Package Leaflet: Information for the User

Posaconazol Stada 100 mg gastro-resistant tablets 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. Do 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.

1.What Posaconazol Stada is and what it is used for

2.What you need to know before you start taking Posaconazol Stada

3.How to take Posaconazol Stada

4.Possible side effects

5.Storage of Posaconazol Stada

6.Contents of the pack and additional information

This medication contains an active substance 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.

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

Posaconazol 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 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 2 years or older and weighing more than 40 kg 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 Posaconazol Stada if:

?You are allergic to posaconazol or any of the other components of this medication (listed in section 6).

?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 Medicaments and Posaconazol Stada” 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.

If you develop severe diarrhea or vomiting (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 section 4.

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 experience increased skin sensitivity to UV rays from the sun.

Children and Adolescents

Do not give posaconazol to children under 2 years of age.

Other Medicaments and Posaconazol Stada

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

Do not take Posaconazol Stada 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 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 Medicaments

See the list provided earlier with the medications that you should not use while taking posaconazol. 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 posaconazol. Ensure that you 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.
• 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)
• Tacrólimus 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 posaconazol.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist 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 Stada contains sodium

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

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 tablets and posaconazol oral suspension interchangeably without consulting your doctor or pharmacist, as it may result in a lack of efficacy or increase the risk of adverse reactions.

What dosage is administered

The recommended dose is 300 mg of posaconazol (three gastro-resistant tablets of 100 mg) twice a day on the first day and subsequently 300 mg of posaconazol (three gastro-resistant tablets of 100 mg) once a day.

The duration of treatment may depend on the type of infection you have and may be individually adapted 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.

?The tablets can be taken with or without food.

If you take more Posaconazol Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Posaconazol Stada

?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 usual regimen.

?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 unusual-colored urine, pale stools, feeling sick without apparent reason, stomach problems, unusual loss of appetite or weakness, 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: can 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 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 (sensation of burning 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 detected in blood tests
• fever
• sensation of weakness, dizziness, fatigue, or drowsiness
• eruption
• itching
• constipation
• rectal discomfort

Rare: can affect up to 1 in 100 patients

• anemia, whose signs include headaches, feeling tired or dizzy, difficulty breathing, or paleness and low hemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This can cause bleeding
• low white blood cell levels (leucopenia), 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 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
• inflammation of the pancreas (pancreatitis). This can cause severe stomach pain
• interruption 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 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 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 difficulty sleeping
• 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: can 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 can 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 can 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 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 obstruction, especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include

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

• "uricemic hemolytic syndrome" that appears 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
• 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 can cause weakness, fatigue, loss of appetite, skin discoloration
• inadequate functioning of the pituitary gland, which can 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.
• erythema (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 or 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 blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Posaconazole Stada

The active ingredient is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.

The other components are: copolymer of methacrylic acid – ethyl acrylate (1:1) (Type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, and sodium stearoylfumarate (See section 2 “Posaconazole Stada contains sodium”), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, and yellow iron oxide (E172).

Appearance of the product and contents of the package

Posaconazole Stada 100 mg gastro-resistant tablets have a yellow coating and are in the form of capsules, engraved with "100P" on one side and smooth on the other.

The tablets are packaged in non-perforated blister packs of 24 or 96 tablets, in perforated single-dose blister packs of 24x1 or 96x1, or in HDPE bottles of 60 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Delorbis Pharmaceuticals Ltd.

17, Athinon Street,

Ergates Industrial Area,

2643 Lefkosia,

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Thornton & Ross Ltd

Linthwaite, Huddersfield

HD7 5QH

United Kingdom

This medicine is authorized in the Member States of the European Economic Area with the following names:

GermanyPosaconazol AL 100 mg magensaftresistente Tabletten

AustriaPosaconazol STADA 100 mg magensaftresistente Tabletten

CroatiaPosakonazol STADA 100 mg želucanootporne tablete

DenmarkPosaconazol STADA

SpainPosaconazol STADA 100 mg comprimidos gastrorresistentes EFG

EstoniaPosaconazole STADA

FinlandPosaconazole STADA 100 mg enterotabletti

FrancePOSACONAZOLE EG 100 mg, comprimé gastrorésistant

GreecePosaconazole STADA

IrelandPosaconazole Clonmel 100 mg gastro-resistant tablets

IcelandPosaconazole STADA

ItalyPosaconazolo Eurogenerici

LithuaniaPosaconazole STADA 100 mg skrandyje neirios tabletes

LatviaPosaconazole STADA 100 mg zarnas škistošas tabletes

MaltaPosaconazole Clonmel 100 mg Gastroresistant Tablets

NetherlandsPosaconazol CF 100 mg, maagsapresistente tabletten

PolandPosaconazole STADA

RomaniaPosaconazol STADA 100 mg comprimate gastrorezistente

SwedenPosaconazole STADA 100 mg enterotablett

SloveniaPosakonazol STADA 100 mg gastrorezistentne tablete

SlovakiaPosakonazol STADA 100 mg gastrorezistentne tablete

United KingdomPosaconazole STADA 100 mg Gastro-resistant tablets

Last review date of this leaflet:September 2024

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