Package Leaflet: Information for the User

Posaconazol Abdi 100 mg gastro-resistant tablets

Posaconazol

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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1. What isPosaconazol Abdiand what it is used for

2. What you need to know before you start takingPosaconazol Abdi

3. How to takePosaconazol Abdi

4. Possible side effects

5. Storage ofPosaconazol Abdi

6. Contents of the pack and additional information

Posaconazol Abdi 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 certain types of fungi that can cause infections.

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

Posaconazol Abdi 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 who present a weakened immune system as a result of having received chemotherapy for "acute myeloid leukemia" (AML) or "myelodysplastic syndromes" (MDS)

patients who are receiving "high doses of immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).

Do not take Posaconazol Abdi:

• if you are allergic to posaconazol or any of the other ingredients in this medication (listed in section 6).
• if 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.
• if you have just started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

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

See the section “Taking Posaconazol Abdi with other medications” later for more information, including that related to other medications that may interact with Posaconazol Abdi.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Posaconazol Abdi 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).

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

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

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

Children

Posaconazol Abdi should not be used in children under 2 years of age.

Taking Posaconazol Abdi with other medications

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

Do not take Posaconazol Abdi 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 Abdi 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 Abdi may increase the amount of these medications in your blood, which could cause a severe decrease in 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 Abdi 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 Abdi. 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 Abdi. 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 Abdi by increasing the amount of Posaconazol Abdi in your blood.

The following medications may decrease the effectiveness of Posaconazol Abdi 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.
• some medications used to treat or prevent seizures include: phenitoína, carbamazepina, phenobarbital or primidona.
• efavirenz and fosamprenavir, used to treat HIV infection.
• flucloxacilina (antibiotic used to treat bacterial infections).

Posaconazol Abdi 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).
• 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 Abdi.

Pregnancy and breastfeeding

Inform your doctor if you are or think you may be pregnant before starting to take Posaconazol Abdi. Do not take Posaconazol Abdi 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 Abdi, contact your doctor immediately.

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

Driving and using machines

You may feel dizzy, sleepy or have blurred vision while taking Posaconazol Abdi, 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 Abdi contains lactose and sodium.

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

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

Do not interchange different formulations of posaconazol without consulting your doctor or pharmacist, as it may lead to reduced efficacy or increased risk of adverse reactions.

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.

What dosage is administered

The recommended dose is 300 mg (three 100 mg tablets) twice a day on the first day and subsequently 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 individually adjusted 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.
• Tablets can be taken with or without food.

If you take more Posaconazol Abdi than you should

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

If you forgot to take Posaconazol Abdi

• If you have forgotten a dose, take it as soon as you remember.
• However, if it is almost time for the next dose, do not take the missed dose and resume your regular schedule.
• 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

• change in blood sodium levels detected in blood tests, whose signs include feeling confused or weak
• 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 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 platelet levels (thrombocytopenia), detected in blood tests. This may cause bleeding
• low white blood cell levels (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
• heart rhythm problems
• seizures
• 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
• severe kidney problems, whose signs include increased or decreased urination with urine that has a different color than usual
• high creatinine levels in the blood, detected in blood tests
• toothache, hiccups
• nosebleeds
• 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
• total or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep problems
• coordination or balance problems
• 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: the following may affect up to 1 in 1,000 patients

• pneumonia, whose signs include feeling short of breath and production of 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 exfoliation
• mental problems, such as hearing voices or seeing things that are not there
• syncope
• 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 and large spots on the skin (thrombotic thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• diplopia
• mastalgia
• 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 Posaconazol Abdi
• Redness of the skin

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 prospectus.You can also report them directly through the Spanish System for the Vigilance 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.
• No special storage conditions are required.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Posaconazol Abdi

The active ingredient of Posaconazol Abdi is posaconazole. Each tablet contains 100 mg of posaconazole.

The other components are acetate succinate of hypromellose, hypromellose, cornstarch, anhydrous colloidal silica, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose silicified, hydroxypropylmethylcellulose, magnesium stearate, polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

The gastro-resistant tablets of Posaconazol Abdi have a yellow coating, are biconvex capsule-shaped, marked with "P100" on one face, and are packaged in pre-cut single-dose blisters in boxes of 24 (2x12) or 96 (8x12) tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Abdi Farma, Unipessoal Lda.

Quinta da Fonte, Rua dos Malhões,

Edifício D. Pedro I

2770 – 071 Paço de Arcos, Portugal

[email protected]

Responsible for manufacturing

Interpharmaservices Ltd.

43a Cherni Vrach Blvd; 1407- Sofia

Bulgaria

Local representative:

Cipla Europe NV subsidiary in Spain,

C/ Guzmán el Bueno,

133, Edif.Britannia, 28003,

Madrid, Spain

Last review date of this leaflet:August 2024

Other sources of information

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