POSACONAZOLE STADA 100 mg GASTRO-RESISTANT TABLETS

2. What you need to know before you take Posaconazole Stada

Do not take Posaconazole Stada if:

? you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).

? you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, or a "statin", such as simvastatin, atorvastatin, or lovastatin.

• you have just started taking venetoclax or your venetoclax dose is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

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

See the section "Other medicines and Posaconazole Stada" below for more information, including information about other medicines that may interact with posaconazole.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take posaconazole 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 taking this medicine.
• you develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medicine.
• you have an abnormal heart rhythm (ECG) that shows a problem called QTc interval prolongation.
• you have weakness of the heart muscle or heart failure.
• you have a very slow heart rate.
• you have any abnormal heart rhythm.
• you have any problems with potassium, magnesium, or calcium levels 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).

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

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

You should avoid exposure to the sun while taking this treatment. It is important to cover exposed skin areas with protective clothing and use a sunscreen with a high sun protection factor (SPF), as you may be more sensitive to the UV rays of the sun.

Children and adolescents

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

Other medicines and Posaconazole Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Posaconazole Stada if you are taking any of the following medicines:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat abnormal heart rhythms).

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

• any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole may increase the amount of these medicines in your blood, which could cause a serious decrease in blood flow to your fingers or toes and damage them.
• a "statin", such as simvastatin, atorvastatin, or lovastatin, 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 if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Consult the list provided earlier with the medicines that you should not use while taking posaconazole. In addition to the medicines mentioned earlier, there are other medicines that may increase the 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 side effects of posaconazole by increasing the amount of posaconazole in your blood.

The following medicines may decrease the effectiveness of posaconazole by reducing its levels in your blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have a blood test, as well as be aware of some possible side effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• flucloxacillin (an antibiotic used against bacterial infections).

Posaconazole may increase the risk of side 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)
• cyclosporine (used during or after transplants)
• tacrolimus and sirolimus (used during or after transplants)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given 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)
• digoxin (used to treat heart failure)
• glipizide or other "sulfonylureas" (used to treat high blood sugar levels).
• all-trans retinoic acid (ATRA), also called tretinoin (used to treat certain blood cancers).

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking posaconazole.

Do not take posaconazole if you are pregnant, unless your doctor advises you to.

If you are a woman who can become pregnant, you must use effective contraception while taking this medicine. If you become pregnant while taking posaconazole, contact your doctor immediately.

Do not breast-feed while taking posaconazole, as small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking posaconazole, 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 Stada contains sodium

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

3. How to take Posaconazole Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Do not take posaconazole tablets and posaconazole oral suspension interchangeably without consulting your doctor or pharmacist, as this may lead to a lack of effectiveness or increase the risk of adverse reactions.

How much to take

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

The duration of treatment may depend on the type of infection you have and may be adjusted individually for you by your doctor. Do not adjust your dose yourself before consulting your doctor, or change your treatment schedule.

How to take this medicine

? 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 Posaconazole Stada than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Posaconazole Stada

? If you miss 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 normal schedule.

? Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

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

Allergic reaction

Other Adverse Effects

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

Frequent: may affect up to 1 in 10 patients

• A change in blood salt levels detected in blood tests, whose signs include a feeling of 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
• Lack of appetite, stomach pain, or stomach 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 can make you more prone to infections and are detected in blood tests
• Fever
• Feeling of weakness, dizziness, fatigue, or drowsiness
• Rash
• Itching
• Constipation
• Rectal discomfort

Infrequent: 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 count (thrombocytopenia), detected in blood tests. This can cause bleeding
• Low levels of "leukocytes", a type of white blood cell (leukopenia), 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 occur if you have an inflammatory process
• Inflammation of blood vessels
• Heart rhythm problems
• Seizures (convulsions)
• Nerve damage (neuropathy)
• Abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• Low blood pressure
• Pancreatitis (inflammation of the pancreas). 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 of a different color than usual
• High blood creatinine levels, detected in blood tests
• Cough, hiccups
• Nosebleeds
• Sharp and intense chest pain when breathing (pleuritic pain)
• Inflammation of the 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 of discomfort
• Pain, back or neck pain, pain in arms or legs
• Fluid retention (edema)
• Menstrual problems (abnormal vaginal bleeding)
• Insomnia (inability to sleep)
• Inability to speak totally or partially
• Mouth swelling
• Abnormal dreams or sleep problems
• Coordination or balance problems
• Mucosal inflammation
• Nasal congestion
• Breathing difficulties
• Chest discomfort
• Feeling bloated
• Nausea, vomiting, cramps, and diarrhea from mild to severe, usually caused by a virus, stomach pain
• Belching
• Feeling of restlessness

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

• Pneumonia, whose signs include shortness of breath and production of discolored phlegm
• High blood pressure in the blood vessels of the lungs (pulmonary hypertension), which can cause serious damage to the lungs and heart
• Blood 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
• Fainting
• Problems thinking or speaking, sudden movements, especially in hands, that cannot be controlled
• Stroke, whose signs include pain, weakness, numbness, or tingling in the limbs
• 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, heart rhythm problems 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 shortness of breath or pain when breathing
• Bleeding in the stomach or intestine, 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 of bloating, vomiting, severe constipation, loss of appetite, and abdominal cramps

• "Hemolytic uremic syndrome" that occurs 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 and large spots on the skin (thrombocytopenic purpura)
• Facial or tongue inflammation
• Depression
• Double vision
• Breast pain
• Adrenal gland dysfunction, which can cause weakness, fatigue, loss of appetite, skin discoloration
• Pituitary gland dysfunction, which can cause low blood levels of some hormones that affect the function of male or female sexual organs
• Hearing problems
• Pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)

Frequency not known: cannot be estimated from the available data

• Some patients have also reported feeling confused after taking posaconazole.
• Redness of the skin

Inform your doctor, pharmacist, or nurse if you experience any of the adverse effects described above.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Posaconazol Stada

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Posaconazol Stada

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

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

Appearance of the Product and Package Contents

Posaconazol Stada 100 mg gastro-resistant tablets have a yellow coating and are capsule-shaped, 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 unit-dose blister packs of 24x1 or 96x1, or in HDPE bottles of 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 Wien

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:

Germany Posaconazol AL 100 mg magensaftresistente Tabletten

Austria Posaconazol STADA 100 mg magensaftresistente Tabletten

Croatia Posakonazol STADA 100 mg želucanootporne tablete

Denmark Posaconazol STADA

Spain Posaconazol STADA 100 mg comprimidos gastrorresistentes EFG

Estonia Posaconazole STADA

Finland Posaconazole STADA 100 mg enterotabletti

France POSACONAZOLE EG 100 mg, comprimé gastrorésistant

Greece Posaconazole STADA

Ireland Posaconazole Clonmel 100 mg gastro-resistant tablets

Iceland Posaconazole STADA

Italy Posaconazolo Eurogenerici

Lithuania Posaconazole STADA 100 mg skrandyje neirios tabletes

Latvia Posaconazole STADA 100 mg zarnas škistošas tabletes

Malta Posaconazole Clonmel 100 mg Gastroresistant Tablets

Netherlands Posaconazol CF 100 mg, maagsapresistente tabletten

Poland Posaconazole STADA

Romania Posaconazol STADA 100 mg comprimate gastrorezistente

Sweden Posaconazole STADA 100 mg enterotablett

Slovenia Posakonazol STADA 100 mg gastrorezistentne tablete

Slovakia Posakonazol STADA 100 mg gastrorezistentne tablete

United Kingdom Posaconazole STADA 100 mg Gastro-resistant tablets

Date of the last revision of this prospectus:September 2024

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