Posaconazole Teva

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

Posaconazole Teva 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 inhibiting the growth of fungi that can cause infections.

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

• infections caused by species of the genus Aspergillus, which do not respond to antifungal medicines: amphotericin B or itraconazole, or in cases where treatment with these medicines must be discontinued;
• infections caused by species of the genus Fusarium, which do not respond to amphotericin B, or in cases where treatment with amphotericin B must be discontinued;
• infections caused by fungi known as chromoblastomycosis and mycetoma, which do not respond to treatment with itraconazole or in cases where treatment with itraconazole must be discontinued;
• infections caused by fungi known as Coccidioides, which do not respond to one or more of the following medicines - amphotericin B, itraconazole, or fluconazole, or in cases where treatment with these medicines must be discontinued;
• untreated oral and throat infections (known as thrush), caused by fungi known as Candida.

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

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

2. Important information before taking Posaconazole Teva

When not to take Posaconazole Teva

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

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

Warnings and precautions

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

Children

Posaconazole Teva should not be used in children (under 18 years of age).

Posaconazole Teva and other medicines

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

Do not take Posaconazole Teva 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 Teva may increase the levels of these medicines in your blood, which can lead to serious heart rhythm changes:

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

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

Other medicines

The above list includes medicines that should not be taken with Posaconazole Teva. In addition to the above medicines, taking other medicines may also increase the risk of heart rhythm disorders. This risk may be higher when taking these medicines with Posaconazole Teva. 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 Teva by increasing the levels of posaconazole in your blood.

The following medicines may reduce the effectiveness of Posaconazole Teva by reducing the levels of posaconazole in your blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you may need to have a blood test and be monitored for possible side effects of rifabutin;
• certain medicines used to treat seizures or prevent them, including phenytoin, carbamazepine, phenobarbital, or primidone;
• efavirenz and fosamprenavir used to treat HIV infection;
• medicines used to reduce stomach acid, such as cimetidine, ranitidine, or omeprazole, and similar medicines known as proton pump inhibitors. Posaconazole Teva may increase the risk of side effects of certain medicines by increasing their levels in your blood. These include:
• vincristine, vinblastine, and other vinca alkaloids (used to treat cancer);
• cyclosporine (used during transplants or after transplants);
• tacrolimus and sirolimus (used during transplants or after transplants);
• rifabutin (used to treat certain infections);
• medicines used to treat HIV infection, known as protease inhibitors (including lopinavir and atazanavir, which are used with ritonavir);
• midazolam, triazolam, alprazolam, and other similar medicines, known as benzodiazepines (used as sedatives or muscle relaxants);
• diltiazem, verapamil, nifedipine, nisoldipine, and other calcium channel blockers (used to treat high blood pressure);
• digoxin (used to treat heart failure);
• glipizide or other sulfonylureas (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 you (or if you are in doubt), consult your doctor or pharmacist before taking Posaconazole Teva.

Posaconazole Teva with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, tell your doctor before taking Posaconazole Teva.

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

Women of childbearing age should use effective contraception while taking Posaconazole Teva. If you become pregnant while taking Posaconazole Teva, contact your doctor immediately.

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

Driving and using machines

While taking Posaconazole Teva, you may experience dizziness, drowsiness, or blurred vision, which may affect your ability to drive or operate tools and machines. In this case, do not drive or operate tools and machines, but consult your doctor.

Posaconazole Teva contains glucose

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

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Posaconazole Teva contains sodium

Posaconazole Teva contains 5.91 mg (0.26 mmol) of sodium in 5 ml of suspension.

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

Posaconazole Teva contains sodium benzoate

This medicine contains 10 mg of sodium benzoate (E 211) in each 5 ml of suspension, which corresponds to 2 mg in 1 ml of suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Posaconazole Teva

Posaconazole is available in other forms and strengths, under the same or different trade names. Do not switch between posaconazole tablets and posaconazole 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 unsure, consult your doctor or pharmacist.

Your doctor will monitor your response and condition to determine how long you should take Posaconazole Teva and whether you need to change your 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 Teva with food or immediately after eating or taking a nutritional supplement.

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

Taking a higher dose of Posaconazole Teva than recommended

If you have taken too much of the medicine, contact your doctor or another healthcare professional immediately.

Missing a dose of Posaconazole Teva

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 your next dose, do not take a double dose to make up for the missed dose.

If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Posaconazole Teva 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 symptoms include yellowing of the skin or eyes, unusually dark urine or pale stools, unexplained nausea, stomach discomfort, loss of appetite, or unusual tiredness or weakness, elevated liver enzyme levels 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 feelings of disorientation or weakness)
• abnormal skin sensations, such as numbness, tingling, itching, goosebumps, pricking, or burning
• 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, taste disturbances
• heartburn (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, low hemoglobin levels 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 be associated with inflammation
• vasculitis
• heart rhythm disorders
• seizures (epileptic fits)
• nerve damage (neuropathy)
• heart rhythm disorders - shown in ECG, 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 passing more or less urine than usual, or urine of an unusual color
• high creatinine levels in the blood - shown in blood tests
• cough, hiccups
• nosebleeds
• sharp chest pain during breathing (pleuritic pain)
• lymphadenopathy (enlarged lymph nodes)
• numbness or tingling, especially skin numbness
• tremors
• high or low blood sugar levels
• blurred vision, sensitivity to light
• excessive 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)
• complete or partial loss of speech
• mouth swelling
• unusual dreams or sleep problems
• coordination or balance disorders
• mucosal inflammation
• stuffy nose
• breathing difficulties
• chest discomfort
• bloating
• mild to severe nausea, vomiting, abdominal cramps, and diarrhea, usually of viral origin, stomach pain
• belching
• restlessness

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 pulmonary arteries (pulmonary hypertension), which may lead to severe lung and heart damage
• blood disorders, such as abnormal blood clotting, prolonged bleeding
• severe allergic reactions, including generalized blistering and skin peeling
• psychiatric disorders, such as hearing voices or seeing things that are not there
• fainting
• disorders of thinking or speaking, uncontrolled movements of the limbs, especially the arms
• stroke - symptoms include pain, weakness, numbness, or tingling of the limbs
• blind spots or blurred vision
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders leading to 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
• stomach or intestinal bleeding - symptoms include vomiting blood or black stools
• intestinal obstruction, especially of the small intestine. Obstruction prevents the movement of intestinal contents into the lower part of the digestive tract (large intestine); its symptoms include bloating, vomiting, severe constipation, loss of appetite, and intestinal 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 count of all types of blood cells (red and white blood cells and platelets) shown in blood tests
• large purple skin discolorations (thrombocytopenic purpura)
• facial or tongue swelling
• depression
• double vision
• chest pain
• adrenal gland disorders - may cause weakness, fatigue, loss of appetite, or changes in skin color
• pituitary gland disorders - may cause low levels of certain hormones in the blood that affect male or female sex organs
• hearing disorders

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

• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (shown in blood tests)
• some patients have also reported feeling disoriented after taking posaconazole

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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.

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

5. How to store Posaconazole Teva

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 "EXP" or "Expiry date (EXP)". The expiry date refers to the last day of the month stated.

Do not store in the refrigerator or freeze.

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

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 Teva contains

• The active substance of Posaconazole Teva 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), glycerol, xanthan gum, liquid glucose, titanium dioxide (E 171), cherry flavor (PHL-142355), and purified water.

What Posaconazole Teva looks like and contents of the pack

Posaconazole Teva is a white to yellowish oral suspension with a cherry flavor, packaged in orange glass type III bottles containing 105 ml of oral suspension, closed with a plastic child-resistant cap, in a cardboard box. A measuring cup is included with the bottle, allowing you to measure 2.5 ml and 5 ml volumes.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TEVA B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer:

Genepharm S.A.

18 km Marathon Avenue

15351 Pallini Attikis, Greece

Rafarm S.A.,

Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki,

TK 19002, ΤΘ 37, Greece

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Kraków

Poland

To obtain more detailed information on this medicine and its names in other European Economic Area member states, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.,

ul. Emilii Plater 53,

00-113 Warsaw,

tel. (22) 345 93 00

Date of last revision of the leaflet:May 2024