POSACONAZOLE Fresenius Kabi 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Posaconazole Fresenius Kabi 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.

Keep this leaflet, you may need to read it again.

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

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

Posaconazole Fresenius Kabi contains a medicine called posaconazole, which belongs to a group of medicines called "antifungals". It is used to prevent and treat many different fungal infections.

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

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

This medicine can be used in adults and children from 2 years of age and weighing more than 40 kg to treat the following types of fungal infections:

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

infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B or when treatment with amphotericin B has had to be stopped;

• infections caused by fungi that cause diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole or when treatment with itraconazole has had to be stopped;

infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more medicines, amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines has had to be stopped.

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

• patients who have a weakened immune system as a result of having received chemotherapy for "acute myeloid leukemia" (AML) or "myelodysplastic syndromes" (MDS)

patients who are receiving "high-dose immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).

2. What you need to know before you take Posaconazole Fresenius Kabi

Do not takePosaconazole Fresenius Kabi

• 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, any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, or a "statin", such as simvastatin, atorvastatin, or lovastatin.

• if you have recently started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

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

See the section "Taking Posaconazole Fresenius Kabi with other medicines" later for more information, including information about other medicines that may interact with Posaconazole.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking Posaconazole Fresenius Kabi if:

• you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.

you have or have had liver problems. You may need to have blood tests while you are taking this medicine.

• you develop severe diarrhea or vomiting, as these can limit the effectiveness of this medicine.
• you have an abnormal heart rhythm (ECG) that shows a problem called prolonged QTc interval.

you have weakness of the heart muscle or heart failure.

• you have a very slow heart rate.
• you have any abnormal heart rhythm.
• you have any problems with the amounts of potassium, magnesium, or calcium in your blood.
• 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 the sun while you are taking this medicine. It is important to cover areas of skin that are exposed to the sun with protective clothing and to use a sunscreen with a high sun protection factor (SPF), as you may be more sensitive to the UV rays of the sun.

If you are in any of the above situations (or if in doubt), consult your doctor, pharmacist, or nurse before taking this medicine.

If you develop severe diarrhea or vomiting while you are taking Posaconazole Fresenius Kabi, consult your doctor, pharmacist, or nurse immediately, as this can 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 Posaconazole Fresenius Kabi with other medicines

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

Do not take Posaconazole 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 abnormal heart rhythms).

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

• any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole may increase the amount of these medicines in your blood, which could cause a serious decrease in blood flow to your fingers or toes and damage them.

Posaconazole Fresenius Kabi may increase the risk of side effects of other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• ciclosporin (used during or after transplants)
• tacrolimus and sirolimus (used during or after transplants)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir)

Posaconazole Fresenius Kabi may also increase the levels of other medicines in your blood, including:

• 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)

Posaconazole Fresenius Kabi may also increase the levels of other medicines in your blood, including:

• digoxin (used to treat heart failure)
• glipizide or other "sulfonylureas" (used to treat high blood sugar levels).
• all-trans retinoic acid (ATRA), also called tretinoin (used to treat certain blood cancers).

If you are in any of the above situations (or if in doubt), consult your doctor or pharmacist before taking this medicine.

Using Posaconazole Fresenius Kabi with food and drinks

Posaconazole 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 breast-feeding

Tell your doctor if you are pregnant or think you might be pregnant before you start taking Posaconazole Fresenius Kabi. Do not take Posaconazole Fresenius Kabi if you are pregnant unless your doctor tells you to.

If you are a woman who can become pregnant, you must use effective contraception while you are taking this medicine. If you become pregnant while taking Posaconazole, contact your doctor immediately.

Do not breast-feed while you are taking this medicine, as small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while you are taking Posaconazole Fresenius Kabi, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

Posaconazole Fresenius Kabi contains sodium

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

Posaconazole Fresenius Kabi contains lactose

Each tablet contains 80.0 mg of lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Posaconazole Fresenius Kabi

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not take Posaconazole Fresenius Kabi tablets and Posaconazole Fresenius Kabi oral suspension interchangeably without consulting your doctor or pharmacist, as this may lead to a lack of effectiveness or increase the risk of adverse reactions.

How much to take

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

The duration of treatment may depend on the type of infection you have and may be adjusted individually for you by your doctor. Do not change your dose yourself before consulting your doctor, or change your treatment schedule.

How to take this medicine

• Swallow the tablet whole with some water.
• Do not crush, chew, break, or dissolve the tablet.
• The tablets can 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, tell your doctor immediately, go to the hospital, or call the Poison Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Posaconazole Fresenius Kabi

If you miss 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. Take your next dose at the usual time.

Do not take a double dose to make up for forgotten doses.

If you have any further questions on 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 all people suffer from them.

Severe Adverse Effects

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

• nausea or vomiting (feeling or being sick), diarrhea
• signs of liver problems, including yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, feeling sick without an apparent reason, stomach problems, loss of appetite or unusual fatigue or weakness, elevated 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:

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

• a change in blood salt levels detected in blood tests, whose signs include a feeling of confusion or weakness

include feeling of confusion or weakness

• abnormal sensations in the skin, such as numbness, tingling, itching, prickling

prickling, pinching, 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 stomach discomfort, flatulence, dry mouth, changes in taste
• heartburn (a burning sensation in the chest that rises to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which can make you more prone to infections and are detected in blood tests

more prone to infections and are detected in blood tests

• fever
• feeling of weakness, dizziness, fatigue, or drowsiness
• rash
• itching
• constipation
• rectal discomfort

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

• anemia, whose signs include headaches, feeling of fatigue or dizziness, difficult breathing, or paleness and low hemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This can cause bleeding
• low levels of "leukocytes", a type of white blood cell (leukopenia), detected in blood tests. This can make you more susceptible to infections
• high levels of "eosinophils", a type of white blood cell (eosinophilia). This can occur if you have an inflammatory process

if you have an inflammatory process

• inflammation of blood vessels
• heart rhythm problems
• seizures (convulsions)
• nerve damage (neuropathy)
• abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

high or low blood pressure

• low blood pressure
• inflammation of the pancreas (pancreatitis). This can cause severe stomach pain
• disruption of oxygen supply to the spleen (splenic infarction), which can cause severe stomach pain
• severe kidney problems, whose signs include increased or decreased urination with urine that has a different color than usual

with urine that has a different color than usual

• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nasal bleeding
• sharp and intense chest pain when breathing (pleuritic pain)
• inflammation of the lymph nodes (lymphadenopathy)
• decreased sensitivity, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, feeling of discomfort
• pain, back pain or neck pain, pain in arms or legs
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• inability to speak totally or partially
• mouth swelling
• abnormal dreams or sleep problems
• coordination or balance problems
• mucous membrane inflammation
• nasal congestion
• breathing difficulties
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and diarrhea from mild to severe, usually caused by a virus, stomach pain
• belching
• feeling of restlessness

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

• pneumonia, whose signs include shortness of breath and production of discolored mucus

discolored mucus

• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which can cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread skin rash with blisters and skin peeling

and skin peeling

• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems thinking or speaking, sudden movements, especially in your hands, that you cannot control

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 can cause cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), whose signs include intense pain or swelling of the legs
• blood clots in the lungs (pulmonary embolism), whose signs include shortness of breath or pain when breathing
• bleeding in the stomach or intestine, whose signs include vomiting blood or blood in the stool
• blockage of the intestine (intestinal obstruction), especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include feeling of bloating, vomiting, severe constipation, loss of appetite, and cramps

and cramps

• "hemolytic uremic syndrome" which occurs when there is destruction of red blood cells (hemolysis), which can occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red, white, and platelets), detected in blood tests
• large purple spots on the skin (thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction, which can cause weakness, fatigue, loss of appetite, skin discoloration

skin discoloration

• pituitary gland dysfunction, which can cause low levels in the blood of some hormones that affect the function of male or female sexual organs

male or female sexual organs

• hearing problems
• pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)

Frequency Not Known:cannot be estimated from the 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 described above.

Reporting of Adverse Effects

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

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Posaconazole Fresenius Kabi

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

Do not use this medicine after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Posaconazole Fresenius Kabi

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

Appearance of the Product and Package Contents

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

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

Only some package 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) with the following names:

Date of the Last Revision of this Prospectus: 10/2021

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