Posaconazole Viatris, inform the doctor immediately.

Do not breastfeed during treatment with Posaconazole Viatris, as small amounts of the medicine may pass into human milk.

Driving and operating machinery

While taking Posaconazole Viatris, symptoms such as dizziness, drowsiness, or blurred vision may occur, which could impair the ability to drive, use tools, or operate machinery. In such cases, do not drive, use tools, 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. If the patient has been diagnosed by a doctor with intolerance to certain sugars, consult a doctor before using this medicine. This medicine may be harmful to teeth.

Posaconazole Viatris contains sodium benzoate (E211)

This medicinal product contains 2 mg of sodium benzoate per ml, equivalent to 10 mg in 5 ml of suspension. Sodium benzoate may worsen 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, meaning it is essentially “sodium-free”.

3. How to take Posaconazole Viatris

Do not interchange Posaconazole Viatris oral suspension with Posaconazole Viatris tablets or with the delayed-release oral suspension without consulting your doctor or pharmacist. This may lead to lack of effectiveness or an increased risk of adverse effects.

Always take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your treating physician will monitor your response and condition to determine how long Posaconazole Viatris should be taken and whether the daily dose needs adjustment.

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

Posaconazole should be taken during or immediately after a meal or nutritional supplement, if possible.

Taking more than the recommended dose of Posaconazole Viatris
If an excessive dose of the medicine is taken, contact your doctor or other healthcare professional immediately.

Missing a dose of Posaconazole Viatris
If you miss a dose, take it as soon as possible and then continue treatment according to your schedule. 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 a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects
Immediately inform your doctor, pharmacist, or nurse if any of the following serious adverse effects occur,
as immediate medical attention may be required:

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

Other adverse effects
Inform your doctor, pharmacist, or nurse if any of the following adverse effects occur:
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 sensation, including numbness, tingling, itching, goosebumps, pricking, or burning
• headache
• low potassium level shown in blood tests
• low magnesium level shown in blood tests
• 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)
• decreased neutrophil count shown in blood tests (neutropenia), a type of white blood cell, which may increase susceptibility to infections
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• discomfort in the rectum

Uncommon: may affect up to 1 in 100 people

• anaemia – symptoms include headache, 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 shown in blood tests (leukopenia), which may increase susceptibility to infections
• increased number of eosinophils, a type of white blood cell (eosinophilia), which may be associated with inflammatory conditions
• vasculitis (inflammation of blood vessels)
• heart rhythm disorders
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm shown on ECG, palpitations, slow or rapid heartbeat, high or low blood pressure
• low blood pressure
• pancreatitis, which may cause severe abdominal pain
• splenic infarction (splenic ischaemia) – this may cause severe abdominal pain
• serious kidney function disorders – symptoms include reduced or increased urine output, or change in urine colour
• high creatinine level 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
• increased or decreased blood glucose levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulceration
• chills, general malaise
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• difficulty sleeping (insomnia)
• partial or complete loss of speech ability
• swelling of the mouth
• unusual dreams or sleep problems
• coordination or balance disorders
• mucositis (inflammation of mucous membranes)
• nasal congestion
• 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 1,000 people

• pneumonia – symptoms may include shortness of breath and coughing up discoloured sputum, high blood pressure in the pulmonary blood vessels (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 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 in the hands
• stroke – symptoms may include pain, weakness, numbness, or tingling in limbs
• appearance of a blind spot or dark spot (scotoma) 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, particularly 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
• 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 blood cells, 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, skin pigmentation changes
• pituitary gland dysfunction, which may cause reduced levels of certain hormones in the blood affecting male or female reproductive 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 available data

• some patients have also reported feeling disoriented after taking Posaconazole Viatris.
• skin redness

If any of the above-mentioned adverse effects occur, consult your doctor, pharmacist, or nurse.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects 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 181C
02-222 Warsaw,
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Posaconazole Viatris

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label following: EXP. The expiry date refers to the last day of the stated month.
If any suspension remains four weeks after the first opening of the bottle, do not use it. Return the bottle containing unused suspension to a pharmacy.
No special storage instructions apply. Do not store in a refrigerator and do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Posaconazole Viatris contains

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

What Posaconazole Viatris looks like and contents of the pack

Posaconazole Viatris is a white to yellowish cherry-flavoured oral suspension, supplied in a 105 ml amber glass bottle closed with a polyethylene child-resistant cap. Each bottle is supplied with a plastic oral dosing spoon marked for measuring 2.5 ml and 5 ml volumes of the oral suspension. The pack also contains a cardboard outer container.

Marketing Authorisation 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

For further information, please contact the local representative of the Marketing Authorisation Holder:

Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00