Patient leaflet - Posaconazole Accord 100 mg gastro-resistant tablets
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 and children from 2 years of age weighing more than 40 kg to treat the following types of fungal infections:
•
Aspergillus family;
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 of 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 fungi that cause the
•
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.
infections caused by a fungus called
This medicine can also be used to prevent fungal infections in adults and children from 2 years of age
weighing more than 40 kg who are at high risk of getting a fungal infection, such as:
•
to having chemotherapy for “acute myelogenous leukaemia” (AML) or “myelodysplastic syndromes” (MDS)
patients who have a weak immune system due
•
therapy” after “hematopoietic stem cell transplant” (HSCT).
patients having “high- dose immunosuppressive
2.
take Posaconazole Accord
What you need to know before you
Do not take Posaconazole Accord
•
other ingredients of this medicine (listed in section 6).
if you are allergic to posaconazole or any of the
•
cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.
if you are taking: terfenadine, astemizole,
•
venetoclax dose is being slowly increased for treatment of chronic lymphocytic leukaemia (CLL).
if you have just started taking venetoclax or your
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, pharmacist or nurse before taking Posaconazole Accord
•
antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole.
if you have had an allergic reaction to another
•
may need to have blood tests while you are taking this medicine.
if you have or have ever had liver problems. You
•
these conditions may limit the effectiveness of this medicine.
if you develop severe diarrhoea or vomiting, as
•
(ECG) that shows a problem called long QTc interval
if you have an abnormal heart rhythm tracing
•
heart failure
if you have a weakness of the heart muscle or
- if you have a very slow heartbeat
- if you have heart rhythm disturbance
•
magnesium or calcium levels in your blood
if you have any problem with potassium,
•
“vinca alkaloids” (medicines used to treat cancer).
if you are taking vincristine, vinblastine and other
•
treat cancer).
if you are taking venetoclax (a medicine used to
You should avoid sun exposure while being treated. It is important to cover sun exposed areas of skin with protective clothing and use sunscreen with a high sun protection factor (SPF), as an increased sensitivity of skin to the sun’s UV rays may occur.
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 given to children younger than 2 years of age
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)
•
and mental illness)
pimozide (used to treat symptoms of Tourette’s
- 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:
•
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.
any medicines that contain “ergot alkaloids” such
•
lovastatin used to treat high cholesterol.
a “statin” such as simvastatin, atorvastatin or
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of a type of cancer, chronic lymphocytic leukaemia (CLL).
venetoclax when used at the start of the treatment
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:
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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.
rifabutin and rifampicin (used to treat certain
•
primidone (used to treat or prevent fits).
phenytoin, carbamazepine, phenobarbital or
•
infection.
efavirenz and fosamprenavir used to treat HIV
•
infections).
flucloxacillin (antibiotic used against bacterial
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:
•
(used to treat cancer)
vincristine, vinblastine and other “vinca alkaloids”
- venetoclax (used to treat cancer)
•
ciclosporin (used during or after transplant surgery)
•
transplant surgery)
tacrolimus and sirolimus (used during or after
- rifabutin (used to treat certain infections)
•
inhibitors (including lopinavir and atazanavir, which are given with ritonavir)
medicines used to treat HIV called protease
•
“benzodiazepines” (used as sedatives or muscle relaxants)
midazolam, triazolam, alprazolam or other
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other “calcium channel blockers” (used to treat high blood pressure)
diltiazem, verapamil, nifedipine, nisoldipine or
- digoxin (used to treat heart failure)
•
blood sugar).
glipizide or other “sulfonylureas” (used to treat high
•
(used to treat certain blood cancers).
all-trans retinoic acid (ATRA), also called tretinoin
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 contains 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
•
remember it.
If you forget a dose, take it as soon as you
•
skip the missed dose and go back to your regular schedule.
However, if it is almost time for your next dose,
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forgotten dose.
Do not take a double dose to make up for a
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 pharmacist or nurse straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
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nausea or vomit (feeling or being sick), diarrhoea
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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
signs of liver problems - these include yellowing
- 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
•
blood tests - signs include feeling confused or weak
a change in the salt level in your blood shown in
•
tingling, itching, creeping, pricking or burning
abnormal skin sensations, such as numbness,
- headache
- low potassium levels – shown up in blood tests
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low magnesium levels – shown up in blood tests
- high blood pressure
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passing wind, dry mouth, changes in your taste
loss of appetite, stomach pain or upset stomach,
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up to the throat)
heartburn (a burning sensation in the chest rising
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(neutropenia) –this can make you more likely to get infections and be shown up in blood tests
low levels of “neutrophils” a type of white blood cell
- fever
- feeling weak, dizzy, tired or sleepy
- rash
- itching
- constipation
- rectal discomfort
Uncommon: the following may affect up to 1 in 100 people
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or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests
anaemia - signs include headaches, feeling tired
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blood tests – this may lead to bleeding
low level of platelets (thrombocytopenia) shown in
•
(leukopenia) shown in blood tests – this can make you more likely to get infections
low level of “leukocytes” a type of white blood cell
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cell (eosinophilia) – this can happen if you have inflammation
high level of “eosinophils” a type of white blood
- inflammation of the blood vessels
- heart rhythm problems
- fits (convulsions)
nerve damage (neuropathy)
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trace (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
abnormal heart rhythm – shown up on a heart
- low blood pressure
•
may cause severe stomach pain
inflammation of the pancreas (pancreatitis) – this
•
infarction) - this may cause severe stomach pain
oxygen supply to the spleen is interrupted (splenic
•
more or less urine, that is a different colour than usual
severe kidney problems – signs include passing
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tests
high blood levels of creatinine – shown in blood
- cough, hiccups
- nose bleeds
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(pleuritic pain)
severe sharp chest pain when breathing in
- swelling of lymph glands (lymphadenopathy)
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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)
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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
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diarrhoea, usually caused by a virus, stomach pain
mild to severe nausea, vomiting, cramps and
- belching
- feeling jittery
Rare: the following may affect up to 1 in 1 000 people
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and producing discoloured phlegm
pneumonia – signs include feeling short of breath
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lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart
high blood pressure in the blood vessels in the
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prolonged bleeding
blood problems such as unusual blood clotting or
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blistering rash and skin peeling
severe allergic reactions, including widespread
•
things that are not there
mental problems such as hearing voices or seeing
- fainting
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movements, especially in your hands that you cannot control
having problems thinking or talking, having jerking
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or tingling in the limbs
stroke – signs include pain, weakness, numbness,
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having a blind or dark spot in your field of vision
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heart stopping beating and death, heart rhythm problems, with sudden death
heart failure or heart attack which could lead to the
•
signs include intense pain or swelling of the legs
blood clots in your legs (deep vein thrombosis) –
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signs include feeling short of breath or pain while breathing
blood clots in your lungs (pulmonary embolism) –
•
vomiting blood or passing blood in
bleeding into your stomach or gut – signs include your stool
•
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
a blockage in your gut (intestinal obstruction)
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cells breakup (hemolysis) which may happen with or without kidney failure
“haemolytic uraemic syndrome” when red blood
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white blood cells and platelets) shown in blood tests
“pancytopenia” low level of all blood cells (red and
•
(thrombotic thrombocytopenic purpura)
large purple discolourations on the skin
- swelling of the face or tongue
- depression
- double vision
- breast pain
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cause weakness, tiredness, loss of appetite, skin discolouration
adrenal glands not working properly – this may
•
cause low blood levels of some hormones that affect the function of the male or female sex organs
pituitary gland not working properly – this may
- hearing problems
•
pseudoaldosteronism, which results in high blood pressure with a low potassium level (shown in blood test)
Not known: frequency cannot be estimated from the available data
•
after taking Posaconazole Accord.
some patients have also reported feeling confused
- redness of the skin.
Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
information
Contents of the pack and other
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 Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
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
Accord Healthcare Single Member S.A.
64th Km National Road Athens,Lamia,
Schimatari, 32009,
Greece
This leaflet was last revised in 08/2026.
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