Posaconazole glenmark

Package leaflet: Information for the patient

Posaconazole Glenmark, 40 mg/ml, oral suspension
Posaconazolum
Please read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Posaconazole Glenmark contains a medicine called posaconazole, which belongs to a group of antifungal medicines. This medicine is used to prevent and treat many types of fungal infections.
This medicine kills or stops the growth of certain types of fungi that can cause infections in humans.
Posaconazole Glenmark may be used in adults to treat the following fungal infections when other antifungal medicines do not work or must be discontinued:

• infections caused by fungi of the genus Aspergillus that do not respond to antifungal medicines - amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by fungi of the genus Fusarium that do not respond to amphotericin B or when treatment with amphotericin B must be discontinued;
• infections caused by fungi leading to diseases known as “chromoblastomycosis” and “eumycetoma” that do not respond to itraconazole treatment or when treatment with itraconazole must be discontinued;
• infections caused by fungi called Coccidioides that do not respond to one or more of the following medicines - amphotericin B, itraconazole or fluconazole, or when treatment with these medicines must be discontinued;
• infections of the mouth and throat (known as oral thrush), which have not been previously treated, caused by fungi called Candida.

This medicine may also be used prophylactically to prevent fungal infections in adults who are at high risk of such infections, such as:

• patients whose immune system is weakened due to chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome;
• patients receiving high-dose immunosuppressive therapy after haematopoietic stem cell transplantation.

2. Important information before using Posaconazole Glenmark

When not to use Posaconazole Glenmark:

• 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 medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, or statins such as simvastatin, atorvastatin or lovastatin,
• if the patient has just started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of therapy for chronic lymphocytic leukaemia (CLL).

Posaconazole Glenmark must not be used if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using Posaconazole Glenmark.
Please refer to the section below “Posaconazole Glenmark and other medicines” for further information, including details on other medicines that may interact with Posaconazole Glenmark.
Warnings and precautions
Before starting treatment with Posaconazole Glenmark, consult your doctor, pharmacist or nurse if:

• the patient has had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole,
• the patient currently has or has previously had liver disease. Blood tests may be required during treatment with this medicine,
• the patient currently has severe diarrhoea or severe vomiting, as these may reduce the effectiveness of this medicine,
• the patient has ECG abnormalities indicating QTc prolongation,
• the patient has been diagnosed with weakened heart muscle or heart failure,
• the patient has significant slowing of the heart rate (pulse),
• the patient has heart rhythm disorders,
• the patient has abnormal blood levels of potassium, magnesium or calcium,
• the patient is taking vincristine, vinblastine or other "vinca alkaloids" (medicines used in cancer treatment),
• the patient is taking venetoclax (a medicine used in the treatment of cancer).

If any of the above situations apply to the patient (or if in doubt), consult a doctor, pharmacist or nurse before using Posaconazole Glenmark.
During treatment, avoid exposure to sunlight. It is important to cover sun-exposed skin areas with protective clothing and to use a high sun protection factor (SPF) sunscreen, as increased sensitivity of the skin to ultraviolet (UV) radiation may occur.
If severe diarrhoea or severe vomiting occurs while taking Posaconazole Glenmark, consult a doctor, pharmacist or nurse immediately due to the potential reduction in effectiveness of the medicine. Refer to section 4 for further information.
Children and adolescents
Posaconazole Glenmark must not be used in children and adolescents (aged 17 years and younger).
Posaconazole Glenmark 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 use Posaconazole Glenmark if the patient is taking any of the following medicines:

• terfenadine (used to treat allergies),
• astemizole (used to treat allergies),
• cisapride (used to treat gastrointestinal problems),
• pimozide (used to treat symptoms of Tourette's syndrome and psychiatric disorders),
• halofantrine (used to treat malaria),
• quinidine (used to treat heart rhythm disorders).

Posaconazole Glenmark may increase blood levels of these medicines, which may lead to serious heart rhythm disturbances:

• any medicines containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Glenmark may increase blood levels of these medicines, leading to severely reduced blood flow to fingers or toes and causing tissue damage,
• "statins" such as simvastatin, atorvastatin or lovastatin, used to lower high cholesterol levels,
• venetoclax, used at the beginning of treatment for a type of cancer called chronic lymphocytic leukaemia (CLL).

Do not use Posaconazole Glenmark if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before using this medicine.
Other medicines
Please refer to the list above of medicines that must not be taken during treatment with Posaconazole Glenmark. In addition to the medicines listed above, there are other medicines that carry a risk of heart rhythm disturbances. This risk may be increased when these medicines are taken together with Posaconazole Glenmark. Make sure to inform your doctor about all medicines being taken (both prescription and non-prescription).
Some medicines may increase the risk of adverse effects of Posaconazole Glenmark by increasing its blood concentration.
The following medicines may reduce the effectiveness of Posaconazole Glenmark by decreasing its blood concentration:

• rifabutin and rifampicin (used to treat certain infections). Patients taking rifabutin should have blood tests and monitor for possible adverse effects of rifabutin,
• phenytoin, carbamazepine, phenobarbital or primidone (used for prevention or treatment of seizures),
• efavirenz and fosamprenavir used in the treatment of 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 Glenmark may likely increase the risk of adverse effects of certain medicines by increasing their blood concentrations. These include:

• vincristine, vinblastine and other vinca alkaloids (used in the treatment of cancer),
• venetoclax (used in the treatment of cancer),
• cyclosporine (used during or after organ transplantation),
• tacrolimus and sirolimus (used during or after organ transplantation),
• rifabutin (used to treat certain infections),
• HIV protease inhibitors (including lopinavir and atazanavir taken together 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 lower high blood sugar levels),
• all-trans retinoic acid (ATRA), also known as tretinoin (used in the treatment of certain blood cancers).

If any of the above situations apply to the patient (or if in doubt), consult a doctor or pharmacist before using Posaconazole Glenmark.
Taking Posaconazole Glenmark with food and drink
To improve absorption of posaconazole, take it during or immediately after a meal or nutritional supplement (see section 3 “How to take Posaconazole Glenmark”). There are no data on the effect of alcohol on posaconazole.
Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, she should consult her doctor before using Posaconazole Glenmark.
Do not use Posaconazole Glenmark during pregnancy unless specifically advised by a doctor.
Women of childbearing potential should use effective contraception during treatment with this medicine. If a woman becomes pregnant while taking Posaconazole Glenmark, she should inform her doctor immediately.
Breastfeeding must not be undertaken during treatment with Posaconazole Glenmark, as small amounts of the medicine may pass into breast milk.
Driving and using machines
While taking Posaconazole Glenmark, symptoms such as dizziness, drowsiness or blurred vision may occur, which may affect the ability to drive, use tools or operate machinery. If such symptoms occur, do not drive, use any tools or operate any machinery, and consult a doctor.
Posaconazole Glenmark contains glucose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Posaconazole Glenmark contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml of oral suspension, meaning the medicine is considered "sodium-free".
Posaconazole Glenmark contains sodium benzoate
The medicine contains 10 mg of sodium benzoate (E211) in 5 ml of oral suspension.

3. How to use Posaconazole Glenmark

Posaconazole Glenmark oral suspension must not be used interchangeably with posaconazole tablets or rectal powder and solvent for oral suspension without consulting a doctor or pharmacist. This may result in reduced effectiveness of the medicine or an increased risk of adverse effects.
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. Your doctor will monitor your response and condition to determine how long treatment with Posaconazole Glenmark should continue and whether adjustment of the daily dose is necessary.
The table below shows the recommended doses and duration of treatment, which depend on the type of infection present in the patient and may be individually adjusted by the doctor. Do not change the dose or dosing regimen on your own without consulting your doctor.
To enhance absorption of posaconazole, if possible, it should be taken during or shortly after a meal or nutritional supplement.

Use of a higher than recommended dose of Posaconazole Glenmark
If the patient thinks they have taken too much medicine, they should contact a doctor or other healthcare professional immediately.

Missed dose of Posaconazole Glenmark
If a dose of the medicine is missed, it should be taken as soon as possible, then treatment should be continued according to recommendations. However, if it is almost time for the next dose, the patient should take the dose as scheduled. Do not take a double dose 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 not everyone will experience them.
Serious adverse reactions
Inform your doctor, pharmacist or nurse immediately if any of the following
serious adverse reactions occur – immediate medical attention may be needed:

• nausea or vomiting, diarrhoea,
• signs of liver disease – including yellowing of the skin or whites of the eyes (sclera), abnormally dark urine or pale stools, nausea without apparent cause, stomach discomfort, loss of appetite, unusual tiredness or weakness, increased liver enzyme activity detected in blood tests,
• allergic reaction.

Other adverse reactions
Inform your doctor, pharmacist or nurse if any of the following adverse reactions occur:
Common: may affect up to 1 in 10 people

• changes in blood electrolyte levels detected in blood tests – symptoms include feeling disoriented or weak,
• abnormal skin sensations, including numbness, tingling, itching, goosebumps, pricking or burning sensations,
• headache,
• low potassium levels – detected in blood tests,
• low magnesium levels – detected in blood tests,
• high blood pressure,
• loss of appetite, stomach pain or upset stomach, gas, dry mouth, altered taste perception,
• heartburn (burning sensation in the chest radiating to the throat),
• decrease in the number of neutrophils, a type of white blood cell (neutropenia) – this may increase susceptibility to infections and is detectable in blood tests,
• fever,
• feeling weak, dizzy, tired or drowsy,
• rash,
• itching,
• constipation,
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anaemia – symptoms include headache, feeling tired or dizzy, shortness of breath or pale skin, and low haemoglobin levels detected in blood tests,
• decrease in the number of platelets (thrombocytopenia) detected in blood tests – may lead to bleeding,
• decrease in the number of leukocytes, a type of white blood cell (leukopenia) detected in blood tests – may increase susceptibility to infections,
• increase in the number of eosinophils (eosinophilia), a type of white blood cell – may occur during inflammatory conditions,
• vasculitis (inflammation of blood vessels),
• heart rhythm disorders,
• seizures,
• nerve damage (neuropathy),
• irregular heartbeat – visible on ECG, palpitations, slow or rapid heartbeat, high or low blood pressure,
• low blood pressure,
• pancreatitis – may cause severe abdominal pain,
• splenic infarction (lack of oxygen to the spleen) – may cause severe abdominal pain,
• serious kidney function disorders – symptoms include reduced or increased urine output, or change in urine colour,
• high blood creatinine levels – detected in blood tests,
• cough, hiccups,
• nosebleeds,
• severe, sharp chest pain occurring during inhalation (pleuritic pain),
• swollen lymph nodes (lymphadenopathy),
• reduced sensation, especially of the skin,
• tremor,
• increased or decreased blood sugar levels,
• blurred vision, light sensitivity,
• hair loss (alopecia),
• mouth ulcers,
• chills, general malaise,
• pain, back or neck pain, pain in arms and legs,
• fluid retention in the body (oedema),
• menstrual disorders (abnormal vaginal bleeding),
• difficulty falling asleep (insomnia),
• complete or partial loss of speech ability,
• swelling of the mouth,
• unusual dreams or sleep problems,
• coordination or balance disorders,
• mucositis (inflammation of mucous membranes),
• nasal congestion,
• breathing difficulties,
• chest discomfort,
• bloating,
• mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by viral infection, abdominal pain,
• burping,
• feeling shaky.

Rare: may affect up to 1 in 1,000 people

• pneumonia – symptoms include shortness of breath and coughing up discoloured sputum,
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may lead to severe lung and heart damage,
• blood disorders, such as abnormal blood clotting or prolonged bleeding time,
• severe allergic reactions, including widespread blistering rash and skin peeling,
• psychiatric disorders, such as hearing voices and seeing things that are not real,
• fainting,
• problems with thinking or speaking, sudden, uncontrolled limb movements, especially of the hands,
• stroke – symptoms include pain, weakness, numbness or tingling in limbs,
• appearance of blind spots or dark spots (scotoma) in the visual field,
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders causing sudden death,
• presence of blood clots in the blood vessels of the lower limbs (deep vein thrombosis) – symptoms include severe leg pain or swelling,
• presence of blood clots in the blood vessels of the lungs (pulmonary embolism) – symptoms include shortness of breath or pain during breathing,
• bleeding from the stomach or intestines – symptoms include vomiting blood or presence of blood in stools,
• intestinal obstruction, particularly of the "sigmoid colon". Obstruction prevents the movement of intestinal contents to the lower part of the digestive tract (large intestine). Symptoms include bloating, vomiting, severe constipation, loss of appetite and intestinal cramps,
• "haemolytic-uraemic syndrome", in which red blood cells break down (haemolysis). This may be accompanied by kidney failure,
• "pancytopenia", i.e. decrease in all types of blood cells (red blood cells, white blood cells and platelets) detectable in blood tests,
• large purple bruises under the skin (thrombotic thrombocytopenic purpura),
• swelling of the face or tongue,
• depression,
• double vision,
• chest pain,
• adrenal gland dysfunction – may cause weakness, fatigue, loss of appetite, changes in skin pigmentation,
• pituitary gland dysfunction – may cause decreased levels of certain hormones in the blood affecting the function of male or female reproductive organs,
• hearing disorders,
• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (detected in blood tests).

Frequency unknown: frequency cannot be estimated from available data

• some patients have also reported feeling disoriented after taking Posaconazole Glenmark,
• skin redness.

If any of the above adverse reactions occur, consult your
doctor, pharmacist or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your 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 responsible entity.

5. How to store Posaconazole Glenmark

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box after: Expiry (EXP) or on the bottle label after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
• Do not store in the refrigerator or freeze.
• Use within 30 days after opening the bottle.
• If any amount of the suspension remains after four weeks from the first opening of the bottle, do not use it. The bottle containing unused suspension should be returned to the pharmacy where the medicine was purchased.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Posaconazole Glenmark contains

• The active substance is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The other components of the suspension are: citric acid monohydrate, anhydrous monosodium citrate, sodium benzoate (E211), sodium lauryl sulphate, simethicone, 30% emulsion (containing simethicone, methylcellulose, sorbic acid, purified water), glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), cherry flavour, purified water.

What Posaconazole Glenmark looks like and contents of the pack
Posaconazole Glenmark is a white oral suspension with a cherry flavour, contained in an amber glass bottle (Type III), closed with a plastic (polypropylene or polyethylene) child-resistant cap with a three-layer insert (PE), and presented in a cardboard box. A plastic dosing spoon is included with the bottle, allowing measurement of volumes of 2.5 ml and 5 ml.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
153 51 Pallini Attiki
Greece
RAFARM S.A.
Thesi Pousi-Xatzi Agiou Louka
TK 19002 Paiania Attiki
Greece
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Posaconazol Glenmark 40 mg/ml Suspension zum Einnehmen
Spain: Posaconazol Glenmark 40 mg/ml suspensión oral EFG
Netherlands: Posaconazol Glenmark 40 mg/ml suspensie voor oraal gebruik
Poland: Posaconazole Glenmark

For further information, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonińskiego 3
00-728 Warsaw
Email: [email protected]