Noxafil 100 mg comprimidos gastrorresistentes

Label: information for the user

Noxafil 100mg gastro-resistant tablets

posaconazol

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section4.

Noxafil contains a medication called posaconazol, which belongs to a group of medications called "antifungals". It is used to prevent and treat many different types of fungal infections.

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

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

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

• Infections caused by fungi of the familyAspergillusthat have not improved during treatment with the antifungal medications amphotericin B or itraconazole or when treatment with these medications 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 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 had to be interrupted;
• Infections caused by a fungus calledCoccidioidesthat have not improved during treatment with one or more medications, amphotericin B, itraconazole, or fluconazole, or when treatment with these medications had to be interrupted.

This medication can also be used to prevent fungal infections in adults and children aged 2years or older and weighing more than 40kg with a high risk of contracting a fungal infection, such as:

• Patients with a weakened immune system as a result of having received chemotherapy for "acute myeloid leukemia" (AML) or "myelodysplastic syndromes" (MDS)
• Patients receiving "high doses of immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).

Do not take Noxafil

• if you are allergic to posaconazole or any of the other ingredients in this medication (listed in section6).
• if you are taking: terfenadine, astemizol, cisaprida, pimozida, halofantrina, quinidina, any medication 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 gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Noxafil if you are in any of the above circumstances. If in doubt, consult your doctor or pharmacist before taking Noxafil.

See the section “Taking Noxafil with other medications” later for more information, including that related to other medications that may interact with Noxafil.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Noxafil if:

• you have had an allergic reaction to another antifungal medication, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• you have or have had liver problems. You may need to have blood tests while taking this medication.
• you develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medication.
• you have a heart rhythm alteration (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 heart rhythm alteration.
• you have any problem with potassium, magnesium or calcium levels in the blood.
• you are taking vincristine, vinblastine and other “vinca alkaloids” (medications used to treat cancer).
• you are taking venetoclax (a medication used to treat cancer).

You should avoid exposure to the sun while on treatment. It is essential to cover exposed skin areas with protective clothing and use high-factor sunscreen (SPF) as you may be more sensitive to UV rays from the sun.

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

If you develop severe diarrhea or vomiting (feel unwell) while taking Noxafil, consult your doctor, pharmacist or nurse immediately, as this situation may prevent the medication from working correctly. For more information, see section4.

Children

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

Taking Noxafil with other medications

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

Do not take Noxafil if you are taking any of the following medications:

• terfenadine (used to treat allergies)
• astemizol (used to treat allergies)
• cisaprida (used to treat stomach problems)
• pimozida (used to treat symptoms of Tourette syndrome and mental disorders)
• halofantrina (used to treat malaria)
• quinidina (used to treat heart rhythm alterations).

Noxafil may increase the amount of these medications in the blood, which could cause severe changes in your heart rhythm.

• any medication that contains "ergot alkaloids", such as ergotamine or dihidroergotamina used to treat migraines. Noxafil may increase the amount of these medications in the blood, which could cause severe reduction of blood flow to the fingers of the hands or feet 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 Noxafil if you are in any of the above circumstances. If in doubt, consult your doctor or pharmacist before taking this medication.

Other medications

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

Some medications may increase the risk of adverse effects of Noxafil by increasing the amount of Noxafil in the blood.

The following medications may decrease the effectiveness of Noxafil by reducing its levels in the 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.
• phenytoin, carbamazepine, phenobarbital or primidona (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• flucloxacilina (antibiotic used to treat bacterial infections).

Noxafil may increase the risk of adverse effects of other medications by increasing the amount of these medications in the blood. These medications 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)
• medications 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 certain blood cancers).

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

Pregnancy and breastfeeding

Inform your doctor if you are or may be pregnant before starting to take Noxafil.

Do not take Noxafil 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 medication. If you become pregnant while taking Noxafil, contact your doctor immediately.

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

Driving and operating machinery

You may feel dizziness, drowsiness or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machinery. If this occurs, do not drive or use any tools or machinery and contact your doctor.

Noxafil contains sodium

This medication contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Do not switch between Noxafil tablets and Noxafil oral suspension without consulting your doctor or pharmacist, as it may lead to a lack of effectiveness or increase the risk of adverse reactions.

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

What dosage 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, or 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 Noxafil than you should

If you think you may have taken too much Noxafil, inform your doctor immediately or go to the hospital right away.

If you forget to take Noxafil

• If you have forgotten 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 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, 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

• 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, crawling, 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 discomfort, flatulence, dry mouth, changes in taste
• heartburn (sensation of burning in the chest that rises to the throat)

• low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and detected in blood tests

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

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

• anemia, whose signs include headaches, feeling tired or dizzy, difficult breathing or paleness and low hemoglobin levels detected in blood tests
• low platelet levels (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 present 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 fast heart rate, high or 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 presents 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 lymph nodes (lymphadenopathy)
• decreased sensitivity, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, usual feeling of discomfort
• pain, back or neck pain, arm or leg pain
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• insomnia (inability to sleep)

• total or partial inability to speak
• swelling of the mouth

• abnormal dreams or sleep problems

• problems with coordination or balance
• inflammation of the mucosa

• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps and diarrhea of mild to severe, usually caused by a virus, stomach pain
• belching

• sensation of anxiety

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

• pneumonia, whose signs include feeling short of breath and production of discolored mucus
• 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 intense pain or swelling of 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 obstruction, especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include feeling bloated, vomiting, severe constipation, loss of appetite and abdominal cramps
• "uricemic 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 and large spots on the skin (thrombotic thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• diplopia (double vision)
• breast pain
• inadequate functioning of the adrenal glands, which may cause weakness, fatigue, loss of appetite, skin discoloration
• inadequate functioning of the pituitary gland, which may cause low levels in the blood of some hormones that affect the function of male or female sex organs
• hearing problems
• pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported feeling confused after taking Noxafil
• skin flushing

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 thenational notification system included in theAppendix V.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 EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Noxafil

• The active ingredient of Noxafil is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are acetate of hypromellose succinate, microcrystalline cellulose, hydroxypropylcellulose (E-463), dental type silica, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, macrogol 3350, titanium dioxide (E-171), talc, and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Noxafil gastro-resistant tablets have a yellow coating, are capsule-shaped, marked with the digits "100" on one side, and are packaged in blisters in boxes of 24 (2x12) or 96 (8x12) tablets.

Only some package sizes may be commercially available.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:<{MM/AAAA}><{mes AAAA}>.

Other sources of information

More detailed information about this medicine is available on the website of the European Medicines Agency:https://www.ema.europa.eu.