Prospecto: Information for the User

Posaconazole Fresenius Kabi 100 mg gastro-resistant tablets

posaconazole

Read this prospectus carefully before starting to take this medicine, because

it contains important information for you.

- Keep this prospectus, as you may have to read it again.

- If you have any doubts, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed only for you, and you must not give it to other people

although they may have the same symptoms as you, as it may harm them.

- If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they

are not listed in this prospectus. See section 4.

1. What isPosaconazole Fresenius Kabiand for what it is used

2. What you need to know before starting to takePosaconazole Fresenius Kabi

3. How to takePosaconazole Fresenius Kabi

4. Possible adverse effects

5. Storage ofPosaconazole Fresenius Kabi

6. Contents of the package and additional information

Posaconazol Fresenius Kabicontains a medicine called posaconazol, which belongs to a group of medicines called "antifungals". It is used to prevent and treat many different types of fungal infections.

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

Posaconazol can be used in adults to treat fungal infections caused by fungi of the familyAspergillus.

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

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

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

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

infections caused by a fungus calledCoccidioidesthat 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 interrupted.

• infections caused by a fungus calledCoccidioidesthat 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 interrupted.

This medicine can also be used to prevent fungal infections in adults and children aged 2 years or older and weighing more than 40 kg who are at high risk of contracting 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 doses of immunosuppressive treatment” after a

“hematopoietic stem cell transplant” (HSCT).

Do not takePosaconazole Fresenius Kabi

• if you are allergic to posaconazole or any of the other ingredients in this medicine

(listed in section 6).

• if you are taking: terfenadine, astemizol, cisaprida, pimozida, halofantrina, quinidina, any medicine that contains "ergot alkaloids", such as ergotamine or dihidroergotamina, or a "statin", such as simvastatina, atorvastatina or lovastatina.
• if you have just 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 circumstances. 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 that related to other medicines that may interact with Posaconazole.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take 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 diarrhoea or vomiting, as these situations may limit the effectiveness of this medicine.
• you have an abnormal heart rhythm (ECG) that shows a problem called

prolongation of the QTc interval.

• you have heart muscle weakness or heart failure.
• you have a very slow heart rate.
• you have any abnormal heart rhythm.
• you have any problem with the amounts of potassium, magnesium or calcium in your blood.
• you are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
• you are taking venetoclax (a medicine used to treat cancer).

You must avoid exposure to the sun while you are being treated. It is essential to cover exposed skin areas with protective clothing and use a high-factor sunscreen (SPF) as you may be more sensitive to the sun's UV rays.

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

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

Children

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

TakingPosaconazole Fresenius Kabiwith other medicines

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

Do not takePosaconazole Fresenius Kabiif you are taking any of the following medicines:

• terfenadine (used to treat allergies)
• astemizol (used to treat allergies)
• cisaprida (used to treat stomach problems)
• pimozida (used to treat symptoms of Tourette's syndrome and mental illnesses)
• halofantrina (used to treat malaria)
• quinidina (used to treat abnormal heart rhythms).

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

• any medicine that contains "ergot alkaloids", such as ergotamine or

dihidroergotamina used to treat migraines. Posaconazole may increase the amount of these medicines in your blood, which could cause a severe reduction in blood flow to your fingers or toes and damage them.

• a "statin", such as simvastatina, atorvastatina or lovastatina used to treat high cholesterol levels.
• venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

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

Other medicines

See the list provided earlier with the medicines that you should not use while taking Posaconazole Fresenius Kabi. In addition to the medicines mentioned above, there are other medicines that present a risk of heart rhythm problems, which may be greater when taken with Posaconazole. Make sure to inform your doctor of all the medicines you are taking (with or without a prescription).

Some medicines may increase the risk of adverse effects of Posaconazole by increasing the amount of this medicine in your blood.

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

• rifabutina and rifampicina (used to treat certain infections). If you are already taking

rifabutina, you will need to have a blood test, as well as be aware of some possible adverse effects of rifabutina.

• some medicines used to treat or prevent seizures include: fenitoína,

carbamazepina, fenobarbital or primidona.

• efavirenz and fosamprenavir, used to treat HIV infection.
• Flucloxacilina (antibiotic used to treat bacterial infections).

Posaconazole Fresenius Kabi may increase the risk of adverse effects of other medicines by increasing the amount of these medicines in your blood. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
• venetoclax (used to treat cancer)
• ciclosporina (used during or after transplants)
• tacrolimus and sirolimus (used during or after transplants)
• rifabutina (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including

lopinavir and atazanavir, which are administered with ritonavir)

• midazolam, triazolam, alprazolam or other "benzodiazepines" (used as sedatives or

muscle relaxants)

• diltiazem, verapamilo, nifedipino, nisoldipino or other "calcium channel blockers"

(used to treat high blood pressure)

• digoxina (used to treat heart failure)
• glipizida or other "sulfonilureas" (used to treat high blood sugar levels).
• acid transretinoico (ATRA), also known as tretinoína (used to treat some blood cancers).

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

Use of Posaconazole Fresenius Kabi with food and drink

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 breastfeeding

Inform your doctor if you are or think you may be pregnant before starting to take 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 may become pregnant, you should use effective contraceptive measures while taking this medicine. If you become pregnant while taking Posaconazole, 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 feel dizzy, sleepy or have blurred vision while 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, so it 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 a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not take Posaconazol Fresenius Kabi tablets and Posaconazol Fresenius Kabi oral suspension interchangeably without consulting your doctor or pharmacist, as it may result in reduced efficacy or increased risk of adverse reactions.

What dose is administered

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

subsequently 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 individually adjusted for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment regimen.

How to administer this medication

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

If you take more Posaconazol Fresenius Kabi than you should

If you think you may have taken too much Posaconazol, immediately inform your doctor, go to the hospital immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Posaconazol Fresenius Kabi

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

However, if it is almost time for the next dose, do not take the missed dose and resume your regular schedule.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Severe side effects

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following severe side 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 white of the eyes, dark or pale urine, feeling sick without apparent reason, stomach problems, loss of appetite or unusual weakness or fatigue, or an increase in liver enzymes detected in blood tests
• allergic reaction

Other side effects

Inform your doctor, pharmacist, or nurse if you notice any of the following side effects:

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

• an abnormal change in blood sodium levels detected in blood tests, whose signs

include confusion or weakness

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

recurring, stabbing, or aching

• headache
• low levels of potassium detected in blood tests
• low levels of magnesium detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or 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 may make you

more susceptible to infections and detected in blood tests

• fever
• sensation of weakness, dizziness, fatigue, or drowsiness
• eruption
• itching
• constipation
• rectal discomfort

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

• anemia, whose signs include headaches, feeling tired or dizzy, difficult breathing, or pale skin and low hemoglobin levels detected in blood tests
• low levels of platelets (thrombocytopenia), detected in blood tests. This may cause bleeding
• low levels of "leukocytes", 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 appear if

you have an inflammatory process

• inflammation of blood vessels
• problems with heart rhythm
• seizures (convulsions)
• neurological damage (neuropathy)
• abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or rapid heart rate, high or low blood pressure

low blood pressure

• low blood pressure
• inflammation of the pancreas (pancreatitis). This may cause severe stomach pain
• interruption of oxygen supply to the spleen (splenic infarction), which may cause severe stomach pain
• severe kidney problems, whose signs include increased or decreased urination with

urine that is a different color from normal

• high levels of creatinine in the blood, detected in blood tests
• coughing, hiccups
• nasal bleeding
• sharp, stabbing pain in the chest when breathing (pleuritic pain)
• inflammation of 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 unwell
• pain, back or neck pain, arm or leg pain
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• insomnia (difficulty sleeping)
• total or partial inability to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of the mucous membranes
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and diarrhea of mild to severe intensity, usually caused by a virus, stomach pain
• belching
• feeling anxious

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

• neumonia, whose signs include feeling short of breath and producing discolored mucus

from the lungs

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

skin peeling

• mental problems, such as hearing voices or seeing things that are not there
• syncope (fainting)
• problems with thinking or speaking, sudden movements, especially in the hands, that you

cannot control

• stroke, whose signs include pain, weakness, numbness, or tingling in the extremities
• presence of a blind spot or dark spot in the field of vision
• heart failure or heart attack, which may cause cardiac arrest and death, problems with heart rhythm 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 feeling short of breath or chest pain
• bleeding in the stomach or intestines, whose signs include vomiting blood or blood in the stool
• intestinal blockage (obstruction), especially of the "ileum". This blockage

prevents the contents of the intestine from passing through the colon and whose signs include

swelling, vomiting, severe constipation, loss of appetite, and abdominal cramps

• "uric acid hemolytic syndrome" that appears when there is destruction of red blood cells (hemolysis), which may occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red, white, and platelets), detected in blood tests
• purple spots and large patches on the skin (thrombotic thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• double vision
• breast pain
• inadequate functioning of the adrenal glands, which may cause weakness, fatigue, loss of appetite, skin discoloration

or other symptoms

• inadequate functioning of the pituitary gland, which may cause low levels of hormones in the blood that affect male or female reproductive organs

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

Unknown frequency:cannot be estimated from available data

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

Inform your doctor, pharmacist, or nurse if you experience any of the side effects

described above.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es

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

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

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition ofPosaconazol Fresenius Kabi

• The active ingredient is posaconazol. Each tablet contains 100 mg of posaconazol.
• The other components are acetate succinate of hypromellose, hypromellose, cornstarch, anhydrous colloidal silica, sodium croscarmellose, anhydrous lactose spray-dried, microcrystalline cellulose silicified, 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 contents of the package

Posaconazol Fresenius Kabi tablets are yellow-coated, gastro-resistant, biconvex capsules, approximately 19.9 mm in length, marked with ‘P100’ on one side.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Fresenius Kabi España, S.A.U

C/ Marina 16-18

Barcelona

08005 Spain

Responsible 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:

Last review date of this leaflet: 10/2021

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