POSACONAZOL 40 mg /Ml Suspensão Oral

Patient Information Leaflet

Posaconazole Tillomed 40 mg/ml Oral Suspension EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Table of Contents

1. What Posaconazole Tillomed is and what it is used for
2. What you need to know before you start taking Posaconazole Tillomed
3. How to take Posaconazole Tillomed
4. Possible side effects
5. Storage of Posaconazole Tillomed
6. Contents of the pack and additional information

Posaconazol Tillomed contains 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 the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:

• 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 in the mouth or throat area (called "aphthae") caused by fungi calledCandidathat have not been previously treated.

This medicine can also be used to prevent fungal infections in adults at 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 Posaconazol Tillomed if you:

• are allergic to posaconazole or any of the other components of this medication (listed in section 6).
• 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 slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazol if you are in any of the above circumstances. In case of doubt, consult your doctor or pharmacist before taking this medication.

See the section «Taking Posaconazol Tillomed with other medications» later for more information, including that related to other medications that may interact with Posaconazol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Posaconazol if you:

• have had an allergic reaction to another antifungal medication, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• have or have had liver problems. You may need to have blood tests while taking this medication.
• develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medication.
• have an abnormal heart rhythm (ECG) that shows a problem called prolongation of the QTc interval.
• have heart muscle weakness or heart failure.
• have a very slow heart rate.
• have any abnormal heart rhythm.
• have any problem with the amounts of potassium, magnesium or calcium in the blood.
• are taking vincristine, vinblastine and other «vinca alkaloids» (medications used to treat cancer).
• are taking venetoclax (a medication used to treat cancer).

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

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

You must avoid exposure to the sun while receiving 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.

Children and adolescents

Posaconazol Tillomed should not be used in children (17 years of age and younger).

Taking Posaconazol Tillomed 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 Posaconazol Tillomed 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 abnormal heart rhythms).

Posaconazol 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. Posaconazol 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 this medication if you are in any of the above circumstances. In case of 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 Posaconazol Tillomed. In addition to the medications mentioned earlier, there are other medications that present a risk of heart rhythm problems, which may be greater when taken with Posaconazol. 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 Posaconazol by increasing the amount of the medication in the blood.

The following medications may reduce the effectiveness of Posaconazol 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 primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• medications used to reduce stomach acidity such as cimetidine and ranitidine or omeprazole and similar medications called proton pump inhibitors.
• flucloxacillin (antibiotic used to treat bacterial infections)

Posaconazol Tillomed may possibly 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, verapamil, nifedipine, nisoldipine 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).
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

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

Taking Posaconazol Tillomed with food and drinks

To improve the absorption of posaconazole, it is best to take it during or immediately after a meal or a food drink (see section 3 «How to take Posaconazol Tillomed»). There is no information on the effect of alcohol on posaconazol.

Pregnancy and breastfeeding

Inform your doctor if you are or think you may be pregnant before starting to take Posaconazol Tillomed.

Do not take this medication if you are pregnant, unless your doctor tells you to.

If you are of childbearing age, you must use effective contraceptive measures while taking this medication. If you become pregnant while taking Posaconazol Tillomed, contact your doctor immediately.

Do not breastfeed while taking Posaconazol, as it may pass into breast milk in small amounts.

Driving and using machines

You may feel dizzy, sleepy or have blurred vision while taking Posaconazol, 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.

Posaconazol Tillomed contains glucose, propylene glycol, sodium benzoate, benzoic acid and sodium.

Posaconazol Tillomed contains approximately 350 mg of glucose per 1 ml of suspension. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medication. It may cause tooth decay.

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially «sodium-free».

This medication contains 2 mg of sodium benzoate per ml, which is equivalent to 10 mg/5 ml.

This medication contains 0.03 mg of benzoic acid per ml.

This medication contains 2.87 mg of propylene glycol (E1520) per ml, which is equivalent to 14.35 mg/5 ml.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will monitor your response and condition to determine for how long you should take Posaconazol and if you need any change in your daily dose.

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

The table below shows the recommended dose and treatment duration, which depend on the type of infection you have and may be adapted individually for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment schedule.

Whenever possible, take posaconazol during or immediately after a meal or food intake.

If you take more Posaconazol Tillomed than you should

If you are concerned that you may have taken too much, inform your doctor or healthcare professional immediately. In case of overdose or accidental ingestion, contact your doctor or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Posaconazol Tillomed

If you have forgotten a dose, take it as soon as you remember and then continue as before. However, if it is almost time for the next dose, take your dose when it is due. 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

• change in blood sodium levels detected in blood tests, whose signs include feeling confused or weak
• 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, difficulty breathing, or pale skin 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 have an inflammatory process
• inflammation of blood vessels
• heart rhythm problems
• seizures
• 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 is a different color than usual
• high creatinine levels in the blood, 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, feeling of habitual discomfort
• back, neck, arm, or leg pain
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• insomnia
• total or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep problems
• coordination or balance problems
• 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 producing 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
• 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 blockage (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 spots and large patches on the skin (thrombotic thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• diplopia
• mastalgia
• 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 of certain hormones in the blood 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)
• skin flushing

Frequency not known: cannot be estimated from available data

• Some patients have also reported feeling confused after taking Posaconazol.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 label after “CAD”. The expiration date is the last day of the month indicated.

Do not freeze.

If there is any suspension left in the bottle after more than four weeks of its first opening, do not use this medication. Return the bottle with the remaining suspension to your pharmacist.

Medications should not be thrown away through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Posaconazol Tillomed

• The active ingredient is posaconazol. Each milliliter of oral suspension contains 40 milligrams of posaconazol.
• The other components of the suspension are polisorbate 80 (E433), xanthan gum (E415), sodium benzoate, citric acid monohydrate (E330), sodium citrate (E331), glycerol (E422), emulsion of simethicone 30% (polidimethylsiloxane, triestearate of polyethylene glycol sorbitan, methylcellulose, silica gel, polyethylene glycol stearate, glycerides, sorbic acid, benzoic acid, sulfuric acid, water), liquid glucose, titanium dioxide, artificial cherry flavor (which contains ethyl acetate, benzaldehyde, hexanal, sassafras bark oil, propylene glycol (E1520), purified water, coumarin), purified water.

Appearance of the product and contents of the package

Posaconazol Tillomed is a white to off-white suspension with a characteristic odor, cherry flavor, a 105 ml oral suspension packaged in amber glass bottles. A measuring spoon is provided with each bottle to measure doses of 2.5 ml and 5 ml of the oral suspension.

Marketing Authorization Holder

Laboratorios Tillomed Spain S.L.U.

C/ Cardenal Marcelo Spínola 8, 1st floor, door F

28016 Madrid

Spain

Responsible for manufacturing(1)

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road, Portmarnock,

Co. Dublin, Ireland

Tillomed Malta Limited,

Malta Life Sciences Park,

LS2.01.06 Industrial Estate,

San Gwann, SGN 3000, Malta

(1)Only the responsible manufacturer will be indicated in each case

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 10/2024

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