Posaconazole AHCL 40 mg/ml oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Posaconazole HCl 40 mg/ml oral suspension EFG

Posaconazole

Read all of this leaflet carefully before you start 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Posaconazol AHCL is and what it is used for

Posaconazol AHCL contains a medicine called posaconazole, which belongs to a group of medicines known as "antifungals". It is used to prevent and treat many different fungal infections.

This medicine works by killing or stopping the growth of certain types of fungi that can cause infections.

Posaconazol AHCL 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 of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines has had to be discontinued;
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when treatment with amphotericin B has had to be discontinued;
• infections caused by fungi leading to diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole or when treatment with itraconazole has had to be discontinued;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more medicines, such as amphotericin B, itraconazole or fluconazole, or when treatment with these medicines has had to be discontinued;
• infections in the mouth or throat area (called "oral thrush") caused by fungi known as Candida, which have not been previously treated.

This medicine may also be used to prevent fungal infections in adults at high risk of developing a fungal infection, such as:

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

2. What you need to know before taking Posaconazol AHCL

Do not take Posaconazol AHCL if you:

• are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• 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.
• have just started taking venetoclax or your venetoclax dose is being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazol AHCL if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Posaconazol AHCL.

See the section “Taking Posaconazol AHCL with other medicines” below for further information, including medicines that may interact with Posaconazol AHCL.

Warnings and precautions

Talk to your doctor or pharmacist before starting Posaconazol AHCL if you:

• have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• have or have previously had liver problems. You may need blood tests while taking this medicine.
• develop severe diarrhea or vomiting, as these conditions may reduce the effectiveness of this medicine.
• have a heart rhythm disorder (ECG) showing a problem called QTc interval prolongation.
• have weakened heart muscle or heart failure.
• have a very slow heart rate.
• have any heart rhythm disorder.
• have any imbalance in blood levels of potassium, magnesium, or calcium.
• are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer).
• are taking venetoclax (a medicine used to treat cancer).

If any of the above apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before taking Posaconazol AHCL.

If you develop severe diarrhea or vomiting (feel unwell) while taking Posaconazol AHCL, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. For more information, see section 4.

You should avoid exposure to sunlight during treatment. It is important to cover exposed skin areas with protective clothing and use sunscreen with a high sun protection factor (SPF), as increased skin sensitivity to UV rays from the sun may occur.

Children

Posaconazol AHCL must not be used in children and adolescents (17 years of age and younger).

Taking Posaconazol AHCL with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Posaconazol AHCL if you are taking any of the following medicines:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders)

Posaconazol AHCL may increase the levels of these medicines in the blood, which could cause serious changes in your heart rhythm.

• any medicine containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazol AHCL may increase the levels of these medicines in the blood, which could cause a severe reduction in blood flow to the fingers or toes and cause damage.
• 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 leukemia (CLL).

Do not take Posaconazol AHCL if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Refer to the list above of medicines you must not take while using Posaconazol AHCL. In addition to the medicines mentioned above, there are other medicines that carry a risk of heart rhythm problems, which may be increased when taken with Posaconazol AHCL. Make sure to inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of adverse effects of Posaconazol AHCL by increasing the amount of Posaconazol AHCL in the blood.

The following medicines may reduce the effectiveness of Posaconazol AHCL by lowering its blood levels:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need a blood test and should monitor for possible adverse 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.
• flucloxacillin (an antibiotic used to treat bacterial infections).

Posaconazol AHCL may possibly increase the risk of adverse effects of other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• ciclosporin (used during or after organ transplants)
• tacrolimus and sirolimus (used during or after organ transplants)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, 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)
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers)

If any of the above apply to you (or if you are unsure), consult your doctor or pharmacist before taking Posaconazol AHCL.

Taking Posaconazol AHCL with food and drinks

To improve absorption of posaconazole, it should always be taken during or immediately after a meal or nutritional drink (see section 3 “How to take Posaconazol AHCL”). There is no information available on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you might be pregnant before starting Posaconazol AHCL.

Do not take Posaconazol AHCL if you are pregnant, unless specifically instructed by your doctor.

If you are of childbearing age, you should use effective contraception while taking this medicine. If you become pregnant while taking Posaconazol AHCL, contact your doctor immediately.

Do not breastfeed while taking Posaconazol AHCL, as it may pass into breast milk in small amounts.

Driving and using machines

You may experience dizziness, drowsiness, or blurred vision while taking Posaconazol AHCL, which may affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use any tools or machinery and contact your doctor.

Posaconazol AHCL contains glucose

Posaconazol AHCL contains approximately 1.75 g of glucose per 5 ml of suspension. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of suspension, which essentially means it is "sodium-free".

3. How to take Posaconazole AHCL

Do not interchange Posaconazole tablets and posaconazole oral suspension without consulting your doctor or pharmacist, as this may result in lack of efficacy or increased risk of adverse reactions.

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will monitor your response and condition to determine how long you should take Posaconazole AHCL and whether any adjustment of your daily dose is needed.

The table below shows the recommended dose and duration of treatment, which depend on the type of infection you have and may be individually adjusted for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment regimen.

Take posaconazole with food or immediately after a meal or nutritional drink whenever possible.

If you take more Posaconazole HCl than you should

If you are concerned that you may have taken too much, inform your doctor or healthcare professional immediately.

If you forget to take Posaconazole HCl

If you forget 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 your dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment:

• nausea or vomiting (feeling sick or being sick), diarrhoea
• signs of liver problems, including yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, feeling sick for no apparent reason, stomach problems, loss of appetite, or unusual tiredness or weakness, or increased liver enzymes detected in blood tests
• allergic reaction

Other adverse effects

Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Frequent: the following may affect up to 1 in 10 patients

• a change in blood electrolyte levels detected in blood tests, which may include symptoms such as confusion or weakness
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling sensations, 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 pain or discomfort, flatulence, dry mouth, changes in taste sensation
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and is detected in blood tests
• fever
• feeling weak, dizzy, tired, or drowsy
• rash
• itching
• constipation
• rectal discomfort

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

• anaemia, whose signs include headaches, feeling tired or dizzy, shortness of breath, paleness, and low haemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This may cause bleeding
• low levels of "leucocytes", a type of white blood cell (leucopenia), detected in blood tests. This may make you more susceptible to infections
• high levels of "eosinophils", a type of white blood cell (eosinophilia). This may occur if you have an inflammatory condition
• inflammation of blood vessels
• heart rhythm problems
• seizures (fits)
• neurological damage (neuropathy)
• abnormal heart rhythm detected on an 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), which may cause severe stomach pain
• serious kidney problems, whose signs include increased or decreased urination with urine of unusual colour
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain when breathing (pleuritic pain)
• swelling of lymph nodes (lymphadenopathy)
• reduced sensation, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of discomfort
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep problems
• coordination or balance problems
• inflammation of mucous membranes
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, stomach cramps, and diarrhoea, usually caused by a virus, stomach pain
• burping
• feeling restless

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

• pneumonia, whose signs include feeling short of breath and producing 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 disorders such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread rash with blisters and skin peeling
• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, sudden jerky movements, especially in the hands, that you cannot control
• stroke, whose signs include pain, weakness, numbness, or tingling in the limbs
• presence of a blind spot or dark spot in the field of vision
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), whose signs include severe pain and swelling of the legs
• blood clots in the lungs (pulmonary embolism), whose signs include feeling short of breath or pain when breathing
• bleeding in the stomach or intestine, whose signs include vomiting blood or blood in the stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon and its signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramping
• "haemolytic uraemic syndrome" which occurs when red blood cells are destroyed (haemolysis), which may occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red cells, white cells, and platelets), detected in blood tests
• large purple spots on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• inadequate functioning of the adrenal glands, which may cause weakness, tiredness, loss of appetite, and skin discolouration
• inadequate functioning of the pituitary gland, which may cause low blood levels of certain hormones affecting male or female sexual organ function
• hearing problems
• pseudoaldosteronism, causing high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported feeling confused after taking Posaconazole HCl.
• skin redness

Inform your doctor, pharmacist, or nurse if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Posaconazole AHCL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.
• This medicine does not require any special storage conditions.
• If any suspension remains in the bottle more than four weeks after first opening, this medicine should not be used. Return the bottle containing the remaining suspension to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Posaconazole AHCL

• The active substance is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The other components of the suspension are macrogol glyceryl hydroxystearate, sodium citrate dihydrate, citric acid monohydrate, simethicone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan triestearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulphuric acid (E513)), xanthan gum (E415), sodium benzoate (E211), liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavour (containing propylene glycol) and purified water.

Appearance of the product and contents of the pack

Posaconazole AHCL is a white to off-white, free-flowing oral suspension, supplied in amber glass bottles. Each bottle is supplied with a dosing spoon to measure doses of 2.5 ml and 5 ml of the oral suspension.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6th floor, Barcelona,

08039 Barcelona, Spain

Manufacturer

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

95-200 Pabianice

Poland

Laboratori Fundacio Dau

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Wessling Hungary Kft.

Anomymus u 6

H-1045 Budapest

Hungary

Date of the most recent revision of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.