Posaconazole Accord - patient leaflet, side effects, dosage

Patient leaflet - Posaconazole Accord

1. What Posaconazole Accord is and what it is used for

Posaconazole Accord contains a medicine called 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.

Posaconazole Accord 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 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 caused by a fungus 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.

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).

2. What you need to know before you take Posaconazole Accord

Do not take Posaconazole Accord

– 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, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin

Do not take Posaconazole Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Posaconazole Accord

– if you have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.
– if you have or have ever had liver problems. You may need to have blood tests while you are taking this medicine.
– if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
– if you have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
– if you have a weakness of the heart muscle or heart failure
– if you have a very slow heartbeat
– if you have heart rhythm disturbance
– if you have any problem with potassium, magnesium or calcium levels in your blood
– if you are 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 Posaconazole Accord.

If you develop severe diarrhoea or vomiting (being sick) while taking Posaconazole Accord, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. See Section 4 for more information

Children

Posaconazole Accord should not be used in children (17 years of age and younger).

Other medicines and Posaconazole Accord

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

Do not take Posaconazole Accord 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).

Posaconazole Accord 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 to treat migraines. Posaconazole Accord 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 Posaconazole Accord 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 Posaconazole Accord. 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 Posaconazole Accord. 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 Posaconazole Accord by increasing the amount of Posaconazole Accord in the blood.

The following medicines may decrease the effectiveness of Posaconazole Accord by decreasing the amount of Posaconazole Accord in the blood:

– rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will 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, phenobarbital or primidone).
– efavirenz and fosamprenavir used to treat HIV infection.

Posaconazole Accord 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, which are 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 blood cancers).

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

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Posaconazole Accord.

Do not take Posaconazole Accord 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 Posaconazole Accord, contact your doctor straight away.

Do not breast-feed while taking Posaconazole Accord. 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 Posaconazole Accord, 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.

Posaconazole Accord contain sodium

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

3. How to take Posaconazole Accord

Do not switch between taking Posaconazole Accord tablets and posaconazole 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.

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

How much to take

The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg 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 change 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 Posaconazole Accord than you should

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

If you forget to take Posaconazole Accord

– 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.

4. Possible side effects

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

Serious side effects

Tell your doctor or 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 Posaconazole Accord.

5. How to store Posaconazole Accord

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 or carton after EXP. That expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Posaconazole Accord contains

The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.

The other ingredients are: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).

What Posaconazole Accord looks like and contents of the pack

Posaconazole Accord gastro-resistant tablets are yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side, packaged in a blister or in perforated unit dose blister in cartons of 24 or 96 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n,

Edifici Est, 6a planta, Barcelona,

08039 Barcelona, Spain

Manufacturer

Delorbis Pharmaceuticals Ltd.

17, Athinon Street

Ergates Industrial Area

2643 Nicosia

Cyprus

Laboratori Fundacio Dau

C/ C, 12–14 Pol. Ind. Zona Franca,

Barcelona, 08040, Spain

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: