POSACONAZOLO 100 mg Enteric-Coated Tablet

Зміст інструкції

1. POSACONAZOLO TEVA 100 mg gastro-resistant tablets
   1. What POSACONAZOLO TEVA is and what it is used for
   2. What you need to know before taking POSACONAZOLO TEVA
2. POSACONAZOLO TEVA, consult your doctor, pharmacist or nurse immediately,
   1. How to take POSACONAZOLO TEVA
   2. Possible side effects
   3. How to store POSACONAZOLO TEVA
   4. Package Contents and Other Information

POSACONAZOLO TEVA 100 mg gastro-resistant tablets

Equivalent Medicinal Product

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again. If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What POSACONAZOLO TEVA is and what it is used for
• 2. What you need to know before you take POSACONAZOLO TEVA
• 3. How to take POSACONAZOLO TEVA
• 4. Possible side effects
• 5. How to store POSACONAZOLO TEVA
• 6. Contents of the pack and other information

1. What POSACONAZOLO TEVA is and what it is used for

POSACONAZOLO TEVA contains the active ingredient posaconazole. It belongs to a
category of medicines called “antifungals”. It is used to prevent and treat
many different types of fungal infections.
This medicine works by killing or stopping the growth of certain types of fungi that
can cause infections.
POSACONAZOLO TEVA can be used in adults to treat fungal infections
caused by fungi of the Aspergillusfamily.
POSACONAZOLO TEVA can be used in adults and children from 2 years of age with
a weight greater than 40 kg to treat the following types of fungal infections:

• infections caused by fungi of the Aspergillusfamily that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole or when treatment with these medicines had to be stopped;
• infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B or when treatment with amphotericin B 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 treatment with itraconazole had to be stopped;
• infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more of the following medicines: amphotericin B,

itraconazole or fluconazole, or when treatment with
these medicines had to be stopped.
This medicine can also be used to prevent fungal infections in
adults and children from 2 years of age with a weight greater than 40 kg who are at high risk of
developing a fungal infection, such as:

• patients who have a weakened immune system due to chemotherapy for “acute myeloid leukemia” (AML) or “myelodysplastic syndromes” (MDS);
• patients who are using a “high-dose immunosuppressive therapy” following “hematopoietic stem cell transplantation” (HSCT).

2. What you need to know before taking POSACONAZOLO TEVA

Do not take POSACONAZOLO TEVA

• 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 medicine that contains “alkaloids derived from ergot” such as ergotamine or dihydroergotamine or a “statin” such as simvastatin, atorvastatin or lovastatin.
• if you have just started taking venetoclax or if the dose of venetoclax is slowly increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take POSACONAZOLO TEVA if you are in any of the above conditions. If you are not
sure, ask your doctor or pharmacist before taking POSACONAZOLO TEVA.
See below “Other medicines and POSACONAZOLO TEVA” for more information,
including information about other medicines that may interact with POSACONAZOLO
TEVA.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking POSACONAZOLO TEVA
if:

• you have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole or voriconazole
• you have or have ever had liver problems. You may need to have blood tests while taking this medicine
• you develop severe diarrhea or vomiting, as these conditions may limit the effectiveness of this medicine
• you have an abnormal heart rhythm tracing (ECG) showing a problem called prolonged QTc interval
• you have a weak heart muscle or heart failure
• you have a very slow heartbeat
• you have an irregular heartbeat
• you have any problems with your potassium, magnesium or calcium levels in the blood
• you are taking vincristine, vinblastine or other “vinca alkaloids” (medicines used to treat cancer)
• you are taking venetoclax (a medicine used to treat cancer).

If you have any of the conditions above (or if you are not sure), talk to your doctor,
pharmacist or nurse before taking POSACONAZOLO TEVA.
If you develop severe diarrhea or vomiting (feeling unwell) while taking

POSACONAZOLO TEVA, consult your doctor, pharmacist or nurse immediately,

as this may prevent it from working correctly. See section 4 for more
information.

Children
POSACONAZOLO TEVA should not be administered to children under 2 years of age.

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

Do not take POSACONAZOLO TEVA if you are taking any of the medicines that
follow:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat the symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat irregular heartbeats). POSACONAZOLO TEVA may increase the amount of these medicines in the blood, which may lead to very serious changes in heart rhythm.
• any medicine that contains “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraine. POSACONAZOLO TEVA may increase the amount of these medicines in the blood, which may lead to a severe reduction in blood flow to the fingers or toes and could damage them.
• a “statin” such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels.
• venetoclax if used at the beginning of treatment - or in case of slow increase for the treatment - of a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take POSACONAZOLO TEVA if you are in any of the above conditions. If you are
not sure, ask your doctor or pharmacist before taking this medicine.
Other medicines
Check the list of medicines above that should not be taken while you are
taking POSACONAZOLO TEVA. In addition to the medicines listed above, there are other
medicines that carry a risk of heart rhythm changes that may be greater
if taken with POSACONAZOLO TEVA. Make sure to tell your doctor about
all the medicines you are taking (with or without a prescription).
Some medicines may increase the risk of side effects of POSACONAZOLO
TEVA by increasing the amount in the blood (e.g. clarithromycin, erythromycin used to
treat some infections).
The following medicines may decrease the effectiveness of POSACONAZOLO TEVA
by decreasing the amount in the blood:

• rifabutin and rifampicin (used to treat some infections). If you are already being treated with rifabutin, you will need to have a blood test and pay attention to some possible side effects of rifabutin.
• phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir used to treat HIV infection.

POSACONAZOLO TEVA may likely 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 tumors)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after transplant surgery)
• Tacrolimus and sirolimus (used during or after a transplant)
• rifabutin (used to treat some infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are administered 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 levels)
• all-trans retinoic acid (ATRA), also called tretinoin (used to treat some blood cancers).

If you have any of the conditions listed above (or if you are not sure), ask your doctor
or pharmacist before taking POSACONAZOLO TEVA.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy,
or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take POSACONAZOLO TEVA during pregnancy unless you have been
told to do so by your doctor.
If you are a woman of childbearing potential, you should use effective contraception while
taking this medicine. Contact your doctor immediately if you become
pregnant while being treated with POSACONAZOLO TEVA.
Do not breastfeed while taking POSACONAZOLO TEVA. This is because small amounts
can pass into breast milk.

Driving and operating machinery
During treatment with POSACONAZOLO TEVA you may experience dizziness, drowsiness or
blurred vision, which may affect your ability to drive or operate
tools or machinery. If this happens, do not drive or operate tools or machinery
and contact your doctor.

POSACONAZOLO TEVA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially “sodium-free”.

3. How to take POSACONAZOLO TEVA

Do not switch from POSACONAZOLO TEVA tablets to posaconazole oral suspension without
consulting your doctor or pharmacist as this may lead to a lack of efficacy or
an increased risk of adverse reactions.
Take this medicine following exactly the instructions of your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.

How much to take
The usual dose is 300 mg posaconazole (three 100 mg gastro-resistant tablets) twice
daily on the first day, followed by 300 mg posaconazole (three
100 mg gastro-resistant tablets) once daily, subsequently.
The duration of treatment may depend on the type of infection you have and may be adapted
personally for you by your doctor. Do not adjust the dose yourself before consulting your
doctor or do not modify the treatment regimen.

How to take this medicine

• Swallow the tablet whole with water.
• Do not crush, chew, break or dissolve the tablet.
• The tablets can be taken with or without food.

If you take more POSACONAZOLO TEVA than you should
If you think you have taken more POSACONAZOLO TEVA than you should, inform a doctor or
go to the hospital immediately.

If you forget to take POSACONAZOLO TEVA

• If you forget to take a dose, take it as soon as you remember.
• However, if it is almost time for the next dose, skip the forgotten dose and return to the normal dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any doubts about 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 everyone gets them.

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

• nausea or vomiting (feeling or being sick), diarrhoea
• signs of problems with your liver - these include yellowing of the skin or the white part of your eyes, urine that is unusually dark in colour, or pale stools, feeling unwell without justification, problems with your stomach, loss of appetite or unusual tiredness or weakness, increased liver enzymes detected 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 levels of salt in your blood detected in blood tests - the signs include feeling confused or weak
• abnormal skin sensations, such as numbness, tingling, itching, goosebumps, prickling or burning
• headache
• low levels of potassium in your blood - detected in blood tests
• low levels of magnesium - detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or stomach discomfort, passing gas, dry mouth, changes in taste
• heartburn (a burning sensation in your chest that rises into your throat)
• low levels of “neutrophils” a type of white blood cells (neutropenia) - this can increase the risk of getting infections and can be detected in blood tests
• fever
• feeling weak, dizziness, tiredness or sleepiness
• skin rash
• itching
• constipation
• rectal discomfort

Not common: may affect up to 1 in 100 people

• anaemia - the signs include headache, feeling tired or dizzy, shortness of breath or pale appearance and a low level of haemoglobin detected in blood tests
• low level of platelets (thrombocytopenia) detected in blood tests - this can lead to bleeding
• low level of “leukocytes”, a type of white blood cells (leukopenia) detected in blood tests - this can increase the risk of getting infections
• high level of “eosinophils”, a type of white blood cells (eosinophilia) - this can occur if you have inflammation
• inflammation of the blood vessels
• changes in heart rate
• convulsions
• nerve damage (neuropathy)
• abnormal heart rhythm - detected in an electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis) - this can cause severe stomach pain
• interruption of the oxygen supply to the spleen (splenic infarction) - this can cause severe stomach pain
• serious kidney problems - the signs include increased or decreased production of urine that has a different colour than usual
• high levels of creatinine in the blood - detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sense of feeling, especially on the skin
• tremor
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, feeling generally unwell
• pain, back pain or neck pain, pain in your arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• being completely or partially unable to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of the mucous membranes
• stuffy nose
• difficulty breathing
• chest discomfort
• feeling of fullness
• nausea, from mild to severe, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling nervous
• inflammation or redness of the skin, tiny spots of blood under the skin
• some patients have also reported feeling confused after taking posaconazole.

Rare: may affect up to 1 in 1000 people

• pneumonia - the signs include feeling short of breath and coughing up sputum of a different colour
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) which can cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• serious allergic reactions, including widespread blistering skin rashes and peeling of the skin
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, jerky movements, especially in the hands that you cannot control
• stroke - the 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 can lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) - the signs include severe pain or swelling of the legs
• blood clots in the lungs (pulmonary embolism) - the signs include feeling short of breath or pain during breathing
• bleeding in the stomach or intestine - the signs include vomiting blood or blood in your stools
• blockage in the intestine (intestinal obstruction) especially in the “ileum”. The blockage will prevent the contents of the intestine from passing into the lower part of the intestine
• the signs include feeling bloated, vomiting, severe constipation, loss of appetite and cramps
• “hemolytic uremic syndrome” when red blood cells break down (hemolysis) a condition that can occur with or without kidney failure
• “pancytopenia” a low level of all blood cells (red blood cells and white blood cells and platelets) detected in blood tests
• widespread purple discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• malfunctioning adrenal glands - this can cause weakness, tiredness, loss of appetite, discolouration of the skin
• malfunctioning pituitary gland - this can cause low blood levels of some hormones that affect the function of male or female sex organs
• changes in hearing
• pseudoaldosteronism, which results in high blood pressure with a low level of potassium (shown by blood test).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Italian Medicines Agency (AIFA) through the website www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store POSACONAZOLO TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the blister / bottle
and on the package after Exp. The expiry date refers to the last day of that
month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in the drain water <or in household waste >. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package Contents and Other Information

What POSACONAZOLO TEVA contains
The active ingredient is posaconazole. Each gastro-resistant tablet contains 100 mg
of posaconazole.
The other ingredients are: Ethyl acrylate-methacrylic acid copolymer (1:1) (Type B),
triethyl citrate, xylitol, hydroxypropyl cellulose, propyl gallate, microcrystalline cellulose,
anhydrous colloidal silica, sodium croscarmellose, sodium stearyl fumarate (see section 2
“POSACONAZOLO TEVA contains sodium”), polyvinyl alcohol, titanium dioxide (E171),
macrogol 3350, talc, yellow iron oxide (E172).

Description of the appearance of POSACONAZOLO TEVA and package contents
The gastro-resistant tablets of POSACONAZOLO TEVA are capsule-shaped and
yellow in colour, with “100P” imprinted on one side and smooth on the other side. The tablets are
packaged in boxes of 24 or 96 tablets in non-perforated blisters, 24x1 or 96x1
tablets in perforated single-dose blisters or 60 tablets in HDPE bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5 - 2031GA Haarlem
Netherlands
Manufacturer
Delorbis Pharmaceuticals Ltd;
17 Athinon Street,
Ergates Industrial Area, 2643 Ergates,
P.O. BOX 28629, 2081 Lefkosia, Cyprus

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Germany Posaconazol-ratiopharm 100 mg magensaftresistente
Tabletten
Austria Posaconazol ratiopharm 100 mg magensaftresistente
Tabletten
Belgium Posaconazole Teva 100 mg maagsapresistente tabletten /
comprimés gastrorésistants / Magensaftresistente
Tabletten
Czech Republic Posaconazole Teva Pharma
Denmark Posaconazol Teva
France Posaconazole Teva 100 mg comprimé gastro résistant
Croatia Posakonazol Teva 100 mg želučanootporne tablete
Hungary Posaconazol Teva 100 mg gyomornedv-ellenálló tabletta
Ireland Posaconazole Teva 100 mg Gastro-resistant Tablets
Italy Posaconazolo Teva
Netherlands Posaconazol Teva 100 mg, maagsapresistente tabletten
Poland Posaconazole Teva
Portugal Posaconazol Teva
Sweden Posaconazole Teva
Slovenia Posakonazol Teva 100 mg gastrorezistentne tablete
Slovak Republic Posakonazol Teva 100 mg gastrorezistentné tablety
United Kingdom (Northern Ireland) Posaconazole Teva 100 mg Gastro-resistant Tablets