40 mg / ml oral suspension
posaconazole
What Posaconazole AHCL is and what it is used for
Posaconazole AHCL 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 AHCL 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.
- infection er, caused by fungi causing the conditions chromoblastomycosis and mycetoma, which have not improved with itraconazole treatment or when it has been necessary to discontinue itraconazole treatment.
- 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.
- infection in the mouth or throat region (known as “cod”) caused by fungi called Candida, which have not been treated before.
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 AHCL
Do not take Posaconazole AHCL
- 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 AHCL if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole AHCL.
See the section “Other medicines and Posaconazole AHCL” below for more information including information on other medicines that may affect Posaconazole AHCL.
Warnings and cautions
Talk to your doctor or pharmacist before taking Posaconazole AHCL
- 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 AHCL.
If you develop severe diarrhea or vomiting (feeling unwell) while taking Posaconazole AHCL, talk to a doctor, pharmacist, or nurse immediately as this may prevent it from working properly. See section 4 for more information.
Children
Posaconazole AHCL should not be given to children (17 years and younger).
Other medicines and Posaconazole AHCL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Posaconazole AHCL if you are taking 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 AHCL can increase the amount of these drugs 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 AHCL 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 AHCL 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 AHCL. In addition to the drugs mentioned above, other drugs carry a risk of arrhythmias that can be greater when taken with Posaconazole AHCL. Tell your doctor about any medicines you take (prescription or over-the-counter).
Some medicines may increase the risk of side effects of Posaconazole AHCL by increasing the amount of Posaconazole AHCL in the blood. The following medicines may reduce the effect of Posaconazole AHCL by reducing the amount of Posaconazole AHCL 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.
- drugs used to reduce stomach acids such as cimetidine and ranitidine or omeprazole and similar drugs called proton pump inhibitors.
Posaconazole AHCL 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 apply to you (or you are not sure) talk to your doctor or pharmacist before taking Posaconazole AHCL.
Posaconazole AHCL with food and drink
To improve the uptake of posaconazole, it should be taken with or immediately after a meal or a nutritional drink whenever possible (see section 3 “How to take Posaconazole AHCL”). There is no information on the effect of alcohol on posaconazole.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or think you may be pregnant before using Posaconazole AHCL. Do not take Posaconazole AHCL 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 AHCL.
Do not breastfeed while you are being treated with Posaconazole AHCL, as small amounts may pass into breast milk.
Driving and using machines
You may feel dizzy, drowsy, or have blurred vision while taking Posaconazole AHCL, which may affect your ability to drive or use machines. If this happens, do not drive or use machines and consult your doctor.
Posaconazole AHCL contains glucose
Posaconazole AHCL contains approximately 1.75 g glucose per 5 ml suspension. You should not take this medicine if you have a condition called glucose-galactose malabsorption and you should take this amount of glucose into account if you need to control your sugar intake for any reason.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml suspension, ie essentially ‘sodium-free’.
How to take Posaconazole AHCL
Do not switch between taking posaconazole 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. Your doctor will monitor the effect and your condition and determine how long Posaconazole AHCL must be given and if any changes in your daily dose are required.
The table below shows the recommended dose and duration of treatment, these depend 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.
Whenever possible you should take posaconazole during or immediately after food or a nutritional drink.
| Indication | Recommended dose and duration of treatment |
|---|---|
| Treatment of resistant fungal infections ( invasive aspergillus infection, fusarium infection, chromoblastomycosis infection / mycetoma, coccidioidomycosis infection) | The recommended dose is 200 mg (a 5 ml spoon) taken four times daily. Alternatively, if your doctor recommends it, you can take 400 mg (two 5 ml spoons) twice daily provided you can take both doses during or after a meal or a nutritional drink. |
| First-time treatment of cod | On the first day of treatment, you should take 200 mg (a 5 ml spoon) once. After the first day, you should take 100 mg (2.5 ml) once a day. |
| Prevention of serious fungal infections | Take 200 mg (a 5 ml spoon) three times daily. |
If you take more Posaconazole AHCL than you should
If you think you may have used too much, contact a doctor or healthcare professional immediately.
If you forget to take Posaconazole AHCL
If you miss a dose, take it as soon as you remember and continue as before. However, if it is almost time for your next dose, take your dose when the time comes. 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, 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 convulsions “hemolytic uremic syndrome” with red blood cell dissolution ( hemolysis ) – which can happen with or without kidney 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 AHCL.
Talk to your doctor, pharmacist, or nurse if you get any of the side effects listed above.
How to store Posaconazole AHCL
- 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 label. The expiration date is the last day of the specified month.
- This medicine does not require any special storage instructions.
- If you have medicine left in the bottle more than 30 days after it was first opened, do not use this medicine. Return the bottle with any remaining suspension to the pharmacy.
- 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 AHCL is posaconazole. One milliliter of oral suspension contains 40 milligrams of posaconazole.
The other ingredients in suspension one are macrogol glycerol hydroxy stearate, sodium citrate dihydrate, citric acid monohydrate, simethicone (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, [e], liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavor (containing propylene glycol), purified water.
What the medicine looks like and the contents of the pack
Posaconazole AHCL is a white to off-white free-flowing suspension, packaged in an amber glass bottle. A dosing spoon is included with each bottle to measure 2.5 and 5 ml doses of the oral suspension.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona s / n,
Estifici Est, 6 a planta, Barcelona,
08039 Barcelona, Spain
Manufacturer
Accord Healthcare Polska Sp. z oo
ul. Lutomierska 50
95-200 Pabianice
Poland
Laboratori Fundacio Dau
C / C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Wessling Hungary Kft.
Anonymous u 6
H-1045 Budapest
Hungary