Posaconazole Accord 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Posaconazole Accord 100 mg gastro-resistant tablets EFG

Posaconazole

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Posaconazol Accord can be used in adults and children aged 2 years and older 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 leading to the 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 may also be used to prevent fungal infections in adults and children aged 2 years and older who weigh more than 40 kg and who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to receiving chemotherapy for "acute myelogenous leukemia" (AML) or "myelodysplastic syndromes" (MDS);
• patients receiving "high doses of immunosuppressive therapy" following "haematopoietic stem cell transplantation" (HSCT).

2. What you need to know before taking Posaconazol Accord

Do not take Posaconazol Accord if:

• you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• 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.
• you have recently started taking venetoclax or your venetoclax dose is being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Posaconazol Accord if:

• you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazol, or voriconazole.
• you currently have or have previously had liver problems. You may need blood tests while taking this medicine.
• you develop severe diarrhea 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 irregular heart rhythm.
• you have any problems with levels of potassium, magnesium, or calcium in your blood.
• you are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer).
• you are taking venetoclax (a medicine used to treat cancer).

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

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

You should avoid exposure to sunlight while on 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.

Children

Posaconazol Accord must not be given to children under 2 years of age.

Taking Posaconazol Accord with other medicines

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

Do not take Posaconazol Accord 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 syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders)

Posaconazol Accord may increase the levels of these medicines in the 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 Accord may increase the levels of these medicines in the blood, which could cause a serious reduction in blood flow to the fingers of the hands or feet, potentially causing damage.
• 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 Accord if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Please refer to the list above of medicines you must not take while using Posaconazol Accord. 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 Accord. Make sure to 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 Accord by increasing the amount of Posaconazol Accord in the blood.

The following medicines may reduce the effectiveness of Posaconazol Accord 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.
• 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).

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

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• ciclosporin (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, 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 known as tretinoin (used to treat certain blood cancers)

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Posaconazol Accord.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you might be pregnant before starting to take Posaconazol Accord.

Do not take Posaconazol Accord if you are pregnant, unless your doctor specifically tells you to.

If you are of childbearing age, you should use effective contraception while taking this medicine. If you become pregnant while taking Posaconazol Accord, contact your doctor immediately.

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

Driving and using machines

You may experience dizziness, drowsiness, or blurred vision while taking Posaconazol Accord, which may affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use any tools or machinery and contact your doctor.

Posaconazol Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Posaconazole Accord

Do not switch interchangeably between Posaconazole Accord tablets and Posaconazole Accord oral suspension without consulting your doctor or pharmacist, as this may result in lack of effectiveness or increased 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.

What dose to take

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

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 this medicine is administered

• Swallow the tablet whole with water.
• Do not crush, chew, break, or dissolve the tablet.
• Tablets may be taken with or without food.

If you take more Posaconazole Accord than you should

If you think you may have taken too much Posaconazole Accord, contact your doctor or go immediately to the hospital.

If you forget to take Posaconazole Accord

• If you forget 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 usual dosing 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 gets them.

Serious adverse effects

Tell your doctor, pharmacist or nurse immediately if you notice any of the following serious adverse effects; you may need 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 sick for no apparent reason, stomach problems, loss of appetite, or unusual tiredness or weakness, an increase in 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, signs of which include feeling confused or weak
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling sensations, prickling 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 sensation
• 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 of weakness, dizziness, tiredness or drowsiness
• rash
• itching
• constipation
• rectal discomfort

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

• anaemia, signs of which include headaches, feeling tired or dizzy, shortness of breath or 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 process
• inflammation of blood vessels
• problems with heart rhythm
• seizures (fits)
• nerve 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 oxygen supply to the spleen (splenic infarction), which may cause severe stomach pain
• serious kidney problems, signs of which include increased or decreased urination with urine that is a different colour than usual
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain when breathing (pleuritic pain)
• swelling of the 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 trouble sleeping
• problems with coordination or balance
• inflammation of the mucosa
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps and diarrhoea from mild to severe, usually caused by a virus, stomach pain
• belching
• feeling restless

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

• pneumonia, signs of which include feeling short of breath and producing discoloured phlegm

• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart

• blood problems such as unusual blood clotting or prolonged bleeding

• severe allergic reactions, including widespread rash with blisters and peeling of the skin

• 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, signs of which include pain, weakness, numbness or tingling in limbs

• 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, heart rhythm problems with sudden death

• blood clots in the legs (deep vein thrombosis), signs of which include severe pain or swelling of the legs

• blood clots in your lungs (pulmonary embolism), signs of which include feeling short of breath or pain when breathing

• bleeding in the stomach or intestines, signs of which include vomiting blood or blood in the stools

• a blockage of the intestine (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, signs of which include feeling bloated, 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 functioning of the adrenal glands, which may cause weakness, tiredness, loss of appetite, skin discolouration

• inadequate functioning of the pituitary gland, which may cause low blood levels of certain hormones affecting male or female sexual organ function

• hearing problems

• pseudoaldosteronism, which causes high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported feeling confused after taking Posaconazol Accord
• redness of the skin

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, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Posaconazole Accord

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

6. Contents of the pack and other information

Composition of Posaconazole Accord

The active substance is posaconazole. Each tablet contains 100 mg of posaconazol.

The other components are methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), microcrystalline cellulose (E460), colloidal anhydrous silica, sodium croscarmellose, sodium stearoyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).

Appearance of the product and contents of the pack

Posaconazole Accord gastro-resistant tablets have a yellow coating, are capsule-shaped with dimensions of approximately 17.5 mm in length and 6.7 mm in width. They are marked with the digits "100" on one side, while the other side is smooth. The tablets are packaged in blisters or perforated unit-dose blisters, in cartons containing 24 or 96 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6th floor, Barcelona,

08039 Barcelona, Spain

Manufacturer

Delorbis Pharmaceuticals Limited

Ergates Industrial Area

Athinon 17 V, Ergates

Nicosia, 2643

Cyprus

Laboratori Fundacio Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PL / PT / RO / SE / SI / SK

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

EL

Win Medica Α.Ε.

Tel: +30 210 74 88 821

Date of the most recent review of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.