Posaconazole aurovitas

Package leaflet: Information for the patient

Posaconazole Aurovitas, 100 mg, enteric-coated tablets
Posaconazolum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

Posaconazole Aurovitas contains the active substance called posaconazole. It belongs to a group of medicines known as "antifungal agents". It is used to prevent and treat many types of infections caused by fungi.
This medicine works by killing or inhibiting the growth of certain types of fungi that may cause infections.
Posaconazole Aurovitas may be used in adults for the treatment of fungal infections caused by fungi of the genus Aspergillus.
Posaconazole Aurovitas may be used in adults and children aged 2 years and older with body weight above 40 kg for the treatment of the following types of fungal infections:

• infections caused by species of fungi of the genus Aspergillus, when there has been no improvement with antifungal treatment with amphotericin B or itraconazole, or when it has been necessary to discontinue these medicines;
• infections caused by fungi belonging to the genus Fusarium, when there has been no improvement with amphotericin B or when it has been necessary to discontinue amphotericin B;
• fungal infections causing diseases such as "chromoblastomycosis" and "phaeohyphomycosis", when there has been no improvement with itraconazole or when it has been necessary to discontinue itraconazole;
• infections caused by fungi belonging to the genus Coccidioides, when there has been no improvement with one or more of the following medicines: amphotericin B, itraconazole, or fluconazole, or when it has been necessary to discontinue these medicines.

This medicine may also be used prophylactically to prevent fungal infections in adults and children aged 2 years and older with body weight above 40 kg who are at high risk of fungal infection, for example:

• in patients whose immune system is weakened due to chemotherapy used 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).

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

Warnings and precautions

Before starting to take Posaconazole Aurovitas, 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 previously had liver problems. Blood tests may be necessary during treatment with this medicine.
• if the patient currently has severe diarrhoea or severe vomiting, as these may reduce the effectiveness of this medicine.
• if the patient has ECG abnormalities indicating QTc interval prolongation.
• if the patient has been diagnosed with weakened heart muscle or heart failure.
• if the patient has been diagnosed with 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 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, because increased sensitivity of the skin to ultraviolet (UV) sunlight 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, consult a doctor, pharmacist or nurse immediately due to the risk of inadequate medicine effectiveness. Further information on this is provided in section 4.

Children

Posaconazole Aurovitas must not be given to children under 2 years of age.

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 the 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 the levels of these medicines in the blood, which may lead to significant reduction in blood flow to fingers or toes and consequently to 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 take Posaconazole Aurovitas if any of the above situations apply to the patient. If in doubt before taking this medicine, consult a doctor or pharmacist.

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 higher when these medicines are taken together with Posaconazole Aurovitas. 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 Aurovitas by increasing the concentration of Posaconazole Aurovitas in the blood.

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

• 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).

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 medicines called protease inhibitors (including lopinavir and atazanavir taken together 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 taking Posaconazole Aurovitas.

Pregnancy and breastfeeding

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

Do not take Posaconazole Aurovitas during pregnancy unless specifically advised by a doctor.

Women of childbearing age 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 using machines

While taking Posaconazole Aurovitas, dizziness, drowsiness or blurred vision may occur, which could affect the ability to drive, use tools or operate machinery. In such cases, do not drive, use any tools or operate any machinery, and inform the doctor immediately.

Posaconazole Aurovitas contains sodium

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

3. How to take Posaconazole Aurovitas

This medicine should always be taken exactly as instructed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Posaconazole in tablet form must not be used interchangeably with posaconazole oral suspension without consulting your doctor or pharmacist, as this may lead to lack of efficacy or increased risk of adverse effects.

What dose should be taken
The usual dose is 300 mg (three 100 mg tablets) twice on the first day, followed by 300 mg (three 100 mg tablets) once daily.
The duration of treatment may depend on the type of infection present and may be individually adjusted by the doctor. Do not adjust the dose or treatment regimen independently without consulting your doctor.

How to take the medicine

• Swallow the tablet whole with water.
• Do not crush, chew, divide, or dissolve the tablets.
• Tablets may be taken with food or independently of meals.

If you take more Posaconazole Aurovitas than you should
If you suspect that you have taken an excessive dose of Posaconazole Aurovitas, contact your doctor immediately or go to hospital.

If you forget to take Posaconazole Aurovitas

• If you miss a dose, take it as soon as possible.
• However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
• 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Contact your doctor, pharmacist or nurse immediately if you experience any of the following
serious adverse reactions, as immediate medical help may be required:

• 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), abnormally 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 reactions
Contact your doctor, pharmacist or nurse if you experience any of the following adverse reactions:
Common: may affect up to 1 in 10 people

• change in blood electrolyte levels shown in blood tests – symptoms include confusion or weakness
• abnormal skin sensation, including numbness, tingling, itching, goosebumps, pricking or burning sensations
• 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
• 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
• reduced platelet count shown in blood tests (thrombocytopenia), which may lead to bleeding
• reduced white blood cell count (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 change 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)
• oral 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
• swelling of the mouth
• unusual dreams or sleep problems
• coordination or balance disorders
• mucosal inflammation
• 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 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 limb movements, especially in the arms
• stroke – symptoms may include pain, weakness, numbness or tingling in the limbs
• appearance of a defect 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 into 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 number of all blood cells (white and red blood cells and platelets) shown in blood tests
• large purple skin bruises (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, changes in skin pigmentation
• pituitary gland dysfunction, which may cause reduced levels of certain hormones in the blood affecting the function of male or female reproductive organs
• hearing problems
• pseudoaldosteronism, resulting in high blood pressure with low potassium levels (shown in blood tests)

Frequency unknown: frequency cannot be estimated from available data

• some patients have also reported confusion after taking posaconazole
• skin redness

If any of the above adverse reactions occur, consult your doctor, pharmacist or nurse.
Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

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 blister pack or the cardboard
box after: EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
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 pack and other information

What Posaconazole Aurovitas contains

• The active substance is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.
• The other ingredients are:
  Tablet core: hypromellose acetate succinate, microcrystalline cellulose (Type-102), low-viscosity hydroxypropylcellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), black iron oxide (E 172).

What Posaconazole Aurovitas looks like and contents of the pack
Gastro-resistant tablets.
Yellow, matte, elongated coated tablets, embossed with "P" on one side and "100" on the other.
Posaconazole Aurovitas tablets are available in blister packs containing 24, 48 or 96 tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
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 Generiques
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:
Belgium: Posaconazol AB 100 mg maagsapresistente tabletten/comprimés gastro-résistants/magensaftresistente Tabletten
France: Posaconazole Arrow 100 mg, comprimé gastro-résistant
Germany: Posaconazol PUREN 100 mg magensaftresistente Tabletten
Italy: Posaconazolo Aurobindo
Malta: Posaconazole Aurobindo 100 mg gastro-resistant tablets
Netherlands: Posaconazol Aurobindo 100 mg, maagsapresistente tabletten
Poland: Posaconazole Aurovitas
Portugal: Posaconazol Generis
Spain: FMPosaconazol Aurovitas 100 mg comprimidos gastrorresistentes EFG