Posaconazole Teva

Package leaflet: Information for the patient

POSACONAZOLE TEVA 100 mg gastro-resistant tablets

Generic Medicine
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

POSACONAZOLE TEVA contains the active substance posaconazole. It belongs to a
group of medicines called "antifungals". It is used to prevent and treat
many different types of fungal infections.
This medicine works by killing or inhibiting the growth of certain types of fungi
that can cause infections.
POSACONAZOLE TEVA can be used in adults to treat fungal infections
caused by fungi of the Aspergillus family.
POSACONAZOLE TEVA can be used in adults and children aged 2 years and older
weighing more than 40 kg to treat the following types of fungal infections:

• infections caused by fungi of the Aspergillus family that have not improved with treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines had to be discontinued;

• infections caused by fungi of the Fusarium family that have not improved with treatment with amphotericin B, or when treatment with amphotericin B had to be discontinued;

• infections caused by fungi leading to conditions known as "chromoblastomycosis" and "mycetoma" that have not improved with treatment with itraconazole, or when treatment with itraconazole had to be discontinued;

• infections caused by a fungus called Coccidioides that have not improved with treatment with one or more of the following medicines: amphotericin B,
  itraconazole or fluconazole, or when treatment with
  these medicines had to be discontinued.
  This medicine can also be used to prevent fungal infections in adults and children aged 2 years and older weighing more than 40 kg who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to chemotherapy for "acute myeloid leukaemia" (AML) or "myelodysplastic syndromes" (MDS);

• patients receiving "high-dose immunosuppressive therapy" following "haematopoietic stem cell transplantation" (HSCT).

2. What you should know before taking POSACONAZOLE TEVA

Do not take POSACONAZOLE TEVA

• if you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine containing “ergot alkaloids” 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 being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take POSACONAZOLE TEVA if you are in any of the above conditions. If you are
unsure, consult your doctor or pharmacist before taking POSACONAZOLE TEVA.
See below “Other medicines and POSACONAZOLE TEVA” for further information,
including details on other medicines that may interact with POSACONAZOLE TEVA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking POSACONAZOLE 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 blood tests while taking this medicine
• you develop severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine
• you have an abnormal heart rhythm trace (ECG) indicating a condition called prolonged QTc interval
• you have weakened heart muscle or heart failure
• you have a very slow heart rate
• you have a heart rhythm disorder
• you have any problem with potassium, magnesium or calcium levels in your 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 above conditions (or if you are unsure), consult your doctor,
pharmacist or nurse before taking POSACONAZOLE TEVA.
If you develop severe diarrhoea or vomiting (feeling unwell) while taking
POSACONAZOLE TEVA, contact your doctor, pharmacist or nurse immediately,
as this may prevent the medicine from working properly. See section 4 for further
information.

Children

POSACONAZOLE TEVA must not be given to children under 2 years of age.

Other medicines and POSACONAZOLE TEVA

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

Do not take POSACONAZOLE TEVA if you are taking any of the following medicines:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette’s syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders). POSACONAZOLE TEVA may increase the levels of these medicines in the blood, which can lead to very serious changes in heart rhythm.
• any medicine containing “ergot alkaloids” such as ergotamine or dihydroergotamine, used to treat migraine. POSACONAZOLE TEVA may increase the levels of these medicines in the blood, which can lead to a severe reduction in blood flow to the fingers or toes and may 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 during gradual dose escalation for the treatment of a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take POSACONAZOLE TEVA if you are in any of the above conditions. If you are
unsure, consult your doctor or pharmacist before taking this medicine.

Other medicines

Check the list above of medicines that must not be taken while you are taking POSACONAZOLE TEVA. In addition to the medicines listed above, there are other medicines that carry a risk of rhythm disturbances, which may be increased when taken with POSACONAZOLE TEVA. Make sure you inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of side effects of POSACONAZOLE TEVA by increasing its levels in the blood (e.g. clarithromycin, erythromycin used to treat certain infections).

The following medicines may reduce the effectiveness of POSACONAZOLE TEVA by decreasing its levels in the blood:

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

POSACONAZOLE TEVA may likely increase the risk of side effects of certain other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat tumours)
• venetoclax (used to treat cancer)
• ciclosporin (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after a transplant)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, 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 known as tretinoin (used to treat certain blood cancers).

If you have any of the above conditions (or if you are unsure), consult your doctor or
pharmacist before taking POSACONAZOLE TEVA.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant,
or if you are breastfeeding, consult your doctor or pharmacist before taking this
medicine.
Do not take POSACONAZOLE TEVA during pregnancy unless specifically instructed by your
doctor.
If you are a woman of childbearing potential, you must use an effective method of contraception while taking this medicine. Contact your doctor immediately if you become pregnant while being treated with POSACONAZOLE TEVA.
Do not breastfeed while taking POSACONAZOLE TEVA. This is because small amounts may pass into breast milk.

Driving and using machines

While being treated with POSACONAZOLE TEVA, you may experience dizziness, drowsiness or blurred vision, which could affect your ability to drive or use tools or machines. If this occurs, do not drive or use tools or machines and contact your doctor.

POSACONAZOLE TEVA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take POSACONAZOLE TEVA

Do not switch from POSACONAZOLE TEVA tablets to posaconazole oral suspension without
consulting your doctor or pharmacist, as this may result in reduced effectiveness or an
increased risk of adverse reactions.
Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any
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 thereafter.
The duration of treatment may depend on the type of infection you have and may be
individually adjusted by your doctor. Do not adjust the dose on your own or change your
treatment regimen without first consulting your doctor.
How to take this medicine

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

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

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

If you have any questions about the use of this medicine, consult your doctor, pharmacist,
or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
Serious side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following serious side effects,
as you may require urgent medical treatment:

• nausea or vomiting (feeling or state of sickness), diarrhoea
• signs of liver problems – these include yellowing of the skin or the white part of the eyes, unusually dark-coloured urine or pale stools, unexplained feeling of sickness, stomach problems, 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

• changes in blood salt levels detected in blood tests – signs include feeling confused or weak
• abnormal skin sensations such as numbness, tingling, itching, goosebumps, pricking, or burning
• headache
• low levels of potassium in the blood – detected in blood tests
• low levels of magnesium – detected in blood tests
• high blood pressure
• loss of appetite, stomach ache or stomach discomfort, passing wind, dry mouth, altered taste
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cells (neutropenia) – this may increase the risk of developing infections and can be detected in blood tests
• fever
• feeling weak, dizzy, tired, or sleepy
• skin rash
• itching
• constipation
• rectal discomfort

Uncommon: may affect up to 1 in 100 people

• anaemia – signs include headache, feeling tired or dizzy, shortness of breath, pale appearance, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia) detected in blood tests – this may lead to bleeding
• low levels of "leucocytes", a type of white blood cells (leucopenia) detected in blood tests – this may increase the risk of developing infections
• high levels of "eosinophils", a type of white blood cells (eosinophilia) – this may occur if you have inflammation
• inflammation of blood vessels
• changes in heart rhythm
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm – detected on electrocardiogram (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
• interruption of oxygen supply to the spleen (splenic infarction) – this may cause severe stomach pain
• severe kidney problems – signs include increased or decreased urine production with urine of unusual colour
• high levels of creatinine in the blood – detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain during breathing (pleuritic pain)
• enlarged lymph nodes (lymphadenopathy)
• reduced sensation of sensitivity, especially at skin level
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of illness
• pain, back pain or neck pain, pain in 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 mucous membranes
• 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 nervous
• skin inflammation or redness, tiny spots of blood under the skin
• some patients have also reported feeling confused after taking posaconazole.

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

• pneumonia – signs include shortness of breath and discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering skin rashes and skin peeling
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems thinking or speaking, jerky movements, especially in the hands that you cannot control
• stroke – signs include pain, weakness, numbness, or tingling in limbs
• having a blind or dark spot in the visual field
• heart failure or heart attack which could lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) – signs include severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism) – signs include shortness of breath or pain during breathing
• bleeding in the stomach or intestines – signs include vomiting blood or blood in stools
• blockage in the intestine (intestinal obstruction), especially in the "ileum". The blockage will prevent intestinal contents from passing into the lower part of the intestine
• signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
• "haemolytic uraemic syndrome" when red blood cells break down (haemolysis), a condition that may occur with or without kidney failure
• "pancytopenia", a low level of all blood cells (red and white blood cells and platelets) detected in blood tests
• extensive purplish discolouration on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction – this may cause weakness, tiredness, loss of appetite, skin discolouration
• pituitary gland dysfunction – this may cause low blood levels of certain hormones affecting the function of male or female sex organs
• changes in hearing
• pseudoaldosteronism, resulting in hypertension with low potassium levels (shown in blood tests).

Tell your doctor, pharmacist, or nurse if you notice any of the side effects
listed above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report side effects via
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 POSACONAZOLE TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister/aluminum bottle
and on the outer carton after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater < or 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 POSACONAZOLE TEVA contains
The active substance is posaconazole. Each gastro-resistant tablet contains 100 mg of posaconazole.
The other components are: methacrylic acid-ethyl acrylate copolymer (1:1) (Type B), triethyl citrate, xylitol, hydroxypropylcellulose, propyl gallate, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, sodium stearyl fumarate (see section 2 "POSACONAZOLE TEVA contains sodium"), polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

Description of the appearance of POSACONAZOLE TEVA and package contents
POSACONAZOLE TEVA gastro-resistant tablets are yellow, capsule-shaped tablets, embossed with "100P" on one side and plain on the other. The tablets are packaged in boxes of 24 or 96 tablets in non-perforated blisters, 24x1 or 96x1 tablets in perforated unit-dose blisters, or 60 tablets in HDPE bottles.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5 - 2031GA Haarlem
The 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 European Economic Area countries under the following names:
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
The 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