Label: information for the user

Posaconazol Glenmark 40mg/ml oral suspension EFG

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 are not listed in this label. See section4.

This medication contains a medication called posaconazol, which belongs to a group of medications known as "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.

Posaconazol can be used in adults to treat the following types of fungal infections when other antifungal medications have not worked or you have had to stop taking them:

• Infections caused by fungi from the familyAspergillusthat have not improved during treatment with the antifungal medications amphotericin B or itraconazole or when treatment with these medications has had to be interrupted;
• Infections caused by fungi from 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 medications, amphotericin B, itraconazole, or fluconazole, or when treatment with these medications has had to be interrupted;
• Infections in the mouth or throat area (called “aphthae”) caused by fungi calledCandidathat have not been previously treated.

This medication 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 if:

• You are allergic to posaconazol or any of the other components of this medication (including those listed in section6).
• 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.
• 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 posaconazol if you are in any of the above circumstances. If in doubt, consult your doctor or pharmacist before taking posaconazol.

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

Warnings and precautions

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

• You have had an allergic reaction to another antifungal medication, such as ketoconazol, fluconazol, itraconazol or voriconazol.
• 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 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” (medications used to treat cancer).
• You are taking venetoclax (a medication used to treat cancer).

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

You should avoid exposure to the sun while taking 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 develop severe diarrhea or vomiting (you feel unwell) while taking posaconazol, consult your doctor, pharmacist or nurse immediately, as this situation may prevent the medication from working correctly. For more information, see section4.

Children and adolescents

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

Other medications and Posaconazol Glenmark

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

Do not take posaconazol 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's syndrome and mental illnesses)
• halofantrina (used to treat malaria)
• quinidina (used to treat abnormal heart rhythms).

Posaconazol may increase the amount of these medications in your 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 your blood, which could cause severe reduction of 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 posaconazol 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 posaconazol. 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 posaconazol in your blood.

The following medications may reduce the effectiveness of posaconazol 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.
• fenitoína, carbamazepina, fenobarbital or primidona (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• medications used to reduce stomach acidity such as cimetidina and ranitidina or omeprazol and similar medications called proton pump inhibitors.
• Flucloxacilina (antibiotic used to treat bacterial infections).

Posaconazol may possibly increase the risk of adverse effects of other medications by increasing the amount of these medications in your 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).
• Ácido transretinoico (ATRA), also called 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 posaconazol.

Taking Posaconazol with food and drinks

To improve the absorption of posaconazol, it is best to take it during or immediately after a meal or a food drink (see section 3 “How to take Posaconazol Glenmark oral suspension EFG). 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.

Do not take posaconazol 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 posaconazol, contact your doctor immediately.

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

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 contains sodium benzoate (E-211)

This medication contains 10 mg of sodium benzoate (E-211) per 5 ml of suspension.

Posaconazol contains Glucose

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Posaconazol contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 milliliters; that is, it is essentially “sodium-free”.

Do not interchange posaconazole oral suspension and posaconazole tablets or oral suspension gastrorresistantwithout consulting your doctor or pharmacist, as it may result in a lack of efficacy or increase the risk of adverse reactions.

Follow exactly the administration instructions of this medication 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 posaconazole should be administered and if any change in your daily dose is needed.

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 posaconazole during or immediately after a meal or food intake.

If you take more posaconazole 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, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take posaconazole

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 as scheduled. 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

• 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, crawling, pinching, or burning
• 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 (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 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 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
• serious kidney problems, whose signs include increased or decreased urination with urine that is a different color from usual

• high levels of creatinine in the blood detected in blood tests
• cough, hiccups
• nasal bleeding
• sharp, 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, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, habitual feeling of discomfort
• 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 mucosa
• nasal congestion
• difficulty breathing
• chest discomfort
• sensation of swelling
• nausea, vomiting, cramps, and diarrhea of mild to severe, usually caused by a virus, stomach pain
• belching
• sensation of unease

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 (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 spots and large patches on the skin (thrombotic thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• diplopia (double vision)
• mastalgia (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 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)

Unknown frequency: cannot be estimated from available data

• Some patients have also reported feeling confused after taking posaconazole
• 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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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. The expiration date is the last day of the month indicated.
• Do not refrigerate or freeze.
• Use within 30 days after opening the container.
• 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. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Posaconazol Glenmark oral suspension EFG

• The active ingredient is posaconazol. Each milliliter of oral suspension contains 40milligrams of posaconazol.
• The other components of the suspension are citric acid monohydrate, monosodium citrate anhydrous, sodium benzoate (E-211), sodium lauryl sulfate, 30% simethicone emulsion (containing simethicone, methylcellulose, sorbic acid, and purified water), glycerol, xanthan gum, liquid glucose, titanium dioxide (E-171), cherry flavor, and purified water.

Appearance of the product and contents of the package

Posaconazol Glenmark oral suspension EFG is a white to yellowish oral suspension with a cherry flavor, packaged in amber glass bottles (type III) closed with a plastic screw cap (made of polypropylene or polyethylene) child-resistant with a three-layer polyethylene coating, containing 105 ml of oral suspension. With each bottle, a suitable plastic dosing spoon is provided for administering doses of 2.5 ml and 5 ml.

Holder of the marketing authorization and manufacturer:

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Genepharm, S.A.

Marathonos Avenue 18 Th Km,

153 51 Pallini. Attikis

Greece

RAFARM S.A.

Thesi Pousi-Xatzi Agiou Louka

TK 19002 Paiania Attiki

Greece

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

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

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

Last review date of this leaflet:November 2024.

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