POSACONAZOLE ALMOVAR 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Posaconazole Almovar 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 or pharmacist.

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Posaconazole Almovar contains a medicine 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 aged 2 years and older 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 has 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 has 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 has 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 has had to be stopped.

This medicine can also be used to prevent fungal infections in adults and children aged 2 years and older 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 as a result of having received chemotherapy for “acute myelogenous leukaemia” (AML) or “myelodysplastic syndromes” (MDS)
• patients who are receiving “high-dose immunosuppressive treatment” after a “haematopoietic stem cell transplant” (HSCT).

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

Do not take Posaconazole Almovar

• 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 recently started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukaemia (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 Almovar” below for more information, including information about other medicines that may interact with posaconazole.

Warnings and precautions

Consult your doctor or pharmacist before you start taking this medicine if you:

• have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• have or have had liver problems. You may need to have blood tests while you are taking this medicine.
• develop severe diarrhoea or vomiting, as these conditions can limit the effectiveness of this medicine.
• have a heart rhythm problem (ECG) that shows a problem called prolonged QTc interval
• have weakness of the heart muscle or heart failure
• have a very slow heart rate
• have any heart rhythm problems
• have any problems with the levels of potassium, magnesium or calcium in your blood
• are taking vincristine, vinblastine and other “vinca alkaloids” (medicines used to treat cancer).
• are taking venetoclax (a medicine used to treat cancer).

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

If you develop severe diarrhoea or vomiting while taking posaconazole, consult your doctor or pharmacist immediately, as this condition can prevent the medicine from working properly. For more information, see section 4.

Children

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

Other medicines and Posaconazole Almovar

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

Do not take Posaconazole Almovar 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 heart rhythm problems).

Posaconazole may increase the levels of these medicines in your blood, which could lead to 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 levels of these medicines in your blood, which could lead to a serious reduction 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 leukaemia (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 must 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 levels of posaconazole in your blood.

The following medicines may reduce 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.

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)
• ciclosporin (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 “sulphonylureas” (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 think you may be pregnant, consult your doctor before taking this medicine.

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 Almovar contains sodium

Posaconazole Almovar contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Posaconazole Almovar

Do not switch between posaconazole 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.

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

How much to take

The recommended dose is 300 mg (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 adapted individually for you by your doctor. Do not change 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 Almovar 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Posaconazole Almovar

• 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 or pharmacist.

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 or pharmacist 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 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 or pharmacist 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 drowsiness
• 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 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 appear 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 that has a different color than usual
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nasal bleeding
• 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)
• 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 bloated, vomiting, severe constipation, loss of appetite, and abdominal cramps
• "hemolytic uremic 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
• large purple spots on the skin (thrombocytopenic purpura)
• inflammation of the face or tongue
• 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.

Tell your doctor or pharmacist 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, 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: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Posaconazol Almovar

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

Do not use this medicine after the expiration date that appears on the box and blister after "EXP". 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. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Posaconazol Almovar

• The active ingredient is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are Core of the tablet: acetate succinate of hypromellose, microcrystalline cellulose, hydroxypropylcellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate Coating material: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)

Appearance of the Product and Package Contents

Posaconazol Almovar gastro-resistant tablets are film-coated tablets of yellow color, oblong and biconvex (17.7 mm in length and 7.0 mm in width).

Posaconazol Almovar film-coated tablets are available in boxes of 24, 48, and 96 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua,

Portugal

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16

3450-232 Mortágua

Portugal

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

LAPHYSAN, S.A.U.

Anabel Segura 11, Edificio A, Planta 4, Puerta D,

28108 Alcobendas - Madrid

Spain

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

Portugal Posaconazol Almovar

Spain Posaconazol Almovar 100 mg gastro-resistant tablets EFG

Date of the last revision of this leaflet: 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/