POSACONAZOLO 40 mg /Ml Zawiesina Doustna

Treść ulotki

1. Posaconazole Mylan 40 mg/ml oral suspension
   1. What is Posaconazolo Mylan and what is it used for
   2. What you need to know before taking Posaconazolo Mylan
   3. How to take Posaconazolo Mylan
   4. Possible side effects
   5. How to store Posaconazolo Mylan
   6. Contents of the pack and other information

Posaconazole Mylan 40 mg/ml oral suspension

Posaconazole

Generic medicine

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 they have the same symptoms as you, as it may be harmful.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Posaconazolo Mylan contains a medicine called posaconazole. It belongs to a category of
medicines called “antifungals”. It is used to prevent and treat many different varieties of
fungal infections.
This medicine works by killing or stopping the growth of certain types of fungi that can
cause infections.
Posaconazolo Mylan can be used in adults to treat the following types of fungal
infections when other antifungal medicines have not worked or you have had to stop taking them:

• infections caused by fungi from the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole or when you have had to stop treatment with these medicines;
• infections caused by fungi from the Fusarium family that have not improved during treatment with amphotericin B or when you have had to stop treatment with this medicine;
• infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when you have had to stop treatment with this medicine;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of the following medicines amphotericin B, itraconazole or fluconazole or when you have had to stop treatment with these medicines;
• infections of the mouth or throat (known as “thrush”) caused by fungi called Candida that have not been previously treated.

This medicine can also be used to prevent fungal infections in adults who are at
high risk of contracting 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 Mylan

Do not take Posaconazolo Mylan 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.

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Posaconazolo Mylan if:

• you have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.
• you have or have ever had liver problems. You may need to have blood tests while taking this medicine.
• you develop severe diarrhoea or vomiting, as these conditions can limit the effectiveness of this medicine.
• you have an abnormal heart rhythm tracing (ECG) showing a problem called a prolonged QTc interval.
• you have a weak heart muscle 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 and other “vinca alkaloids” (medicines used to treat cancer).

If you have any of the conditions listed above (or if you are not sure) talk to your doctor,
pharmacist or nurse before taking Posaconazolo Mylan.
If you develop severe diarrhoea or vomiting (feeling sick) while taking Posaconazolo
Mylan, contact your doctor, pharmacist or nurse immediately, as this may prevent
it from working properly. See section 4 for more information.

Children
Posaconazolo Mylan should not be used in children (aged 17 years or younger).

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

Do not take Posaconazolo Mylan if 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 Mylan 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 Mylan can increase the amount of these medicines in the blood, which can lead to a serious reduction in blood flow to the fingers or toes and could damage them.
• a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high levels of cholesterol. Do not take Posaconazolo Mylan 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 Mylan. In addition to the medicines listed above there are other medicines that carry a risk of heart rhythm problems that may be greater if they are taken with Posaconazolo Mylan. Make sure you tell your doctor about all the medicines you are taking (whether or not they require a prescription).

Some medicines can increase the risk of side effects of Posaconazolo Mylan
by increasing the amount of Posaconazolo Mylan in the blood.
The following medicines can decrease the effectiveness of Posaconazolo Mylan by decreasing
the amount of Posaconazolo Mylan 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 be careful for some 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.
• medicines used to reduce stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines called proton pump inhibitors.

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

• vincristine, vinblastine and other “vinca alkaloids” (used to treat cancers)
• 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 “sulphonylureas” (used to treat high blood sugar levels).

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

Posaconazolo Mylan with food and drink
To increase the absorption of posaconazole, it should be given
during or immediately after food or a dietary supplement whenever possible (see
section 3 “How to take Posaconazolo Mylan”). There is no information on the effect
of alcohol on posaconazole.

Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine. Do not take
Posaconazolo Mylan 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.
Contact your doctor immediately if you become pregnant while being treated with Posaconazolo
Mylan.
Do not breastfeed while being treated with Posaconazolo Mylan. This is because small amounts can
pass into breast milk.

Driving and using machines
While taking Posaconazolo Mylan you may feel dizzy, sleepy or your vision may become
blurred, which can affect your ability to drive or operate tools or machines. If this
happens, do not drive or operate tools or machines and contact your doctor.

Posaconazolo Mylan contains glucose
Posaconazolo Mylan contains approximately 2.11 g of glucose per 5 ml of suspension. If your doctor has
diagnosed you with intolerance to some sugars, contact him before taking this medicine. It
may be harmful to your teeth.

Posaconazolo Mylan contains sodium benzoate (E211)
Posaconazolo Mylan contains 2 mg of sodium benzoate (E211) per ml equivalent to 10 mg/5ml.
Benzoate salts can increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4
weeks old).
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially “sodium-free”.

3. How to take Posaconazolo Mylan

Do not switch from taking posaconazole tablets to taking Posaconazolo Mylan without
consulting your doctor or pharmacist because this may lead to a lack of efficacy or an increase
in the risk of adverse reactions.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The doctor will monitor your response and your condition to
determine how long you should take Posaconazolo Mylan and if any
change in the daily dose is necessary.
The following table shows the recommended dose and duration of treatment which depend on the type of
infection you have and may be modified by the doctor to adapt to you. Do not change the dose
or treatment regimen on your own without consulting your doctor.
Whenever possible, you should take posaconazole during or immediately after
taking food or a dietary supplement.

If you take more Posaconazolo Mylan than you should
If you feel that you have taken too much, contact your doctor or healthcare professional immediately.

If you forget to take Posaconazolo Mylan
If you have forgotten to take a dose, take it as soon as you remember and then continue as before.
However, if it is almost time for the next dose, take it as scheduled. Do not take a double
dose to make up for a missed dose.
If you have any questions 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 gets 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 attention:

• nausea or vomiting (feeling or being sick), diarrhoea
• signs of problems with your liver, these include yellowing of the skin or the white part of your eyes, unusually dark urine or pale stools, feeling unwell for no reason, problems with your stomach, loss of appetite or unusual tiredness or weakness, an increase in 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: these may affect up to 1 in 10 people

• a change in the levels of salt in your blood 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 your blood - detected in blood tests
• low levels of magnesium - detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or stomach discomfort, passing gas, dry mouth, changes in taste
• heartburn (a burning sensation in your chest that rises into your throat)
• low levels of “neutrophils” a type of white blood cells (neutropenia) - this can increase the risk of getting infections and can be detected in blood tests
• fever
• feeling weak, dizziness, tiredness or sleepiness
• skin rash
• itching

• constipation
• rectal discomfort

Not common: these may affect up to 1 in 100 people

• anaemia - signs include headache, feeling tired or dizzy, shortness of breath or pale appearance and a low level of haemoglobin detected in blood tests
• low level of platelets (thrombocytopenia) detected in blood tests - this can lead to bleeding
• low level of “leucocytes” a type of white blood cells (leukopenia) detected in blood tests - this can increase the risk of getting infections
• high level of “eosinophils” a type of white blood cells (eosinophilia) - this can happen if you have inflammation
• inflammation of the blood vessels
• problems with your heart rhythm
• convulsions
• nerve damage (neuropathy)
• abnormal heart rhythm - detected in an 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 the oxygen supply to the spleen (splenic infarction) - this can cause severe stomach pain
• serious kidney problems - signs include an increase or decrease in urine production that is a different colour than usual
• high levels of creatinine in your blood - detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain when breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation of feeling, especially in the skin
• tremor
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, feeling generally unwell
• pain, back pain or neck pain, pain in your arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• 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 diarrhoea, usually caused by a virus, stomach pain
• burping
• feeling nervous

Rare: these may affect up to 1 in 1,000 people

• pneumonia - signs include feeling short of breath and coughing up phlegm of a different colour
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) which can cause serious damage to the lungs and heart
• problems with your blood 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
• having problems thinking or speaking, having jerky movements, especially in your hands that you cannot control
• stroke - signs include pain, weakness, numbness or tingling in your limbs
• having a blind or dark spot in your vision
• heart failure or heart attack which could lead to cardiac arrest and death, problems with your heart rhythm with sudden death
• blood clots in your legs (deep vein thrombosis) - signs include severe pain or swelling in your legs
• blood clots in your lungs (pulmonary embolism) - signs include feeling short of breath or pain when breathing
• bleeding in your stomach or intestines - signs include vomiting blood or blood in your stools
• a blockage in your intestine (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of your intestine from passing into the lower part of your intestine - signs include feeling bloated, vomiting, severe constipation, loss of appetite and cramps
• “haemolytic uraemic syndrome” when red blood cells break down (haemolysis) 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
• widespread purplish discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• malfunctioning adrenal glands - this can cause weakness, tiredness, loss of appetite, skin discolouration
• malfunctioning pituitary gland - this can cause low blood levels of some hormones that affect the function of male or female sex organs
• hearing problems.

Some patients have also reported feeling confused after taking posaconazole, the frequency of this is
not known.
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above
or any other side effects.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Posaconazolo Mylan

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 label and the packaging. The expiry
date refers to the last day of that month.
If any suspension remains in an opened bottle for more than 30 days after first opening, do not use
this medicine. Return the bottle containing the remaining solution to the pharmacist.
This veterinary medicine does not require any particular storage conditions. Do not refrigerate
or freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Posaconazole Mylan contains

• The active ingredient is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The excipients of the suspension are citric acid monohydrate, anhydrous monosodium citrate, sodium benzoate (E211) (see section 2 “Posaconazole Mylan contains sodium benzoate”), sodium lauryl sulfate, simethicone emulsion 30% (containing simethicone, methylcellulose, sorbic acid, water), xanthan gum, glycerol, liquid glucose (see section “Posaconazole Mylan contains glucose”), titanium dioxide (E171), artificial cherry flavouring, purified water.

Description of the appearance of Posaconazole Mylan and contents of the pack
Posaconazole Mylan is a white, cherry-flavoured oral suspension equivalent to 105 ml contained in
amber glass bottles with a child-resistant screw cap. Each bottle is supplied with a
measuring spoon for measuring doses of 2.5 and 5 ml of oral suspension.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy
Manufacturer
Genepharm S.A.
18 km Marathon Avenue
15351 Pallini Attikis
Greece
JSC “Grindeks”
53 Krustpils Street
Riga, LV-1057
Latvia

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Croatia Posakonazol Mylan 40 mg/ml oralna suspenzija
Czech Republic Posakonazol Mylan
Estonia Posaconazole Mylan
France Posaconazole Mylan 40 mg/ml, suspension available
Italy Posaconazolo Mylan
Poland Posaconazole Mylan
Portugal Posaconazol Mylan
Romania Posaconazol Mylan 40 mg/ml suspensie orala
Slovak Republic Posakonazol Mylan 40 mg/ml
Slovenia Posakonazol Mylan 40 mg/ml peroralna raztopina
June 2019