100 mg enteric-tablet is
posaconazole
What Posaconazole Accord is and what it is used for
Posaconazole Accord contains a drug called posaconazole. It belongs to a group of medicines called “antifungal medicines”. It is used to prevent or treat many different fungal infections.
This medicine works by killing or stopping the growth of certain types of fungi that can cause infection.
Posaconazole Accord can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have stopped taking them:
- infection er, caused by fungi of the family Aspergillus, which have not improved in treatment with the antifungal drugs amphotericin B or itraconazole or when it has been necessary to discontinue treatment with these drugs.
- infection er, caused by fungi of the family Fusarium, which have not improved during treatment with amphotericin B or when it has been necessary to discontinue treatment with amphotericin B.
- infections, caused by fungi that cause the conditions ‘chromoblastomycosis’ and ‘mycetoma’, which have not improved with treatment with itraconazole or when it has been necessary to discontinue treatment with itraconazole.
- infection er, caused by fungi called Coccidioides, which have not improved with treatment with one or more of the drugs amphotericin B, itraconazole, or fluconazole or when it has been necessary to discontinue treatment with these drugs.
This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection such as:
- patients who have a weak immune system due to chemotherapy for “acute myeloid leukemia” (AML) or “myelodysplastic syndrome” (MDS)
- Patients using a high-dose treatment that inhibits the immune system following “hematopoietic stem cell transplantation” ( HSCT ).
What you need to know before you take Posaconazole Accord
Do not take Posaconazole Accord:
- 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, medicines containing ‘ergot alkaloids’ such as ergotamine or dihydroergotamine, or a ‘statin’ such as simvastatin, atorvastatin or lovastatin.
Do not take Posaconazole Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.
See the section “Other medicines and Posaconazole Accord” below for more information including information on other medicines that may affect Posaconazole Accord.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole Accord:
- if you have had an allergic reaction to any other antifungal medicines such as ketoconazole, fluconazole, itraconazole, and voriconazole.
- if you have or have ever had liver problems. You may need to take blood samples while taking this medicine.
- if you develop severe diarrhea or vomiting, as these conditions may limit the effect of this medicine.
- if you have an abnormal heart rhythm, on examination ( ECG ), which indicates a problem called long QTc interval.
- if you have a weakness in the heart muscle or heart failure.
- if you have a very slow heartbeat.
- if you have any kind of heart rhythm disorder.
- if you have any kind of problem with your blood levels of potassium, magnesium, or calcium.
- if you are taking vincristine, vinblastine, or other ‘vinca alkaloids’ (medicines used to treat cancer).
If any of the above apply to you (or you are not sure) talk to your doctor, pharmacist, or nurse before taking Posaconazole Accord.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole Accord, talk to a doctor, pharmacist, or nurse immediately as this may prevent it from working properly. See section 4 for more information.
Children
Posaconazole Accord should not be given to children (17 years and younger).
Other medicines and Posaconazole Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Posaconazole Accord if you take any of the following:
- terfenadine (used to treat allergies )
- astemizole (used to treat allergies )
- cisapride (used to treat stomach upset)
- pimozide (used to treat symptoms of Tourette’s syndrome )
- halofantrine (used to treat malaria )
- quinidine (used to treat abnormal heart rhythms).
Posaconazole Accord can increase the amount of these medicines in the blood which can cause very serious disorders of your heart rhythm.
- drugs that contain “ergot alkaloids” such as ergotamine or dihydroergotamine which are used to treat migraines. Posaconazole Accord can increase the amount of these drugs in the blood which can lead to a sharp decrease in blood flow to your fingers or toes and cause damage.
- a “statin” such as simvastatin, atorvastatin, or lovastatin is used to treat high cholesterol.
Do not take Posaconazole Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Other drugs
See the list above of medicines that must not be used while you are taking Posaconazole Accord. In addition to the medicines mentioned above, other medicines carry a risk of arrhythmias that can be greater when taken with Posaconazole Accord. Tell your doctor about any medicines you take (prescription or over-the-counter).
Some medicines may increase the risk of side effects of Posaconazole Accord by increasing the amount of Posaconazole Accord in the blood.
The following medicines may reduce the effect of Posaconazole Accord by reducing the amount of Posaconazole Accord in your blood:
- rifabutin and rifampicin (used to treat certain infections ). If you are already being treated with rifabutin, your blood counts must be tested and certain probable side effects of rifabutin monitored.
- certain medicines used to treat or prevent epileptic seizures, including phenytoin, carbamazepine, phenobarbital, or primidone.
- efavirenz and fosamprenavir are used to treat HIV infection.
Posaconazole Accord may increase the risk of side effects from certain other medicines by increasing the amount of these medicines in the blood. These medicines include:
- vincristine, vinblastine, and other “vinca alkaloids” (used to treat cancer)
- ciclosporin (used during or after transplant surgery)
- tacrolimus and sirolimus (used during or after transplant surgery)
- rifabutin (used to treat certain infections )
- antiviral 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).
- all-trans retinoic acid (ATRA), also called tretinoin (used to treat certain types of blood cancer).
If any of the above applies to you (or you are not sure) talk to your doctor or pharmacist before taking Posaconazole Accord.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or think you may be pregnant before using Posaconazole Accord. Do not take Posaconazole Accord during pregnancy unless your doctor tells you to.
You should use effective contraception while taking this medicine if you are a woman and could become pregnant. Contact your doctor immediately if you become pregnant during treatment with Posaconazole Accord.
Do not breastfeed while you are being treated with Posaconazole Accord as small amounts may pass into breast milk.
Driving and using machines
You may feel dizzy, drowsy, or have blurred vision while taking Posaconazole Accord, which may affect your ability to drive or use machines. If this happens, do not drive or use machines and consult your doctor.
Posaconazole Accord contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Posaconazole Accord
Do not switch between taking Posaconazole Accord tablets and posaconazole oral suspension without talking to a doctor or pharmacist, as this may lead to a lack of effect or an increased risk of side effects.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
The usual dose is 300 mg (three 100 mg tablets) twice a day for the first day and then 300 mg (three 100 mg tablets) once a day.
The length of treatment depends on the type of infection you have and can be individually tailored for you by your doctor. Do not change the dose or treatment schedule yourself until you have consulted your doctor.
Use of this medicine
- Swallow the tablet whole with a little water.
- Do not crush, chew, break or dissolve the tablet.
- The tablet can be taken with or without food.
If you take more Posaconazole Accord than you should
If you think you may have taken too much Posaconazole Accord, talk to a doctor or go to the hospital right away.
If you forget to take Posaconazole Accord
- If you miss 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 schedule.
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Talk to a doctor, pharmacist, or nurse immediately if you experience any of the following serious side effects – you may need immediate medical attention:
- nausea or vomiting (feeling or pronounced symptoms), diarrhea
- signs of liver problems – characterized by yellowing of the skin or whites of the eyes, dark-colored urine or pale stools, feeling unwell for a reason, stomach problems, decreased appetite or abnormal fatigue or weakness, increase in liver enzymes detected by blood tests
- allergic reaction
Other side effects are
Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:
Common (may affect up to 1 in 10 people)
- a change in the salt levels in the blood detected by blood tests – characterized by the fact that you may feel confused or weak
- an abnormal sensation in the skin, such as numbness, tingling, itching, crawling, stinging, or burning sensation
- headache
- low potassium levels – detected by blood tests
- low magnesium levels – detected by blood tests
- high blood pressure
- loss of appetite, abdominal pain or upset stomach, flatulence, dry mouth, taste changes
- heartburn (a burning sensation in the chest that rises in the throat)
- lower levels of “neutrophils”, a type of white blood cell ( neutropenia ) – which can increase the risk of infection and can be detected in blood tests
- fever
- weakness, dizziness, fatigue, or drowsiness
- rash
- itching
- constipation
- rectal problems.
Uncommon (may affect up to 1 in 100 people)
- anemia – characterized by headache, fatigue or dizziness, shortness of breath or paleness, and a low level of hemoglobin detected in blood tests
- low level of platelets ( thrombocytopenia ) detected in blood tests – which can lead to bleeding
- low level of “leukocytes”, a type of white blood cell ( leukopenia ) detected by blood tests – which may increase the risk of infection
- high level of “eosinophils”, a type of white blood cell ( eosinophilia ) – which can occur in inflammation
- inflammation of the blood vessels
- heart rhythm problems
- seizures (convulsions)
- nerve damage ( neuropathy )
- irregular heartbeat, detected by ECG, palpitations, slow or fast heartbeat, high or low blood pressure
- low blood pressure
- pancreatitis ( pancreatitis ) – which can cause intense abdominal pain
- interrupted oxygen supply to the spleen (splenic infarction) – which can cause intense abdominal pain
- severe kidney problems – characterized by increased or decreased urine output or discolored urine
- high blood levels of creatinine – detected by blood tests
- cough, hiccup
- nosebleeds
- severe sharp chest pain if inhaled (pleuritic pain)
- enlarged lymph nodes ( lymphadenopathy )
- decreased sensation especially in the skin
- tremor
- high or low blood sugar levels
- blurred vision, photosensitivity
- hair loss ( alopecia )
- cold sores
- tremors, general malaise
- pain, back pain or neck pain, pain in arms or legs
- accumulation of water in the body ( edema )
- menstrual disorders (abnormal vaginal bleeding )
- inability to sleep (insomnia)
- completely or partially unable to speak
- swelling in the mouth
- abnormal dreams or difficulty sleeping
- problems with coordination or balance
- inflammation of the mucous membranes
- nasal congestion
- breathing difficulties
- the feeling of discomfort in the chest
- feeling of bloating
- Mild to severe nausea, vomiting, cramps, and diarrhea, usually caused by a virus, abdominal pain
- belching
- feeling nervous.
Rare (may affect up to 1 in 1,000 people)
- pneumonia – characterized by a feeling of shortness of breath and discolored mucous vomiting
- high blood pressure in vessels one in the lungs (pulmonary hypertension) can seriously damage the lungs and heart
- problems with the blood such as unusual blood clotting or prolonged bleeding
- severe allergic reactions including scattered blisters and peeling
- mental problems such as hearing voices or seeing things that are not there
- fainting
- difficulty thinking or speaking, involuntary muscle twitching, especially in the hands
- A stroke – is characterized by pain, weakness, numbness, or tingling in the extremities
- a blind or dark spot in the field of view
- heart failure or heart attack which can lead to the heart-stopping beating and death, disturbed heart rhythm with sudden death
- blood clots in the legs (deep vein thrombosis ) – characterized by intense pain or swelling of the leg
- blood clots in the lungs ( pulmonary embolism ) – characterized by shortness of breath or pain when breathing
- bleeding in the stomach or intestines – characterized by bloody vomiting or blood in the stool
- blockage of the intestine (intestinal obstruction) especially in the “ileum”, the lower part of the small intestine. The blockage prevents the contents of the intestine from passing to the large intestine, resulting in bloating, vomiting, severe constipation, loss of appetite, and cramps
- “Hemolytic uremic syndrome” with red blood cell dissolution ( hemolysis ) – which can occur with or without renal failure
- “Pancytopenia” abnormal deficiency of all blood cells ( red blood cells, white blood cells, and platelets ) detected by blood tests
- large purple discolorations of the skin (thrombotic thrombocytopenic purpura)
- swelling of the face or tongue
- Depression
- double vision
- chest pain
- impaired adrenal function – this can cause weakness, fatigue, loss of appetite, discoloration of the skin
- impaired function of the pituitary gland – this can lead to decreased blood levels of hormones that affect the function of the male or female gonads
- hearing problems.
No known frequency (can not be calculated from the available data)
- pseudoaldosteronism, which causes high blood pressure and low levels of potassium (shown in blood tests)
- Some patients have also reported feeling confused after taking Posaconazole Accord.
Talk to your doctor, pharmacist, or nurse if you get any of the side effects listed above.
How to store Posaconazole Accord
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 or carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance in Posaconazole Accord is posaconazole. One tablet contains 100 mg posaconazole.
- The other ingredients are methacrylic acid ‑ ethyl acrylate copolymer (1: 1), triethyl citrate (E1505), xylitol (E967), hydroxypropylcellulose (E463), propyl gallate (E310), microcrystalline cellulose (E460), colloidal anhydrous sodium aosulphylarium sodium amyl carbonyl titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Posaconazole Accord enteric tablets are yellow-coated, capsule-shaped tablets approximately 17.5 mm long and 6.7 mm wide, marked with “100P” on one side and smooth on the other side, packaged in a blister or perforated single-dose blister in cartons of 24 or 96 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona s / n,
Estifici Est, 6a planta, Barcelona,
08039 Barcelona, Spain
Manufacturer
Deloris Pharmaceuticals Ltd.
17, Athinon Street
Ergates Industrial Area
2643 Nicosia
Cyprus
Laboratori Fundacio Dau
C / C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040, Spain
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland