Posaconazole Fresenius Kabi 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Posaconazole Fresenius Kabi 100 mg gastro-resistant tablets

posaconazole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Posaconazole Fresenius Kabi is and what it is used for
2. What you need to know before taking Posaconazole Fresenius Kabi
3. How to take Posaconazole Fresenius Kabi
4. Possible side effects
5. How to store Posaconazole Fresenius Kabi
6. Contents of the pack and other information

1. What Posaconazol Fresenius Kabi is and what it is used for

Posaconazol Fresenius Kabi contains a medicine called posaconazole, which belongs to a group of medicines known as "antifungals". It is used to prevent and treat various fungal infections.

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

Posaconazole can be used in adults to treat fungal infections caused by fungi of the Aspergillus family.

This medicine can be used in adults and children aged two years and older who weigh more than 40 kg to treat the following types of fungal infections:

• infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines has had to be discontinued;

• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B, or when treatment with amphotericin B has had to be discontinued;

• infections caused by fungi responsible for diseases known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole, or when treatment with itraconazole has had to be discontinued;

• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more medicines, such as amphotericin B, itraconazole or fluconazole, or when treatment with these medicines has had to be discontinued.

This medicine can also be used to prevent fungal infections in adults and children aged two years and older who weigh more than 40 kg and who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to receiving chemotherapy for "acute myelogenous leukemia" (AML) or "myelodysplastic syndromes" (MDS);

• patients receiving "high-dose immunosuppressive therapy" following "haematopoietic stem cell transplantation" (HSCT).

2. What you need to know before taking Posaconazol Fresenius Kabi

Do not take Posaconazol Fresenius Kabi

• if you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine containing "ergot alkaloids", such as ergotamine or dihydroergotamine, or a "statin", such as simvastatin, atorvastatin or lovastatin.
• if you have just started taking venetoclax or your venetoclax dose is being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazol Fresenius Kabi if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

See section “Taking Posaconazol Fresenius Kabi with other medicines” below for further information, including details on other medicines that may interact with Posaconazol.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Posaconazol Fresenius Kabi if:

• you have ever had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• you currently have or have previously had liver problems. You may need blood tests while taking this medicine.
• you develop severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine.
• you have a heart rhythm disorder (ECG) showing a problem called QTc prolongation.
• you have weakened heart muscle or heart failure.
• you have a very slow heart rate.
• you have any heart rhythm disorder.
• you have any imbalance in blood levels of potassium, magnesium or calcium.
• you are taking vincristine, vinblastine or other "vinca alkaloids" (medicines used to treat cancer).
• you are taking venetoclax (a medicine used to treat cancer).

You should avoid exposure to sunlight during treatment. It is important to cover exposed skin areas with protective clothing and to use sunscreen with a high sun protection factor (SPF), as increased sensitivity of the skin to UV rays from sunlight may occur.

If any of the above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before taking this medicine.

If you develop severe diarrhoea or vomiting (feel unwell) while taking Posaconazol Fresenius Kabi, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. For more information, see section 4.

Children

This medicine must not be given to children under 2 years of age.

Taking Posaconazol Fresenius Kabi with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Posaconazol Fresenius Kabi 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 symptoms of Tourette’s syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders)

Posaconazole may increase blood levels of these medicines, which could cause serious changes in your heart rhythm.

• any medicine containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole may increase blood levels of these medicines, which could cause a serious reduction in blood flow to the fingers or toes, potentially causing damage.

• a "statin", such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels.

• venetoclax when used at the beginning of treatment for chronic lymphocytic leukemia (CLL).

Do not take Posaconazol Fresenius Kabi if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Refer to the list above for medicines you must not take while using Posaconazol Fresenius Kabi. In addition to the medicines listed above, there are other medicines that may pose a risk of heart rhythm problems, and this risk may be increased when taken with Posaconazol. Make sure to inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of adverse effects from Posaconazol by increasing its blood levels.

The following medicines may reduce the effectiveness of Posaconazol by decreasing its blood levels:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have a blood test and monitor for possible adverse effects of rifabutin.
• some medicines used to treat or prevent seizures, including: phenytoin, carbamazepine, phenobarbital or primidone.
• efavirenz and fosamprenavir, used to treat HIV infection.
• Flucloxacillin (an antibiotic used for bacterial infections).

Posaconazol Fresenius Kabi may increase the risk of adverse effects from other medicines by increasing their blood levels. These medicines include:

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

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

Taking Posaconazol Fresenius Kabi with food and drink

Posaconazol Fresenius Kabi 100 mg gastro-resistant tablets can be taken with or without food. Food does not affect the bioavailability of the medicine.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you may be pregnant before starting Posaconazol Fresenius Kabi. Do not take Posaconazol Fresenius Kabi if you are pregnant unless instructed by your doctor.

If you are a woman of childbearing potential, you must use effective contraception while taking this medicine. If you become pregnant while taking Posaconazol, contact your doctor immediately.

Do not breastfeed while taking this medicine, as small amounts may pass into breast milk.

Driving and using machines

You may experience dizziness, drowsiness or blurred vision while taking Posaconazol Fresenius Kabi, which may affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use any tools or machinery and contact your doctor.

Posaconazol Fresenius Kabi contains sodium

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

Posaconazol Fresenius Kabi contains lactose

Each tablet contains 80.0 mg of lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Posaconazol Fresenius Kabi

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not interchange Posaconazole Fresenius Kabi tablets and Posaconazole Fresenius Kabi oral suspension without consulting your doctor or pharmacist, as this may result in lack of effectiveness or increased risk of adverse reactions.

What dose to take

The recommended dose is 300 mg (three 100 mg tablets) twice daily on the first day, and
then 300 mg (three 100 mg tablets) once daily.

The duration of treatment may depend on the type of infection you have and may be individually adjusted by your doctor. Do not adjust your dose yourself or change your treatment schedule without first consulting your doctor.

How to take this medicine

• Swallow the tablet whole with some water.
• Do not crush, chew, break, or dissolve the tablet.
• The tablets may be taken with or without food.

If you take more Posaconazole Fresenius Kabi than you should

If you think you may have taken too much Posaconazole, inform your doctor immediately, go to the hospital straight away, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Posaconazole Fresenius Kabi

If you have missed a dose, take it as soon as you remember.

However, if it is almost time for your next dose, do not take 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment:

• nausea or vomiting (feeling sick or being sick), diarrhoea
• signs of liver problems, including yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, feeling unwell without apparent reason, stomach problems, loss of appetite, or unusual tiredness or weakness, or increased liver enzymes detected in blood tests
• allergic reaction

Other adverse effects

Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Common: the following may affect up to 1 in 10 patients

• a change in blood electrolyte levels detected in blood tests, which may include symptoms such as confusion or weakness
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling sensations, prickling, or burning
• headache
• low potassium levels, detected in blood tests
• low magnesium levels, detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or discomfort, flatulence, dry mouth, changes in taste sensation
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and is detected in blood tests
• fever
• feeling weak, dizzy, tired, or drowsy
• rash
• itching
• constipation
• rectal discomfort

Uncommon: the following may affect up to 1 in 100 patients

• anaemia, whose signs include headaches, feeling tired or dizzy, difficulty breathing, paleness, and low haemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This may cause bleeding
• low levels of "leucocytes", a type of white blood cell (leucopenia), detected in blood tests. This may make you more susceptible to infections
• high levels of "eosinophils", a type of white blood cell (eosinophilia). This may occur if you have an inflammatory condition
• inflammation of blood vessels
• heart rhythm problems
• seizures (fits)
• nerve damage (neuropathy)
• abnormal heart rhythm, detected on an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis). This may cause severe stomach pain
• interruption of blood supply to the spleen (splenic infarction), which may cause severe stomach pain
• severe kidney problems, whose signs include increased or decreased urination with urine of unusual colour
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain when breathing (pleuritic pain)
• swelling of the lymph nodes (lymphadenopathy)
• reduced sensation, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of discomfort
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep problems
• coordination or balance problems
• inflammation of the mucosa
• nasal congestion
• breathing difficulties
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and mild to severe diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling restless

Rare: the following may affect up to 1 in 1,000 patients

• pneumonia, whose signs include shortness of breath and production of discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, sudden jerky movements, especially in the hands, that you cannot control
• stroke, whose signs include pain, weakness, numbness, or tingling in the limbs
• presence of a blind spot or dark spot in the field of vision
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), whose signs include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism), whose signs include shortness of breath or pain when breathing
• bleeding in the stomach or intestines, whose signs include vomiting blood or blood in the stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, and whose signs include bloating, vomiting, severe constipation, loss of appetite, and colicky pain
• "haemolytic uraemic syndrome" that occurs when red blood cells are destroyed (haemolysis), which may occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red cells, white cells, and platelets), detected in blood tests
• large purple spots on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• inadequate functioning of the adrenal glands, which may cause weakness, tiredness, loss of appetite, skin discoloration
• inadequate functioning of the pituitary gland, which may cause low blood levels of certain hormones affecting male or female sex organ function
• hearing problems
• pseudoaldosteronism, which causes high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported feeling confused after taking Posaconazole Fresenius Kabi.
• skin redness

Tell your doctor, pharmacist, or nurse if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es

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

5. Storage of Posaconazole Fresenius Kabi

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 blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the container and other information

Composition of Posaconazole Fresenius Kabi

• The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are succinyl acetate of hypromellose, hypromellose, corn starch, anhydrous colloidal silica, sodium croscarmellose, spray-dried lactose monohydrate, silicified microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate, partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol, talc, yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Posaconazole Fresenius Kabi gastro-resistant tablets are yellow, film-coated, biconvex capsule-shaped tablets, approximately 19.9 mm in length, marked with 'P100' on one side.

They are packaged in blisters, in packs of 24 or 96 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U
C/ Marina 16-18
Barcelona
08005 Spain

Manufacturer

Interpharma Services Ltd.
43A Cherni Vrach Blvd.,
1407 Sofia
Bulgaria

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

Date of the most recent review of this leaflet: 10/2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es