Pozakonazol Altan

Leaflet accompanying the packaging: information for the user

Pozakonazol Altan, 300 mg, concentrate for solution for infusion

Posaconazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Pozakonazol Altan and what is it used for
• 2. Important information before using Pozakonazol Altan
• 3. How to use Pozakonazol Altan
• 4. Possible side effects
• 5. How to store Pozakonazol Altan
• 6. Contents of the packaging and other information

1. What is Pozakonazol Altan and what is it used for

Pozakonazol Altan contains the active substance posaconazole, which belongs to a group of antifungal medicines. Pozakonazol Altan is used to prevent and treat many different fungal infections.

Pozakonazol Altan works by killing or inhibiting the growth of certain types of fungi that can cause infections. Pozakonazol Altan may be used in adults to treat the following fungal infections when other antifungal medicines do not work or cannot be taken for a longer period:

• infections caused by species of the genus Aspergillus, which do not respond to antifungal medicines, amphotericin B, or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by species of the genus Fusarium, which do not respond to treatment with amphotericin B, or when treatment with amphotericin B must be discontinued;
• infections caused by fungi called chromoblastomycosis and mycetoma, which do not respond to treatment with itraconazole or when treatment with itraconazole must be discontinued;
• infections caused by fungi called Coccidioides, which 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.

Pozakonazol Altan may also be used 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 leukemia (AML) or myelodysplastic syndrome (MDS);
• in patients taking high-dose immunosuppressive therapy after hematopoietic stem cell transplantation (HSCT).

2. Important information before using Pozakonazol Altan

When not to use Pozakonazol Altan:

Do not use Pozakonazol Altan if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before using Pozakonazol Altan.

Warnings and precautions

Before starting to use Pozakonazol Altan, discuss it with a 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 had liver disease in the past. During treatment with Pozakonazol Altan, blood tests may be necessary.
• the patient's ECG shows heart rhythm disturbances indicating a prolonged QTc interval;
• the patient has been diagnosed with heart failure or weakened heart muscle;
• the patient has significant bradycardia;
• the patient has heart rhythm disturbances;
• the patient has abnormal changes in potassium, magnesium, or calcium levels in the blood;
• the patient is taking vincristine, vinblastine, and other vinca alkaloids (medicines used to treat cancer).

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

Children

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

Pozakonazol Altan and other medicines

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

Do not use Pozakonazol Altan if the patient is taking any of the following medicines:

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

Pozakonazol Altan may increase the levels of the following medicines in the blood, which can lead to serious changes in heart rhythm:

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraine headaches. Pozakonazol Altan may increase the levels of these medicines in the blood, which can lead to significant reduction of blood flow to the fingers or toes and consequent damage;
• statins, such as simvastatin, atorvastatin, or lovastatin, used to lower high cholesterol levels.

Do not use Pozakonazol Altan if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before using Pozakonazol Altan.

Pregnancy and breastfeeding

If the patient is pregnant or thinks she may be pregnant, she should inform her doctor before starting to use Pozakonazol Altan.

Do not use Pozakonazol Altan during pregnancy, unless the doctor recommends it.

Women of childbearing age should use effective contraception during treatment with Pozakonazol Altan. If the patient becomes pregnant during treatment with Pozakonazol Altan, she should immediately inform her doctor.

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

Driving and using machines

During treatment with Pozakonazol Altan, the patient may experience symptoms such as dizziness, drowsiness, or blurred vision, which may affect the ability to drive or operate machinery. In such cases, the patient should not drive, use tools, or operate machinery and should consult a doctor.

Pozakonazol Altan contains sodium

This medicine contains 477 mg of sodium (the main component of common salt) per dose.

This corresponds to 23.8% of the maximum recommended daily intake of sodium in the diet for adults.

If the patient needs to use Pozakonazol Altan, 300 mg, concentrate for solution for infusion, daily for a longer period, they should consult a pharmacist or doctor, especially if they have been advised to follow a low-sodium diet.

Pozakonazol Altan contains cyclodextrins

This medicine contains 6680 mg of cyclodextrin per vial, which corresponds to 6680 mg/16.7 mL.

3. How to use Pozakonazol Altan

This medicine should always be used exactly as prescribed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

The recommended dose is 300 mg twice a day on the first day, and then 300 mg once a day.

Pozakonazol Altan concentrate for solution for infusion will be diluted by a pharmacist or nurse to the appropriate concentration.

Pozakonazol Altan concentrate for solution for infusion will always be prepared and administered to the patient by a healthcare professional.

The patient will receive Pozakonazol Altan:

• through a plastic tube inserted into a vein (intravenous infusion),
• usually over a period of about 90 minutes.

The duration of treatment may depend on the type of infection the patient has or how long the patient's immune system is not working properly and may be adjusted individually by the doctor.

The patient should not change the dose or treatment schedule without consulting a doctor.

Missing a dose of Pozakonazol Altan

Since this medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, if the patient thinks they may have missed a dose, they should tell their doctor or pharmacist.

If treatment with Pozakonazol Altan is discontinued by the doctor, the patient should not experience any effects.

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

4. Possible side effects

Like all medicines, Pozakonazol Altan can cause side effects, although not everybody gets them.

Severe side effects

Tell the doctor, pharmacist, or nurse immediately if the patient experiences any of the following severe side effects, as they may require immediate medical attention:

• nausea or vomiting, diarrhea;
• symptoms of liver failure, such as yellowing of the skin or whites of the eyes, dark urine, or pale stools, unexplained nausea, stomach upset, loss of appetite, unusual fatigue or weakness, elevated liver enzyme levels in blood tests;
• allergic reaction.

Other side effects

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

Common: may affect up to 1 in 10 people

• changes in electrolyte levels in the blood, as shown in blood tests, including feelings of disorientation or weakness;
• abnormal skin sensations, including numbness, tingling, itching, gooseflesh, prickling, or burning;
• swelling, redness, and tenderness along the vein where Pozakonazol Altan was administered;
• 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 nausea, gas, dry mouth, changes in taste;
• heartburn (a burning sensation in the chest that may spread to the throat);
• reduced neutrophil count, a type of white blood cell, as shown in blood tests (neutropenia), which can increase the risk of infections;
• fever;
• feeling weak, dizzy, tired, or sleepy;
• rash;
• itching;
• constipation;
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anemia, which can cause symptoms such as headaches, fatigue, dizziness, shortness of breath, or pale skin, low hemoglobin levels in blood tests;
• reduced platelet count, as shown in blood tests (thrombocytopenia), which can increase the risk of bleeding;
• reduced white blood cell count, as shown in blood tests (leukopenia), which can increase the risk of infections;
• increased eosinophil count, a type of white blood cell, as shown in blood tests (eosinophilia), which can be associated with inflammation;
• vasculitis (inflammation of blood vessels);
• heart rhythm disturbances;
• seizures;
• nerve damage (neuropathy);
• abnormal heart rhythm, as shown in ECG, irregular heartbeat, slow or fast heart rate, high or low blood pressure;
• low blood pressure;
• pancreatitis, which can cause severe stomach pain;
• splenic infarction (a condition where the spleen does not receive enough blood), which can cause severe stomach pain;
• severe kidney problems, which can cause symptoms such as 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);
• numbness or tingling, especially in the skin;
• tremors;
• high or low blood sugar levels;
• blurred vision, sensitivity to light;
• hair loss (alopecia);
• mouth sores;
• 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);
• loss of speech or speech disturbances;
• mouth swelling;
• vivid dreams or sleep disturbances;
• 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;
• shakiness;
• inflammation or pain at the injection site.

Rare: may affect up to 1 in 1000 people

• pneumonia, which can cause symptoms such as shortness of breath and coughing up discolored sputum;
• pulmonary hypertension, which can 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 hands;
• stroke, which can cause symptoms such as 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 can lead to cardiac arrest and death, heart rhythm disturbances that can cause sudden death;
• blood clots in the deep veins of the legs (deep vein thrombosis), which can cause symptoms such as severe pain or swelling in the legs;
• blood clots in the lungs (pulmonary embolism), which can cause symptoms such as shortness of breath or chest pain;
• bleeding from the stomach or intestines, which can cause symptoms such as vomiting blood or blood in the stool;
• intestinal obstruction, especially "twisted intestine", which can cause symptoms such as bloating, vomiting, severe constipation, loss of appetite, and abdominal cramps;
• hemolytic-uremic syndrome, which can cause symptoms such as breakdown of red blood cells (hemolysis) and kidney failure;
• pancytopenia, a reduction in the number of all blood cells (white blood cells, red blood cells, and platelets), as shown in blood tests;
• large purple spots under the skin (thrombocytopenic purpura);
• facial or tongue swelling;
• depression;
• double vision;
• chest pain;
• adrenal disorders, which can cause symptoms such as weakness, fatigue, loss of appetite, changes in skin color;
• pituitary disorders, which can cause a decrease in the levels of certain hormones in the blood that affect the function of male or female reproductive organs;
• hearing problems.

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

• pseudoaldosteronism, which can cause high blood pressure with low potassium levels (as shown in blood tests)
• some patients have also reported feelings of disorientation after taking Pozakonazol Altan
• skin redness.

Tell the doctor, pharmacist, or nurse if the patient experiences any of the side effects listed above.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, 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.

5. How to store Pozakonazol Altan

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

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

There are no special storage instructions for this medicine.

The product should be used immediately after preparation. If the solution is not used immediately, it can be stored for a maximum of 24 hours at a temperature between 2°C and 8°C, unless the solution was prepared in controlled and validated aseptic conditions.

This medicinal product is for single use only, and any remaining solution should be discarded.

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

6. Contents of the packaging and other information

What Pozakonazol Altan contains

The active substance is posaconazole. One vial contains 300 mg of posaconazole.

The other ingredients are sulfobutylether beta-cyclodextrin sodium, disodium edetate, hydrochloric acid (1 mol/L), sodium hydroxide, water for injections.

What Pozakonazol Altan looks like and contents of the pack

Pozakonazol Altan is a concentrate for solution for infusion, which is a clear, colorless to light yellow solution.

Changes in color within this range do not affect the quality of the product.

Pozakonazol Altan is available in a 20 mL glass vial, type I, with a bromobutyl rubber stopper and an aluminum seal, containing 16.7 mL of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Altan Pharma Ltd

The Lennox Building, 50 South Richmond Street

Dublin 2, D02FK02

Ireland

info@altanpharma.com

Manufacturer:

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo, Álava

Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:

Posaconazol Altan 300 mg

Konzentrat zur Herstellung einer Infusionslösung

Spain:

Posaconazol Altan 300 mg

concentrado para solución para perfusión EFG

France:

Posaconazole Altan 300 mg

solution à diluer pour perfusion

Italy:

Posaconazolo Altan

Germany:

Posaconazol Altan 300 mg

Konzentrat zur Herstellung einer Infusionslösung

Poland:

Pozakonazol Altan

United Kingdom (Northern Ireland):

Posaconazole 300 mg concentrate for solution for infusion

Date of last revision of the leaflet: 09/2024

Information intended for healthcare professionals only

Instructions for the administration of Pozakonazol Altan 300 mg concentrate for solution for infusion

• Depending on the final concentration to be achieved (not less than 1 mg/mL and not more than 2 mg/mL), transfer 16.7 mL of posaconazole to an infusion bag (or bottle) containing a compatible diluent (see list of diluents below) in a volume of 150 mL to 283 mL, maintaining aseptic conditions.
• Administer through a central venous line or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes. Pozakonazol Altan concentrate for solution for infusion should not be administered by rapid intravenous injection (bolus).
• If a central venous line is not available, a single infusion of a volume that allows a dilution of approximately 2 mg/mL can be administered through a peripheral venous line. When administered through a peripheral venous line, the infusion should last approximately 30 minutes.

Note: In clinical studies, multiple infusions administered peripherally through the same vein led to reactions at the infusion site (see section 4.8).

• Pozakonazol Altan is intended for single use.

The following medicinal products can be administered in infusion at the same time as Pozakonazol Altan concentrate for solution for infusion through the same intravenous line (or cannula):

Ciprofloxacin

Daptomycin

Gentamicin sulfate

Levofloxacin

Morphine sulfate

Norepinephrine bitartrate

Potassium chloride

Any products not listed above should not be administered simultaneously with Pozakonazol Altan through the same intravenous line (or cannula).

Pozakonazol Altan concentrate for solution for infusion should be inspected visually for particulate matter before administration. The solution for infusion may be colorless or light yellow. Variations in color within this range do not affect the quality of the product.

Any unused medicinal product or waste materials should be disposed of in accordance with local requirements.

Pozakonazol Altan should not be diluted with:

Ringer's solution with lactate

5% glucose solution with Ringer's solution and lactate

4.2% sodium bicarbonate solution

This medicine should not be mixed with other medicinal products except those mentioned below:

5% glucose solution in water

0.9% sodium chloride solution

0.45% sodium chloride solution

5% glucose solution and 0.45% sodium chloride solution

5% glucose solution and 0.9% sodium chloride solution

5% glucose solution and 20 mEq KCl