100 mg enteric-tablet is
posaconazole
What Posaconazole Mylan is and what it is used for
Posaconazole Mylan contains the active substance 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 Mylan 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 ).
Posaconazole contained in Posaconazole Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Posaconazole Mylan
Do not take Posaconazole Mylan
- 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 Mylan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Mylan.
See the section “Other medicines and Posaconazole Mylan” below for more information including information on other medicines that may affect Posaconazole Mylan.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole Mylan if you:
- have had an allergic reaction to any other antifungal medicines such as ketoconazole, fluconazole, itraconazole, and voriconazole.
- have or have ever had liver problems. You may need to take blood samples while taking this medicine.
- develops severe diarrhea or vomiting, as these conditions may limit the effect of this medicine.
- has an abnormal heart rhythm, on examination ( ECG ), which indicates a problem called long QTc interval.
- have a weakness in the heart muscle or heart failure.
- have very slow heartbeats.
- have some form of heart rhythm disorder.
- have any kind of problem with the blood levels of potassium, magnesium, or calcium.
- take 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 Mylan.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole Mylan, talk to a doctor, pharmacist, or nurse immediately as this may prevent it from working properly. See section 4 for more information.
Children and young people
Posaconazole Mylan should not be given to children and adolescents (17 years and younger).
Other medicines and Posaconazole Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Posaconazole Mylan 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 Mylan can increase the amount of these drugs in your 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 Mylan can increase the amount of these drugs in the blood which can lead to greatly reduced 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 Mylan 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 Mylan. In addition to the drugs mentioned above, other drugs carry a risk of arrhythmias that can be greater when taken with Posaconazole Mylan. Tell your doctor about any medicines you take (prescription or over-the-counter).
Some medicines may increase the risk of side effects of Posaconazole Mylan by increasing the amount of Posaconazole Mylan in your blood.
The following medicines can reduce the effect of Posaconazole Mylan by reducing the amount of Posaconazole Mylan 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 Mylan 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 )
- anti- 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).
- All-trans retinoic acid (ATRA), also called tretinoin (is used to treat certain types of blood cancer).
If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking Posaconazole Mylan.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Posaconazole Mylan 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 Mylan.
Do not breastfeed while you are being treated with Posaconazole Mylan as small amounts may pass into breast milk.
Driving and using machines
You may feel dizzy, drowsy, or have blurred vision when taking Posaconazole Mylan, which may affect your ability to drive or use tools and machines. If this happens, do not drive, use tools or machines and consult your doctor.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Posaconazole Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Posaconazole Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Do not switch between taking Posaconazole Mylan 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.
Dosage
The recommended dose is 300 mg posaconazole (three 100 mg enteric tablets ) twice a day for the first day and then 300 mg posaconazole (three 100 mg enteric 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 Mylan than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you forget to take Posaconazole Mylan
- 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 blood vessels 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
- stroke – 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 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.
Has been reported (occurs in an unknown number of users)
- 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, the frequency is unknown.
Talk to your doctor, pharmacist, or nurse if you get any of the side effects listed above.
How to store Posaconazole Mylan
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/jar and the outer 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 is posaconazole. Each enteric-containing tablet contains 100 mg of posaconazole.
The other ingredients are methacrylic acid-ethyl acrylate copolymer (1: 1) (type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, croscarmellose sodium, sodium stearyl fumarate (see section 2, “Polly vinyl”) (E171), macrogol 3350, talc, yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Posaconazole Mylan enteric tablets are gold-plated and capsule-shaped, marked with “100P” on one side and glossy on the other side. The tablets are packed in cartons of 24 or 96 tablets in non-perforated blisters. 24 x 1 or 96 x 1 tablets in perforated unit dose blisters or 60 tablets in plastic jars.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm
Manufacturer
Deloris Pharmaceuticals Ltd.
17, Athinon Street,
Ergates Industrial Area,
2643 Ergates, Nicosia,
Cyprus
MEDIS INTERNATIONAL as
Premyslov 961/16
747 23 Police
Czech Republic
This medicinal product is authorized under the European Economic Area under the names:
Germany Posaconazole Mylan 100 Mg Gastric Juice Resistant Tablet
Denmark Posaconazole Mylan
Finland Posaconazole Mylan 100 mg enterotabletti
France POSACONAZOLE MYLAN 100 mg, compressed gastro-resistant
Croatia Posakonazole Mylan 100 mg zelučanootporne tablet
Hungary Pozakonazole Mylan 100 mg gyomornedv-ellenálló tablets
Ireland Posaconazole Mylan 100 mg gastro-resistant tablets
Italy Posaconazolo Mylan Pharma
Netherlands Posaconazole Mylan 100mg, gastro-resistant tablet
Norway Posaconazole Mylan
Poland Posaconazole Mylan
Portugal Posaconazole Mylan
Romania Posaconazole Mylan 100mg compress gastro-resistant
United Kingdom (Northern Ireland) Posaconazole Mylan 100 mg GR tablets