Posaconazole aurovitas

Package leaflet: Information for the user

Posaconazole Aurovitas, 40 mg/mL, oral suspension
Posaconazole
Please read 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, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience 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 Aurovitas is and what it is used for
2. What you need to know 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 Posaconazole Aurovitas is and what it is used for

Posaconazole Aurovitas contains an active substance called posaconazole, which belongs to a group of medicines known as antifungals. This medicine is used to prevent and treat many types of fungal infections.
It works by killing or stopping 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 medicines are not effective or cannot be continued:

• infections caused by fungi of the genus Aspergillus, when there has been no improvement with amphotericin B or itraconazole treatment, or when treatment with these medicines had to be discontinued;
• infections caused by fungi of the genus Fusarium, when there has been no improvement with amphotericin B treatment, or when treatment with amphotericin B had to be discontinued;
• fungal infections causing diseases such as chromoblastomycosis and mycetoma (maduromycosis), when there has been no improvement with itraconazole treatment, or when treatment with itraconazole had to be discontinued;
• infections caused by fungi of the genus Coccidioides, when there has been no improvement with amphotericin B, itraconazole, or fluconazole treatment, or when treatment with these medicines had to be discontinued;
• untreated oral and throat infections (known as "thrush") caused by fungi called Candida.

This medicine may also be used preventively 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 myelogenous leukaemia" (AML) or "myelodysplastic syndromes" (MDS);
• in patients receiving "high-dose immunosuppressive therapy after haematopoietic stem cell transplant" (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 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 started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of therapy for chronic lymphocytic leukaemia (CLL).

Posaconazole Aurovitas must not be used if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Posaconazole Aurovitas.
Further information on this, including information about other medicines that may interact with Posaconazole Aurovitas, is provided below in section "Posaconazole Aurovitas and other medicines".

Warnings and precautions

Before starting Posaconazole Aurovitas, 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.
• the patient currently has or has previously had liver problems. Blood tests may be necessary during treatment with this medicine.
• the patient is experiencing severe diarrhoea or severe vomiting, which may reduce the effectiveness of this medicine.
• the patient has ECG abnormalities indicating QTc interval prolongation.
• the patient has been diagnosed with weakened heart muscle or heart failure.
• the patient has significant slowing of the heart rate.
• the patient has heart rhythm disorders.
• the patient has abnormal levels of potassium, magnesium or calcium in the blood.
• the patient is taking vincristine, vinblastine or other "vinca alkaloids" (medicines used in cancer treatment).
• the patient is taking venetoclax (a medicine used in cancer treatment).

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

If any of the above situations apply to the patient (or if in doubt), consult a doctor, pharmacist or nurse before taking Posaconazole Aurovitas.
If severe diarrhoea or severe vomiting occurs while taking Posaconazole Aurovitas, contact a doctor, pharmacist or nurse immediately, as the effectiveness of the medicine may be reduced. Further information on this is provided in section 4.

Children

Posaconazole Aurovitas must not be used in children and adolescents (aged 17 years and younger).

Posaconazole Aurovitas and other medicines

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

Do not take Posaconazole Aurovitas 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 problems)
• 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 Aurovitas 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 Aurovitas may increase blood levels of these medicines, potentially leading to severely reduced blood flow to fingers or toes and resulting in 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 Aurovitas if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.

Other medicines

Review the above list of medicines that must not be taken during treatment with Posaconazole Aurovitas. In addition to the medicines listed above, there are other medicines associated with a risk of heart rhythm disturbances. This risk may be increased when these medicines are taken with Posaconazole Aurovitas. Ensure that the treating doctor is informed about all medicines the patient is taking (both prescription and non-prescription).

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

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

Posaconazole Aurovitas 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 sulfonylurea derivatives (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 Aurovitas.

Posaconazole Aurovitas 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 Aurovitas"). There are no data 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 Aurovitas.

Do not use Posaconazole Aurovitas 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 Aurovitas, inform the doctor immediately.

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

Driving and operating machinery

Dizziness, drowsiness or blurred vision may occur while taking Posaconazole Aurovitas, which may adversely affect 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 Aurovitas contains glucose

Posaconazole Aurovitas contains approximately 2.175 g of glucose in 5 mL of oral suspension. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

Posaconazole Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per mL, meaning the medicine is considered "sodium-free".

Posaconazole Aurovitas contains sodium benzoate

This medicine contains 2 mg of sodium benzoate (E 211) in each mL of oral suspension.

Posaconazole Aurovitas contains benzoic acid

This medicine contains less than 0.03 mg of benzoic acid (E 210) in each mL of oral suspension dose.

Posaconazole Aurovitas contains benzyl alcohol

This medicine contains less than 0.3 mg of benzyl alcohol in each mL of oral suspension dose.
Benzyl alcohol may cause allergic reactions.

Posaconazole Aurovitas contains propylene glycol

This medicine contains 9.4 mg of propylene glycol (E 1520) in each mL of oral suspension.

3. How to take Posaconazole Aurovitas

Do not interchange the oral suspension form of Posaconazole Aurovitas with posaconazole tablets or the granules for oral suspension without consulting a doctor or pharmacist, as this may lead to lack of effectiveness or increased risk of adverse effects.
This medicine should always be taken according to the instructions provided by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Your doctor will monitor your response and condition to determine how long treatment with Posaconazole Aurovitas should continue and whether the daily dose needs to be adjusted.
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 independently without consulting your doctor.
If possible, posaconazole should be taken during or immediately after a meal or nutritional supplement.
The oral suspension must be shaken well before use.

Taking an overdose of Posaconazole Aurovitas
If an excessive dose of the medicine is taken, contact a doctor or
other qualified healthcare professional immediately.

Missing a dose of Posaconazole Aurovitas
If a dose of the medicine is missed, take it as soon as possible, then continue treatment according to the prescribed 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 about 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 help may be needed:

• nausea or vomiting (feeling sick or being sick), diarrhoea
• symptoms of liver failure – these include yellowing of the skin or whites of the eyes (jaundice), unusually dark urine or pale stools, nausea without apparent cause, stomach discomfort, loss of appetite, unusual tiredness 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 concentration shown in blood tests – symptoms include feeling disoriented or weak
• abnormal skin sensation, including numbness, tingling, itching, goosebumps, pricking or burning
• headache
• low potassium levels shown in blood tests
• low magnesium levels 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)
• reduced neutrophil count (a type of white blood cell) shown in blood tests (neutropenia), which may increase susceptibility to infections
• fever
• feeling weak, dizziness, fatigue or drowsiness
• rash
• itching
• constipation
• rectal discomfort

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
• reduced platelet count shown in blood tests (thrombocytopenia), which may lead to bleeding
• reduced white blood cell count shown in blood tests (leukopenia), which may increase susceptibility to infections
• increased eosinophil count (a type of white blood cell) shown in blood tests (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 fast heartbeat, high or low blood pressure
• low blood pressure
• pancreatitis, which may cause severe abdominal pain
• splenic infarction (spleen infarction) – this may cause severe abdominal pain
• serious kidney function disorders – symptoms include reduced or increased urine output, or changes in urine colour
• high creatinine levels 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 sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general malaise
• pain, back or neck pain, pain in arms and legs
• fluid retention in the body (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• difficulty falling asleep (insomnia)
• partial or complete loss of speech
• mouth swelling
• unusual dreams or sleep problems
• coordination or balance disturbances
• mucositis (inflammation of mucous membranes)
• stuffy nose
• breathing difficulties
• chest discomfort
• bloating
• mild to severe nausea, vomiting, abdominal cramps and diarrhoea, usually caused by a virus, abdominal pain
• belching
• 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 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 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 movements of limbs, especially 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 blood in the stool
• 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
• haemolytic-uraemic syndrome, in which red blood cells break down (haemolysis). This may be accompanied by kidney failure
• pancytopenia, i.e. reduced counts 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)
• facial or tongue swelling
• 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, resulting in high blood pressure with low blood 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 adverse effects occur, consult your doctor, pharmacist or nurse.

Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse effects helps gather more information on the safety of the medicine.
Adverse effects can also be reported to the responsible entity.

5. How to store Posaconazole Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Shelf-life after first opening of the bottle: 45 days.
If any suspension remains in the bottle after more than 45 days from first opening, this medicine must not be used.
The bottle containing unused suspension should be returned to a pharmacy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Posaconazole Aurovitas contains

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

Composition of simethicone emulsion: dimethicone, polyethylene glycol sorbitan tristearate,
methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid, benzoic acid (E 210) and sulfuric acid.
Composition of cherry flavour: propylene glycol USP E 1520, benzaldehyde, benzyl alcohol,
aldehyde C20, vanillin, allyl caproate, amyl acetate, citrus oil, alpha ionone, benzyl acetate and
phenethyl acetate.

What Posaconazole Aurovitas looks like and contents of the pack
Posaconazole Aurovitas is a white or almost white oral suspension with a cherry flavour, contained in an amber glass bottle with a child-resistant closure, holding 105 mL of suspension. Each bottle is supplied with a dosing spoon for measuring 2.5 mL and 5 mL doses of the oral suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area
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