Posaconazole TilloyMed

PACKAGE LEAFLET

Package leaflet: information for the patient

Posaconazole Tillomed 40 mg/ml oral suspension

Generic medicine
Please read this entire 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, consult your doctor, pharmacist, or nurse. This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Posaconazolo Tillomed 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 Tillomed may 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 may 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 Tillomed

Do not take Posaconazole Tillomed

• 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.

Do not take Posaconazole Tillomed if you have any of the conditions listed above. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Tillomed.
See below "Other medicines and Posaconazole Tillomed" for further information, including details on other medicines that may interact with Posaconazole Tillomed.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Posaconazole Tillomed 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 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 levels of potassium, magnesium or calcium in your blood.
• you are taking vincristine, vinblastine or other "vinca alkaloids" (medicines 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 Tillomed.
If you develop severe diarrhoea or vomiting (feeling unwell) while taking Posaconazole Tillomed, contact your doctor, pharmacist or nurse immediately, as this may prevent the medicine from working properly. See section 4 for further information.

Children and adolescents
Posaconazole Tillomed must not be used in children (age 17 years or younger).

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

Do not take Posaconazole Tillomed 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 Tillomed can increase the levels of these medicines in the blood, which may lead to serious changes in heart rhythm.

• any medicine containing "ergot alkaloids" such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole Tillomed can increase the levels of these medicines in the blood, which may lead to a severe reduction in blood flow to the fingers or toes and may cause damage.
• a "statin" such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels.

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

Some medicines may increase the risk of side effects of Posaconazole Tillomed by increasing the amount of Posaconazole Tillomed in the blood.

The following medicines may reduce the effectiveness of Posaconazole Tillomed by decreasing the amount of Posaconazole Tillomed in the 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 pay attention to 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 Tillomed 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)
• ciclosporin (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after transplant surgery)
• rifabutin (used to treat certain infections)
• HIV medicines 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)

If you have any of the conditions listed above (or if you are unsure), consult your doctor or pharmacist before taking Posaconazole Tillomed.

Posaconazole Tillomed with food and drink
To increase 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 Tillomed").
There is no information on the effect of alcohol on posaconazole.

Pregnancy, breast-feeding and fertility
Inform your doctor before taking Posaconazole Tillomed if you are pregnant or suspect you may be pregnant.
Do not take Posaconazole Tillomed during pregnancy unless specifically instructed 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 Tillomed.
Do not breast-feed while being treated with Posaconazole Tillomed. This is because small amounts may pass into breast milk.

Driving and using machines
During treatment with Posaconazole Tillomed, 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 Tillomed contains glucose and benzyl alcohol
Posaconazole Tillomed contains approximately 350 mg of glucose per 1 ml of suspension. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains 2 mg of sodium benzoate per ml, equivalent to 10 mg/5 ml.
This medicine contains 0.0175 mg of benzyl alcohol per ml, equivalent to 0.0875 mg/5 ml. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).

3. How to take Posaconazole Tillomed

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 Tillomed and whether any adjustment of the daily dose is needed.
Do not switch from taking posaconazole oral suspension to posaconazole tablets without consulting your doctor or pharmacist, as this may result in reduced effectiveness or an increased risk of adverse reactions.
The following table shows the recommended dose and duration of treatment, which depend on the type of infection you have. These may be adjusted 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 nutritional supplement.

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

If you forget to take Posaconazole Tillomed
If you forget to take a dose, take it as soon as you remember and 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 questions about the use of this medicine, consult 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 treatment:

• nausea or vomiting (feeling or state of sickness), 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 sickness, 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 – signs include feeling confused or weak
• abnormal skin sensations such as numbness, tingling, itching, goosebumps, prickling or burning
• headache
• low potassium levels – detected in blood tests
• low magnesium levels – detected in blood tests
• high blood pressure
• loss of appetite, stomach ache or stomach discomfort, 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 cell (neutropenia) – this may increase the risk of infections and can be detected in blood tests
• fever
• feeling weak, dizzy, tired or sleepy
• skin rash
• itching
• constipation
• rectal discomfort

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

• anaemia – signs include headache, feeling tired or dizzy, shortness of breath or 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 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 blood supply and oxygen 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 creatinine levels in the blood – detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph glands (lymphadenopathy)
• reduced sensation, especially in the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of illness
• pain, back pain or neck pain, pain in arms or legs
• 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 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: the following 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 or 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
• problems with thinking or speaking, 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 may lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) – signs include leg pain or swelling
• blood clots in the lungs (pulmonary embolism) – signs include shortness of breath or chest pain during breathing
• bleeding in the stomach or intestines – signs include vomiting blood or blood in 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 – 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", low levels 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 and 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 Tillomed; 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, pharmacist or nurse. You can 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 Tillomed

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Do not freeze.
If any suspension remains in a bottle opened for more than four weeks, do not use this
medicine. Return the pack containing the remaining solution to the pharmacist.
Do not use this medicine after the expiry date stated on the bottle and the carton, after
"Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Posaconazole Tillomed contains

• The active substance is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The excipients of the suspension are: polysorbate 80 (E433); xanthan gum (E415), sodium benzoate, citric acid monohydrate (E330), sodium citrate (E331), glycerol (E422), simeticone 30% emulsion (polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, glycerides, sorbic acid, benzoic acid, sulfuric acid, water), liquid glucose, titanium dioxide, artificial cherry flavouring [containing propylene glycol, benzaldehyde, vanillin, ethyl butyrate (ethyl butanoate), benzyl alcohol, decanoic acid (n-capric acid), isoamyl acetate (isopentyl acetate), ethyl acetate, limonene (dipentene), acetic acid, cis-3-hexenyl acetate, ethyl isovalerate, p-tolualdehyde (4-methylbenzaldehyde), benzyl acetate], purified water.

Description of the appearance of Posaconazole Tillomed and package contents
Posaconazole Tillomed is a white to off-white suspension with a characteristic odour, flavoured with cherry. It is an oral suspension available in 105 mL amber glass bottles.
Each bottle is supplied with a dosing spoon to measure doses of 2.5 mL and 5 mL of oral suspension.

Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Torre A
20143 Milano (MI), Italy

Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland

Tillomed Pharma GmbH
Mittelstraße 5/5a
12529 Schönefeld
Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:
Netherlands: Posaconazol Tillomed 40 mg/ml suspensie voor oraal gebruik
France: POSACONAZOLE TILLOMED 40 mg/ml suspension buvable
Italy: Posaconazolo Tillomed
Portugal: Posaconazole Tillomed
Spain: Posaconazol Tillomed 40 mg/ml suspensión oral EFG
United Kingdom (Northern Ireland): Posaconazole 40 mg/ml oral suspension