POSACONAZOLE VIVANTA 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Posaconazole Vivanta 100 mg Gastro-Resistant Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Posaconazole Vivanta and what is it used for

This medicine contains the active substance called posaconazole, which belongs to a group of medicines called "antifungals". It is used to prevent and treat many different fungal infections.

This medicine works by killing or stopping the growth of certain types of fungi that can cause infections.

Posaconazole can be used in adults to treat fungal infections caused by fungi of the Aspergillusfamily.

Posaconazole can be used in adults and children from 2 years of age and weighing more than 40 kg to treat the following types of fungal infections:

• infections caused by fungi of the Aspergillusfamily that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines had to be stopped;
• infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B, or when treatment with amphotericin B had to be stopped;
• infections caused by fungi that cause diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole, or when treatment with itraconazole had to be stopped;
• infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more medicines, amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines had to be stopped.

This medicine can also be used to prevent fungal infections in adults and children from 2 years of age and weighing more than 40 kg who are at high risk of getting a fungal infection, such as:

• patients who have a weakened immune system due to chemotherapy for "acute myelogenous leukemia" (AML) or "myelodysplastic syndromes" (MDS)
• patients who are receiving "high-dose immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).

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

Do not take Posaconazole Vivanta

• if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
• if 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.
• if 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 Vivanta 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 Vivanta” 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 conditions can limit the effectiveness of this medicine.
• you have an abnormal heart rhythm (ECG) that shows a problem called prolonged QTc interval.
• 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 while taking posaconazole, consult your doctor, pharmacist, or nurse immediately, as this condition can 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 sunscreen with a high sun protection factor (SPF), as you may be more sensitive to the UV rays of the sun.

Children

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

Other medicines and Posaconazole Vivanta

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

Do not take Posaconazole Vivanta 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 their levels 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 for advice before taking posaconazole. Do not take posaconazole if you are pregnant, unless your doctor tells 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 Vivanta 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 Vivanta

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Do not switch between posaconazole gastro-resistant tablets and posaconazole oral suspension 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 tablets) twice a day on the first day and then 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 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 Vivanta than you should

If you think you may have taken too much posaconazole, 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 Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Posaconazole Vivanta

• 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 return to your normal schedule.
• Do not take a double dose to make up for missed 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

Tell 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 apparent reason, stomach problems, loss of appetite or unusual fatigue or weakness, elevated liver enzymes detected in blood tests
• allergic reaction

Other Adverse Effects

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

Frequent: the following may affect up to 1 in 10 patients

• a change in blood salt levels detected in blood tests, whose signs include feelings 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
• loss 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 somnolence
• rash
• itching
• constipation
• rectal discomfort

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

• anemia, whose signs include headaches, feeling tired or dizzy, difficult breathing, or pallor 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
• 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 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 pain or neck pain, pain in arms or legs
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• 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: the following 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 your hands, that you cannot control
• 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 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
• large purple spots on the skin (thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• double vision
• 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 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
• skin redness

Tell 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 leaflet. You can also report them 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 Vivanta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister 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.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Posaconazol Vivanta

• The active ingredient is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are acetate succinate hypromellose, microcrystalline cellulose, hydroxypropylcellulose (E463), sodium croscarmellose (E468), anhydrous colloidal silica, magnesium stearate (E470b), partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172).

Appearance of the Product and Package Contents

Posaconazol Vivanta 100 mg gastro-resistant tablets are biconvex, textured, capsule-shaped, yellow, approximately 18 mm long, engraved with "MP 1" on one side and smooth on the other.

Package sizes:

Blisters in boxes of 24, 48, or 96 tablets and single-dose perforated blisters in boxes of 24, 48, or 96 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Vivanta Generics s.r.o

Trtinová 260/1, Cakovice

19600, Praga 9

Czech Republic

Manufacturer

Pharmadox Healthcare LimitedKW20A Kordin Industrial Park, Paola,

PLA3000, Malta

or

MSN Labs Europe LimitedKW20A Corradino Park, Paola,

PLA3000, Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. branch in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

Spain

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

Germany Posaconazol Vivanta 100 mg magensaftresistente Tabletten

Netherlands Posaconazol Vivanta 100 mg maagsapresistente tablet

Spain Posaconazol vivanta 100 mg comprimidos gastrorresistentes EFG

Finland Posaconazole Vivanta 100 mg enterotabletit

Norway Posaconazole Vivanta

Sweden Posaconazole Vivanta 100 mg enterotabletter

Denmark Posaconazole Vivanta

Date of the last revision of this leaflet: August 2024

Other Sources of Information

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/.