Posaconazole Mylan Pharma

Package leaflet: Information for the patient

Posaconazole Mylan Pharma 100 mg gastro-resistant tablets

posaconazole
Equivalent medicine
Please read all of this leaflet carefully before you take 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Posaconazolo Mylan Pharma contains the active substance posaconazole. It belongs to a group of
medicines called "antifungals". It is used to prevent and treat many different types of fungal
infections.
This medicine works by killing or stopping the growth of certain types of fungi that can cause
infections.
Posaconazolo Mylan Pharma can be used in adults to treat fungal infections caused by fungi of the
Aspergillus family.
Posaconazolo Mylan Pharma can be used in adults and children from the age of 2 years and weighing 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 antifungal medicines such as amphotericin B or itraconazole, or when treatment with these medicines had to be stopped;
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B, or when treatment with amphotericin B had to be stopped;
• infections caused by fungi leading to 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 Coccidioides that 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 children from the age of 2 years and weighing more than 40 kg who are at high risk of developing a fungal infection, such as:

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

2. What you need to know before taking Posaconazole Mylan Pharma

Do not take Posaconazole Mylan Pharma 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 leukaemia (CLL).

Do not take Posaconazole Mylan Pharma if you have any of the conditions listed above. If you are
unsure, consult your doctor or pharmacist before taking Posaconazole Mylan Pharma.
See below “Other medicines and Posaconazole Mylan Pharma” for further information, including
details on other medicines that may interact with Posaconazole Mylan Pharma.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Posaconazole Mylan Pharma 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 may reduce the effectiveness of this medicine
• you have an abnormal heart rhythm trace (ECG) showing a condition called prolonged QTc interval
• you have weakened heart muscle or heart failure
• you have a very slow heart rate
• you have a heart rhythm disorder
• you have any problem with potassium, magnesium or calcium levels 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 you have any of the conditions listed above (or if you are unsure), consult your doctor,
pharmacist or nurse before taking Posaconazole Mylan Pharma.
If you develop severe diarrhoea or vomiting (feeling unwell) while taking Posaconazole Mylan
Pharma, contact your doctor, pharmacist or nurse immediately, as this may prevent the medicine
from working properly. See section 4 for more information.
Children and adolescents
Posaconazole Mylan Pharma must not be given to children under 2 years of age.
Other medicines and Posaconazole Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Do not take Posaconazole Mylan Pharma 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 symptoms of Tourette’s syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm abnormalities).

Posaconazole Mylan Pharma can increase the levels of these medicines in your blood, which may
lead to very serious changes in heart rhythm:

• any medicine containing “ergot alkaloids” such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole Mylan Pharma can increase the levels of these medicines in your blood, which may lead to a severe 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 cholesterol levels.
• venetoclax when used at the beginning of treatment for a type of cancer, chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Mylan Pharma if you have any of the conditions listed above. If you are
unsure, consult 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 Posaconazole Mylan
Pharma. In addition to the medicines listed above, there are other medicines that carry a risk of
heart rhythm disturbances, which may be increased when taken with Posaconazole Mylan Pharma.
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 of Posaconazole Mylan Pharma by
increasing the amount of Posaconazole Mylan Pharma in your blood.
The following medicines may reduce the effectiveness of Posaconazole Mylan Pharma by
decreasing the amount of Posaconazole Mylan Pharma in your blood:

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

Posaconazole Mylan Pharma may likely increase the risk of side effects of some other medicines
by increasing their levels in your blood. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat tumours)
• venetoclax (used to treat cancer)
• ciclosporin (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after transplant surgery)
• 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 known as tretinoin (used to treat certain blood cancers).

If you have any of the conditions listed above (or if you are unsure), consult your doctor or
pharmacist before taking Posaconazole Mylan Pharma.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Posaconazole Mylan Pharma during pregnancy unless specifically instructed to do so
by your doctor.
If you are a woman of childbearing age, you must use an effective method of contraception while
taking this medicine. Contact your doctor immediately if you become pregnant while being
treated with Posaconazole Mylan Pharma.
Do not breastfeed while taking Posaconazole Mylan Pharma. This is because small amounts may
pass into breast milk.
Driving and using machines
While being treated with Posaconazole Mylan Pharma, you may experience dizziness, drowsiness
or blurred vision, which could affect your ability to drive or operate tools or machinery. If this
occurs, do not drive or use tools or machinery and contact your doctor.
Posaconazole Mylan Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Posaconazole Mylan Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Do not switch from taking Posaconazole Mylan Pharma tablets to taking
posaconazole oral suspension without consulting your doctor or pharmacist, as this may
result in reduced effectiveness or an increased risk of adverse reactions.
How much to take
The recommended dose is 300 mg of posaconazole (three gastro-resistant tablets of 100 mg) twice on
the first day, followed by 300 mg of posaconazole (three gastro-resistant tablets of 100 mg) 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 the dose yourself or change the treatment regimen without first consulting your doctor.
How to take this medicine

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

If you take more Posaconazole Mylan Pharma than you should
If you think you may have taken more Posaconazole Mylan Pharma than you should, inform a doctor or
go to hospital immediately.
If you forget to take Posaconazole Mylan Pharma

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

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following serious side effects – you may need urgent medical treatment:

• nausea or vomiting (feeling or state of being unwell), diarrhoea
• signs of liver problems, including yellowing of the skin or the white part of the eyes, unusually dark urine or pale stools, unexplained feeling of being unwell, stomach problems, loss of appetite, or unusual tiredness 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 may affect up to 1 in 10 people

• changes in blood salt levels detected in blood tests – symptoms include feeling confused or weak
• abnormal sensations of the skin, 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 ache or stomach discomfort, passing wind, dry mouth, altered taste
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia) – this may increase the risk of developing infections and can be detected in blood tests
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• rectal discomfort

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

• anaemia – symptoms include headache, feeling tired or dizzy, shortness of breath, pale appearance, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia) detected in blood tests – this may lead to bleeding
• low levels of "leucocytes", a type of white blood cell (leucopenia) detected in blood tests – this may increase the risk of developing infections
• high levels of "eosinophils", a type of white blood cell (eosinophilia) – this may occur if you have inflammation
• inflammation of blood vessels
• changes in heart rhythm
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm – detected on 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) – this may cause severe stomach pain
• severe kidney problems – symptoms include increased or decreased urine production with urine of unusual colour
• high levels of creatinine in the blood – detected in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• enlarged lymph nodes (lymphadenopathy)
• reduced sensation, especially of the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of being unwell
• pain, back pain or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of the mucosa
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, cramps, and diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling nervous

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

• pneumonia – symptoms include shortness of breath and 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 problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including extensive blistering skin rashes and skin peeling
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, jerky movements, especially in the hands that you cannot control
• stroke – symptoms include pain, weakness, numbness, or tingling in limbs
• having a dark or blind spot in your 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) – symptoms include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism) – symptoms include shortness of breath or pain when breathing
• bleeding in the stomach or intestines – symptoms include vomiting blood or blood in the stools
• blockage in the intestine (intestinal obstruction), especially in the "ileum". The blockage will prevent intestinal contents from passing to the lower part of the intestine – symptoms include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
• "haemolytic uraemic syndrome" when red blood cells break down (haemolysis), a condition that may occur with or without kidney failure
• "pancytopenia", a low level of all blood cells (red and white blood cells and platelets) detected in blood tests
• extensive purplish discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction – this may cause weakness, tiredness, loss of appetite, skin discolouration
• pituitary gland dysfunction – this may cause low blood levels of certain hormones affecting the function of male or female sex organs
• hearing changes
• pseudoaldosteronism, resulting in high blood pressure with low potassium levels (shown in blood tests)

Not known: frequency cannot be estimated from the available data

• some patients have also reported feeling confused after taking posaconazole

Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posaconazole Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/ bottle and outer packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 Mylan Pharma contains
The active substance is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.
The other components are: methacrylic acid-ethyl acrylate copolymer (1:1) (type B), triethyl citrate,
xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, sodium
croscarmellose, sodium stearil fumarate (see section 2 “Posaconazole Mylan Pharma contains
sodium”), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).
Description of the appearance of Posaconazole Mylan Pharma and package contents
The gastro-resistant tablets of Posaconazole Mylan Pharma are yellow, capsule-shaped, with “100P” printed on one side and smooth on the other side. The tablets are packed in boxes of 24 or 96 tablets in non-perforated blisters, 24x1 or 96x1 tablets in unit-dose perforated blisters, or 60 tablets in plastic bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Delorbis Pharmaceuticals Ltd
17, Athinon Street, Ergates Industrial Area
2643 Ergates
P.O. Box 28629 Nicosia
Cyprus
MEDIS INTERNATIONAL a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany Posaconazol Mylan 100 mg magensaftresistente Tabletten
Denmark Posaconazol Mylan
Finland Posaconazole Mylan 100 mg enterotabletti
France POSACONAZOLE VIATRIS 100 mg, comprimé gastrorésistant
Croatia Posakonazol Mylan 100 mg želučanootporne tablete
Ireland Posaconazole Mylan 100 mg gastro-resistant tablets
Italy Posaconazolo Mylan Pharma
Netherlands Posaconazol Mylan 100mg, maagsapresistente tabletten
Norway Posaconazole Mylan
Poland Posaconazole Mylan
Portugal Posaconazol Mylan
Romania Posaconazol Mylan 100mg comprimate gastrorezistente
Sweden Posaconazole Mylan
United Kingdom Posaconazole Mylan 100 mg GR tablets
(Northern Ireland)