Posaconazole Mylan

Package leaflet: Information for the user

Posaconazole Mylan 40 mg/ml oral suspension

Posaconazole
Generic medicine
Read this leaflet carefully before taking 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 they have the same symptoms as yours, because it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform 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 taking 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 Posaconazolo Mylan is and what it is used for

Posaconazolo Mylan contains a medicine called 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 can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or had to be discontinued:

• 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 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 this medicine 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 this medicine 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;
• infections of the mouth or throat (known as "oral thrush") caused by fungi called Candida, when not previously treated.

This medicine can also be used to prevent fungal infections in adults 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

Do not take Posaconazole Mylan if:

• you are allergic to posaconazole or to any of the excipients 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.

Do not take Posaconazole Mylan if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Mylan.
See below “Other medicines and Posaconazole Mylan” for further information, including details on other medicines that may interact with Posaconazole Mylan.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole 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 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 (ECG) showing a problem called long QTc interval.
• you have weakened heart muscle or heart failure.
• you have a very slow heartbeat.
• you have a heart rhythm disorder.
• you have any problems with potassium, magnesium, or calcium levels in your blood.
• you are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer).

If you have any of the above conditions (or if you are unsure), consult your doctor, pharmacist, or nurse before taking Posaconazole Mylan.
If you develop severe diarrhoea or vomiting (feeling unwell) while taking Posaconazole Mylan, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. See section 4 for further information.
Children
Posaconazole Mylan must not be used in children (age 17 years or younger).
Other medicines and Posaconazole Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Posaconazole 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 symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm abnormalities).

Posaconazole Mylan can increase the amount 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 can increase the amount of these medicines in your blood, which may lead to a severe 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 cholesterol levels.

Do not take Posaconazole Mylan if you have any of the above conditions. 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. In addition to the medicines listed above, there are other medicines that carry a risk of heart rhythm problems, which may be greater when taken with Posaconazole Mylan. Make sure to inform your doctor about all medicines you are taking (with or without prescription).

Some medicines may increase the risk of side effects of Posaconazole Mylan by increasing the amount of Posaconazole Mylan in your blood.
The following medicines may reduce the effectiveness of Posaconazole Mylan by decreasing the amount of Posaconazole Mylan in your blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already being treated with rifabutin, you will need a blood test and should watch for possible side effects of rifabutin.
• certain 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.

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

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat tumours)
• cyclosporine (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 administered 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).

If you have any of the above conditions (or if you are unsure), consult your doctor or pharmacist before taking Posaconazole Mylan.
Posaconazole Mylan with food and drinks
To increase the absorption of posaconazole, it should be taken with food or a nutritional supplement whenever possible, either during or immediately after a meal (see section 3 “How to take Posaconazole Mylan”). There is no information available on the effect of alcohol on posaconazole.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not take Posaconazole Mylan during pregnancy unless specifically instructed by your doctor. Women of childbearing potential 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.
Do not breastfeed while being treated with Posaconazole Mylan. This is because small amounts may pass into breast milk.
Driving and using machines
While being treated with Posaconazole Mylan, 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 contains glucose
Posaconazole Mylan contains approximately 2.11 g of glucose in every 5 ml of suspension. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine. It may be harmful to teeth.
Posaconazole Mylan contains sodium benzoate (E211)
Posaconazole Mylan contains 2 mg of sodium benzoate (E211) per ml, equivalent to 10 mg/5 ml.
Benzoate salts may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially "sodium-free".

3. How to take Posaconazole Mylan

Do not switch from taking posaconazole tablets to taking Posaconazole Mylan without consulting your doctor or pharmacist, as this may result in reduced effectiveness or an increased risk of adverse reactions.
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will monitor your response and condition to determine how long you should take Posaconazole Mylan and whether any adjustment of 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. These may be modified by your doctor according to your individual needs. 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 a meal or a nutritional supplement.

If you take more Posaconazole Mylan than you should
If you think you have taken too much, contact your doctor or healthcare provider immediately.

If you forget to take Posaconazole Mylan
If you forget to take a dose, take it as soon as you remember, then continue as before.
However, if it is almost time for your next dose, take it at the scheduled time. Do not take a double
dose to make up for the missed 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 immediately 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 liver problems, these include yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, unexplained feeling of being unwell, stomach problems, 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

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

Uncommon: these may affect up to 1 in 100 people

• anaemia – signs include headache, feeling tired or dizzy, shortness of breath or looking pale, 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 cells (leucopenia) detected in blood tests – this may increase the risk of getting infections
• high levels of "eosinophils", a type of white blood cells (eosinophilia) – this may occur if you have inflammation
• inflammation of blood vessels
• heart rhythm problems
• 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 – signs 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)
• swollen lymph glands (lymphadenopathy)
• reduced sensation of sensitivity, especially in 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)
• insomnia
• being completely or partially unable to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of mucous membranes
• 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: these may affect up to 1 in 1,000 people

• pneumonia – signs include shortness of breath and coloured 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 widespread blistering skin rash and skin peeling
• mental problems such as hearing voices or seeing things that are not there
• fainting
• having problems thinking or speaking, having jerky movements, especially in the hands that you cannot control
• stroke – signs include pain, weakness, numbness or tingling in 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, heart rhythm problems 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 shortness of breath or pain when breathing
• bleeding in the stomach or intestines – signs include vomiting blood or blood in stools
• a blockage in the intestine (intestinal obstruction), especially in the "ileum". The blockage will prevent intestinal contents 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 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
• widespread 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 male or female sex organ function
• hearing problems

Some patients have also reported feeling confused after taking posaconazole; the frequency of this is unknown.
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, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 Posaconazole Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of that month.
If any suspension remains in a bottle opened for the first time for more than 30 days, this medicine must not be used. Return the bottle containing the remaining solution to the pharmacist.
This veterinary medicine does not require any special storage conditions. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Posaconazole Mylan contains

• The active substance is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The excipients of the suspension are monohydrate citric acid, anhydrous monosodium citrate, sodium benzoate (E211) (see section 2 “Posaconazole Mylan contains sodium benzoate”), sodium lauryl sulphate, simeticone emulsion 30% (containing simeticone, 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, 105 ml contained in amber glass bottles with a child-resistant screw cap made of plastic. A dosing spoon is supplied with each bottle to measure 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 European Economic Area Member States under 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 buvable
Italy Posaconazolo Mylan
Poland Posaconazole Mylan
Portugal Posaconazol Mylan
Romania Posaconazol Mylan 40 mg/ml suspensie orala
Slovakia Posakonazol Mylan 40 mg/ml
Slovenia Posakonazol Mylan 40 mg/ml peroralna raztopina
June 2019