Posazox contains the active substance posaconazole. This belongs to a group of medicines called “antifungals”. It is used to prevent and treat many different fungal infections. This medicine works by killing or stopping the growth of some types of fungi that can cause infections. Posazox can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:

•               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 withamphotericin 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 caused by a fungus called Coccidioides that have not improved during treatment withone or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped. 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 having chemotherapy for “acute myelogenous

leukemia” (AML) or “myelodysplastic syndromes” (MDS)

•               patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).

Do not take Posazox if:

•  you are allergic to posaconazole or any of the other ingredients of this medicine.

•  you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicinesthat contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin. 

Do not take Posazox if any of the above apply to you. 

If you are not sure, talk to your doctor or pharmacist before taking Posazox. 

See “Other medicines and Posazox” below for more information including information on other medicines which may interact with Posazox. 

Warnings and precautions 

Talk to your doctor, pharmacist or nurse before taking Posazox if you,

•  Have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole,itraconazole or voriconazole. 

•  Have or have ever had liver problems. You may need to have blood tests while you are taking thismedicine.

•  develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of thismedicine.

•  Have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval.

•  Have a weakness of the heart muscle or heart failure.

•  Have a very slow heartbeat.

•  Have heart rhythm disturbance.

•  Have any problem with potassium, magnesium or calcium levels in your blood

•  Taking vincristine, vinblastine and 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 Posazox. 

If you develop severe diarrhoea or vomiting (being sick) while taking Posazox, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. 

Children and adolescents 

Posazox should not be used in children and adolescents (17 years of age younger).
Other medicines and Posazox

 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 

Do not take Posazox if you are taking any of the following

•  Terfenadine (used to treat allergies)

•  Astemizole (used to treat allergies)

•  Cisapride (used to treat stomach problems)

•  Pimozide (used to treat symptoms of Tourette’s and mental illness)

•  Halofantrine (used to treat malaria)

•  Quinidine (used to treat abnormal heart rhythms)

Posazox can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm:

•  Any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used totreat migraines. Posazox can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.

•  A “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.Do not take Posazox if any of the above apply to you. 

If you are not sure, talk to your doctor or pharmacist before taking this medicine. 

Other medicines 

Look at the list of medicines given above that must not be taken while you are taking Posazox. In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Posazox. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).

Certain medicines may increase the risk of side effects of Posazox by increasing the amount of Posazox in the blood. 

The following medicines may decrease the effectiveness of Posazox by decreasing the amount of Posazox e in the blood:

•  rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, youwill need a blood test and you will need to look out for some possible side effects of rifabutin. 

•  some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbitalor primidone.

•  efavirenz and Fos amprenavir used to treat HIV infection.

Posazox may possibly increase the risk of side effects of some 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)

•  medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, whichare given with ritonavir)

•  midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or musclerelaxants)

•  diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treathigh 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 blood cancers).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Posazox.

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, 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 Posazox if you are pregnant unless you are told to by your doctor. 

If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine. If you become pregnant while you are taking Posazox, contact your doctor straight away.

Do not breast-feed while taking Posazox. This is because small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking Posazox, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor. 

Posazox contains sodium 

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

 Do not switch between taking Posazox tablets and Posazox oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.

How much to take 

The recommended dose is 300 mg Posazox (three 100 mg gastro-resistant tablets) twice a day on the first day, then 300 mg Posazox (three 100 mg gastro-resistant tablets) once a day, thereafter. The length of treatment may depend on the type of infection that you have and may be individually adapted for you by your doctor. Do not adapt your dose yourself before consulting your doctor or changing your treatment regimen.

Taking this medicine

•  Swallow the tablet whole with some water.

•  Do not crush, chew, break or dissolve the tablet.

•  Tablets may be taken with or without food.

If you take more Posazox than you should 

If you think that you may have taken too much Posazox, talk to a doctor or go to the hospital straight away.

 If you forget to take Posazox

•  If you forget a dose, take it as soon as you remember it.

•  However, if it is almost time for your next dose, skip the missed dose and go back 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 medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

•       nausea or vomit (feeling or being sick), diarrhoea

•       signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests

•       allergic reaction

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Common: the following may affect up to 1 in 10 people

•       a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak

abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning

•       headache

•       low potassium levels – shown up in blood tests

•       low magnesium levels – shown up in blood tests

•       high blood pressure

•       loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste

•       heartburn (a burning sensation in the chest rising up to the throat)

•       low levels of “neutrophils” a type of white blood cell (neutropenia) –this can make you more likely to get infections and be shown up in blood tests

•       fever

•       feeling weak, dizzy, tired or sleepy

•       rash

•       itching

•       constipation

•       rectal discomfort

Uncommon: the following may affect up to 1 in 100 people

•       anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests

•       low level of platelets (thrombocytopenia) shown in blood tests – this may lead to bleeding

•       low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests – this can make you more likely to get infections

•       high level of “eosinophils” a type of white blood cell (eosinophilia) – this can happen if you have inflammation

•       inflammation of the blood vessels

•       heart rhythm problems

•       fits (convulsions)

•       nerve damage (neuropathy)

•       abnormal heart rhythm – shown up on a heart trace (ECG), palpitations, slow or fast heartbeat, high or low blood pressure

low blood pressure

•       inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain

•       oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain

•       severe kidney problems – signs include passing more or less urine, that is a different colour than usual

•       high blood levels of creatinine – shown in blood tests

•       cough, hiccups

•       nose bleeds

•       severe sharp chest pain when breathing in (pleurritic pain)

•       swelling of lymph glands (lymphadenopathy)

•       reduced feeling of sensitivity especially on the skin

•       tremor

•       high or low blood sugar levels

•       blurred vision, sensitivity to light

•       hair loss (alopecia)

•       mouth ulcers

•       shivering, feeling generally unwell

•       pain, back or neck pain, pain in arms or legs

•       water retention (oedema)

•       menstrual problems (abnormal vaginal bleeding)

•       inability to sleep (insomnia)

•       being completely or partially unable to talk

•       swelling of the mouth

•       abnormal dreams, or difficulty sleeping

•       problems with co-ordination or balance

•       mucosal inflammation

•       stuffy nose

•       difficulty breathing

•       chest discomfort

•       feeling bloated

mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain • belching

•       feeling jittery

Rare: the following may affect up to 1 in 1,000 people

•       pneumonia – signs include feeling short of breath and producing discoloured phlegm

•       high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart

•       blood problems such as unusual blood clotting or prolonged bleeding

•       severe allergic reactions, including widespread blistering rash and skin peeling

•       mental problems such as hearing voices or seeing things that are not there

•       fainting

•       having problems thinking or talking, having jerking movements, especially in your hands that you cannot control

•       stroke – signs include pain, weakness, numbness, or tingling in the limbs

•       having a blind or dark spot in your field of vision

•       heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death

•       blood clots in your legs (deep vein thrombosis) – signs include intense pain or swelling of the legs

•       blood clots in your lungs (pulmonary embolism) – signs include feeling short of breath or pain while breathing

•       bleeding into your stomach or gut – signs include vomiting blood or passing blood in your stool

•       a blockage in your gut (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps

•       “haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure

“pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests

•       large purple discolourations on the skin (thrombotic thrombocytopenic purpura)

•       swelling of the face or tongue

•       depression

•       double vision

•       breast pain

•       adrenal glands not working properly – this may cause weakness, tiredness, loss of appetite, skin discolouration

•       pituitary gland not working properly – this may cause low blood levels of some hormones that affect the function of the male or female sex organs

•       hearing problems

Not known: frequency cannot be estimated from the available data

•       pseudoaldosteronism, which results in high blood pressure with a low potassium level (shown in blood test)

•       some patients have also reported feeling confused after taking Posazox.

Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.

Reporting of side effect

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. By reporting side effects, you can help provide more information on the safety of this medicine

•     Store below 30°C.

•     Store in the original package in order to protect from moisture.

•     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 pack after EXP. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment