Posaconazole sandoz

Package leaflet: Information for the patient

Posaconazole Sandoz, 40 mg/ml, oral suspension
Posaconazolum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

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

1. What Posaconazole Sandoz is and what it is used for

Posaconazole Sandoz contains the active substance posaconazole. Posaconazole belongs to a group of antifungal medicines. It is used to prevent and treat a number of different fungal infections.
This medicine works by killing or stopping the growth of certain types of fungi that can cause infections.

Posaconazole Sandoz may be used in adults to treat the following fungal infections when other antifungal medicines are ineffective or cannot be continued:

• Infections caused by Aspergillus fungi, which were not successfully treated with or required discontinuation of antifungal therapy such as amphotericin B or itraconazole;
• Infections caused by Fusarium fungi, which were not successfully treated with amphotericin B or required discontinuation of therapy;
• Fungal infections known as "chromoblastomycosis" and "phaeohyphomycosis", which were not successfully treated with itraconazole or required discontinuation of therapy;
• Infections caused by Coccidioides fungi, which were not successfully treated with one or more of the following antifungal medicines: amphotericin B, itraconazole or fluconazole, or required discontinuation of therapy;
• Previously untreated fungal infections of the mouth or throat (so-called "thrush") caused by yeasts (Candida).

This medicine may also be used to prevent fungal infections in the following adult patients at high risk of developing such infections:

• Patients with weakened immune system due to chemotherapy for acute myeloid leukemia or myelodysplastic syndrome;
• Patients undergoing high-dose immunosuppressive therapy following hematopoietic stem cell transplantation.

2. Important information before using Posaconazole Sandoz

When not to use Posaconazole Sandoz

• if the patient is allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or any medicine containing ergot alkaloids (such as ergotamine or dihydroergotamine), or a statin medicine (such as simvastatin, atorvastatin or lovastatin);
• if the patient has just started taking venetoclax or the dose of venetoclax is being gradually increased for the treatment of chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Sandoz if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.
More information about possible interactions with other medicines can be found in the subsection “Posaconazole Sandoz and other medicines”.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Posaconazole Sandoz if:

• the patient has previously had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole;
• the patient has or has ever had liver disease; the doctor may recommend blood tests during treatment;
• the patient has severe diarrhoea or vomiting, as these may reduce the effectiveness of the medicine;
• the patient has an abnormal heart trace on electrocardiogram (ECG), indicating a condition called “prolonged QTc interval”;
• the patient has been diagnosed with weakened heart muscle or heart failure;
• the patient’s heart rate is significantly slow;
• the patient has heart rhythm disorders;
• the patient has abnormal levels of potassium, magnesium, or calcium in the blood;
• the patient is taking medicines containing vincristine, vinblastine, or other vinca alkaloids (medicines used in cancer treatment);
• the patient is taking venetoclax (a medicine used in cancer treatment).

During treatment, avoid exposure to sunlight. It is important to cover exposed skin areas with protective clothing and use a sunscreen with a high sun protection factor (SPF), as increased sensitivity of the skin to ultraviolet (UV) radiation may occur.

If any of the above conditions apply to the patient or if the patient is unsure, consult a doctor, pharmacist, or nurse before using Posaconazole Sandoz.
If the patient develops severe diarrhoea or vomiting while taking the medicine, inform the doctor, pharmacist, or nurse immediately, as there is a risk that the medicine may not work properly. Further information can be found in section 4.

Children and adolescents

Posaconazole Sandoz must not be used in children and adolescents under 18 years of age.

Posaconazole Sandoz and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Posaconazole Sandoz if the patient is taking any of the following medicines:

• terfenadine (a medicine used to treat allergies);
• astemizole (a medicine used to treat allergies);
• cisapride (a medicine used to treat stomach disorders);
• pimozide (a medicine used to treat symptoms of Tourette’s syndrome and psychiatric conditions);
• halofantrine (a medicine used to treat malaria);
• quinidine (a medicine used to treat irregular heart rhythm).

Posaconazole Sandoz may increase the blood levels of the following medicines, which may lead to serious heart rhythm disturbances:

• medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraine). Posaconazole Sandoz may increase the blood levels of these medicines, which may lead to severely reduced blood flow to fingers and toes and tissue damage;
• statins, such as simvastatin, atorvastatin or lovastatin (medicines used to lower high cholesterol levels in the blood);
• venetoclax, when starting treatment for a certain type of cancer, chronic lymphocytic leukaemia (CLL).
  If the patient is taking any of the medicines listed above, do not take Posaconazole Sandoz. If in doubt, consult a doctor or pharmacist before using this medicine.

Other medicines

The above list includes medicines that must not be taken together with Posaconazole Sandoz. In addition, there are other medicines associated with a risk of heart rhythm disturbances, which may be increased when used together with Posaconazole Sandoz. It is essential to inform the doctor about all medicines currently being taken (whether prescribed or available without a prescription).

Some medicines may increase the risk of adverse effects of Posaconazole Sandoz by increasing its blood concentration.

The following medicines may reduce the effectiveness of Posaconazole Sandoz by decreasing its blood concentration:

• rifabutin and rifampicin (medicines used to treat certain infections). If the patient is being treated with rifabutin, blood tests and monitoring for adverse effects of rifabutin may be necessary;
• phenytoin, carbamazepine, phenobarbital, or primidone (used in the treatment of epilepsy or to prevent seizures);
• efavirenz and fosamprenavir (medicines used to treat HIV infection);
• medicines used to reduce stomach acid secretion, such as cimetidine and ranitidine, or omeprazole and similar medicines, known as proton pump inhibitors;
• flucloxacillin (an antibiotic used to prevent bacterial infections).

Posaconazole Sandoz may increase the risk of adverse effects of other medicines by increasing their blood concentration. These include:

• vincristine, vinblastine, and other vinca alkaloids (anticancer medicines);
• venetoclax (used in cancer treatment);
• cyclosporine (a medicine used during or after organ transplantation);
• tacrolimus and sirolimus (medicines used during or after organ transplantation);
• rifabutin (a medicine used to treat certain infections);
• medicines used to treat HIV infection, known as protease inhibitors (including lopinavir and atazanavir given with ritonavir);
• midazolam, triazolam, alprazolam, or other benzodiazepines (sedatives or muscle relaxants);
• diltiazem, verapamil, nifedipine, nisoldipine, or other calcium channel blockers (medicines used to treat high blood pressure);
• digoxin (a medicine used to treat heart failure);
• glipizide or other sulfonylureas (medicines used to treat high blood sugar levels);
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If the patient is taking (or is unsure whether they are taking) any of the medicines listed above, consult a doctor or pharmacist before using Posaconazole Sandoz.

Posaconazole Sandoz with food and drink

To improve absorption of posaconazole, the medicine should be taken, if possible, during or immediately after a meal or nutritional supplement (see section 3 “How to use Posaconazole Sandoz”). There is no information available on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Inform the doctor if the patient thinks she is pregnant before starting Posaconazole Sandoz.

Do not use Posaconazole Sandoz during pregnancy unless otherwise decided by the doctor. Women of childbearing potential must use effective contraception during treatment with this medicine.

If the patient becomes pregnant while taking Posaconazole Sandoz, she should contact her doctor immediately.

Do not breastfeed during treatment with Posaconazole Sandoz, as small amounts of the medicine may pass into breast milk.

Driving and operating machinery

While taking Posaconazole Sandoz, the patient may experience dizziness, drowsiness, or visual disturbances, which may affect the ability to drive or operate tools or machinery. If such symptoms occur, do not perform these activities and contact the doctor.

Posaconazole Sandoz contains glucose, sodium benzoate (E 211), benzoic acid, propylene glycol, and sodium

The medicine contains approximately 608.3 mg of glucose in 5 ml of oral suspension. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine may be harmful to teeth.

This medicine contains less than 1 mmol (23 mg) of sodium per dose (5 ml), meaning the medicine is considered “sodium-free”.

The medicine contains 10 mg of sodium benzoate and 0.033 mg of benzoic acid in each dosage unit (5 ml), equivalent to 2 mg/ml of sodium benzoate and 0.0066 mg/ml of benzoic acid. Benzoic acid/sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

The medicine contains 22.5 mg of propylene glycol in each dosage unit (5 ml), equivalent to 4.5 mg/ml. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to use Posaconazole Sandoz

Other medicines containing posaconazole are available in different pharmaceutical forms and different strengths, but they are not called "Posaconazole Sandoz". Do not substitute posaconazole tablets with the posaconazole oral suspension medicine called Posaconazole Sandoz without consulting your doctor or pharmacist, as this may lead to reduced effectiveness of the treatment or an increased risk of adverse effects.

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Your doctor will monitor your response to treatment and the course of the disease in order to determine how long you need to take Posaconazole Sandoz and whether your daily dose needs to be adjusted.

The table below shows the recommended dosage and duration of treatment, which may be individually adjusted by your doctor depending on the type of infection. Do not change the prescribed dose or treatment schedule without first consulting your doctor. Whenever possible, the medicine should be taken during or immediately after a meal or nutritional supplement.

Shake the bottle well before use.

Taking an overdose of Posaconazole Sandoz
If a patient has taken more than the recommended dose of the medicine, they should contact a doctor or other healthcare professional immediately.

Missing a dose of Posaconazole Sandoz
If a patient misses a dose of the medicine, they should take it as soon as they remember, then continue treatment as directed. However, if it is almost time for the next dose, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for a missed dose.

If there are any further questions about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Serious adverse reactions
If the patient experiences any of the following serious adverse reactions, it is necessary to
immediately inform a doctor, pharmacist or nurse, as urgent medical assistance may be required:
nausea or vomiting, diarrhoea
symptoms of liver disorders (including yellowing of the skin and whites of the eyes, unusual darkening of the urine or pale stools, nausea without apparent cause, stomach problems, loss of appetite, or unusual tiredness or weakness, increased liver enzyme activity detected in blood tests)
allergic reaction

Other adverse reactions
If the patient experiences any of the following adverse reactions, inform a doctor, pharmacist or nurse.
Frequent: may affect up to 1 in 10 people

• changes in blood electrolyte concentrations detected in blood tests (symptoms may include confusion or weakness)
• unusual sensations such as numbness, tingling, itching, chills, pricking or burning of the skin
• headache
• low potassium levels detected in blood tests
• low magnesium levels detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or indigestion, gas, dry mouth, taste changes
• heartburn (a burning sensation in the chest radiating to the throat)
• low neutrophil count, a type of white blood cell (neutropenia), detected in blood tests, which may increase susceptibility to infections
• fever
• feeling of weakness, dizziness, fatigue or drowsiness
• rash
• itching
• constipation
• discomfort in the rectal area

Uncommon: may affect up to 1 in 100 people

• anaemia (symptoms include headache, fatigue or dizziness, shortness of breath or pale skin, and low haemoglobin levels detected in blood tests)
• low platelet count (thrombocytopenia) detected in blood tests, which may lead to bleeding
• reduced white blood cell count, a type of white blood cell (leukopenia) detected in blood tests, which may increase susceptibility to infections
• increased eosinophil count, a type of white blood cell (eosinophilia), which may accompany inflammatory conditions
• vasculitis (inflammation of blood vessels)
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm visible on electrocardiogram (EKG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• pancreatitis, which may cause severe abdominal pain
• interrupted blood supply to the spleen (splenic infarction), which may cause severe stomach pain
• serious kidney function disorders with symptoms such as passing larger or smaller amounts of urine of different than usual colour
• high creatinine levels in blood detected in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensitivity, especially of the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• oral ulceration
• chills, general malaise
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to walk
• swelling of the oral mucosa
• unusual dreams or difficulty falling asleep
• coordination or balance disorders
• mucositis (inflammation of mucous membranes)
• nasal congestion
• breathing difficulties
• discomfort in the chest
• bloating
• mild to severe nausea, vomiting, cramps and diarrhoea, usually of viral origin, stomach pain
• belching
• feeling of motor restlessness

Rare: may affect up to 1 in 1000 people

• pneumonia (symptoms include shortness of breath and production of discoloured sputum)
• high blood pressure in the pulmonary blood vessels (pulmonary hypertension), which may lead to serious damage to the lungs and heart
• blood disorders such as abnormal clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• psychiatric disorders such as hearing voices or seeing things that are not there
• fainting
• disturbances in thinking or speaking, uncontrollable tremor, especially of the hands
• stroke with symptoms including pain, weakness, numbness or tingling in limbs
• blind spots or dark spots in the visual field
• heart failure or myocardial infarction, which may lead to cardiac arrest and death, cardiac arrhythmias with sudden death
• formation of blood clots in the legs (deep vein thrombosis) with symptoms such as severe leg pain or swelling
• blood clots in the lungs (pulmonary embolism) with symptoms such as shortness of breath or pain during breathing
• bleeding in the stomach or intestine with symptoms such as vomiting blood or presence of blood in stool
• intestinal obstruction, especially of the small intestine, which blocks the passage of intestinal contents to further segments (symptoms include bloating, vomiting, severe constipation, loss of appetite and cramps)
• "haemolytic-uraemic syndrome", which occurs due to the breakdown of red blood cells (haemolysis), with or without kidney failure
• "pancytopenia" – reduction in the number of all types of blood cells (red cells, white cells and platelets) detected in blood tests
• large purple skin discolourations (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• chest pain
• adrenal dysfunction, which may cause weakness, fatigue, loss of appetite
• skin depigmentation
• pituitary dysfunction, which may cause low levels of certain hormones in the blood and consequently affect the function of sex organs in both women and men
• hearing disorders
• pseudoaldosteronism, resulting in high blood pressure and low potassium levels (detected in blood tests)

Frequency not known due to lack of available data

• Some patients have also reported confusion after taking Posaconazole Sandoz
• Skin redness

If any of the listed adverse reactions occur, inform a doctor, pharmacist or nurse.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Posaconazole Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label following EXP. The expiry date refers to the last day of the specified month.
Shelf-life after first opening the bottle: 4 weeks.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Posaconazole Sandoz contains

• The active substance is posaconazole. Each millilitre of oral suspension contains 40 mg of posaconazole.
• The other ingredients are: polysorbate 80, simethicone, polysorbate 65, methylcellulose, polyoxyethylene (8) stearate, glycerol monostearate, xanthan gum, benzoic acid, sorbic acid, sulfuric acid, purified water, sodium benzoate (E 211), sodium citrate, citric acid monohydrate, glycerol, spray-dried liquid glucose, titanium dioxide (E171), cherry flavour (825.0275U) containing propylene glycol, natural and artificial flavour, water for injections.

What Posaconazole Sandoz looks like and contents of the pack
Posaconazole Sandoz is a white or almost white suspension with a cherry flavour. Amber glass bottles containing 105 ml of suspension are closed with a child-resistant cap. The carton also contains a sachet with a dosing spoon marked with volumes of 2.5 ml and 5 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

For further information about the medicinal product and its names in other European Economic Area member states, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00