POSACONAZOLO 100 mg Enteric-Coated Tablet

Содержание инструкции

1. Posaconazolo Mylan Pharma 100 mg gastro-resistant tablets
   1. What is Posaconazolo Mylan Pharma and what is it used for
   2. What you need to know before taking Posaconazole Mylan Pharma
   3. How to take Posaconazolo Mylan Pharma
   4. Possible side effects
   5. How to store Posaconazolo Mylan Pharma
   6. Contents of the pack and other information

Posaconazolo Mylan Pharma 100 mg gastro-resistant tablets

posaconazole

Generic medicine

Read this leaflet carefully before 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Posaconazolo Mylan Pharma contains the active ingredient 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 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 Aspergillusfamily.
Posaconazolo Mylan Pharma can be used in adults and children starting from 2 years of
age and 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 starting from 2 years of age and weighing more than 40 kg 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 Posaconazole Mylan Pharma

Do not take Posaconazole Mylan Pharma 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 your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL)

Do not take Posaconazole Mylan Pharma if you have any of the conditions listed above. If you are
not sure, ask your doctor or pharmacist before taking Posaconazole Mylan Pharma.
See below “Other medicines and Posaconazole Mylan Pharma” for more information including
information about 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 diarrhea or vomiting, as these conditions can limit the effectiveness of this medicine
• you have an abnormal heart rhythm tracing (ECG) showing a problem called prolonged QTc interval
• you have weakness of the 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 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), talk to your doctor,
pharmacist or nurse before taking Posaconazole Mylan Pharma.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole
Mylan Pharma, contact your doctor, pharmacist or nurse immediately, as this may
prevent it from working properly. See section 4 for more information.

Children and adolescents
Posaconazole Mylan Pharma should 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 medicines.

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 the symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat abnormal heart rhythms).

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

• any medicine that contains “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraine. Posaconazole Mylan Pharma 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 when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL)

Do not take Posaconazole Mylan Pharma 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
Posaconazole Mylan Pharma. 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
Posaconazole Mylan Pharma. Make sure you tell your doctor about all the medicines you are
taking (with or without a prescription).
Some medicines can increase the risk of side effects of Posaconazole Mylan
Pharma by increasing the amount of Posaconazole Mylan Pharma in the blood.
The following medicines can decrease the effectiveness of Posaconazole Mylan Pharma by decreasing the
amount of Posaconazole Mylan Pharma 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.
• phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir used to treat HIV infection.

Posaconazole Mylan Pharma 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 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 Posaconazole Mylan Pharma.

Pregnancy and breastfeeding
If you are pregnant, suspect 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 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 you are
being treated with Posaconazole Mylan Pharma.
Do not breastfeed while taking Posaconazole Mylan Pharma. This is because small amounts
can pass into breast milk.

Driving and using machines
While taking Posaconazole Mylan Pharma you may feel dizzy, sleepy or have
blurred vision, which can 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.

Posaconazole Mylan Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is
essentially “sodium-free”.

3. How to take Posaconazolo Mylan Pharma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Do not switch from taking Posaconazolo Mylan Pharma tablets to taking
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.

How much to take
The recommended dose is 300 mg of posaconazole (three 100 mg gastro-resistant tablets) twice a
day on the first day, followed by 300 mg of posaconazole (three 100 mg gastro-resistant 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 Mylan Pharma than you should
If you think you may have taken more Posaconazolo Mylan Pharma than you should, inform a doctor or
go to the hospital immediately.

If you forget to take Posaconazolo Mylan Pharma

• 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 further questions on 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
Inform 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 being sick), diarrhoea
• signs of problems with the liver, these include yellowing of the skin or the white part of the eyes, urine that is unusually dark in colour, or pale stools, feeling unwell without justification, stomach problems, loss of appetite or unusual tiredness or weakness, increased liver enzymes detected in blood tests
• allergic reaction

Other side effects
Inform 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 the 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 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, passing 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 getting infections and can be detected in blood tests
• fever
• feeling weak, dizziness, tiredness or drowsiness
• 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 occur if you have inflammation
• inflammation of the blood vessels
• changes in heart rate
• convulsions
• nerve damage (neuropathy)
• abnormal heart rhythm - detected in an electrocardiogram (ECG), palpitations, heartbeat

slow or fast, 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 which is a different colour than usual
• high levels of creatinine in the blood - detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation of sensitivity especially on 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, arm or leg pain
• fluid retention (oedema)
• 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 diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling nervous

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

• pneumonia - signs include feeling short of breath and coughing up sputum 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
• blood problems such as unusual blood clotting or prolonged bleeding
• serious allergic reactions, including widespread 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 - signs include pain, weakness, numbness or tingling in the limbs
• having a blind or dark 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) - signs include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism) - signs include feeling short of breath or pain when breathing
• bleeding in the stomach or intestines - signs include vomiting blood or blood in your stools
• 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 bloated, vomiting, severe constipation, loss of appetite and cramps
• “haemolytic uraemic syndrome” when red blood cells break down (haemolysis) a 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 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
• changes in hearing
• pseudoaldosteronism, which results in high blood pressure with a low level of potassium (shown by blood tests)

Not known: frequency cannot be estimated from available data

• some patients have also reported feeling confused after taking posaconazole

Inform 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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 Posaconazolo Mylan Pharma

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/bottle and on the
outer packaging 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. Contents of the pack and other information

What Posaconazolo Mylan Pharma contains
The active ingredient is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.
The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1) (type B), triethyl citrate,
xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, sodium
croscarmellose, sodium stearyl fumarate (see section 2 “Posaconazolo Mylan Pharma contains
sodium”), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide
(E172).

Description of the appearance of Posaconazolo Mylan Pharma and contents of the pack
The gastro-resistant tablets of Posaconazolo Mylan Pharma are capsule-shaped and yellow in colour,
with “100P” imprinted on one side and smooth on the other side. The tablets are packaged in boxes of 24
or 96 tablets in non-perforated blisters, 24x1 or 96x1 tablets in perforated unit-dose 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 Milan
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 Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
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)