Posaconazol accord 100 mg comprimidos gastrorresistentes efg
Introduction
Package Leaflet: Information for the user
Posaconazol Accord 100 mg gastro-resistant tablets EFG
Posaconazol
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
1. What is Posaconazol Accord and what is it used for
Posaconazol Accord contains a medicine called posaconazol, which belongs to a group of medicines called "antifungals". It is used to prevent and treat many different types of fungal infections.
This medicine works by killing or stopping the growth of some types of fungi that can cause infections.
Posaconazol Accord can be used in adults to treat fungal infections caused by fungi of the familyAspergillus:
Posaconazol Accord can be used in adults and children aged 2 years or older and weighing more than 40 kg to treat the following types of fungal infections:
- Infections caused by fungi of the familyAspergillusthat have not improved during treatment with the antifungal medicines amphotericin B or itraconazole or when treatment with these medicines had to be interrupted;
- Infections caused by fungi of the family Fusarium that have not improved during treatment with amphotericin B or when treatment with amphotericin B had to be interrupted;
- Infections caused by fungi that cause the diseases known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when treatment with itraconazole had to be interrupted;
- 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 had to be interrupted.
This medicine can also be used to prevent fungal infections in adults and children aged 2 years or older and weighing more than 40 kg with a high risk of contracting a fungal infection, such as:
- Patients with a weakened immune system as a result of having received chemotherapy for "acute myeloid leukemia" (AML) or "myelodysplastic syndromes" (MDS)
- Patients receiving "high doses of immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).
2. What you need to know before starting to take Posaconazol Accord
Do not take Posaconazol Accord if:
- You are allergic to posaconazol or any of the other components of this medication (listed in section 6).
- You are taking: terfenadine, astemizol, cisaprida, pimozida, halofantrina, quinidina, any medication that contains "ergot alkaloids", such as ergotamine or dihidroergotamina, or a "statin", such as simvastatina, atorvastatina or lovastatina.
- You have recently started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).
Do not take Posaconazol Accord if you are in any of the above circumstances. If in doubt, consult your doctor or pharmacist before taking Posaconazol Accord.
See the section “Taking Posaconazol Accord with other medications” later for more information, including that related to other medications that may interact with Posaconazol Accord.
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to take Posaconazol Accord if you:
- Have had an allergic reaction to another antifungal medication, such as ketoconazol, fluconazol, itraconazol or voriconazol.
- Have or have had liver problems. You may need to have blood tests while taking this medication.
- Develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medication.
- Have a heart rhythm alteration (ECG) that shows a problem called prolongation of the QTc interval.
- Have heart muscle weakness or heart failure.
- Have a very slow heart rate.
- Have any heart rhythm alteration.
- Have any problem with potassium, magnesium or calcium levels in the blood.
- You are taking vincristine, vinblastine and other “vinca alkaloids” (medications used to treat cancer).
- You are taking venetoclax (a medication used to treat cancer).
If you are in any of the above circumstances (or in doubt), consult your doctor, pharmacist or nurse before taking Posaconazol Accord.
If you develop severe diarrhea or vomiting (feel unwell) while taking Posaconazol Accord, consult your doctor, pharmacist or nurse immediately, as this situation may prevent the medication from working correctly. For more information, see section 4.
Children
Do not give Posaconazol Accord to children under 2 years of age.
Taking Posaconazol Accord with other medications
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.
Do not take Posaconazol Accord if you are taking any of the following medications:
- terfenadine (used to treat allergies)
- astemizol (used to treat allergies)
- cisaprida (used to treat stomach problems)
- pimozida (used to treat symptoms of Tourette's syndrome and mental illnesses)
- halofantrina (used to treat malaria)
- quinidina (used to treat heart rhythm alterations).
Posaconazol Accord may increase the amount of these medications in the blood, which could cause severe changes in your heart rhythm.
- Any medication that contains "ergot alkaloids", such as ergotamine or dihidroergotamina used to treat migraines. Posaconazol Accord may increase the amount of these medications in the blood, which could cause severe reduction of blood flow to the fingers of the hands or feet and damage them.
- A "statin", such as simvastatina, atorvastatina or lovastatina used to treat high cholesterol levels.
- venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).
Do not take Posaconazol Accord if you are in any of the above circumstances. If in doubt, consult your doctor or pharmacist before taking this medication.
Other medications
See the list provided earlier with the medications that you should not use while taking Posaconazol Accord. In addition to the medications mentioned earlier, there are other medications that present a risk of heart rhythm problems, which may be greater when taken with Posaconazol Accord. Make sure to inform your doctor of all the medications you are taking (with or without a prescription).
Some medications may increase the risk of adverse effects of Posaconazol Accord by increasing the amount of Posaconazol Accord in the blood.
The following medications may decrease the effectiveness of Posaconazol Accord by reducing its levels in the blood:
- rifabutina and rifampicina (used to treat certain infections). If you are already taking rifabutina, you will need to have blood tests, as well as be aware of some possible adverse effects of rifabutina.
- fenitoína, carbamazepina, fenobarbital or primidona (used to treat or prevent seizures).
- efavirenz and fosamprenavir, used to treat HIV infection.
Posaconazol Accord may increase the risk of adverse effects of other medications by increasing the amount of these medications in the blood. These medications include:
- vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
- venetoclax (used to treat cancer)
- ciclosporina (used during or after transplants)
- tacrolimus and sirolimus (used during or after transplants)
- rifabutina (used to treat certain infections)
- medications used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are administered with ritonavir)
- midazolam, triazolam, alprazolam or other "benzodiazepines" (used as sedatives or muscle relaxants)
- diltiazem, verapamilo, nifedipino, nisoldipino or other "calcium channel blockers" (used to treat high blood pressure)
- digoxina (used to treat heart failure)
- glipizida or other "sulfonilureas" (used to treat high blood sugar levels).
- acid transretinoico (ATRA), also known as tretinoína (used to treat some blood cancers).
If you are in any of the above circumstances (or in doubt), consult your doctor or pharmacist before taking Posaconazol Accord.
Pregnancy and breastfeeding
Inform your doctor if you are or think you may be pregnant before starting to take Posaconazol Accord.
Do not take Posaconazol Accord if you are pregnant, unless your doctor tells you to.
If you are of childbearing age, you should use effective contraceptive measures while taking this medication. If you become pregnant while taking Posaconazol Accord, contact your doctor immediately.
Do not breastfeed while taking Posaconazol Accord, as it may pass into breast milk in small amounts.
Driving and using machines
You may feel dizziness, drowsiness or have blurred vision while taking Posaconazol Accord, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.
Posaconazol Accord contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially “sodium-free”.
3. How to take Posaconazol Accord
Do not interchange Posaconazol Accord tablets and Posaconazol Accord oral suspension without consulting your doctor or pharmacist, as it may lead to a lack of efficacy or increase the risk of adverse reactions.
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
What dose is administered
The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, and subsequently 300 mg (three 100 mg tablets) once a day.
The duration of treatment may 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.
How to administer this medication
- Swallow the tablet whole with water.
- Do not crush, chew, break, or dissolve the tablet.
- Tablets can be taken with or without food.
If you take more Posaconazol Accord than you should
If you think you may have taken too much Posaconazol Accord, contact your doctor or go to the hospital immediately.
If you forgot to take Posaconazol Accord
- If you have forgotten 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 usual dosing schedule.
- Do not take a double dose to make up for a missed dose.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Inform your doctor, pharmacist or nurse immediately if you notice any of the following severe side effects; you may need urgent medical treatment:
- nausea or vomiting (feeling or being sick), diarrhea
- signs of liver problems, including yellowing of the skin or the white of the eyes, dark or unusual-colored urine, pale stools, feeling sick without apparent reason, stomach problems, loss of appetite or unusual weakness or fatigue, an increase in liver enzymes detected in blood tests
- allergic reaction
Other side effects
Inform your doctor, pharmacist or nurse if you notice any of the following side effects:
Frequent: the following may affect up to 1 in 10 patients
- an abnormal change in blood sodium levels detected in blood tests, whose signs include confusion or weakness
- abnormal sensations in the skin, such as numbness, tingling, itching, crawling, pinching or burning
- headache
- low levels of potassium detected in blood tests
- low levels of magnesium detected in blood tests
- high blood pressure
- loss of appetite, stomach pain or discomfort, flatulence, dry mouth, changes in taste
- heartburn (sensation of burning in the chest that rises to the throat)
- low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and detected in blood tests
- fever
- sensation of weakness, dizziness, fatigue or drowsiness
- eruption
- itching
- constipation
- rectal discomfort
Uncommon: the following may affect up to 1 in 100 patients
- anemia, whose signs include headaches, feeling tired or dizzy, difficulty breathing or paleness and low hemoglobin levels detected in blood tests
- low platelet levels (thrombocytopenia), detected in blood tests. This may cause bleeding
- low white blood cell levels (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 appear if you have an inflammatory process
- inflammation of blood vessels
- problems with heart rhythm
- seizures (convulsions)
- neurological damage (neuropathy)
- abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heart rate, 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
- severe kidney problems, whose signs include increased or decreased urination with urine that is a different color than usual
- high creatinine levels in the blood, detected in blood tests
- hoarseness, hiccups
- nosebleeds
- sharp and intense chest pain when breathing (pleuritic pain)
- inflammation of lymph nodes (lymphadenopathy)
- decreased sensitivity, especially in the skin
- tremors
- high or low blood sugar levels
- blurred vision, light sensitivity
- hair loss (alopecia)
- mouth ulcers
- chills, feeling of habitual discomfort
- back or neck pain, arm or leg pain
- fluid retention (edema)
- menstrual problems (abnormal vaginal bleeding)
- insomnia (difficulty sleeping)
- total or partial inability to speak
- swelling of the mouth
- abnormal dreams or difficulty sleeping
- problems with coordination or balance
- inflammation of the mucosa
- nasal congestion
- difficulty breathing
- chest discomfort
- feeling bloated
- nausea, vomiting, cramps and diarrhea of mild to severe, usually caused by a virus, stomach pain
- belching
- sensation of anxiety
Rare: the following may affect up to 1 in 1,000 patients
- pneumonia, whose signs include feeling short of breath and production of discolored mucus
- high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause severe damage to the lungs and heart
- blood clotting problems, such as unusual blood clotting or prolonged bleeding
- severe allergic reactions, including widespread skin rash with blisters and skin peeling
- mental problems, such as hearing voices or seeing things that are not there
- syncope (fainting)
- problems with thinking or speaking, sudden movements, especially in the hands, that you cannot control
- stroke, whose signs include pain, weakness, numbness or tingling in the extremities
- 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, problems with heart rhythm with sudden death
- blood clots in the legs (deep vein thrombosis), whose signs include intense pain or swelling of the legs
- blood clots in the lungs (pulmonary embolism), whose signs include feeling short of breath or chest pain
- bleeding in the stomach or intestines, whose signs include vomiting blood or blood in the stool
- intestinal obstruction, especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include feeling bloated, vomiting, severe constipation, loss of appetite and abdominal cramps
- "uricemic hemolytic syndrome" that appears when there is destruction of red blood cells (hemolysis), which may occur with or without kidney failure
- "pancytopenia", low levels of all blood cells (red, white and platelets), detected in blood tests
- purple and large spots on the skin (purpura trombocitopénica trombótica)
- inflammation of the face or tongue
- depression
- diplopia (double vision)
- mastalgia (breast pain)
- inadequate functioning of the adrenal glands, which may cause weakness, fatigue, loss of appetite, skin discoloration
- inadequate functioning of the pituitary gland, which may cause low levels of certain hormones in the blood that affect the function of male or female sex organs
- hearing problems
- pseudoaldosteronismo, which causes high blood pressure with low potassium levels (appears in blood tests)
Frequency not known: cannot be estimated from available data
- some patients have also reported feeling confused after taking Posaconazol Accord.
Inform your doctor, pharmacist or nurse if you experience any of the side effects described above.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Posaconazol Accord
- Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.
- No special storage conditions are required.
- Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medication that you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Posaconazol Accord
The active ingredient is posaconazol. Each tablet contains 100 mg of posaconazol.
The other components are copolymer of methacrylic acid-ethyl acrylate (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), microcrystalline cellulose (E460), anhydrous colloidal silica, sodium croscarmellose, sodium stearate fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).
Appearance of the product and contents of the container
Posaconazol Accord gastro-resistant tablets have a yellow coating, are approximately 17.5 mm in length and 6.7 mm in width, are marked with the digits "100" on one face while the other face is smooth, and are packaged in blister or perforated blister with single doses in boxes of 24 or 96 tablets.
Only some container sizes may be commercially available.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th floor, Barcelona,
08039 Barcelona, Spain
Manufacturer
Delorbis Pharmaceuticals Limited
Ergates Industrial Area
Athinon 17 V, Ergates
Nicosia, 2643
Cyprus
Fundacio Dau Laboratory
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice,
Poland
Last review date of this leaflet: {MM/AAAA}
Other sources of information
Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.
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