Posaconazole SP
posaconazole
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posaconazole
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
What Posaconazole SP is and what it is used for
Before you take Posaconazole SP
How to take Posaconazole SP
Possible side effects
How to store Posaconazole SP
Further information
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Posaconazole SP belongs to a group of medicines called triazole antifungal agents. These medicines are used to prevent and treat a wide variety of fungal infections. Posaconazole SP works by killing or stopping the growth of some types of fungi that can cause infections in humans.
Posaconazole SP can be used to treat the following types of fungal infections in adults:
Infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
Infections caused by fungi of the Fusarium family that have not improved during treatment with
amphotericin B or when amphotericin B has had to be stopped;
Infections caused by fungi that cause the conditions known as chromoblastomycosis and mycetoma that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
Infections due to fungi called Coccidioides that have not improved during treatment with one or
more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped;
Medicinal
Infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida,
which are initial infections.
Posaconazole SP can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.
If you are taking medicines that contain ergot alkaloids (used to treat migraines). Posaconazole can increase the blood levels of these medicines, which can lead to severe reductions in blood flow to some parts of the body and damage tissues.
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If you are taking any of the following medicines. Posaconazole can increase the blood levels of these medicines, which can lead to very serious disturbances in heart rhythm:
terfenadine (used to treat allergies)
astemizole (used to treat allergies)
cisapride (used to treat stomach problems)
pimozide (used to treat symptoms of Tourette's disorder)
halofantrine (used to treat malaria)
quinidine (used to treat abnormal heart rhythms).
If you are taking simvastatin, lovastatin, atorvastatin and some similar medicines (called HMG- CoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood.
Please see the section “Taking other medicines” for information on other medicines which may interact with Posaconazole SP.
Ask your doctor or pharmacist for advice before taking any medicine. In addition to the medicines named above that must not be taken with posaconazole because of the risk of heart rhythm disturbances, there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non prescribed).
Tell your doctor:
These include ketoconazole, fluconazole, itraconazole and voriconazole.
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If you have or have had liver problems. You may need special blood tests to be done while you are taking Posaconazole SP.
If you have kidney problems and are taking medicines that affect the kidney.
If you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of Posaconazole SP.
If you have ever been told that you have any of the following conditions:
An abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
A weakness of the heart muscle or heart failure
A very slow heartbeat
Any heart rhythm disturbance
Any problem with amounts of potassium, magnesium or calcium in your blood. Please note that Posaconazole SP is only for use in adults (older than 18 years of age).
Medicinal
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Please look at the list of medicines that must not be taken while you are taking Posaconazole SP that is given above.
There are other medicines that can sometimes be given while you are taking Posaconazole SP but special care may be needed.
Certain medicines may increase (possibly increasing the risk of side effects) or decrease (possibly causing lack of effectiveness) the blood levels of posaconazole.
Medicines that can decrease blood levels of posaconazole include:
Rifabutin and rifampicin (used to treat certain infections). If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored.
Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital, primidone.
Efavirenz, which is used to treat HIV infection.
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Medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Posaconazole SP may increase (possibly increasing the risk of side effects) the blood levels of some other medicines. These include:
Vincristine, vinblastine and other vinca alkaloids (used to treat cancer)
Ciclosporin (used in transplant surgery)
Tacrolimus and sirolimus (used in transplant surgery)
Rifabutin (used to treat certain infections)
Medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir) and non nucleoside reverse transcriptase inhibitors (NNRTIs)
Midazolam, triazolam, alprazolam and some similar medicines called benzodiazepines (used as sedatives or muscle relaxants)
Diltiazem, verapamil, nifedipine, nisoldipine and some of the other medicines called calcium channel blockers (used to treat high blood pressure)
Digoxin (used to treat heart failure)
Sulfonylureas such as glipizide (used to treat high blood sugar).
Each dose of Posaconazole SP should be taken with food or a nutritional supplement if you are unable to tolerate food to enhance the oral absorption. See section 3 of this leaflet for more information on how to take the suspension.
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Tell your doctor if you are or think you are pregnant before you start to take Posaconazole SP. Do not use Posaconazole SP during pregnancy unless you are told by your doctor. You should use effective contraception while you are taking Posaconazole SP if you are a woman who could become pregnant. Contact your doctor immediately if you become pregnant while being treated with Posaconazole SP.
Do not breast-feed while being treated with Posaconazole SP.
There is no information on the effect of Posaconazole SP on the ability to drive and use machines. Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery such as sleepiness or blurred vision.
Medicinal
Posaconazole SP contains approximately 1.75 g of glucose per 5 ml of suspension. You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
Posaconazole SP must only be used as directed by your doctor. Your doctor will monitor your response and condition to determine how long Posaconazole SP needs to be given and whether any change is needed to your daily dose.
Indication | Dose |
Treatment of refractory Fungal Infections | Take 400 mg (two 5 ml spoonfuls) of the suspension twice a day with food or with a nutritional supplement if you are unable to tolerate food. If you are not able to take food or nutritional supplement, your doctor will tell you to take 200 mg (one 5 ml spoonful) four times a day. |
Initial treatment of Thrush | On the first day of treatment take 200 mg (one 5 ml spoonful) once. After the first day, take 100 mg (2.5 ml) once a day with food or nutritional supplement if you are unable to tolerate food. |
Prevention of serious Fungal Infections | Take 200 mg (one 5 ml spoonful) three times a day with food or nutritional supplement if you are unable to tolerate food. |
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If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.
If you have missed a dose, take it as soon as you remember and then carry on as before. However, if it is almost time for your next dose, take your dose when it is due. Do not take a double dose to make up for a forgotten dose.
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Like all medicines, Posaconazole SP can cause side effects, although not everybody gets them. Common side effects (occurring in at least 1 in 100 patients) are:
Headache, dizziness, numbness or tingling
Sleepiness
Nausea (feeling or being sick), loss of appetite, stomach pain, diarrhoea, upset stomach, vomiting, wind, dry mouth
Abnormal liver function tests
Rash
Weakness, tiredness
A decrease in white blood cells (that can increase the risk of infections) Fever
Abnormal levels of salts in the blood.
Medicinal
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells, enlargement of lymph glands
Allergic reaction
High blood levels of glucose
Disturbances in feeling or moving, tremor, fits
Heart rhythm problems including very fast heartbeat (palpitations), abnormal findings on heart tests (like ECGs that show heart rhythm)
High or low blood pressure Inflammation of the pancreas
Inflammation of liver, liver damage, jaundice (yellow colour of the skin or the eyes)
Problems with kidney function, failure of the kidneys Menstrual disorder
Blurred vision Hair loss, itching Mouth ulcers
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Shivering, generally feeling unwell or weak
Scattered body pain, including in muscles and joints, back pain Fluid retention, altered medicine levels.
Rare side effects (occurring in at least 1 in 10,000 patients) are: Pneumonia and other lung damage
Low numbers of all blood cells, blood clotting disorder, bleeding
Severe allergic reactions, including widespread blistering rash and skin peeling Poor functioning of the adrenal gland
Altered brain function, fainting
Sudden behaviour changes, problems with thinking or speech Pain, weakness, numbness, or tingling in the arm or leg Depression
Double vision, a blind or dark spot in the visual field Hearing problems
Heart failure or heart attack, heart rhythm disorders Stroke, blood clots in brain, limbs or lungs Bleeding into the gut
Inflammation or failure of the liver, rarely leading to death Enlargement of both the liver and spleen, liver tenderness
Blistering rash, large purple discolourations on the skin caused by bleeding underneath the skin
Inflammation of the kidneys Breast pain
Swelling of the face or tongue.
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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children. Do not freeze.
Do not use Posaconazole SP after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Medicinal
If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine. Please return the bottle containing any left over suspension to your pharmacist.
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.
The active substance in Posaconazole SP oral suspension is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate
(E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
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Posaconazole SP is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles. A measuring spoon is provided with each bottle for measuring 2.5 and 5 ml doses of the oral suspension.
Marketing Authorisation Holder: SP Europe
Rue de Stalle, 73
B-1180 Bruxelles Belgium
Manufacturer: SP S.A.
2, rue Louis Pasteur
F-14200 Hérouville St Clair France
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Rue de Stalle/Stallestraat 73
B-1180 Bruxelles/Brussel/Brüssel Tél/Tel: + 32-(0)2 370 92 11
Rue de Stalle 73
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