100 mg enteraconablate
posaconazole
What Posaconazole STADA is and what it is used for
Posaconazole Stada 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 Stada 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 Stada 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 use Posaconazole STADA
Do not use Posaconazole STADA
- 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 Stada if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Stada.
See the section “Other medicines and Posaconazole Stada” below for more information including information on other medicines that may affect Posaconazole Stada.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole Stada 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 Stada.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole Stada, 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 Stada should not be given to children (17 years and younger).
Other medicines and Posaconazole STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Posaconazole Stada 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 and mental illness)
- halofantrine (used to treat malaria )
- quinidine (used to treat abnormal heart rhythms).
Posaconazole Stada 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 Stada can increase the amount of these medicines 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 Stada 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 Stada. In addition to the medicines mentioned above, other medicines carry a risk of arrhythmias that can be greater when taken with Posaconazole Stada. Tell your doctor about any medicines you take (prescription or over-the-counter).
Some medicines may increase the risk of side effects of Posaconazole Stada by increasing the amount of Posaconazole Stada in your blood.
The following medicines may reduce the effect of Posaconazole Stada by reducing the amount of Posaconazole Stada 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 Stada may increase the risk of side effects from certain other medicines by increasing the amount of these medicines in your 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 apply to you (or you are not sure) talk to your doctor or pharmacist before taking Posaconazole Stada.
Pregnancy, breastfeeding, and fertility
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 Stada 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 Stada.
Do not breastfeed while you are being treated with Posaconazole Stada as small amounts may pass into breast milk.
Driving and using machines
You may feel dizzy, drowsy, or have blurred vision while taking Posaconazole Stada, which may affect your ability to drive or use machines. If this happens, do not drive or use 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 STADA contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Posaconazole STADA
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 Stada 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 (three 100 mg enteric tablets ) twice a day for the first day and then 300 mg (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 schedule of treatment 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 use more Posaconazole STADA than you should
If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you forget to use Posaconazole STADA
- 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 or pharmacist.
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 no 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 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.
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.
Talk to your doctor, pharmacist, or nurse if you get any of the side effects listed above.
How to store Posaconazole STADA
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/bottle and the carton after EXP. The expiration date is the last day of the specified month.
No 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, silica, colloidal, anhydrous, croscarmellose sodium, sodium stearyl fumarate (see section 2.) polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Posaconazole Stada enteric tablets are gold-plated, capsule-shaped marked with “100P” on one side, and smooth on the other side. The tablets are packed in cartons of 24 or 96 tablets in non-perforated blisters, 24×1 or 96×1 tablets in perforated unit dose blisters, or 60 tablets in HDPE cans.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Clonmel Healthcare Ltd.
Waterford Road
Clonmel Co.Tipperary
Ireland
Centrafarm Services BV
Van de Reijtstraat 31-E
4814 NE Breda
Netherlands
Delorbis Pharmaceuticals Ltd
17 Athinon Street, Ergates Industrial Area
2643 ERGATES
Cyprus
STADA Arzneimittel Gesellschaft mbH – Geschäftsanschrift
Muthgasse 36/2
1190 WienI
Austria
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark