Posaconazole Glenmark 40 mg/ml oral suspension EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Posaconazole Glenmark 40 mg/ml oral suspension EFG

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any further questions, please consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse reactions, talk to your doctor, pharmacist, or nurse, even if they are 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 Posaconazol Glenmark is and what it is used for

This medicine contains a drug 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.

Posaconazole may 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 called Candida, that 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 Glenmark

Do not take Posaconazol if:

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

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

See the section “Other medicines and posaconazole” below for further information, including about other medicines that may interact with posaconazole.

Warnings and precautions

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

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

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 your skin may become more sensitive to UV rays from the sun.

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

Children and adolescents

Posaconazole must not be used in children and adolescents (aged 17 years and younger).

Other medicines and Posaconazol Glenmark

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

Do not take posaconazole 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)

Posaconazole 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). Posaconazole may increase blood levels of these medicines, which could lead to severely reduced blood flow to the fingers of the hands or feet 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 posaconazole 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 for medicines you must not take while using posaconazole. In addition to the medicines listed above, there are other medicines that carry a risk of heart rhythm problems, which may be increased when taken with posaconazole. Make sure to inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of posaconazole side effects by increasing posaconazole levels in the blood.

The following medicines may reduce the effectiveness of posaconazole by decreasing its blood levels:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need blood tests and should monitor for possible side effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir (used to treat HIV infection).
• medicines used to reduce stomach acidity, such as cimetidine and ranitidine, or omeprazole and similar medicines known as proton pump inhibitors.
• flucloxacillin (an antibiotic used to treat bacterial infections).

Posaconazole may increase the risk of side effects from other medicines by increasing their blood levels. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after organ transplants)
• tacrolimus and sirolimus (used during or after organ transplants)
• rifabutin (used to treat certain infections)
• HIV medicines called protease inhibitors (including lopinavir and atazanavir, 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 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 posaconazole.

Taking Posaconazole with food and drink

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

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you may be pregnant before starting posaconazole.

Do not take posaconazole if you are pregnant, unless your doctor specifically tells you to.

If you are a woman who could become pregnant, you should use effective contraception while taking this medicine. If you become pregnant while taking posaconazole, contact your doctor immediately.

Do not breast-feed while taking posaconazole, as small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, drowsy, or experience blurred vision while taking posaconazole, which could affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use any tools or machines, and contact your doctor.

Posaconazole contains sodium benzoate (E-211)

This medicine contains 10 mg of sodium benzoate (E-211) per 5 ml of suspension.

Posaconazole contains glucose

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

Posaconazole contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 milliliters; hence, it is essentially "sodium-free".

3. How to take Posaconazole Glenmark

Do not switch interchangeably between posaconazole oral suspension and posaconazole tablets or gastro-resistant oral suspension without consulting your doctor or pharmacist, as this may result in lack of effectiveness or increased risk of adverse reactions.

Follow exactly the administration instructions for 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 posaconazole should be administered and whether any adjustment in 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.

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

If you take more posaconazole than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take posaconazole

If you miss 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 missed 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 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 unwell without apparent reason, stomach problems, loss of appetite, or unusual tiredness 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:

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

• changes 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 (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, with signs including 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

• problems with heart rhythm

• seizures (fits)

• nerve 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 oxygen supply to the spleen (splenic infarction), which may cause severe stomach pain

• serious kidney problems, with signs including 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 disturbances

• problems with coordination or balance

• inflammation of the mucosa

• nasal congestion

• breathing difficulties

• chest discomfort

• feeling bloated

• nausea, vomiting, cramps, and mild to severe diarrhoea, usually caused by a virus, stomach pain

• belching

• feeling restless

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

• pneumonia, with signs including breathlessness and production of 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 problems 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, with signs including pain, weakness, numbness, or tingling in the limbs
• presence of a blind spot or dark spot in the visual field
• 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), with signs including severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism), with signs including breathlessness or pain when breathing
• bleeding in the stomach or intestine, with signs including vomiting blood or blood in stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, with signs including bloating, vomiting, severe constipation, loss of appetite, and cramps
• "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, 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 the available data

• Some patients have also reported feeling confused after taking posaconazole
• Redness of the skin

Tell 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label. The expiry date refers to the last day of the month indicated.
• Do not refrigerate or freeze.
• Use within 30 days after opening the container.
• If any suspension remains in the bottle more than four weeks after first opening, this medicine must not be used. Return the bottle with any remaining suspension to your pharmacist.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Posaconazole Glenmark oral suspension EFG

• 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 (E-211), sodium lauryl sulfate, simethicone emulsion 30% (containing simethicone, methylcellulose, sorbic acid and purified water), glycerol, xanthan gum, liquid glucose, titanium dioxide (E-171), cherry flavour, and purified water.

Appearance of the product and contents of the container

Posaconazole Glenmark oral suspension EFG is a white to yellowish oral suspension with a cherry flavour, supplied in amber glass bottles (Type III) closed with a child-resistant plastic screw cap (polypropylene or polyethylene) with a three-layer polyethylene liner, containing 105 ml of oral suspension. Each bottle is supplied with a plastic dosing spoon suitable for administering doses of 2.5 ml and 5 ml.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Genepharm, S.A.

Marathonos Avenue 18 Th Km

153 51 Pallini. Attikis

Greece

RAFARM S.A.

Thesi Pousi-Xatzi Agiou Louka

TK 19002 Paiania Attiki

Greece

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: November 2024.

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)