Posaconazole Stada 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Posaconazol Stada 100 mg gastro-resistant tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Posaconazol Stada is and what it is used for

This medicine contains an active substance 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 can be used in adults to treat fungal infections caused by fungi of the Aspergillus family.

Posaconazole can be used in adults and children aged 2 years and older who weigh more than 40 kg to treat the following types of fungal infections:

• 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 responsible for 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, amphotericin B, itraconazole or fluconazole, or when treatment with these medicines has had to be discontinued.

This medicine can also be used to prevent fungal infections in adults and children aged 2 years and older who weigh more than 40 kg and who are 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 a

"haematopoietic stem cell transplant" (HSCT).

2. What you need to know before taking Posaconazol Stada

Do not take Posaconazol Stada if:

? you are allergic to posaconazole or to 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 you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking posaconazole.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting posaconazole if:

• you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
• you 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 you are in any of the above situations (or if in doubt), consult your doctor, pharmacist, or nurse before taking posaconazole.

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.

You should avoid sun exposure during treatment. It is important to cover exposed skin areas with protective clothing and use sunscreen with a high sun protection factor (SPF), as increased skin sensitivity to UV rays from sunlight may occur.

Children and adolescents

Posaconazole must not be given to children under 2 years of age.

Other medicines and Posaconazol Stada

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

Do not take Posaconazol Stada 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 disorders)

Posaconazole may increase blood levels of these medicines, 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 cause a serious reduction in blood flow to the fingers of the hands or feet, potentially causing 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 you are in any of the above situations. 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 mentioned above, other medicines may increase the risk of heart rhythm problems, and this risk may be greater 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 a blood test and should monitor for possible rifabutin side effects.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• flucloxacillin (an antibiotic used against bacterial infections).

Posaconazole may possibly 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 called tretinoin (used to treat certain blood cancers).

If you are in any of the above situations (or if in doubt), consult your doctor or pharmacist before taking posaconazole.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking posaconazole.

Do not take posaconazole if you are pregnant, unless specifically instructed by your doctor.

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

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

Driving and using machines

You may experience dizziness, drowsiness, or blurred vision while taking posaconazole, which may 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.

Posaconazol Stada contains sodium

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

3. How to take Posaconazol Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not interchange posaconazole tablets and posaconazole oral suspension without consulting your doctor or pharmacist, as this may result in lack of efficacy or increased risk of adverse reactions.

What dose to take

The recommended dose is 300 mg of posaconazole (three 100 mg gastro-resistant tablets) twice on the first day, followed by 300 mg of posaconazole (three 100 mg gastro-resistant tablets) once daily.

The duration of treatment may depend on the type of infection you have and may be individually adjusted by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment schedule.

How this medicine is administered

? Swallow the tablet whole with some water.

? Do not crush, chew, break, or dissolve the tablet.

? Tablets may be taken with or without food.

If you take more Posaconazol Stada than you should

If you think you may have taken too much posaconazole, inform your doctor immediately or go to hospital straight away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Posaconazol Stada

? If you forget a dose, take it as soon as you remember.

? However, if it is almost time for your next dose, do not take the missed dose and resume your regular dosing schedule.

? Do not take a double dose to make up for forgotten 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 need 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, or increased 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: may affect up to 1 in 10 patients

• a change in blood electrolyte levels detected in blood tests, signs of which include confusion or weakness
• abnormal skin sensations such as numbness, tingling, itching, crawling sensation, pricking, 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 (a 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 sleepy
• rash
• itching
• constipation
• rectal discomfort

Uncommon: may affect up to 1 in 100 patients

• anaemia, signs of which include headaches, feeling tired or dizzy, shortness of breath, or 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
• heart rhythm problems
• seizures (fits)
• neurological 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, signs of which include 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 problems
• coordination or balance problems
• inflammation of the mucosa
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and mild to severe diarrhoea, usually caused by a virus, stomach pain
• burping
• feeling restless

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

• pneumonia, signs of which include shortness of breath 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, signs of which 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 may lead to cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), signs of which include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism), signs of which include shortness of breath or chest pain when breathing
• bleeding in the stomach or intestines, signs of which include vomiting blood or blood in stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, signs of which include

feeling bloated, vomiting, severe constipation, loss of appetite, and cramping

• "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 adrenal gland function, which may cause weakness, tiredness, loss of appetite, skin discolouration
• inadequate pituitary gland function, which may cause low blood levels of certain hormones affecting male or female sexual organ function
• hearing problems
• pseudoaldosteronism, which causes high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from 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, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Posaconazole Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. If you are unsure how to dispose of unused or expired medicines and packaging, please consult your pharmacist. This helps protect the environment.

6. Contents of the pack and other information

Composition of Posaconazole Stada

The active substance is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.

The other components are: methacrylic acid – ethyl acrylate copolymer (1:1) (Type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium stearyl fumarate (see section 2 “Posaconazole Stada contains sodium”), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Posaconazole Stada 100 mg gastro-resistant tablets are yellow film-coated, capsule-shaped tablets, engraved with "100P" on one side and plain on the other.

The tablets are packed in non-perforated blister packs of 24 or 96 tablets, in single-dose perforated blisters of 24x1 or 96x1, or in HDPE bottles containing 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Delorbis Pharmaceuticals Ltd.

17, Athinon Street,

Ergates Industrial Area,

2643 Lefkosia,

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de?Reijtstraat?31-E?

4814 NE Breda?

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Thornton & Ross Ltd

Linthwaite, Huddersfield

HD7 5QH

United Kingdom

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

Germany Posaconazol AL 100 mg magensaftresistente Tabletten

Austria Posaconazol STADA 100 mg magensaftresistente Tabletten

Croatia Posakonazol STADA 100 mg želucanootporne tablete

Denmark Posaconazol STADA

Spain Posaconazol STADA 100 mg comprimidos gastrorresistentes EFG

Estonia Posaconazole STADA

Finland Posaconazole STADA 100 mg enterotabletti

France POSACONAZOLE EG 100 mg, comprimé gastrorésistant

Greece Posaconazole STADA

Ireland Posaconazole Clonmel 100 mg gastro-resistant tablets

Iceland Posaconazole STADA

Italy Posaconazolo Eurogenerici

Lithuania Posaconazole STADA 100 mg skrandyje neirios tabletes

Latvia Posaconazole STADA 100 mg zarnas škistošas tabletes

Malta Posaconazole Clonmel 100 mg Gastroresistant Tablets

Netherlands Posaconazol CF 100 mg, maagsapresistente tabletten

Poland Posaconazole STADA

Romania Posaconazol STADA 100 mg comprimate gastrorezistente

Sweden Posaconazole STADA 100 mg enterotablett

Slovenia Posakonazol STADA 100 mg gastrorezistentne tablete

Slovakia Posakonazol STADA 100 mg gastrorezistentne tablete

United Kingdom Posaconazole STADA 100 mg Gastro-resistant tablets

Date of the most recent revision of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.