POSACONAZOLO 100 mg Enteric-Coated Tablet

Зміст інструкції

1. Posaconazolo Accord 100 mg gastro-resistant tablets
   1. What is Posaconazolo Accord and what it is used for
   2. What you need to know before taking Posaconazolo Accord
   3. How to take Posaconazolo Accord
   4. Possible side effects
   5. How to store Posaconazolo Accord
   6. Package Contents and Other Information

Posaconazolo Accord 100 mg gastro-resistant tablets

posaconazole

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Posaconazolo Accord contains a medicine called posaconazole. It belongs to a category of
medicines called “antifungals”. It is used to prevent and treat many different types of
fungal infections.
This medicine works by killing or blocking the growth of certain types of fungi that can
cause infections.
Posaconazolo Accord can be used in adults to treat fungal infections
caused by fungi of the Aspergillusfamily:

• Posaconazolo Accord can be used in adults and children 2 years of age and older 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 the conditions 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 of the following 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 in
children 2 years of age and older weighing more than 40 kg who are at high risk of developing a
fungal infection, such as:

• patients who have a weakened immune system due to chemotherapy for “acute myeloid leukemia” (AML) or “myelodysplastic syndromes” (MDS);
• patients who are using a “high-dose immunosuppressive therapy” following “hematopoietic

stem cell transplantation” (HSCT).

2. What you need to know before taking Posaconazolo Accord

Do not take Posaconazolo Accord if:

• you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
• you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine that contains “alkaloids derived from ergot” such as ergotamine or dihydroergotamine or a “statin” such as simvastatin, atorvastatin or lovastatin.
• if you have just started taking venetoclax or if the dose of venetoclax is slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazolo Accord if you have any of the conditions listed above. If you are not sure
ask your doctor or pharmacist before taking Posaconazolo Accord.
See below “Other medicines and Posaconazolo Accord” for more information including
information about other medicines that may interact with Posaconazolo Accord.

Warnings and precautions
Talk to your doctor or pharmacist before taking Posaconazolo Accord if:

• you have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.
• you have or have had problems with your liver. You may need to have blood tests while taking this medicine.
• you develop severe diarrhea or vomiting, as these conditions may limit the effectiveness of this medicine.
• you have an electrocardiogram (ECG) that shows a problem called a prolonged QTc interval.
• you have a weakness of the heart muscle (heart) or heart failure.
• you have a very slow heartbeat.
• you have an irregular heartbeat.
• you have any problems with your potassium, magnesium or calcium levels in the 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 you have any of the conditions listed above (or if you are not sure) ask your doctor, your
pharmacist or nurse before taking Posaconazolo Accord.
If you develop severe diarrhea or vomiting while taking Posaconazolo Accord, contact
your doctor, pharmacist or nurse immediately, as this may prevent it from working
correctly. See section 4 for more information.

Children
Posaconazolo Accord should not be given to children under 2 years of age.

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

Do not take Posaconazolo Accordif you are taking any of the following:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat the symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat abnormal heart rhythms).

Posaconazolo Accord can increase the amount of these medicines in the blood, which can lead
to very serious changes in your heart rhythm:

• any medicine that contains “alkaloids derived from ergot” such as ergotamine or dihydroergotamine used to treat migraine. Posaconazolo Accord can increase the amount of these medicines in the blood, which can lead to a serious reduction in blood flow to the fingers of the hands or feet and could damage them.
• a “statin” such as simvastatin, atorvastatin or lovastatin, used to treat high levels of cholesterol.
• venetoclax if used at the beginning of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take Posaconazolo Accord if you have any of the conditions listed above. If you are not sure
ask your doctor or pharmacist before taking this medicine.
Other medicines
Check the list of medicines, above, that must not be taken while you are taking
Posaconazolo Accord. In addition to the medicines listed above, there are other medicines that carry a
risk of changes in heart rhythm that may be greater if they are taken with
Posaconazolo Accord. Make sure you tell your doctor about all the medicines you are taking (with or
without a prescription).
Some medicines may increase the risk of side effects of Posaconazolo Accord
by increasing the amount of Posaconazolo Accord in the blood.
The following medicines may decrease the effectiveness of Posaconazolo Accord by decreasing the amount of
Posaconazolo Accord in the blood:

• rifabutin and rifampicin (used to treat some infections). If you are already being treated with rifabutin, you will need to have a blood test and pay attention to some possible side effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent convulsions).
• efavirenz and fosamprenavir used to treat HIV infection.

Posaconazolo Accord can increase the risk of side effects of certain other medicines
by increasing the amount of these medicines in the blood. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat tumors)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after transplant surgery)
• rifabutin (used to treat some 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 some blood cancers).

If you have any of the conditions listed above (or if you are not sure), ask your doctor or
pharmacist before taking Posaconazolo Accord.

Pregnancy and breastfeeding
Tell your doctor before taking Posaconazolo Accord if you are pregnant or
suspect you may be pregnant.
Do not take Posaconazolo Accord during pregnancy unless your doctor has told you to.
If you are a woman of childbearing potential, you should use effective contraception while taking
this medicine. Tell your doctor immediately if you become pregnant while
being treated with Posaconazolo Accord.
Do not breastfeed while you are being treated with Posaconazolo Accord. This is because small amounts
may pass into breast milk.

Driving and using machines
During treatment with Posaconazolo Accord you may feel dizzy, sleepy or have
blurred vision, which may affect your ability to drive or operate tools or
machinery. If this happens, do not drive or operate tools or machinery and contact
your doctor.

Posaconazolo Accord contains sodium
Each tablet contains less than 1 mmol of sodium (23 mg), which means this medicine is
essentially “sodium-free”.

3. How to take Posaconazolo Accord

Do not switch from Posaconazolo Accord tablets to other medicines containing posaconazole oral suspension without consulting your doctor or pharmacist because this may lead to a lack of efficacy or an increased risk of adverse reactions.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

How much to take
The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, followed by
300 mg (three 100 mg tablets) once a day, subsequently.
The duration of treatment may depend on the type of infection you have and may be adapted personally for you by your doctor. Do not adjust the dose yourself before consulting your doctor or do not modify
the treatment regimen.

How to take this medicine

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

If you take more Posaconazolo Accord than you should
If you think you may have taken more Posaconazolo Accord than you should, inform a doctor or go
immediately to the hospital.

If you forget to take Posaconazolo Accord

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

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Tell your doctor, pharmacist or nurse immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• nausea or vomiting, diarrhea
• signs of liver problems, these include yellowing of the skin or the white part of the eyes, urine of an unusually dark color or pale stools, unjustified feeling of unwellness, stomach problems, loss of appetite or unusual fatigue or weakness, increased liver enzymes detected in blood tests
• allergic reaction

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Common: the following can affect up to 1 in 10 people

• a change in blood salt levels detected in blood tests - signs include feeling confused or weak
• abnormal skin sensations, such as numbness, tingling, itching, goosebumps, prickling or burning
• headache
• low levels of potassium in the blood - detected in blood tests
• low levels of magnesium - detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or stomach discomfort, release of intestinal gas, dry mouth, changes in taste
• heartburn (a burning sensation in the chest that rises into the throat)
• low levels of “neutrophils” a type of white blood cells (neutropenia) - this can increase the risk of contracting infections and can be detected in blood tests
• fever
• feeling of weakness, dizziness, fatigue or drowsiness
• skin rash
• itching
• constipation
• rectal discomfort

Not common: the following can affect up to 1 in 100 people

• anemia - signs include headache, feeling tired or dizzy, shortness of breath or pale appearance and a low level of hemoglobin detected in blood tests
• low level of platelets (thrombocytopenia) detected in blood tests - this can lead to bleeding
• low level of “leukocytes” a type of white blood cells (leukopenia) detected in blood tests - this can increase the risk of contracting infections
• high level of “eosinophils” a type of white blood cells (eosinophilia) - this can occur if you have inflammation
• inflammation of the blood vessels
• changes in heart rhythm
• convulsions
• nerve damage (neuropathy)
• abnormal heart rhythm - detected by 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) - this can cause severe stomach pain
• serious kidney problems - signs include increased or decreased urine production that has a different color than usual
• high levels of creatinine in the blood - detected in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation of sensitivity, especially at the skin level
• tremor
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of unwellness
• pain, back pain or neck pain, pain in the arms or legs
• fluid retention (edema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• being completely or partially unable to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of the mucous membrane
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling of fullness
• nausea from mild to severe, vomiting, cramps and diarrhea, usually caused by a virus, stomach pain
• belching
• feeling of nervousness

Rare: the following can affect up to 1 in 1,000

• pneumonia - signs include feeling short of breath and expectorating colored sputum
• 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
• serious allergic reactions, including widespread blistering skin rashes and peeling skin
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, jerky movements, especially of the hands that you cannot control
• stroke - signs include pain, weakness, numbness or tingling in the limbs
• having a blind or dark spot in the field of vision
• heart failure or heart attack which could lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) - signs include severe pain or swelling of the legs
• blood clots in the lungs (pulmonary embolism) - signs include feeling short of breath or pain during breathing
• bleeding in the stomach or intestines - signs include vomiting blood or the presence of blood in the stool
• blockage in the intestine (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of the intestine from passing into the lower part of the intestine - signs include feeling of fullness, vomiting, severe constipation, loss of appetite and cramps
• “hemolytic uremic syndrome” when red blood cells break down (hemolysis) condition that can occur with or without kidney failure
• “pancytopenia” a low level of all blood cells (red blood cells and white blood cells and platelets) detected in blood tests
• extensive purplish discoloration on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• malfunctioning of the adrenal glands - this can cause weakness, fatigue, loss of appetite, skin discoloration
• malfunctioning of the pituitary gland - this can cause low blood levels of some hormones that affect the functioning of male or female sex organs
• changes in hearing
• pseudoaldosteronism, which causes high blood pressure with a low level of potassium (detected in blood tests).

Not known: the frequency cannot be estimated on the basis of the available data
Some patients have also reported feeling confused after taking Posaconazolo Accord.
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system reported in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Posaconazolo Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister or the pack after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Posaconazole Accord Contains
The active ingredient of Posaconazole Accord is posaconazole. Each tablet contains 100 mg of
posaconazole.
The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate (E1505),
xylitol (E967), hydroxypropylcellulose (E463), propyl gallate (E310), microcrystalline cellulose
(E460), anhydrous colloidal silica, sodium croscarmellose, sodium stearyl fumarate, polyvinyl alcohol, titanium
dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).

Description of Posaconazole Accord and Package Contents
Posaconazole Accord gastro-resistant tablets are capsule-shaped and yellow in colour, approximately
17.5 mm long and 6.7 mm wide, with “100P” imprinted on one side and smooth
on the other, packaged in blisters or unit-dose divisible blisters in boxes of 24 or 96 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6 planta, Barcelona,
08039 Barcelona, Spain

Manufacturer
Delorbis Pharmaceuticals Ltd.
17, Athinon Street
Ergates Industrial Area
2643 Nicosia
Cyprus
Laboratori Fundacio Dau
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
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

Other Sources of Information
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.