Posaconazole Msn

Package Leaflet: Information for the User

Posaconazole MSN, 100 mg, Gastro-Resistant Tablets

Posaconazole

Read All of This Leaflet Carefully Before You Start Taking This Medicine Because It Contains Important Information for You.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What Posaconazole MSN is and What It is Used For
• 2. Before You Take Posaconazole MSN
• 3. How to Take Posaconazole MSN
• 4. Possible Side Effects
• 5. How to Store Posaconazole MSN
• 6. Contents of the Pack and Other Information

1. What Posaconazole MSN is and What It is Used For

This medicine contains the active substance posaconazole. It belongs to a group of medicines called ‘antifungals’. It is used to prevent and treat many types of fungal infections.

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

Posaconazole MSN can be used to treat fungal infections caused by Aspergillusspecies in adults.

Posaconazole MSN can be used to treat the following fungal infections in adults and children over 2 years old and weighing more than 40 kg:

• fungal infections caused by Aspergillusspecies if there has been no improvement with amphotericin B or itraconazole treatment, or if treatment with these medicines had to be stopped;
• fungal infections caused by Fusariumspecies if there has been no improvement with amphotericin B treatment or if treatment with amphotericin B had to be stopped;
• fungal infections that cause diseases such as chromoblastomycosis and mycetoma (madura foot) if there has been no improvement with itraconazole treatment or if treatment with itraconazole had to be stopped;
• fungal infections caused by Coccidioidesspecies if there has been no improvement with one or more of the following treatments: amphotericin B, itraconazole, or fluconazole, or if treatment with these medicines had to be stopped.

This medicine can also be used to prevent fungal infections in adults and children over 2 years old and weighing more than 40 kg who are at high risk of getting a fungal infection, such as:

• patients whose immune system is weakened due to chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS);
• patients taking high-dose immunosuppressive therapy after hematopoietic stem cell transplantation (HSCT).

2. Before You Take Posaconazole MSN

Do Not Take Posaconazole MSN

• if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6);
• if you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or any medicines containing ergot alkaloids (such as ergotamine or dihydroergotamine), or statins (such as simvastatin, atorvastatin, or lovastatin);
• if you have started treatment with venetoclax or the dose of venetoclax is being slowly increased as part of chronic lymphocytic leukemia (CLL) treatment.

Do not take Posaconazole MSN if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole MSN.

Warnings and Precautions

Before you start taking Posaconazole MSN, tell your doctor, pharmacist, or nurse:

• if you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole;
• if you have liver problems now or have had them in the past. You may need to have blood tests while taking this medicine;
• if you have severe diarrhea or vomiting, which may reduce the effectiveness of this medicine;
• if you have heart rhythm problems, which may be shown by an abnormal ECG;
• if you have weakened heart muscle or heart failure;
• if you have slow heart rate;
• if you have heart rhythm problems;
• if you have abnormal levels of potassium, magnesium, or calcium in your blood;
• if you are taking vincristine, vinblastine, or other vinca alkaloids (used to treat cancer);
• if you are taking venetoclax (used to treat cancer).

If any of the above apply to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before taking Posaconazole MSN.

Children

Posaconazole MSN should not be given to children under 2 years old.

Posaconazole MSN with Other Medicines

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

Do not take Posaconazole MSN if you are taking any of the following medicines:

• terfenadine (used to treat allergies);
• astemizole (used to treat allergies);
• cisapride (used to treat stomach problems);
• pimozide (used to treat Tourette’s syndrome and mental illnesses);
• halofantrine (used to treat malaria);
• quinidine (used to treat heart rhythm problems);
• any medicines containing ergot alkaloids (such as ergotamine or dihydroergotamine), used to treat migraine headaches;
• statins (such as simvastatin, atorvastatin, or lovastatin), used to lower high cholesterol levels;
• venetoclax, used at the start of treatment for a certain type of cancer called chronic lymphocytic leukemia (CLL).

Do not take Posaconazole MSN if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole MSN.

Pregnancy and Breast-Feeding

If you are pregnant or think you might be pregnant, tell your doctor before taking Posaconazole MSN.

Do not take Posaconazole MSN during pregnancy unless your doctor tells you to.

Women of childbearing age should use effective contraception while taking this medicine. If you become pregnant while taking Posaconazole MSN, tell your doctor immediately.

Do not breast-feed while taking Posaconazole MSN, as small amounts of the medicine may pass into breast milk.

Driving and Using Machines

Posaconazole MSN may cause dizziness, sleepiness, or blurred vision, which may affect your ability to drive or use machines. If this happens, do not drive or use machines and talk to your doctor.

Posaconazole MSN Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to Take Posaconazole MSN

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Do not take Posaconazole MSN gastro-resistant tablets instead of posaconazole oral suspension without talking to your doctor or pharmacist first, as this may lead to reduced effectiveness or increased risk of side effects.

The usual dose of posaconazole is 300 mg (three 100 mg tablets) twice on the first day, and then 300 mg (three 100 mg tablets) once a day.

The length of treatment will depend on the type of fungal infection you have and may be adjusted individually by your doctor. Do not change the dose or treatment schedule without talking to your doctor.

How to take Posaconazole MSN:

• Swallow the tablet whole with water.
• Do not crush, chew, break, or dissolve the tablets.
• You can take the tablets with or without food.

If You Take More Posaconazole MSN Than You Should

If you think you have taken too much Posaconazole MSN, contact your doctor or go to the hospital immediately.

If You Forget to Take Posaconazole MSN

• If you miss a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
• Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

Serious Side Effects

Tell your doctor, pharmacist, or nurse immediately if you get any of the following serious side effects:

• nausea or vomiting, diarrhea;
• signs of liver failure - these include yellowing of the skin or the whites of the eyes, dark-colored urine, pale-colored stools, nausea without reason, stomach problems, loss of appetite, unusual tiredness or weakness, or abnormal liver blood tests;
• allergic reaction;

Other Side Effects

Tell your doctor, pharmacist, or nurse if you get any of the following side effects:

Common: may affect up to 1 in 10 people

• changes in blood electrolyte levels shown by blood tests - these can include feelings of disorientation or weakness;
• abnormal sensations of the skin, including numbness, tingling, itching, prickling, or burning;
• headache;
• low potassium levels shown by blood tests;
• low magnesium levels shown by blood tests;
• high blood pressure;
• loss of appetite, stomach pain or upset, gas, dry mouth, taste disturbances;
• heartburn (a burning sensation in the chest and throat);
• low neutrophil count (a type of white blood cell) shown by blood tests, 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 - this can include symptoms such as headaches, feeling tired or dizzy, shortness of breath, or pale skin, and low hemoglobin levels shown by blood tests;
• low platelet count shown by blood tests, which can increase the risk of bleeding;
• low white blood cell count shown by blood tests, which can increase the risk of infections;
• increased eosinophil count (a type of white blood cell) shown by blood tests, which can be associated with inflammation;
• inflammation of blood vessels;
• heart rhythm problems;
• seizures;
• nerve damage (neuropathy);
• abnormal heart rhythm shown by ECG, palpitations, 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 get enough blood), which can cause severe stomach pain;
• severe kidney problems - these can include symptoms such as decreased or increased urine production, or changes in urine color;
• high creatinine levels shown by blood tests;
• cough, hiccups;
• nosebleeds;
• sharp chest pain that gets worse when you breathe in (pleuritic pain);
• enlarged lymph nodes (lymphadenopathy);
• reduced sensation, especially skin sensation;
• tremors;
• high or low blood sugar levels;
• blurred vision, sensitivity to light;
• hair loss (alopecia);
• mouth ulcers;
• chills, general feeling of being unwell;
• pain, back pain or neck pain, arm or leg pain;
• fluid retention (edema);
• menstrual disorders (abnormal vaginal bleeding);
• difficulty sleeping (insomnia);
• partial or complete loss of speech;
• mouth swelling;
• unusual dreams or sleep problems;
• coordination or balance problems;
• inflammation of mucous membranes;
• stuffy nose;
• breathing difficulties;
• chest discomfort;
• bloating;
• mild to severe nausea, vomiting, stomach cramps, and diarrhea, usually caused by a virus, stomach pain;
• belching;
• restlessness;

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

• pneumonia - this can include symptoms such as shortness of breath and coughing up discolored sputum;
• high blood pressure in the blood vessels of the lungs (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 peeling of the skin;
• psychiatric disorders, such as hearing voices or seeing things that are not there;
• fainting;
• problems with thinking or speaking, sudden uncontrolled movements of the arms or legs;
• stroke - this can include symptoms such as pain, weakness, numbness, or tingling of the arms or legs;
• appearance of a hole or blind spot in the field of vision;
• heart failure or heart attack, which can lead to cardiac arrest and death, abnormal heart rhythms that can cause sudden death;
• presence of blood clots in the deep veins of the legs (deep vein thrombosis) - this can include symptoms such as severe pain or swelling of the legs;
• presence of blood clots in the lungs (pulmonary embolism) - this can include symptoms such as shortness of breath or chest pain when breathing;
• bleeding from the stomach or intestines - this can include symptoms such as vomiting blood or black stools;
• blockage of the intestines, especially the small intestine. This can prevent the movement of intestinal contents into the large intestine (colon). Symptoms can include bloating, vomiting, severe constipation, loss of appetite, and intestinal cramps;
• hemolytic-uremic syndrome, where red blood cells are broken down (hemolysis). This can be accompanied by kidney failure;
• pancytopenia, where the number of all blood cells (white blood cells, red blood cells, and platelets) is reduced, as shown by blood tests;
• large purple spots under the skin (thrombocytopenic purpura);
• swelling of the face or tongue;
• depression;
• double vision;
• chest pain;
• adrenal gland problems, which can cause weakness, tiredness, loss of appetite, changes in skin color;
• pituitary gland problems, which can affect the levels of certain hormones in the blood that affect the sex organs;
• hearing problems;
• pseudoaldosteronism, which can cause high blood pressure with low potassium levels (as shown by blood tests).

Frequency Not Known: frequency cannot be estimated from the available data

• some patients have also reported feeling disoriented after taking posaconazole;
• redness of the skin.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Side effects can also be reported directly to the national reporting system listed in the website: www.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 MSN

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

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

No special storage precautions are required.

Medicines should 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 MSN Contains

• The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other ingredients are: hypromellose acetate succinate, microcrystalline cellulose, hydroxypropylcellulose (E 463), sodium croscarmellose (E 468), silicon dioxide, magnesium stearate (E 470b), polyvinyl alcohol (partially hydrolyzed) (E 1203), titanium dioxide (E 171), macrogol 4000 (E 1521), talc (E 553b), yellow iron oxide (E 172).

What Posaconazole MSN Looks Like and Contents of the Pack

Posaconazole MSN gastro-resistant tablets are yellow, capsule-shaped, embossed, and biconvex tablets, approximately 18 mm in length, with “MP 1” engraved on one side and plain on the other.

Pack sizes:

Tablets are packaged in blisters containing 24, 48, or 96 tablets, and perforated unit-dose blisters containing 24 x 1, 48 x 1, or 96 x 1 tablets, in cardboard boxes.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MSN Labs Europe Limited

KW20A, Corradino Park

Paola, PLA 3000

Malta

Phone: (+48) 699 711 147

(logo of the marketing authorization holder)

Manufacturer/Importer:

Pharmadox Healthcare Limited

KW20A, Kordin Industrial Park

Paola, PLA 3000

Malta

MSN Labs Europe Limited

KW20A, Corradino Park

Paola, PLA 3000

Malta

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Germany:

Posaconazol Vivanta Generics 100 mg magensaftresistente Tabletten

Czech Republic:

Posaconazole MSN

Slovakia:

Posaconazole MSN 100 mg

Hungary:

Posaconazole MSN 100 mg gyomornedvellenálló tabletta

Croatia:

Posakonazol MSN 100 mg želučanootporne tablete

Slovenia:

Posakonazol MSN 100 mg gastrorezistentne tablete

Romania:

Posaconazol MSN 100 mg comprimate gastrorezistente

Poland:

Posaconazole MSN

Date of Last Revision of the Leaflet: