Posaconazole Abdi 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Posaconazole Abdi 100 mg gastro-resistant tablets

Posaconazole

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Posaconazol Abdi contains a medicine called posaconazole, which belongs to a group of medicines known as "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.

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

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

• infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines has had to be discontinued;
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B, or when treatment with amphotericin B has had to be discontinued;
• infections caused by fungi that lead to diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole, or when treatment with itraconazole has had to be discontinued;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more medicines, such as amphotericin B, itraconazole or fluconazole, or when treatment with these medicines has had to be discontinued.

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

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

2. What you need to know before taking Posaconazol Abdi

Do not take Posaconazol Abdi:

• if you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine containing "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 gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

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

See the section “Taking Posaconazol Abdi with other medicines” below for more information, including about other medicines that may interact with Posaconazol Abdi.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Posaconazol Abdi if:

• you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• you currently have or have previously had liver problems. You may need blood tests while taking this medicine.
• you develop severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine.
• you have a heart rhythm disorder (ECG) showing a problem called QTc interval prolongation.
• you have weakened heart muscle or heart failure.
• you have a very slow heart rate.
• you have any heart rhythm disorder.
• you have any imbalance in blood levels of potassium, magnesium or calcium.
• you are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer).
• you are taking venetoclax (a medicine used to treat cancer).

You should avoid exposure to sunlight during treatment. It is important to cover exposed skin areas with protective clothing and use sunscreen with a high sun protection factor (SPF), as increased sensitivity of the skin to UV rays from sunlight may occur.

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

If you develop severe diarrhoea or vomiting (feel unwell) while taking Posaconazol Abdi, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. For more information, see section 4.

Children

Posaconazol Abdi must not be used in children aged 2 years.

Taking Posaconazol Abdi with other medicines

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

Do not take Posaconazol Abdi 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 disorders)

Posaconazol Abdi may increase the amount of these medicines in your blood, which could cause serious changes in your heart rhythm.

• any medicine containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazol Abdi may increase the amount of these medicines in your blood, which could cause a serious reduction in blood flow to the fingers of the hands or feet and damage them.
• a "statin", such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels.
• venetoclax when used at the beginning of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take Posaconazol Abdi if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Refer to the list above for medicines you must not take while using Posaconazol Abdi. In addition to the medicines mentioned above, there are other medicines that carry a risk of heart rhythm problems, which may be increased when taken with Posaconazol Abdi. Make sure you inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of side effects from Posaconazol Abdi by increasing the amount of Posaconazol Abdi in the blood.

The following medicines may reduce the effectiveness of Posaconazol Abdi by lowering its blood levels:

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

Posaconazol Abdi may increase the risk of side effects from other medicines by increasing their blood levels. These medicines include:

• vincristine, vinblastine and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after organ transplants)
• tacrolimus and sirolimus (used during or after organ 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 any of the above apply to you (or if you are 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 specifically instructs you to do so.

If you are a woman who could become pregnant, you should use effective contraception while taking this medicine. 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, drowsy or experience blurred vision while taking Posaconazol Abdi, which may affect your ability to drive or use tools or machines. If this occurs, do not drive or operate any tools or machinery and contact your doctor.

Posaconazol Abdi contains lactose and sodium.

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

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

3. How to take Posaconazole Abdi

Do not interchange between different formulations of posaconazole without consulting your
doctor or pharmacist, as this may result in reduced effectiveness or increased risk of adverse reactions.

Always follow exactly the administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is 300 mg (three 100 mg tablets) twice daily on the first day, followed by 300 mg (three 100 mg tablets) once daily thereafter.

The duration of treatment may depend on the type of infection you have and may be individually adjusted by your doctor. Do not adjust your dose yourself before consulting your doctor, nor 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 may be taken with or without food.

If you take more Posaconazole Abdi than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the hospital straight away, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Posaconazole Abdi

• If you forget a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
• Do not take a double dose to make up for a forgotten dose.

If you have any further questions about 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 everyone will experience them.

Serious adverse effects

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment:

• nausea or vomiting (feeling sick or being sick), diarrhoea
• signs of liver problems, including yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, feeling unwell without apparent reason, stomach problems, loss of appetite, or unusual tiredness or weakness, or increased 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:

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

• a change in blood electrolyte levels detected in blood tests, which may include symptoms such as confusion or weakness
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling sensations, pricking, 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 (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and is detected in blood tests
• fever
• feeling weak, dizzy, tired, or drowsy
• rash
• itching
• constipation
• rectal discomfort

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

• anaemia, with symptoms including headaches, feeling tired or dizzy, shortness of breath, paleness, and low haemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This may cause bleeding
• low levels of "leucocytes", a type of white blood cell (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 occur if you have an inflammatory condition
• inflammation of blood vessels
• heart rhythm problems
• seizures (fits)
• neurological damage (neuropathy)
• abnormal heart rhythm detected on an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis). This may cause severe stomach pain
• interruption of blood supply to the spleen (splenic infarction), which may cause severe stomach pain
• serious kidney problems, with symptoms including increased or decreased urination with urine of unusual colour
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain when breathing (pleuritic pain)
• swelling of lymph nodes (lymphadenopathy)
• reduced sensation, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of discomfort
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep disturbances
• coordination or balance problems
• inflammation of the mucosa
• nasal congestion
• breathing difficulties
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and mild to severe diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling restless

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

• pneumonia, with symptoms including shortness of breath and production of discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood disorders such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread rash with blisters and skin peeling
• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, sudden jerky movements, especially in the hands, that you cannot control
• stroke, with symptoms including pain, weakness, numbness, or tingling in the limbs
• presence of a blind spot or dark spot in the visual field
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), with symptoms including severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism), with symptoms including shortness of breath or pain when breathing
• bleeding in the stomach or intestine, with symptoms including vomiting blood or blood in stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, with symptoms including bloating, vomiting, severe constipation, loss of appetite, and cramps
• "haemolytic uraemic syndrome" which occurs when red blood cells are destroyed (haemolysis), which may occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red cells, white cells, and platelets), detected in blood tests
• large purple spots on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• inadequate adrenal gland function, which may cause weakness, tiredness, loss of appetite, skin discolouration
• inadequate pituitary gland function, which may cause low blood levels of certain hormones affecting male or female sexual organ function
• hearing problems
• pseudoaldosteronism, causing high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from the available data

• Some patients have also reported feeling confused after taking Posaconazol Abdi
• Skin redness

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Posaconazole Abdi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Posaconazol Abdi

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

The other components are succinate acetate of hypromellose, hypromellose, corn starch, colloidal anhydrous silica, sodium croscarmellose, lactose monohydrate, silicified microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, polyvinyl alcohol (E1203), titanium dioxide (E 171), macrogol (E 1521), talc (E 553b), yellow iron oxide (E 172).

Appearance of the product and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Abdi Farma, Unipessoal Lda.

Quinta da Fonte, Rua dos Malhões,

Edifício D. Pedro I

2770 – 071 Paço de Arcos, Portugal

[email protected]

Manufacturer

Interpharmaservices Ltd.;

43a Cherni Vrach Blvd; 1407 - Sofia

Bulgaria

Local representative:

Cipla Europe NV, Spanish branch,

C/ Guzmán el Bueno,

133, Edif. Britannia, 28003,

Madrid, Spain

Date of the latest revision of this leaflet: August 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es