Posaconazole Tarbis 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Posaconazol Tarbis 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Posaconazol Tarbis contains a medicine called posaconazole, which belongs to a group of medicines known as "antifungals". It is used to prevent and treat various fungal infections.

This medicine works by killing or stopping the growth of certain types of fungi that can cause infections.

This medicine 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 that lead 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—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 "hematopoietic stem cell transplantation" (HSCT).

2. What you need to know before taking Posaconazol Tarbis

Do not take Posaconazol Tarbis

• if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
• if 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.
• if 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 the section “Taking Posaconazol Tarbis with other medicines” below for further information, including details on other medicines that may interact with posaconazole.

Warnings and precautions

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

• you have ever 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 you are unsure), 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 exposure to sunlight during treatment. It is important to cover sun-exposed skin areas with protective clothing and use sunscreen with a high sun protection factor (SPF), as the skin may become more sensitive to UV rays from sunlight.

Children

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

Taking Posaconazol Tarbis with other medicines

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

Do not take Posaconazol Tarbis 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. Posaconazol Tarbis may increase the levels of these medicines in the blood, which could cause a serious reduction in blood flow to the fingers of the hands or feet and lead to tissue 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 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 adverse effects of posaconazole by increasing posaconazole levels in the blood.

The following medicines may reduce the effectiveness of posaconazole by lowering 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 adverse effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.
• flucloxacillin (an antibiotic used for bacterial infections).

Posaconazole may possibly increase the risk of adverse effects of 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, administered 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 you are in any of the above situations (or if you are unsure), consult your doctor or pharmacist before taking posaconazole.

Pregnancy and breastfeeding

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

Do not take posaconazole if you are pregnant, unless your doctor specifically instructs you to do so. If you are a woman of childbearing potential, you must use effective contraception while taking this medicine. If you become pregnant while taking Posaconazol Tarbis, 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 machinery, and contact your doctor.

Posaconazol Tarbis contains sodium

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

3. How to take Posaconazole Tarbis

Do not interchange Posaconazole Tarbis tablets with Posaconazole Tarbis oral suspension without consulting your doctor or pharmacist, as this may result in lack of effectiveness or increased risk of adverse reactions.

Always follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is 300 mg (three 100 mg tablets) twice on the first day, followed by 300 mg (three 100 mg tablets) once daily thereafter.

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 to take this medicine

• Swallow the tablet whole with some water.
• Do not crush, chew, break, or dissolve the tablet.
• The tablets may be taken with or without food.

If you take more Posaconazole Tarbis 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, indicating the medicine and the amount ingested.

If you forget to take Posaconazole Tarbis

• If you forget a dose, take it as soon as you remember.
• However, if it is almost time for your next dose, skip the missed dose and return to 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 sick 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 sick for no 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:

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

• changes in blood electrolyte levels detected in blood tests, which may include feeling confused or weak
• 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 (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 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
• 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 blood 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
• breathing difficulties
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, cramps, and diarrhoea, usually caused by a virus, stomach pain
• burping
• feeling restless

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

• pneumonia, signs of which include feeling short of breath and producing discoloured phlegm
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood disorders 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 cause 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 feeling short of breath or pain when breathing
• bleeding in the stomach or intestine, signs of which include vomiting blood or blood in the stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, and signs include feeling bloated, 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 discoloration
• 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 available data

• some patients have also reported feeling confused after taking posaconazole.
  • skin redness.

Inform 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 Tarbis

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Posaconazol Tarbis

The active substance is posaconazole.

Each gastro-resistant tablet contains 100 mg of posaconazole.

Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, hydroxypropylcellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Tablet coating: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

Posaconazol Tarbis gastro-resistant tablets are light orange, film-coated, oblong tablets, marked with an "H" on one side and "P11" on the other.

Blister packs of 24 and 96 tablets, and single-dose perforated blisters of 24 x 1 and 96 x 1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

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

Germany: Posaconazol Amarox 100 mg magensaftresistente Tabletten

Spain: Posaconazol Tarbis 100 mg comprimidos gastrorresistentes EFG

The Netherlands: Posaconazol Amarox 100 mg, maagsapresistente tabletten

Date of the most recent review of this leaflet:

September 2024

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