Posaconazole stada

Package leaflet: Information for the patient

Posaconazole STADA, 100 mg, enteric-coated tablets
posaconazole
Please read carefully the entire 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 further 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 identical.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Posaconazole STADA contains the active substance posaconazole. It belongs to a group of antifungal medicines. This medicine is used to prevent and treat various types of fungal infections.
This medicine works by killing or inhibiting the growth of fungi that may cause infections.
Posaconazole STADA may be used in adults for the treatment of fungal infections caused by fungi of the genus Aspergillus.
Posaconazole STADA may be used in adults and in children aged 2 years and older with body weight above 40 kg for the treatment of the following types of fungal infections:

• infections caused by species of the genus Aspergillus that are unresponsive to antifungal medicines – amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by species of the genus Fusarium that are unresponsive to amphotericin B, or when treatment with amphotericin B must be discontinued;
• infections caused by fungi known as chromoblastomycosis and phaeohyphomycosis that are unresponsive to itraconazole treatment, or when treatment with itraconazole must be discontinued;
• infections caused by fungi of the genus Coccidioides that are unresponsive to one or more of the following medicines – amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines must be discontinued;

This medicine may also be used to prevent fungal infections in adults and in children aged 2 years and older with body weight above 40 kg who are at high risk of such infections, namely:

• in patients with weakened immune systems due to chemotherapy used in the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS);
• in patients receiving high-dose immunosuppressive therapy following hematopoietic stem cell transplantation (HSCT).

2. Important information before taking Posaconazole STADA

Do not take Posaconazole STADA:

• 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, any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, or a statin medicine 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 therapy for chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole STADA if any of the above situations apply. If in doubt, consult a doctor or pharmacist before taking Posaconazole STADA.
Further information about other medicines that may interact with Posaconazole STADA can be found in the section “Posaconazole STADA and other medicines”.

Warnings and precautions

Before starting Posaconazole STADA, consult a doctor, pharmacist or nurse if any of the following apply:

• the patient has ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole or voriconazole,
• the patient has had or currently has liver problems. Blood tests may be required during treatment with this medicine,
• the patient has severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine,
• abnormalities in the heart rhythm (ECG) indicating prolonged QTc interval,
• weakened heart muscle or heart failure,
• very slow heart rate,
• heart rhythm disorders,
• any disturbances related to blood levels of potassium, magnesium or calcium,
• use of vincristine, vinblastine or other vinca alkaloids (used in the treatment of cancer),
• if the patient is taking venetoclax (a medicine used in the treatment of cancer).

If any of the above apply (or are suspected), the patient must inform the doctor, pharmacist or nurse before starting Posaconazole STADA.
If severe diarrhoea or vomiting occurs while taking Posaconazole STADA, inform the doctor, pharmacist or nurse immediately, as this may result in the medicine not working properly. More information can be found in section 4.

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

Children and adolescents

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

Posaconazole STADA and other medicines

Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.

Do not take Posaconazole STADA 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 STADA may increase blood levels of these medicines, which could lead to serious heart rhythm disturbances.

• any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole STADA may increase blood levels of these medicines, potentially leading to severe reduction in blood flow to fingers and toes and tissue damage,
• statin medicines such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels,
• venetoclax, used at the beginning of treatment for a type of cancer called chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole STADA if any of the above situations apply. If in doubt, consult a doctor or pharmacist before taking this medicine.

Other medicines:

The list above includes medicines that must not be taken during treatment with Posaconazole STADA. In addition to the medicines listed above, other medicines may also carry a risk of heart rhythm disturbances, which may be increased when taken together with Posaconazole STADA. The patient should inform the doctor about all medicines being taken (both prescription and over-the-counter).

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

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

• rifabutin and rifampicin (used to treat certain infections). Patients already taking rifabutin may require blood tests and monitoring 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 to prevent bacterial infections).

Posaconazole STADA may likely increase the risk of adverse effects of certain medicines by increasing their blood levels. 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 after transplantation),
• rifabutin (used to treat certain infections),
• HIV protease inhibitors (including lopinavir and atazanavir, used with ritonavir),
• midazolam, triazolam, alprazolam and other similar medicines known as benzodiazepines (used as sedatives or muscle relaxants),
• diltiazem, verapamil, nifedipine, nisoldipine and other calcium channel blockers (used to treat high blood pressure),
• digoxin (used in heart failure),
• sulfonylurea derivatives such as glipizide (used to treat diabetes),
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If any of the above apply (or are suspected), inform the doctor or pharmacist before starting Posaconazole STADA.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Posaconazole STADA must not be used during pregnancy unless otherwise advised by a doctor.

Women of childbearing potential should use effective contraception during treatment with Posaconazole STADA. If pregnancy occurs during treatment with Posaconazole STADA, contact the doctor immediately.

Breastfeeding is not allowed during treatment with Posaconazole STADA, as small amounts of the medicine may pass into breast milk.

Driving and operating machinery

While taking Posaconazole STADA, dizziness, drowsiness or blurred vision may occur, which could affect the ability to drive or use tools and machinery. In such cases, do not drive or operate tools or machinery, and contact the doctor.

Posaconazole STADA contains sodium

The sodium content is less than 1 mmol (23 mg) per tablet, which is considered essentially "sodium-free".

3. How to take Posaconazole STADA

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Do not interchange Posaconazole STADA tablets with posaconazole oral suspension without
consulting a doctor or pharmacist, as this may lead to ineffective treatment or an increased
risk of adverse reactions.
What dose of the medicine should be taken
The usual dose of posaconazole is 300 mg (three 100 mg enteric-coated tablets) twice on the
first day, followed by 300 mg (three 100 mg enteric-coated tablets) once daily.
The duration of treatment may depend on the type of infection present in the patient and may
be individually adjusted by the doctor. Do not adjust the dose or change the prescribed treatment
regimen without consulting a doctor.
How to take Posaconazole STADA

• Swallow the tablets whole with a small amount of water.
• Do not crush, chew, break, or dissolve the tablets.
• The tablets may be taken with or without food.

Accidental overdose of Posaconazole STADA
If an overdose of Posaconazole STADA is suspected, consult a doctor or go to the hospital
immediately.
Missed dose of Posaconazole STADA

• If a dose is missed, take it as soon as possible.
• However, if it is almost time for the next dose, do not take the missed dose and take the next dose according to the prescribed schedule.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
If you notice any of the serious adverse reactions listed below, contact your doctor, pharmacist or nurse immediately, as you may require urgent medical attention:

• nausea or vomiting (feeling sick or bringing up stomach contents), diarrhoea
• symptoms of liver problems – these include: yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, feeling sick for no apparent reason, stomach problems, loss of appetite or unusual feeling of tiredness or weakness, increased liver enzyme activity shown in blood tests
• allergic reaction

Other adverse reactions
If you notice any of the following adverse reactions, contact your doctor, pharmacist or nurse.

Common: may affect up to 1 in 10 patients

• changes in blood electrolyte levels shown in blood tests (manifesting, among others, as confusion or weakness)
• abnormal skin sensations such as numbness, tingling, itching, stinging, pricking or burning
• headache
• low potassium levels – shown in blood tests
• low magnesium levels – shown in blood tests
• high blood pressure
• loss of appetite, stomach pain or upset, gas, dry mouth, taste disturbances
• heartburn (burning sensation in the chest rising up to the throat)
• low neutrophil counts – a type of white blood cell (neutropenia), visible in blood tests, which may increase the risk of infections
• fever
• feeling weak, dizziness, feeling tired or drowsy
• rash
• itching
• constipation
• feeling of discomfort in the rectum

Uncommon: may affect up to 1 in 100 patients

• anaemia – symptoms include headaches, feeling tired or dizzy, breathlessness or paleness, and low haemoglobin levels visible in blood tests
• low platelet counts (thrombocytopenia), visible in blood tests, which may lead to bleeding
• low white blood cell counts (leukopenia), a type of white blood cell, visible in blood tests – this may increase the risk of infections
• high eosinophil counts, a type of white blood cell (eosinophilia) – this may occur in inflammatory conditions
• inflammation of blood vessels
• seizures (epileptic fits)
• nerve damage (neuropathy)
• abnormal heart rhythm shown on ECG, palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas – may cause severe pain in the upper abdomen (stomach pain)
• interruption of blood supply to the spleen (splenic infarction) – may cause severe pain in the upper abdomen (stomach pain)
• serious kidney problems – symptoms include passing increased or decreased amounts of urine, or urine of unusual colour
• high blood creatinine levels – visible in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation, particularly affecting 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 hands or feet
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• difficulty sleeping (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• unusual dreams or sleep problems
• problems with coordination or balance
• mucosal inflammation
• stuffy nose
• breathing difficulties
• chest tightness
• feeling of bloating
• mild to severe nausea, vomiting, muscle cramps, diarrhoea (usually of viral origin), stomach pain
• belching
• feeling shaky

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

• pneumonia – symptoms include breathlessness and coughing up discoloured sputum
• high blood pressure in the lung vessels (pulmonary hypertension), which may lead to serious damage to the lungs and heart
• blood-related problems such as abnormal blood clotting parameters, prolonged bleeding
• severe allergic reactions, including generalized blistering rash and skin peeling
• psychiatric problems such as hearing voices or seeing things that are not there
• fainting
• disturbances in thinking or speech, abnormal tremor involving uncontrollable movements, particularly of the hands, which cannot be controlled
• stroke – symptoms include pain, weakness, numbness or tingling in limbs
• blind spots or patches in the field of vision
• heart failure or heart attack, which may lead to cardiac arrest and death, as well as rhythm disturbances with sudden death
• blood clots in the legs (deep vein thrombosis) – symptoms include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism) – symptoms include breathlessness or pain when breathing
• bleeding in the stomach or intestines – symptoms include vomiting blood or passing blood in stool
• intestinal blockage (intestinal obstruction); this particularly affects the colon. The blockage prevents intestinal contents from passing to lower parts of the digestive tract; symptoms include bloating, vomiting, severe constipation, loss of appetite and cramps
• haemolytic-uraemic syndrome – a condition characterized by rupture of red blood cells (haemolysis), which may occur with or without kidney failure
• pancytopenia – low levels of all types of blood cells (red and white blood cells and platelets) visible in blood test results
• large purple skin discolourations (thrombotic thrombocytopenic purpura)
• swelling of the face and tongue
• depression
• double vision
• chest pain
• abnormal adrenal gland function – may cause weakness, fatigue, loss of appetite, skin pigmentation
• abnormal pituitary gland function – may cause low blood levels of certain hormones affecting male and female reproductive organs
• hearing problems
• pseudoaldosteronism, resulting in high blood pressure with low potassium levels (visible in blood tests)

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

• some patients have also reported confusion after taking posaconazole
• skin redness

If you notice any of the adverse reactions listed above, contact your doctor, pharmacist or nurse.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Posaconazole STADA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or bottle and
on the carton after the words "expiry date" ("EXP"). The expiry date refers to the last day
of the stated month.
No special storage precautions are required for this medicine.
Ask your pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the packaging and other information

What Posaconazole STADA contains
The active substance is posaconazole. Each enteric-coated tablet contains 100 mg of posaconazole.
The other ingredients are: methacrylic acid-ethyl acrylate copolymer (1:1) (type B), triethyl citrate,
xylitol, hydroxypropyl cellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silicon dioxide,
sodium croscarmellose, sodium stearyl fumarate (see section 2 "Posaconazole STADA contains sodium"),
polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E 172).

What Posaconazole STADA looks like and contents of the pack
Posaconazole STADA enteric-coated tablets have a yellow coating and are capsule-shaped, with "100P" embossed on one side and smooth on the other. The tablets are packed in blisters: packs of 24 or 96 tablets in non-perforated blisters, 24 x 1 tablet or 96 x 1 tablet in perforated blisters divisible into single doses, or 60 tablets in HDPE bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers/Importers
STADA Arzneimittel AG
Stadastrasse 2 - 18
61118 Bad Vilbel
Germany

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

Centrafarm Services B.V.
Van de Reijtstraat 31-E
4814 NE Breda
The Netherlands

Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area
2643 Ergates, P.O. Box 28629
2081 Lefkosia
Cyprus

Clonmel Healthcare Limited
Waterford Road
Clonmel, E91 D768
Ireland

This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Austria Posaconazol STADA 100 mg magensaftresistente Tabletten
Croatia Posakonazol STADA 100 mg želučanootporne tablete
Denmark Posaconazol STADA
Estonia Posaconazole STADA
Finland Posaconazole STADA 100 mg enterotabletti
France POSACONAZOLE EG 100 mg, comprimé gastrorésistant
Greece Posaconazole STADA
Spain Posaconazol STADA 100 mg comprimidos gastrorresistentes EFG
Netherlands Posaconazol CF 100 mg, maagsapresistente tabletten
Ireland Posaconazole Clonmel 100 mg gastro-resistant tablets
Iceland Posaconazole STADA
Lithuania Posaconazole STADA 100 mg skrandyje neirios tabletės
Latvia Posaconazole STADA 100 mg zarnās šķīstošās tabletes
Malta Posaconazole Clonmel 100 mg Gastroresistant Tablets
Germany Posaconazol AL 100 mg magensaftresistente Tabletten
Poland Posaconazole STADA
Romania Posaconazol STADA 100 mg comprimate gastrorezistente
Slovakia Posaconazol STADA 100 mg gastrorezistentne tablete
Slovakia Posakonazol STADA 100 mg gastrorezistentne tablete
Sweden Posaconazole STADA 100 mg enterotablett
United Kingdom Posaconazole STADA 100 mg Gastro-resistant tablets
Italy Posaconazolo EG STADA