Patient leaflet - Posaconazole Amarox 100 mg gastro-resistant tablets

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

Posaconazole Amarox 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 Amarox 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:

infections caused by fungi of the 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 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 and children from 2 years of age weighing more than 40 kg 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 leukaemia’’ (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 Amarox

Do not take Posaconazole Amarox

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. · if you have just started taking venetoclax or your
venetoclax dose is being slowly increased for treatment of chronic lymphocytic leukaemia (CLL)

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

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Posaconazole Amarox 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 this medicine.
develop severe diarrhoea or vomiting, as these
conditions may limit the effectiveness of this medicine.
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
are taking vincristine, vinblastine and other
“vinca alkaloids” (medicines used to treat cancer).
are taking venetoclax (a medicine used to treat
cancer).

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 Amarox.

If you develop severe diarrhoea or vomiting (being sick) while taking Posaconazole Amarox, 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 Amarox should not be given to children younger than 2 years of age.

Other medicines and Posaconazole Amarox

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

Do not take Posaconazole Amarox 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 Amarox 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 Amarox 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. · venetoclax when used at the start of the treatment of a type of cancer, chronic lymphocytic leukaemia (CLL)

Do not take Posaconazole Amarox 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 Amarox. 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 Amarox. 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 Amarox by increasing the amount of Posaconazole Amarox in the blood. The following medicines may decrease the effectiveness of Posaconazole Amarox by decreasing the amount of Posaconazole Amarox 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.

phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent fits). · efavirenz and fosamprenavir used to treat HIV infection.
Flucloxacillin (antibiotic used against bacterial infections)

Posaconazole Amarox 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)
venetoclax (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 Amarox.

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Posaconazole Amarox. Do not take Posaconazole Amarox 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 Amarox, contact your doctor straight away.

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

Do not switch between Posaconazole Amarox 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.

UK (Unit-III) Posaconazole 100 mg Leaﬂet

2085738

Front Page: 12064

Back Page: 12065

12065 12064 12064 12064 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 Amarox than you should

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

If you forget to take Posaconazole Amarox

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, 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: 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: 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
(pleuritic 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: 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 (haemolysis) 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
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

some patients have also reported feeling confused after taking Posaconazole Amarox.
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 Amarox

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 carton and the blister after EXP. The 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 Amarox contains

The active substance is posaconazole.

Each gastro-resistant tablet contains 100 mg of posaconazole.

Tablet core: Hypromellose acetate succinate, cellulose, microcrystalline, hydroxypropylcellulose, croscarmellose sodium, silica, colloidal anhydrous and magnesium stearate.

Film coating: Polyvinyl alcohol-part. hydrolyzed (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172) and iron oxide red (E172).

What Posaconazole Amarox looks like and contents of the pack

Posaconazole Amarox gastro-resistant tablets are light orange, oblong shaped, film-coated tablets de-bossed with "H" on one side and "P11" on the other side.

Blister pack of 24 and 96 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Amarox Limited

Congress House, 14 Lyon Road

Harrow, HA1 2EN

United Kingdom

This leaflet was last revised in 08/2026.