POSACONAZOLE 40 mg /Ml Suspension

Contents of the leaflet

1. What is Posaconazole Sandoz and what is it used for
2. Important information before taking Posaconazole Sandoz
   1. When not to take Posaconazole Sandoz
   2. Warnings and precautions
   3. Children and adolescents
   4. Posaconazole Sandoz and other medicines
   5. If the patient is taking any of the following medicines, they should not take Posaconazole Sandoz:
   7. Posaconazole Sandoz with food and drink
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Posaconazole Sandoz contains glucose, sodium benzoate (E 211), benzoic acid, propylene glycol, and sodium
3. How to take Posaconazole Sandoz
   1. Taking more than the recommended dose of Posaconazole Sandoz
   2. Missing a dose of Posaconazole Sandoz
4. Possible side effects
   1. Severe side effects
   2. If the patient experiences any of the following severe side effects, they should immediately consult a doctor, pharmacist, or nurse, as urgent medical attention may be necessary:
   3. Other side effects
   4. Reporting side effects
5. How to store Posaconazole Sandoz
6. Package contents and other information
   1. What Posaconazole Sandoz contains
   2. What Posaconazole Sandoz looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. To obtain more detailed information on the medicine and its names in other European Economic Area member states, please contact:

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

Posaconazole Sandoz contains the active substance posaconazole. Posaconazole belongs to a group of antifungal medicines. It is used to prevent and treat various fungal infections.

The action of this medicine is to kill or inhibit the growth of certain types of fungi that can cause infections.

Posaconazole Sandoz can be used in adults to treat the following fungal infections when other antifungal medicines are ineffective or cannot be taken for a longer period:

• infections caused by fungi of the genus Aspergillus, whose treatment with antifungal medicines amphotericin B or itraconazole was ineffective or had to be discontinued;
• infections caused by fungi of the genus Fusarium, whose treatment with amphotericin B was ineffective or had to be discontinued;
• fungal infections called "chromoblastomycosis" and "mycetoma", whose treatment with itraconazole was ineffective or had to be discontinued;
• infections caused by fungi of the genus Coccidioides, whose treatment with one or more of the following medicines: amphotericin B, itraconazole, or fluconazole, was ineffective or had to be discontinued;
• untreated oral or throat infections (so-called "thrush") caused by yeast (Candida).

This medicine may also be used to prevent fungal infections in adults with a high risk of developing fungal infections:

• patients with impaired immune system function due to chemotherapy for acute myeloid leukemia or myelodysplastic syndrome;
• patients undergoing high-dose immunosuppression after hematopoietic stem cell transplantation.

2. Important information before taking Posaconazole Sandoz

When not to take Posaconazole Sandoz

• 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 medicine containing ergot alkaloids (such as ergotamine or dihydroergotamine) or a statin (such as simvastatin, atorvastatin, or lovastatin).
• if the patient has just started taking venetoclax or their venetoclax dose is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL)

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

Warnings and precautions

Before taking Posaconazole Sandoz, discuss it 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 has or has had liver disease; the doctor may recommend blood tests during treatment;
• the patient has severe diarrhea or vomiting, as they may reduce the effectiveness of the medicine;
• the patient has an abnormal electrocardiogram (ECG) showing a condition called "prolonged QTc interval";
• the patient has weakened heart muscle or heart failure;
• the patient's heart rate is significantly slowed;
• the patient has heart rhythm disorders;
• the patient has abnormal levels of potassium, magnesium, or calcium in the blood;
• the patient is taking medicines containing vincristine, vinblastine, and other vinca alkaloids (medicines used to treat cancer).
• if the patient is taking venetoclax (a medicine used to treat cancer).

Avoid sun exposure during treatment. It is essential to cover exposed skin areas with protective clothing and use a sunscreen with a high sun protection factor (SPF) because the skin may be more sensitive to sunlight.

Children and adolescents

Posaconazole Sandoz should not be used in children and adolescents under 18 years of age.

Posaconazole Sandoz and other medicines

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

If the patient is taking any of the following medicines, they should not take Posaconazole Sandoz:

• terfenadine (a medicine used to treat allergies)
• astemizole (a medicine used to treat allergies)
• cisapride (a medicine used to treat stomach disorders)
• pimozide (a medicine used to treat symptoms of Tourette's syndrome and mental disorders)
• halofantrine (a medicine used to treat malaria)
• quinidine (a medicine used to treat irregular heart rhythm).

Posaconazole Sandoz may increase the levels of the following medicines in the blood, which can lead to serious heart rhythm disorders:

• medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines). Posaconazole Sandoz may increase the levels of these medicines in the blood, which can lead to significant reduction of blood flow to the fingers and toes and their damage.
• statins, such as simvastatin, atorvastatin, or lovastatin (medicines used to lower high cholesterol levels in the blood).
• venetoclax used at the start of treatment for a certain type of cancer, chronic lymphocytic leukemia (CLL) If the patient is taking any of the above medicines, they should not take Posaconazole Sandoz. In case of doubt before taking this medicine, consult a doctor or pharmacist.

Other medicines

The above list includes medicines that should not be taken with Posaconazole Sandoz. In addition to these, there are other medicines that may increase the risk of heart rhythm disorders when taken with Posaconazole Sandoz. It is essential to tell the doctor about all medicines currently being taken (prescription or over-the-counter).

Some medicines may increase the risk of side effects of Posaconazole Sandoz due to increased levels of the medicine in the blood.

The following medicines may reduce the effectiveness of Posaconazole Sandoz by reducing its levels in the blood:

• rifabutin and rifampicin (medicines used to treat certain infections). If the patient is being treated with rifabutin, blood tests and monitoring for side effects of rifabutin are necessary.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat epilepsy or prevent seizures).
• efavirenz and fosamprenavir (medicines used to treat HIV infection).
• medicines used to reduce stomach acid production, such as cimetidine and ranitidine or omeprazole and similar medicines, known as proton pump inhibitors.
• flucloxacillin (an antibiotic used to prevent bacterial infections)

Posaconazole Sandoz may increase the risk of side effects of other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine, and other vinca alkaloids (anticancer medicines)
• venetoclax (used to treat cancer)
• cyclosporine (a medicine used during or after transplantation)
• tacrolimus and sirolimus (medicines used during or after transplantation)
• rifabutin (a medicine used to treat certain infections)
• medicines used to treat HIV infection, known as protease inhibitors (including lopinavir and atazanavir given with ritonavir)
• midazolam, triazolam, alprazolam, or other benzodiazepines (sedatives or muscle relaxants)
• diltiazem, verapamil, nifedipine, nizoldipine, or other calcium channel blockers (medicines used to treat high blood pressure)
• digoxin (a medicine used to treat heart failure)
• glipizide or other sulfonylurea derivatives (medicines used to treat high blood sugar levels)
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers)

If the patient is taking (or is unsure if they are taking) any of the above medicines, they should consult their doctor or pharmacist before taking Posaconazole Sandoz.

Posaconazole Sandoz with food and drink

To improve the absorption of posaconazole, the medicine should be taken, if possible, during or immediately after a meal or nutritional supplement (see section 3 "How to take Posaconazole Sandoz"). There is no information on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Women should inform their doctor if they are pregnant or think they may be pregnant before taking Posaconazole Sandoz.

Posaconazole Sandoz should not be used during pregnancy unless the doctor decides otherwise.

During treatment with this medicine, women of childbearing age must use effective contraception.

If a patient becomes pregnant while taking Posaconazole Sandoz, they should consult their doctor immediately.

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

Driving and using machines

While taking Posaconazole Sandoz, the patient may experience dizziness, drowsiness, or vision disturbances, which may affect their ability to drive or operate tools or machines. If these disturbances occur, the patient should not perform these activities and should consult their doctor.

Posaconazole Sandoz contains glucose, sodium benzoate (E 211), benzoic acid, propylene glycol, and sodium

The medicine contains approximately 608.3 mg of glucose in 5 ml of oral suspension. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may be harmful to teeth.

This medicine contains less than 1 mmol (23 mg) of sodium per dose (5 ml), which means the medicine is considered "sodium-free".

The medicine contains 10 mg of sodium benzoate and 0.033 mg of benzoic acid per dose (5 ml), equivalent to 2 mg/ml of sodium benzoate and 0.0066 mg/ml of benzoic acid.

Benzoic acid/sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

The medicine contains 22.5 mg of propylene glycol per dose (5 ml), equivalent to 4.5 mg/ml. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Posaconazole Sandoz

There are other medicines containing posaconazole, in different pharmaceutical forms and strengths, but they are not called "Posaconazole Sandoz". Do not switch from posaconazole tablets to Posaconazole Sandoz oral suspension without consulting a doctor or pharmacist, as this may lead to ineffective treatment or increased risk of side effects.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. The doctor will monitor the patient's response to treatment and the course of the disease to determine how long the patient needs to take Posaconazole Sandoz and whether a change in daily dose is necessary.

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

If possible, take the medicine during or immediately after a meal or nutritional supplement.

Shake the bottle with the medicine well before use.

Taking more than the recommended dose of Posaconazole Sandoz

If the patient has taken more than the recommended dose of the medicine, they should immediately consult a doctor or other healthcare professional.

Missing a dose of Posaconazole Sandoz

If the patient misses a dose, they should take it as soon as they remember, and then continue treatment as recommended. However, if it is almost time for the next dose, they should skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should immediately consult a doctor, pharmacist, or nurse, as urgent medical attention may be necessary:

nausea or vomiting, diarrhea

symptoms of liver disorders (including yellowing of the skin and whites of the eyes, unusual darkening of urine or pale stools, unexplained nausea, stomach problems, loss of appetite, or unusual fatigue or weakness, increased liver enzyme activity in blood tests

allergic reaction

Other side effects

If the patient experiences any of the following side effects, they should consult a doctor, pharmacist, or nurse

Common: may occur in less than 1 in 10 people

• changes in electrolyte levels in the blood, as shown in blood tests (symptoms may include confusion or weakness)
• unusual sensations, such as numbness, tingling, itching, shivering, or burning of the skin
• 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 indigestion, gas, dry mouth, changes in taste
• heartburn (a burning sensation in the chest that radiates to the throat)
• low neutrophil count, a type of white blood cell (neutropenia), as shown in blood tests, which can increase the risk of infection
• fever
• feeling of weakness, dizziness, fatigue, or drowsiness
• rash
• itching
• constipation
• discomfort in the rectal area

Uncommon: may occur in less than 1 in 100 people

• anemia (symptoms include headache, fatigue, or dizziness, shortness of breath, or pale skin and low hemoglobin levels in blood tests)
• low platelet count, as shown in blood tests, which can lead to bleeding
• reduced white blood cell count (leukopenia), as shown in blood tests, which can increase the risk of infection
• increased eosinophil count, a type of white blood cell (eosinophilia), which can accompany an inflammatory condition
• vasculitis
• heart rhythm disorders
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm, as shown in an electrocardiogram (ECG), palpitations, slow or fast heart rate, high or low blood pressure
• low blood pressure
• pancreatitis, which can cause severe abdominal pain
• interrupted blood flow to the spleen (splenic infarction), which can cause severe stomach pain
• severe kidney disorders with symptoms such as increased or decreased urine output or changes in urine color
• high creatinine levels in the blood, as shown in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during inhalation (pain related to pleurisy)
• lymphadenopathy (swollen lymph nodes)
• reduced skin sensitivity
• tremors
• high or low blood sugar levels
• blurred vision, increased sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, general malaise
• pain, back pain, or neck pain, arm or leg pain
• fluid retention (edema)
• menstrual disorders (abnormal vaginal bleeding)
• insomnia
• complete or partial inability to walk
• swelling of the oral mucosa
• unusual dreams or difficulty sleeping
• coordination or balance disorders
• mucosal inflammation
• nasal congestion
• breathing difficulties
• discomfort in the chest
• bloating
• mild to severe nausea, vomiting, cramps, and diarrhea, usually of viral origin, stomach pain
• belching
• restlessness

Rare: may occur in less than 1 in 1000 people

• pneumonia (symptoms include shortness of breath and production of discolored sputum)
• high blood pressure in the pulmonary blood vessels (pulmonary hypertension), which can cause serious lung and heart damage
• blood disorders, such as abnormal clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• psychiatric disorders, such as hearing voices or seeing things that do not exist
• fainting
• thinking or speech disorders, uncontrolled tremors, especially of the hands
• stroke with symptoms including pain, weakness, numbness, or tingling of the limbs
• blind spots or dark spots in the field of vision
• heart failure or heart attack, which can lead to cardiac arrest and death, heart rhythm disorders with sudden death
• blood clots in the legs (deep vein thrombosis) with symptoms such as severe leg pain or swelling
• blood clots in the lungs (pulmonary embolism) with symptoms such as shortness of breath or chest pain during breathing
• bleeding in the stomach or intestines with symptoms such as vomiting blood or blood in the stool
• intestinal obstruction, especially of the small intestine, which can prevent the passage of intestinal contents to further sections (symptoms include bloating, vomiting, severe constipation, loss of appetite, and cramps)
• "hemolytic-uremic syndrome", which occurs as a result of red blood cell breakdown (hemolysis), with or without kidney failure
• "pancytopenia" - a decrease in the number of all types of blood cells (red, white, and platelets) shown in blood tests
• large purple discolorations on the skin (thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• chest pain
• abnormal adrenal gland function, which can cause weakness, fatigue, loss of appetite
• skin discoloration
• abnormal pituitary gland function, which can lead to low levels of certain hormones in the blood and affect the function of reproductive organs in women and men
• hearing disorders
• pseudoaldosteronism, which results in high blood pressure with low potassium levels (as shown in blood tests)

Frequency not known due to lack of available data

• Some patients have also reported feeling confused after taking Posaconazole Sandoz
• Redness of the skin

If the patient experiences any of the above side effects, they should tell their doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Posaconazole Sandoz

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

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

Shelf life after first opening the bottle: 4 weeks.

Do not freeze.

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

6. Package contents and other information

What Posaconazole Sandoz contains

• The active substance is posaconazole. Each milliliter of oral suspension contains 40 mg of posaconazole.
• The other ingredients are: polysorbate 80, simethicone, polysorbate 65, methylcellulose, polyoxyl 8 stearate
• (8) stearyl, glycerol monostearate, xanthan gum, benzoic acid, sorbic acid, sulfuric acid, purified water, sodium benzoate (E 211), sodium citrate, citric acid monohydrate, glycerol, spray-dried glucose liquid, titanium dioxide (E171), cherry flavor (825.0275U) containing propylene glycol, natural and artificial flavor, water for injection.

What Posaconazole Sandoz looks like and contents of the pack

Posaconazole Sandoz is a white or almost white oral suspension with a cherry flavor. The orange glass bottles contain 105 ml of suspension and are closed with a child-resistant cap. The cardboard box also contains a measuring spoon with marked volumes of 2.5 ml and 5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana, Slovenia

To obtain more detailed information on the medicine and its names in other European Economic Area member states, please contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of leaflet approval:10/2024

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