Posaconazole Stada

Package Leaflet: Information for the User

Posaconazole Stada, 40 mg/ml, Oral Suspension

Posaconazole

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Posaconazole Stada contains the active substance posaconazole. It belongs to a group of antifungal medicines. This medicine is used to prevent and treat many types of fungal infections.

This medicine works by killing or stopping the growth of fungi that can cause infections.

Posaconazole Stada can be used in adults to treat the following fungal infections, if other antifungal medicines have not worked or the patient has had to stop taking them:

• infections caused by Aspergillus species that do not respond to amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by Fusarium species that do not respond to amphotericin B, or when treatment with amphotericin B must be discontinued;
• infections caused by fungi and 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;
• untreated oral and throat infections (known as thrush), caused by fungi called Candida.

This medicine can also be used to prevent fungal infections in adults who are at high risk of such infections, i.e.:

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

2. Important information before taking Posaconazole Stada

When not to take Posaconazole Stada:

Do not take Posaconazole Stada if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Posaconazole Stada.

Additional information on other medicines that may interact with Posaconazole Stada can be found in the section "Posaconazole Stada and other medicines".

Warnings and precautions

Before taking Posaconazole Stada, consult your doctor, pharmacist, or nurse in the following cases:

• if you have ever had an allergic reaction to other antifungal medicines, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• if you have had or currently have liver problems. Blood tests may be necessary while taking this medicine.
• if you have severe diarrhea or vomiting, as these conditions may reduce the effectiveness of this medicine.
• abnormalities in the electrocardiogram (ECG) that indicate a prolonged QTc interval
• heart muscle weakness or heart failure
• very slow heart rate
• heart rhythm disorders
• any disorders related to potassium, magnesium, or calcium levels in the blood.
• taking vincristine, vinblastine, and other vinca alkaloids (used to treat cancer)
• if you are taking venetoclax (a medicine used to treat cancer). If any of the above applies to you (or is suspected), tell your doctor, pharmacist, or nurse before taking Posaconazole Stada.

Avoid exposure to the sun during treatment. 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

Posaconazole Stada should not be used in children and adolescents (up to 17 years of age).

Posaconazole Stada and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Do not take Posaconazole Stada if you are 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 disorders).

Posaconazole Stada may increase the levels of these medicines in the blood, which can lead to serious heart rhythm changes:

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole Stada may increase the levels of these medicines in the blood, which can lead to a serious decrease in blood flow to the fingers and toes and damage to them
• statins, such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol
• venetoclax, used to treat a certain type of cancer called chronic lymphocytic leukemia (CLL)

Do not take Posaconazole Stada if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines:

The above list includes medicines that should not be taken during treatment with Posaconazole Stada. In addition to the above-mentioned medicines, other medicines may also carry a risk of heart rhythm disorders, which may be increased when taken with Posaconazole Stada. You should inform your doctor about all medicines you are taking (both prescription and over-the-counter). Some medicines may increase the risk of side effects of Posaconazole Stada by increasing the levels of posaconazole in the blood.

• rifabutin and rifampicin (used to treat certain infections). Patients already taking rifabutin will require blood tests and will need to be monitored for possible side effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures)
• efavirenz and fosamprenavir, used to treat HIV infection
• medicines used to reduce stomach acid, such as cimetidine, ranitidine, or omeprazole, and similar medicines called proton pump inhibitors
• flucloxacillin (an antibiotic used to prevent bacterial infections). Posaconazole Stada may increase the risk of side effects of certain medicines by increasing their levels in the blood. These include:
• vincristine, vinblastine, and other vinca alkaloids (used to treat cancer)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after transplants)
• tacrolimus and sirolimus (used after transplants)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV infection, called protease inhibitors (including lopinavir and atazanavir, which are used with ritonavir)
• midazolam, triazolam, alprazolam, and other similar medicines, called benzodiazepines (used as sedatives or muscle relaxants)
• diltiazem, verapamil, nifedipine, nisoldipine, and other medicines called calcium channel blockers (used to treat high blood pressure)
• digoxin (used to treat heart failure)
• sulfonylureas, such as glipizide (used to treat diabetes)
• all-trans retinoic acid (ATRA), also called tretinoin (used to treat certain blood cancers). If any of the above applies to you (or is suspected), tell your doctor or pharmacist before taking Posaconazole Stada.

Taking Posaconazole Stada with food and drink

If possible, to improve the absorption of posaconazole, take it during or immediately after a meal or nutritional supplement (see section 3 "How to take Posaconazole Stada"). There is no information available on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Pregnant women and women who think they may be pregnant must inform their doctor before taking Posaconazole Stada.

Do not take Posaconazole Stada during pregnancy, unless your doctor advises you to do so.

Women of childbearing age should use effective contraception during treatment with Posaconazole Stada. If you become pregnant during treatment with Posaconazole Stada, contact your doctor immediately.

Do not breastfeed during treatment with Posaconazole Stada, as small amounts of the medicine may pass into breast milk.

Driving and using machines

While taking Posaconazole Stada, dizziness, drowsiness, or blurred vision may occur, which may affect your ability to drive or operate machinery. In this case, do not drive or operate machinery, but contact your doctor.

Posaconazole Stada contains glucose, sodium, and sodium benzoate.

Glucose

Posaconazole Stada contains a maximum of 2.1 g of glucose in 5 ml of suspension.

If your doctor has informed you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It may be harmful to your teeth.

Sodium

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

Sodium benzoate

This medicine contains 10 mg of sodium benzoate (E211) per 5 ml of suspension.

3. How to take Posaconazole Stada

Posaconazole is available in other forms and strengths, but not under this trade name. Do not substitute posaconazole oral suspension with posaconazole tablets or posaconazole oral suspension and solvent for oral suspension without consulting your 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.

Your doctor will monitor your response and condition to determine how long you should take Posaconazole Stada and whether you need to change the daily dose.

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

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

Before administering the suspension, shake it well by inverting the bottle for 5-10 seconds.

Taking more Posaconazole Stada than prescribed

If you have taken more than the prescribed dose of the medicine, contact your doctor or another healthcare professional immediately.

Missing a dose of Posaconazole Stada

If you miss a dose, take it as soon as possible, and then continue taking the medicine as usual. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Posaconazole Stada can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following serious side effects, tell your doctor, pharmacist, or nurse immediately, as you may need urgent medical attention:

• nausea or vomiting (feeling sick or vomiting), diarrhea
• symptoms of liver problems - these include yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, unexplained nausea, stomach discomfort, loss of appetite, or unusual tiredness or weakness, increased liver enzyme levels shown in blood tests
• allergic reaction

Other side effects

If you experience any of the following side effects, tell your doctor, pharmacist, or nurse:

Common: (may affect up to 1 in 10 people)

• changes in electrolyte levels in the blood, shown in blood tests (which may cause symptoms such as confusion or weakness)
• abnormal skin sensations, such as numbness, tingling, itching, burning, prickling, or stabbing
• headache
• low potassium levels - shown in blood tests
• low magnesium levels - shown in blood tests
• high blood pressure
• loss of appetite, stomach pain, or stomach upset, gas, dry mouth, changes in taste
• heartburn (a burning sensation in the chest rising to the throat)
• low neutrophil count - a type of white blood cell (neutropenia), shown 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 affect up to 1 in 100 people)

• anemia - symptoms include headaches, feeling tired or dizzy, shortness of breath, or pale skin, and low hemoglobin levels shown in blood tests
• low platelet count (thrombocytopenia), shown in blood tests, which may lead to bleeding
• low white blood cell count (leukopenia), shown in blood tests, which may increase the risk of infections
• increased eosinophil count - a type of white blood cell (eosinophilia), which may occur in inflammatory conditions
• blood vessel inflammation
• heart rhythm disorders
• seizures (fits)
• nerve damage (neuropathy)
• heart rhythm disorders - shown in electrocardiogram (ECG) recordings, palpitations, slow or fast heart rate, high or low blood pressure
• low blood pressure
• pancreatitis - which may cause severe stomach pain
• splenic infarction - which may cause severe stomach pain
• severe kidney problems - symptoms include increased or decreased urine output, or changes in urine color
• high creatinine levels in the blood - shown in blood tests
• cough, hiccups
• nosebleeds
• sharp chest pain during breathing (pleuritic pain)
• lymph node swelling (lymphadenopathy)
• numbness or tingling, especially of 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
• pains, back pain, or neck pain, arm or leg pain
• fluid retention (edema)
• menstrual disorders (abnormal vaginal bleeding)
• insomnia
• complete or partial loss of speech
• mouth swelling
• unusual dreams or sleep problems
• coordination or balance problems
• mucosal inflammation
• stuffy nose
• breathing difficulties
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, abdominal cramps, diarrhea, usually of viral origin, stomach pain
• belching
• feeling shaken

Rare: (may affect up to 1 in 1,000 people)

• pneumonia - symptoms include shortness of breath and coughing up discolored sputum
• high blood pressure in the lungs (pulmonary hypertension), which can lead to serious lung and heart damage
• blood disorders, such as abnormal blood clotting parameters, prolonged bleeding
• severe allergic reactions, including generalized blistering rash and skin peeling
• psychiatric problems, such as hearing voices or seeing things that do not exist
• fainting
• thinking or speech disorders, abnormal tremors, consisting of uncontrolled movements, especially of the hands, which cannot be controlled
• stroke - symptoms include pain, weakness, numbness, or tingling in the limbs
• blind spots or loss of vision
• heart failure or heart attack, which can lead to cardiac arrest and death, and heart rhythm disorders with sudden death
• blood clots in the legs (deep vein thrombosis) - symptoms include severe leg pain or swelling
• blood clots in the lungs (pulmonary embolism) - symptoms include shortness of breath or chest pain during breathing
• bleeding into the stomach or intestines - symptoms include vomiting blood or passing blood in the stool
• intestinal blockage (intestinal obstruction); this is especially true for the small intestine. The blockage prevents the passage of intestinal contents into the lower parts of the digestive tract; symptoms include bloating, vomiting, severe constipation, loss of appetite, and cramps.
• hemolytic-uremic syndrome - a condition characterized by the breakdown of red blood cells (hemolysis), which may occur with or without kidney failure
• pancytopenia - low levels of all types of blood cells (red and white blood cells and platelets) shown in blood tests
• large purple discolorations on the skin (thrombocytopenic purpura)
• face and tongue swelling
• depression
• double vision
• chest pain
• abnormal adrenal gland function - which may cause weakness, fatigue, loss of appetite, skin discoloration
• abnormal pituitary gland function - which may cause low levels of certain hormones in the blood that affect the function of male and female sex organs
• hearing problems
• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (shown in blood tests)

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

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

If you experience any of the above side effects, tell your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posaconazole Stada

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

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

Do not store in the refrigerator or freeze.

If some suspension remains after 30 days of opening the bottle, do not use it. Return the bottle containing the unused suspension to the pharmacy that accepts such returns.

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

6. Contents of the pack and other information

What Posaconazole Stada contains

• The active substance of Posaconazole Stada is posaconazole. Each milliliter of oral suspension contains 40 milligrams of posaconazole.
• The other ingredients of the suspension are: citric acid monohydrate, anhydrous sodium citrate, sodium benzoate (E 211), sodium lauryl sulfate, simethicone emulsion 30% (containing simethicone, methylcellulose, sorbic acid, and purified water), xanthan gum, glycerol, liquid glucose, titanium dioxide (E 171), cherry flavor (PHL-142355), and purified water.

What Posaconazole Stada looks like and contents of the pack

Posaconazole Stada is a white to yellowish oral suspension with a cherry flavor, packaged in orange glass type III bottles, closed with a plastic cap (with an inner LDPE part) with a child-resistant closure, in a cardboard box. A measuring cup is attached to the bottle, allowing the measurement of 2.5 ml and 5 ml volumes.

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer/Importer:

Genepharm S.A., 18th km Marathonos Avenue, 15351 Pallini Attiki, Greece

STADA Arzneimittel AG, Stadastrasse 2 - 18, 61118 Bad Vilbel, Germany

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

Rafarm S.A, Thesi Pousi-Xatzi Agiou Louka, 19002 Paiania Attiki, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:

Posaconazol STADA 40 mg/ml Suspension zum Einnehmen

Denmark:

Posaconazole Stada

Germany:

Posaconazol AL 40 mg/ml Suspension zum Einnehmen

Finland:

Posaconazole STADA 40 mg/ml oraalisuspensio

Poland:

Posaconazole Stada

Sweden:

Posaconazole STADA, 40 mg/ml oral suspension

Slovakia:

Posakonazol STADA

United Kingdom:

Posaconazole Thornton & Ross 40mg/ml oral suspension

Italy:

Posaconazolo EG

Date of last revision of the leaflet: 11/2024