Posaconazole Aurovitas

Package Leaflet: Information for the User

Posaconazole Aurovitas, 40 mg/mL, Oral Suspension

Posaconazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

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

Posaconazole Aurovitas contains the active substance posaconazole, which belongs to a group of antifungal medications. This medication is used to prevent and treat various types of fungal infections.

This medication works by killing or inhibiting the growth of certain types of fungi that can cause infections in humans.

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

• infections caused by Aspergillus species, if there is no improvement after treatment with amphotericin B or itraconazole, or if these medications need to be discontinued;
• infections caused by Fusarium species, if there is no improvement after treatment with amphotericin B or if amphotericin B needs to be discontinued;
• infections caused by fungi that cause chromoblastomycosis and mycetoma, if there is no improvement after treatment with itraconazole or if itraconazole needs to be discontinued;
• infections caused by Coccidioides species, if there is no improvement after treatment with amphotericin B, itraconazole, or fluconazole, or if these medications need to be discontinued;
• untreated oral and throat infections (known as "thrush") caused by Candida fungi.

This medication may also be used to prevent fungal infections in adults who are at high risk of developing such infections, such as:

• patients with weakened immune systems due to chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS);
• patients undergoing high-dose immunosuppressive therapy after hematopoietic stem cell transplantation (HSCT).

2. Important information before taking Posaconazole Aurovitas

When not to take Posaconazole Aurovitas

• if the patient is allergic to posaconazole or any of the other ingredients of this medication (listed in section 6);
• if the patient is taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or any medications 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 is gradually increasing the dose of venetoclax for chronic lymphocytic leukemia (CLL).

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

Warnings and precautions

Before starting to take Posaconazole Aurovitas, discuss the following with a doctor, pharmacist, or nurse:

• if the patient has had an allergic reaction to another antifungal medication, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• if the patient currently has or has had liver disease in the past. Blood tests may be necessary during treatment with this medication.
• if the patient has severe diarrhea or vomiting, which may reduce the effectiveness of the medication.
• if the patient has a heart rhythm disorder, as indicated by an abnormal electrocardiogram (ECG).
• if the patient has been diagnosed with heart failure or weakened heart muscle.
• if the patient has a slow 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 (medications used to treat cancer).
• if the patient is taking venetoclax (a medication used to treat cancer).

If any of the above situations apply to the patient (or in case of doubts), consult a doctor, pharmacist, or nurse before taking Posaconazole Aurovitas.

Children

Posaconazole Aurovitas should not be used in children and adolescents (under 18 years of age).

Posaconazole Aurovitas and other medications

Tell a doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.

Do not take Posaconazole Aurovitas if the patient is taking any of the following medications:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach disorders)
• pimozide (used to treat Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders)

Posaconazole Aurovitas may increase the levels of these medications in the blood, leading to serious heart rhythm changes:

• any medications containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Aurovitas may increase the levels of these medications in the blood, leading to reduced blood flow to the fingers or toes and potentially causing damage.
• statins, such as simvastatin, atorvastatin, or lovastatin, used to lower high cholesterol levels.
• venetoclax, used to treat a type of cancer called chronic lymphocytic leukemia (CLL).

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

Posaconazole Aurovitas with food and drink

Whenever possible, take posaconazole with a meal or shortly after a meal or nutritional supplement to improve absorption (see section 3 "How to take Posaconazole Aurovitas"). There is no data on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

If the patient is pregnant or thinks they may be pregnant, they should inform their doctor before starting to take Posaconazole Aurovitas.

Do not take Posaconazole Aurovitas during pregnancy, unless a doctor recommends it.

Women of childbearing age should use effective contraception while taking this medication. If the patient becomes pregnant while taking Posaconazole Aurovitas, they should immediately inform their doctor.

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

Driving and using machines

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

Posaconazole Aurovitas contains glucose

Posaconazole Aurovitas contains approximately 2.175 g of glucose in 5 mL of suspension. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medication.

Posaconazole Aurovitas contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per mL, which means it is considered "sodium-free".

Posaconazole Aurovitas contains sodium benzoate

This medication contains 2 mg of sodium benzoate (E 211) per mL of oral suspension.

Posaconazole Aurovitas contains benzoic acid

This medication contains less than 0.03 mg of benzoic acid (E 210) per mL of oral suspension.

Posaconazole Aurovitas contains benzyl alcohol

This medication contains less than 0.3 mg of benzyl alcohol per mL of oral suspension. Benzyl alcohol may cause allergic reactions.

Posaconazole Aurovitas contains propylene glycol

This medication contains 9.4 mg of propylene glycol (E 1520) per mL of oral suspension.

3. How to take Posaconazole Aurovitas

Do not take Posaconazole Aurovitas oral suspension interchangeably with posaconazole tablets or powder for oral suspension without consulting a doctor or pharmacist, as this may lead to lack of efficacy or increased risk of side effects.

Always take this medication exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The doctor will monitor the patient's response and condition to determine how long to take Posaconazole Aurovitas and whether the daily dose needs to be adjusted.

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

Whenever possible, take posaconazole with a meal or shortly after a meal or nutritional supplement to improve absorption (see section 3 "How to take Posaconazole Aurovitas").

Shake the oral suspension well before use.

Overdose of Posaconazole Aurovitas

In case of overdose, immediately consult a doctor or other healthcare professional.

Missed dose of Posaconazole Aurovitas

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 next dose as scheduled. Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medications, Posaconazole Aurovitas can cause side effects, although not everyone will experience them.

Severe side effects

Immediately inform a doctor, pharmacist, or nurse 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, dark urine, pale stools, unexplained nausea, stomach discomfort, loss of appetite, unusual fatigue or weakness, elevated liver enzymes in blood tests
• allergic reaction

Other side effects

Inform 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 blood electrolyte levels, which may cause feelings of disorientation or weakness
• abnormal sensations 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 discomfort, gas, dry mouth, taste disturbances
• heartburn (a burning sensation in the chest and throat)
• reduced neutrophil count (a type of white blood cell) in blood tests, 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 - symptoms include headaches, feeling tired or dizzy, shortness of breath, pale skin, and low hemoglobin levels in blood tests
• reduced platelet count (thrombocytopenia) in blood tests, which may lead to bleeding
• reduced white blood cell count (leukopenia) in blood tests, which may increase the risk of infections
• increased eosinophil count (a type of white blood cell) in blood tests, which may be associated with inflammation
• vasculitis (inflammation of blood vessels)
• heart rhythm disorders
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm 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 (a condition where the spleen does not receive enough blood), which may cause severe stomach pain
• severe kidney problems, including reduced or increased urine output, or changes in urine color
• high creatinine levels in blood tests
• cough, hiccups
• nosebleeds
• sharp chest pain that occurs when breathing in (pleuritic pain)
• enlarged lymph nodes (lymphadenopathy)
• reduced sensation, 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 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 1,000 people

• pneumonia - symptoms include 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 skin peeling
• 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 in the limbs
• 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 disorders that can cause sudden death
• blood clots in the deep veins of the legs (deep vein thrombosis) - symptoms include severe pain or swelling in the legs
• 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
• intestinal obstruction, especially of the small intestine. Obstruction 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, a condition where red blood cells are broken down (hemolysis). It may be accompanied by kidney failure
• pancytopenia, a reduction in the number of all blood cells (white blood cells, red blood cells, and platelets) in blood tests
• large purple spots under the skin (thrombotic thrombocytopenic purpura)
• face 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 affect hormone levels in the blood that influence the function of male or female reproductive organs
• hearing problems
• pseudoaldosteronism, which leads to high blood pressure with low potassium levels (visible in blood tests)

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

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

If any of the above side effects occur, consult a doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a 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, website: www.smz.ezdrowie.gov.pl

Reporting side effects helps to gather more information on the safety of the medication.

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

5. How to store Posaconazole Aurovitas

Keep the medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label and carton: EXP.

The expiration date refers to the last day of the month stated.

There are no special storage instructions for this medication.

Shelf life after first opening the bottle: 45 days.

If any suspension remains in the bottle after more than 45 days after first opening, do not use this medication. Return the bottle containing any unused suspension to a pharmacy.

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

6. Contents of the pack and other information

What Posaconazole Aurovitas contains

• The active substance is posaconazole. Each mL of oral suspension contains 40 mg of posaconazole.
• The other ingredients are: polysorbate 80, simethicone emulsion, sodium citrate (E 331), citric acid monohydrate (E 330), xanthan gum, sodium benzoate (E 211), glucose liquid, glycerol (85%), cherry flavor, titanium dioxide (E 171), and purified water.

Simethicone emulsion contains: polydimethylsiloxane, sorbitan glycerol polyethylene glycol trioleate, methylcellulose, silicon dioxide, polyethylene glycol stearate, sorbic acid, benzoic acid (E 210), and sulfuric acid.

Cherry flavor contains: propylene glycol USP E 1520, benzaldehyde, benzyl alcohol, aldehyde C20, vanillin, allyl caproate, amyl acetate, citrus oil, alpha-ionone, benzyl acetate, and phenylethyl acetate.

What Posaconazole Aurovitas looks like and contents of the pack

Posaconazole Aurovitas is a white or almost white oral suspension with a cherry flavor, in a brown glass bottle containing 105 mL of suspension, with a child-resistant closure. A measuring spoon is provided with each bottle to measure 2.5 and 5 mL doses of the oral suspension.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warsaw

e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus 19, Venda Nova

2700-487 Amadora

Portugal

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the European Economic Area member states under the following names:

France:

Posaconazole Arrow 40 mg/mL, suspension buvable

Germany:

Posaconazol PUREN 40 mg/ml Suspension zum Einnehmen

Poland:

Posaconazole Aurovitas

Portugal:

Posaconazol Generis

Date of last revision of the leaflet: 10/2024