POSACONAZOLE AHCL 40 mg/mL ORAL SUSPENSION

2. What you need to know before you take Posaconazole AHCL

Do not take Posaconazole AHCL if you:

• are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
• are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, or a "statin", such as simvastatin, atorvastatin, or lovastatin.
• have recently started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazole AHCL if you are in any of the above situations. If you are in doubt, consult your doctor or pharmacist before taking Posaconazole AHCL.

See the section "Taking Posaconazole AHCL with other medicines" later for more information, including information about other medicines that may interact with Posaconazole AHCL.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Posaconazole AHCL if you:

• have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• have or have had liver problems. You may need to have blood tests while you are taking this medicine.
• develop severe diarrhea or vomiting, as these situations can limit the effectiveness of this medicine.
• have a heart rhythm problem (ECG) that shows a problem called QTc interval prolongation.
• have weakness of the heart muscle or heart failure.
• have a very slow heart rate.
• have any heart rhythm problems.
• have any problems with the amounts of potassium, magnesium, or calcium in your blood.
• are taking vincristine, vinblastine, and other "vinca alkaloids" (medicines used to treat cancer).
• are taking venetoclax (a medicine used to treat cancer).

If you are in any of the above situations (or if you are in doubt), talk to your doctor, pharmacist, or nurse before taking Posaconazole AHCL.

If you develop severe diarrhea or vomiting while taking Posaconazole AHCL, talk to your doctor, pharmacist, or nurse immediately, as this situation can prevent the medicine from working properly. For more information, see section 4.

You should avoid exposure to the sun while you are taking this medicine. It is important to cover exposed skin areas with protective clothing and use a high sun protection factor (SPF) sunscreen, as you may be more sensitive to the UV rays of the sun.

Children

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

Taking Posaconazole AHCL with other medicines

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

Do not take Posaconazole 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's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm problems).

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

• any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole AHCL may increase the amount of these medicines in your blood, which could cause a serious decrease in blood flow to your fingers or toes and damage them.
• a "statin", such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol levels.
• venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

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

Other medicines

Talk to your doctor or pharmacist about the list of medicines that you should not take while you are taking Posaconazole AHCL. In addition to the medicines mentioned above, there are other medicines that may increase the risk of heart rhythm problems, which may be greater when taken with Posaconazole AHCL. Make sure to tell your doctor about all the medicines you are taking (with or without a prescription).

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

The following medicines may decrease the effectiveness of Posaconazole AHCL by reducing its levels in your blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have a blood test and be aware of some 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.
• Flucloxacillin (an antibiotic used to treat bacterial infections).

Posaconazole AHCL may increase the risk of side effects of other medicines by increasing the amount of these medicines in your blood. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• ciclosporin (used during or after transplants)
• tacrolimus and sirolimus (used during or after transplants)
• 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 called tretinoin (used to treat certain blood cancers).

If you are in any of the above situations (or if you are in doubt), talk to your doctor or pharmacist before taking Posaconazole AHCL.

Taking Posaconazole AHCL with food and drinks

To improve the absorption of posaconazole, you should take it during or immediately after a meal or a nutritional drink (see section 3 "How to take Posaconazole AHCL"). There is no information on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you may be pregnant before you start taking Posaconazole AHCL.

Do not take Posaconazole AHCL if you are pregnant, unless your doctor tells you to.

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

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

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while you are taking Posaconazole AHCL, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and talk to your doctor.

Posaconazole AHCL contains glucose

Posaconazole 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 some sugars, talk to them before taking this medicine.

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

3. How to take Posaconazole AHCL

Do not take Posaconazole AHCL tablets and Posaconazole AHCL oral suspension interchangeably without talking to your doctor or pharmacist, as this may lead to a lack of effectiveness or increase the risk of adverse reactions.

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, talk to your doctor or pharmacist again. Your doctor will monitor your response and condition to determine how long you need to take Posaconazole AHCL and if you need any changes in your daily dose.

The table below shows the recommended dose and duration of treatment, which depend on the type of infection you have and may be adapted individually for you by your doctor. Do not change your dose yourself before talking to your doctor, and do not change your treatment schedule.

Whenever possible, take posaconazole during or immediately after a meal or a nutritional drink.

If you take more Posaconazole AHCL than you should

If you are concerned that you may have taken too much of the medicine, talk to your doctor or healthcare professional immediately.

If you forget to take Posaconazole AHCL

If you have missed 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 when it is due. Do not take a double dose to make up for missed doses.

If you have any other 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 all people suffer from them.

Severe Adverse Effects

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

• nausea or vomiting (feeling or being sick), diarrhea
• signs of liver problems, including yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, feeling sick without an apparent reason, stomach problems, loss of appetite or unusual fatigue or weakness, an increase in 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 salt levels detected in blood tests, whose signs include a feeling of confusion or weakness
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling, pinching, 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 stomach discomfort, flatulence, dry mouth, changes in taste
• heartburn (a burning sensation in the chest that rises to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which can make you more prone to infections and are detected in blood tests
• fever
• feeling of weakness, dizziness, fatigue, or drowsiness
• rash
• itching
• constipation
• rectal discomfort

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

• anemia, whose signs include headaches, feeling tired or dizzy, difficult breathing, or paleness and low hemoglobin levels detected in blood tests
• low platelet levels (thrombocytopenia), detected in blood tests. This can cause bleeding
• low levels of "leukocytes", a type of white blood cell (leukopenia), detected in blood tests. This can make you more susceptible to infections
• high levels of "eosinophils", a type of white blood cell (eosinophilia). This can appear if you have an inflammatory process
• inflammation of blood vessels
• heart rhythm problems
• seizures (convulsions)
• nerve damage (neuropathy)
• abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heartbeat, 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), which can cause severe stomach pain
• severe kidney problems, whose signs include increased or decreased urination with urine of a different color than usual
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp and intense chest pain when breathing (pleuritic pain)
• inflammation of the lymph nodes (lymphadenopathy)
• decreased sensitivity, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, feeling of discomfort
• pain, back or neck pain, pain in arms or legs
• fluid retention (edema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• inability to speak totally or partially
• mouth swelling
• abnormal dreams or sleep problems
• coordination or balance problems
• mucosal inflammation
• nasal congestion
• breathing difficulties
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and diarrhea from mild to severe, usually caused by a virus, stomach pain
• belching
• feeling of restlessness

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

• pneumonia, whose signs include shortness of breath and production of discolored phlegm
• 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
• severe allergic reactions, including widespread skin rash with blisters and skin peeling
• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems thinking or speaking, sudden movements, especially in your 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 can cause cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), whose signs include intense pain and swelling of the legs
• blood clots in the lungs (pulmonary embolism), whose signs include shortness of breath or pain when breathing
• bleeding in the stomach or intestine, whose signs include vomiting blood or blood in the stool
• blockage of the intestine (intestinal obstruction), especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
• "hemolytic uremic syndrome" that appears when there is destruction of red blood cells (hemolysis), which can occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red, white, and platelets), detected in blood tests
• large purple spots on the skin (thrombocytopenic purpura)
• inflammation of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction, which can cause weakness, fatigue, loss of appetite, skin discoloration
• pituitary gland dysfunction, which can cause low blood levels of some hormones that affect the function of male or female sexual organs
• hearing problems
• pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)

Frequency not known: cannot be estimated from the available data

• some patients have also reported feeling confused after taking Posaconazol AHCL.
• skin redness

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Posaconazol AHCL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the label. The expiration date is the last day of the month indicated.
• This medicine does not require any special storage measures.
• If there is suspension left in the bottle after more than four weeks of its first opening, you should not use this medicine. Return the bottle with the remaining suspension to your pharmacist.
• Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Posaconazol AHCL

• The active ingredient is posaconazole. Each milliliter of oral suspension contains 40 milligrams of posaconazole.
• The other components of the suspension are macrogolglycerol 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 sulfuric acid (E513)), xanthan gum (E415), sodium benzoate (E211), liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavor (contains propylene glycol), and purified water.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6a planta, 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 Last Revision of this Prospectus: {MM/AAAA}

Other Sources of Information

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