Posaconazole Glenmark

Leaflet accompanying the packaging: patient information

Posaconazole Glenmark, 40 mg/ml, oral suspension

Posaconazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Posaconazole Glenmark and what is it used for
• 2. Important information before taking Posaconazole Glenmark
• 3. How to take Posaconazole Glenmark
• 4. Possible side effects
• 5. How to store Posaconazole Glenmark
• 6. Package contents and other information

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

Posaconazole Glenmark contains the active substance 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 inhibits 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 their use must be discontinued:

• fungal infections caused by the genus Aspergillusthat do not respond to antifungal medicines - amphotericin B or itraconazole, or when the use of these medicines must be discontinued;
• fungal infections caused by the genus Fusariumthat do not respond to amphotericin B or when the use of amphotericin B must be discontinued;
• fungal infections that cause diseases known as "chromoblastomycosis" and "mycetoma", which do not respond to treatment with itraconazole or when the use of itraconazole must be discontinued;
• fungal infections caused by Coccidioidesthat 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;
• mouth and throat infections (known as thrush), which have not been previously treated, caused by fungi called Candida.

This medicine may also be used 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 leukemia or myelodysplastic syndrome;
• patients taking immunosuppressive therapy in high doses after hematopoietic stem cell transplantation.

2. Important information before taking Posaconazole Glenmark

When not to take 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 started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of the treatment of chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Glenmark if any of the above situations apply to the patient. In case of doubt, before taking Posaconazole Glenmark, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Posaconazole Glenmark, discuss with 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 had liver disease in the past. During treatment with this medicine, blood tests may be necessary.
• the patient has severe diarrhea or vomiting, as this may reduce the effectiveness of the medicine,
• the patient's ECG shows heart rhythm disturbances indicating a prolonged QTc interval,
• the patient has been diagnosed with heart failure or weakened heart muscle,
• the patient has a significantly slowed heart rate (bradycardia),
• the patient has heart rhythm disturbances,
• the patient has abnormal levels of potassium, magnesium, or calcium in the blood,
• the patient is taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer),
• the patient is taking venetoclax (a medicine used to treat cancer).

If any of the above situations apply to the patient (and in case of doubt), before taking Posaconazole Glenmark, consult a doctor, pharmacist, or nurse.

Avoid exposure to the sun during treatment. It is essential to cover exposed skin areas with protective clothing and use a sunscreen with a high sun protection factor (SPF), as increased skin sensitivity to UV radiation may occur.

If severe diarrhea or vomiting occurs while taking Posaconazole Glenmark, consult a doctor, pharmacist, or nurse immediately, as this may reduce the effectiveness of the medicine. See section 4 for more information.

Children and adolescents

Posaconazole Glenmark should not be used in children and adolescents (under 18 years of age).

Posaconazole Glenmark and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.

Do not take 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 stomach disorders),
• pimozide (used to treat symptoms of Tourette's syndrome and mental illnesses),
• halofantrine (used to treat malaria),
• quinidine (used to treat heart rhythm disturbances).

Posaconazole Glenmark may increase the levels of these medicines in the blood, which can cause serious heart rhythm changes:

• any medicines containing "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Glenmark may increase the levels of these medicines in the blood, which can lead to significant reduction of blood flow to the fingers or toes and cause damage to them.
• "statins", such as simvastatin, atorvastatin, or lovastatin, used to lower high cholesterol levels.
• venetoclax used in the initial treatment of a certain type of cancer called chronic lymphocytic leukemia (CLL).

Do not take Posaconazole Glenmark if any of the above situations apply to the patient. In case of doubt, before taking this medicine, consult a doctor or pharmacist.

Other medicines

Check the list of medicines that should not be taken with Posaconazole Glenmark. Apart from the medicines listed above, there are other medicines that may increase the risk of heart rhythm disturbances. This risk may be higher when taken with Posaconazole Glenmark. Make sure the patient has told the doctor about all medicines being taken (prescription and non-prescription).

Some medicines may increase the risk of side effects of Posaconazole Glenmark by increasing its levels in the blood.

The following medicines may reduce the effectiveness of Posaconazole Glenmark by reducing its levels in the blood:

• rifabutin and rifampicin (used to treat certain infections). Patients taking rifabutin should have blood tests and monitor for possible side effects of rifabutin,
• phenytoin, carbamazepine, phenobarbital, or primidone (used to prevent or treat seizures),
• 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 prevent bacterial infections).

Posaconazole Glenmark may increase the risk of side effects of certain 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),
• cyclosporine (used during or after organ transplantation),
• tacrolimus and sirolimus (used during or after organ transplantation),
• rifabutin (used to treat certain infections),
• medicines used to treat HIV infection called protease inhibitors (including lopinavir and atazanavir taken 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 to treat certain blood cancers).

If any of the above situations apply to the patient (or in case of doubt), before taking Posaconazole Glenmark, consult a doctor or pharmacist.

Taking Posaconazole Glenmark with food and drink

If possible, to improve the absorption of posaconazole, it should be taken during or immediately after a meal or nutritional supplement (see section 3 "How to take Posaconazole Glenmark"). There is no data on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

If the patient is pregnant or thinks they may be pregnant, they should consult a doctor before taking Posaconazole Glenmark.

Do not take Posaconazole Glenmark during pregnancy unless advised by a doctor.

Women of childbearing age should use effective contraception while taking this medicine. If a woman becomes pregnant while taking Posaconazole Glenmark, she should inform her doctor immediately.

Do not breastfeed while taking 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 can affect the ability to drive or operate machinery. If these symptoms occur, do not drive or operate machinery and consult a doctor.

Posaconazole Glenmark contains glucose

If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.

Posaconazole Glenmark contains sodium

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

Posaconazole Glenmark contains sodium benzoate

The medicine contains 10 mg of sodium benzoate (E211) per 5 ml of oral suspension.

3. How to take Posaconazole Glenmark

Posaconazole Glenmark oral suspension should not be taken in place of posaconazole tablets or gastro-resistant granules for oral suspension without consulting a doctor or pharmacist. This may lead to reduced effectiveness or increased risk of side effects.

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist. The doctor will monitor the patient's response and condition to determine how long to take Posaconazole Glenmark and whether the daily dose needs to be adjusted.

The table below shows the recommended doses and duration of treatment, which depend on the type of infection and may be adjusted individually by the doctor. Do not change the dose or recommended dosing schedule without consulting a doctor.

If possible, to improve the absorption of posaconazole, it should be taken during or immediately after a meal or nutritional supplement.

Taking more Posaconazole Glenmark than recommended

If the patient thinks they have taken too much of this medicine, they should immediately consult a doctor or other healthcare professional.

Missing a dose of Posaconazole Glenmark

If a dose is missed, it should be taken as soon as possible, and then the treatment should be continued as prescribed. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

In case of further doubts about taking this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Posaconazole Glenmark can cause side effects, although not everybody gets them.

Severe side effects

Tell a doctor, pharmacist, or nurse immediately if any of the following severe side effects occur - immediate medical attention may be needed:

• nausea or vomiting, diarrhea,
• symptoms of liver disease - including yellowing of the skin or whites of the eyes, dark urine, or pale stools, unexplained nausea, stomach upset, loss of appetite, unusual tiredness or weakness, elevated liver enzymes in blood tests,
• allergic reaction.

Other side effects

Tell a doctor, pharmacist, or nurse if any of the following side effects occur:

Common: may affect up to 1 in 10 people

• change in blood electrolyte levels - symptoms include feeling disoriented or weak,
• abnormal skin sensations, including numbness, tingling, itching, gooseflesh, prickling, or burning,
• headache,
• low potassium levels - seen in blood tests,
• low magnesium levels - seen in blood tests,
• high blood pressure,
• loss of appetite, stomach pain or upset, gas, dry mouth, taste disturbances;
• heartburn (a burning sensation in the chest that may spread to the throat),
• reduced number of "neutrophils", a type of white blood cell (neutropenia) - this can increase the risk of infection and is seen in blood tests,
• fever,
• feeling weak, dizzy, tired, or sleepy,
• rash,
• itching,
• constipation,
• discomfort in the rectum.

Uncommon: may affect up to 1 in 100 people

• anemia - symptoms include headaches, feeling tired or dizzy, shortness of breath, or pale skin, and low hemoglobin levels in blood tests,
• reduced number of platelets (thrombocytopenia) - seen in blood tests, which can lead to bleeding,
• reduced number of "leukocytes", a type of white blood cell (leukopenia) - seen in blood tests, which can increase the risk of infection,
• increased number of "eosinophils" (a type of white blood cell) - seen in blood tests, which can occur during inflammation,
• vasculitis (inflammation of blood vessels),
• heart rhythm disturbances,
• seizures,
• nerve damage (neuropathy),
• abnormal heart rhythm - seen on an ECG, palpitations, slow or fast heart rate, high or low blood pressure,
• low blood pressure,
• pancreatitis - which can cause severe stomach pain,
• splenic infarction (a condition where the spleen does not receive enough blood) - which can cause severe stomach pain,
• severe kidney problems - symptoms include reduced or increased urine output, or changes in urine color,
• high creatinine levels in the blood - seen in blood tests,
• cough, hiccups,
• nosebleeds,
• sharp chest pain that occurs when breathing in (pleuritic pain),
• enlarged lymph nodes (lymphadenopathy),
• reduced sensation, especially skin sensation,
• tremors,
• high or low blood sugar levels,
• blurred vision, sensitivity to light,
• hair loss (alopecia),
• mouth ulcers,
• chills, general feeling of being unwell,
• pain, back or neck pain, arm or leg pain,
• fluid retention (edema),
• menstrual disorders (abnormal vaginal bleeding),
• difficulty sleeping (insomnia),
• complete or partial loss of speech,
• mouth swelling,
• unusual dreams or sleep problems,
• coordination or balance problems,
• mucosal inflammation,
• stuffy nose,
• breathing difficulties,
• chest discomfort,
• bloating,
• mild to severe nausea, vomiting, cramps, and diarrhea, usually caused by a viral infection, stomach pain,
• belching,
• feeling shaken.

Rare: may affect up to 1 in 1000 people

• pneumonia - symptoms include shortness of breath and coughing up discolored sputum,
• high blood pressure in the pulmonary arteries (pulmonary hypertension), which can lead to severe lung and heart damage,
• blood disorders, such as abnormal blood clotting or prolonged bleeding time,
• severe allergic reactions, including widespread blistering and skin peeling,
• psychiatric disorders, such as hearing voices or seeing things that do not exist,
• fainting,
• problems with thinking or speaking, sudden uncontrolled movements of the limbs, especially the hands,
• stroke - symptoms include pain, weakness, numbness, or tingling of the limbs,
• appearance of a blind spot or dark spot in the field of vision,
• heart failure or heart attack, which can lead to cardiac arrest and death, heart rhythm disturbances that can cause sudden death,
• presence of blood clots in the deep veins of the legs (deep vein thrombosis) - symptoms include severe leg pain or swelling,
• presence of blood clots in the lungs (pulmonary embolism) - symptoms include shortness of breath or chest pain when breathing,
• bleeding from the stomach or intestines - symptoms include vomiting blood or black stools,
• intestinal obstruction, especially "twisted intestine". 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.
• "hemolytic-uremic syndrome", in which red blood cells are broken down (hemolysis). This may be accompanied by kidney failure.
• "pancytopenia", a reduction in the number of all blood cells (red blood cells, white blood cells, and platelets) seen in blood tests,
• large purple spots under the skin (thrombocytopenic purpura),
• facial or tongue swelling,
• depression,
• double vision,
• chest pain,
• adrenal disorders - which can cause weakness, fatigue, loss of appetite, changes in skin color,
• pituitary disorders - which can cause low levels of certain hormones in the blood that affect male or female reproductive organs,
• hearing problems,
• pseudoaldosteronism, which can contribute to high blood pressure with low potassium levels (seen in blood tests).

Frequency not known: frequency cannot be estimated from the available data

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

If any of the above side effects occur, consult a doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

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 carton after EXP. or on the bottle label after EXP. The expiry date refers to the last day of the month.
• Do not store in a refrigerator or freeze.
• Use within 30 days of opening the bottle.
• If after four weeks from the first opening of the bottle some suspension remains, do not use it. Return the bottle containing unused suspension to the pharmacy where the medicine was purchased.
• Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Posaconazole Glenmark contains

• The active substance is posaconazole. Each milliliter of oral suspension contains 40 milligrams of posaconazole.
• The other ingredients of the suspension are citric acid monohydrate, anhydrous sodium citrate, sodium benzoate (E211), sodium lauryl sulfate, simethicone, emulsion 30% (containing simethicone, methylcellulose, potassium sorbate, purified water), glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), cherry flavor, purified water.

What Posaconazole Glenmark looks like and contents of the pack

Posaconazole Glenmark is a white oral suspension with a cherry flavor, in an orange glass bottle (type III), closed with a plastic (polypropylene or polyethylene) cap with a three-layer liner (with PE) and a child-resistant closure. A plastic measuring cup is provided with the bottle, allowing measurement of 2.5 and 5 ml volumes.

Marketing authorization 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 authorized 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, contact your local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.

ul. Dziekońskiego 3

00-728 Warsaw

Email: poland.receptionist@glenmarkpharma.com

Date of last revision of the leaflet:October 2024