Posaconazole teva

Package leaflet: Information for the user

Posaconazole Teva, 40 mg/ml, oral suspension
Posaconazolum
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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Posaconazole Teva is and what it is used for
2. What you need to know before you take 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 called posaconazole. It belongs to a group of antifungal medicines. This medicine is used to prevent and treat many types of fungal infections.
This medicine works by killing or stopping the growth of fungi that can cause infections.
Posaconazole Teva may be used in adults to treat the following fungal infections when other antifungal medicines have not worked or had to be stopped:

• infections caused by Aspergillus species that do not respond to antifungal medicines: amphotericin B or itraconazole, or when treatment with these medicines must be discontinued;
• infections caused by Fusarium species that do not respond to amphotericin B, or when treatment with amphotericin B must be discontinued;
• infections caused by fungi known as chromoblastomycosis and mycetoma that do not respond to itraconazole treatment, or when treatment with itraconazole must be discontinued;
• infections caused by fungi called Coccidioides that do not respond to one or more of the following medicines – amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines must be discontinued;
• untreated infections of the mouth and throat (known as oropharyngeal candidiasis) caused by fungi called Candida.

This medicine can also be used to prevent fungal infections in adults who are at high risk of such infections, for example:

• in patients with weakened immune systems due to chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS);
• in patients receiving high-dose immunosuppressive therapy after hematopoietic stem cell transplant (HSCT).

2. Important information before using Posaconazole Teva

When not to use Posaconazole Teva

• if the patient is allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, or statins such as simvastatin, atorvastatin or lovastatin.

Do not take Posaconazole Teva if any of the above situations apply to the patient. If in doubt, the patient should consult a doctor or pharmacist before taking Posaconazole Teva.
Additional information about other medicines that may interact with Posaconazole Teva can be found in the section “Posaconazole Teva with other medicines”.
Warnings and precautions
Before starting Posaconazole Teva, consult a doctor, pharmacist or nurse in the following cases:

• if the patient has ever had an allergic reaction to other antifungal medicines such as ketoconazole, fluconazole, itraconazole or voriconazole;
• if the patient has had or currently has liver problems. Blood tests may be necessary during treatment with this medicine;
• if the patient has severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine;
• abnormalities in the heart rhythm (ECG) indicating QTc interval prolongation;
• weakened heart muscle or heart failure;
• very slow heart rate;
• heart rhythm disorders;
• any disturbances related to blood levels of potassium, magnesium or calcium;
• if the patient is taking vincristine, vinblastine or other vinca alkaloids (used in cancer treatment).

If any of the above situations apply to the patient (or if there is any uncertainty), the patient should consult a doctor, pharmacist or nurse before starting Posaconazole Teva. If severe diarrhoea or vomiting occurs during treatment with Posaconazole Teva, contact a doctor, pharmacist or nurse immediately, as this may reduce the effectiveness of the medicine. More information can be found in section 4.

Children
Posaconazole Teva must not be used in children (aged 17 years and younger).
Posaconazole Teva with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
Do not take Posaconazole Teva if the patient is taking any of the following medicines:

• terfenadine (used to treat allergies);
• astemizole (used to treat allergies);
• cisapride (used to treat gastrointestinal disorders);
• pimozide (used to treat symptoms of Tourette’s syndrome and psychiatric disorders);
• halofantrine (used to treat malaria);
• quinidine (used to treat heart rhythm disorders).

Posaconazole Teva may increase blood levels of these medicines, which could lead to serious heart rhythm disturbances:

• any medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine, used to treat migraine headaches. Posaconazole Teva may increase blood levels of these medicines, which could lead to severely reduced blood flow to the fingers and toes, potentially causing tissue damage;
• statins such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol.

Do not take Posaconazole Teva if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before taking this medicine.
Other medicines
The above list includes medicines that must not be taken during treatment with Posaconazole Teva. In addition to the medicines listed above, taking other medicines may also carry a risk of heart rhythm disturbances. This risk may be higher when these medicines are taken together with Posaconazole Teva. The patient should inform the doctor about all medicines being taken (both prescription and over-the-counter medicines).
Some medicines may increase the risk of adverse effects of Posaconazole Teva by increasing blood levels of posaconazole.
The following medicines may reduce the effectiveness of Posaconazole Teva by decreasing blood levels of posaconazole:

• rifabutin and rifampicin (used to treat certain infections). A patient already taking rifabutin may require blood tests and monitoring for possible adverse effects of rifabutin;
• certain medicines used to treat or prevent seizures, including phenytoin, carbamazepine, phenobarbital or primidone;
• efavirenz and fosamprenavir used in the treatment of HIV infection;
• medicines used to reduce stomach acid secretion, such as cimetidine, ranitidine, omeprazole and similar medicines classified as proton pump inhibitors.

Posaconazole Teva may probably increase the risk of adverse effects of certain medicines by increasing their blood levels. These include:

• vincristine, vinblastine and other vinca alkaloids (used in cancer treatment);
• cyclosporine (used during or after organ transplantation);
• tacrolimus and sirolimus (used during or after organ transplantation);
• rifabutin (used to treat certain infections);
• medicines used in the treatment of HIV infection known as protease inhibitors (including lopinavir and atazanavir, which are used together with ritonavir);
• midazolam, triazolam, alprazolam and similar medicines known as benzodiazepines (used as sedatives or muscle relaxants);
• diltiazem, verapamil, nifedipine, nisoldipine and other calcium channel blockers (used to treat high blood pressure);
• digoxin (used in heart failure);
• glipizide or other sulfonylurea derivatives (used to lower high blood sugar levels);
• all-trans retinoic acid (ATRA), also known as tretinoin (used in the treatment of certain blood cancers).

If any of the above situations apply to the patient (or if there is any uncertainty), consult a doctor or pharmacist before starting Posaconazole Teva.
Posaconazole Teva with food and drink
To improve absorption of posaconazole, it should be taken during or shortly after a meal or nutritional supplement (see section 3 “How to take Posaconazole Teva”). There are no available data on the effect of alcohol on posaconazole.
Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, she should inform her doctor before starting Posaconazole Teva.
Do not use Posaconazole Teva during pregnancy unless specifically advised by a doctor.

Women of childbearing potential should use effective contraception during treatment with Posaconazole Teva. If pregnancy occurs during treatment with Posaconazole Teva, contact a doctor immediately.
Do not breastfeed while taking Posaconazole Teva, as small amounts of the medicine may pass into human milk.
Driving and operating machinery
Dizziness, drowsiness or blurred vision may occur during treatment with Posaconazole Teva, which may affect the ability to drive or use tools and machinery. In such cases, do not drive or operate tools or machinery, and contact a doctor.
Posaconazole Teva contains glucose
Posaconazole Teva contains up to 2.1 g of glucose in 5 ml of oral suspension.
If the doctor has informed the patient of an intolerance to certain sugars, contact the doctor before taking this medicine.
Posaconazole Teva contains sodium
Posaconazole Teva contains 5.91 mg (0.26 mmol) of sodium in 5 ml of oral suspension.
This medicine contains less than 1 mmol of sodium (23 mg) in 5 ml of oral suspension, meaning the medicine is considered “sodium-free”.
Posaconazole Teva contains sodium benzoate
This medicine contains 10 mg of benzoic acid salt (sodium benzoate E211) in each 5 ml of oral suspension, equivalent to 2 mg in 1 ml of oral suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to use Posaconazole Teva

Posaconazole is available in other forms and strengths, under the same or different brand names. Do not interchange posaconazole tablets with posaconazole oral suspension without consulting your doctor or pharmacist, as this may lead to ineffective treatment or increased risk of adverse effects.
This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Your doctor will monitor your response and condition to determine how long Posaconazole Teva should be taken and whether the daily dose should be adjusted.
The table below shows the recommended doses and duration of treatment, which depend on the type of infection present in the patient and may be individually adjusted by the doctor. Do not adjust the dose or change the prescribed treatment regimen without consulting your doctor.
If possible, Posaconazole Teva should be taken during or immediately after a meal or nutritional supplement.
Before administration, the oral suspension should be shaken well for 5–10 seconds.

Overdose of Posaconazole Teva
If you take more than the recommended dose of this medicine, contact your doctor or other healthcare professional immediately.

Missed dose of Posaconazole Teva
If you miss a dose, take it as soon as possible and then continue with your regular dosing schedule. However, if it is almost time for your next dose, take the dose as planned. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If you notice any of the serious adverse reactions listed below, contact your doctor, pharmacist or nurse immediately, as
you may need urgent medical treatment:

• nausea or vomiting (feeling sick or bringing up stomach contents), diarrhoea
• signs of liver problems – these include: yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, unexplained nausea, stomach discomfort, loss of appetite, or unusual tiredness or weakness, increased liver enzyme activity shown in blood tests
• allergic reaction

Other adverse reactions
If you notice any of the following adverse reactions, contact your doctor, pharmacist or nurse.
Frequent: (may occur in up to 1 in 10 people)

• changes in blood electrolyte levels shown in blood tests (manifesting, among others, as confusion or weakness)
• abnormal skin sensations such as numbness, tingling, itching, goosebumps, pricking or burning
• headache
• low potassium levels – shown in blood tests
• low magnesium levels – shown in blood tests
• high blood pressure
• loss of appetite, stomach pain or upset stomach, flatulence, dry mouth, taste disturbances
• heartburn (burning sensation in the chest rising to the throat)
• low neutrophil count – a type of white blood cell (neutropenia), visible in blood tests, which may increase the risk of infections
• fever
• feeling weak, dizziness, feeling tired or drowsy
• rash
• itching
• constipation
• feeling of discomfort in the rectum

Uncommon: (may occur in up to 1 in 100 people)

• anaemia – symptoms include headache, feeling tired or dizzy, breathlessness or paleness, and low haemoglobin levels shown in blood tests
• low platelet count (thrombocytopenia), shown in blood tests, which may lead to bleeding
• low white blood cell count (leucopenia), shown in blood tests – this may increase the risk of infections
• increased eosinophil count, a type of white blood cell (eosinophilia) – this may be associated with inflammatory conditions
• blood vessel inflammation
• heart rhythm disorders
• seizures (epileptic fits)
• nerve damage (neuropathy)
• heart rhythm disorders – visible on heart tracing (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• pancreatitis – this may cause severe abdominal pain
• interruption of blood supply to the spleen (splenic infarction) – this may cause severe abdominal pain
• serious kidney function disorders – symptoms include passing more or less urine than usual, or urine of different colour than normal
• high blood creatinine levels – shown in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation, especially of the skin
• tremor
• increased or decreased blood sugar levels
• blurred vision, light sensitivity
• excessive hair loss (alopecia)
• mouth ulceration
• chills, general malaise
• pain-related complaints, back or neck pain, pain in arms or legs
• fluid retention in the body (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• difficulty falling asleep (insomnia)
• complete or partial loss of speech ability
• swelling of the mouth
• unusual dreams or sleep problems
• coordination or balance disorders
• mucosal inflammation
• stuffy nose
• breathing difficulties
• chest discomfort
• bloating
• mild to severe nausea, vomiting, abdominal cramps and diarrhoea usually of viral origin, abdominal pain
• belching
• feeling of motor restlessness

Rare: (may occur in up to 1 in 1,000 people)

• pneumonia – symptoms include breathlessness and coughing up discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may lead to severe lung and heart damage
• blood disorders, such as abnormal blood clotting, prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• psychiatric disorders, such as hearing voices or seeing things that are not there
• fainting
• disturbances in thinking or speaking, sudden uncontrolled limb movements, especially of the hands
• stroke – symptoms include pain, weakness, numbness or tingling in limbs
• visual field defects or blind spots
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders leading to sudden death
• blood clots in the legs (deep vein thrombosis) – symptoms include severe leg pain or swelling
• blood clots in the lungs (pulmonary embolism) – symptoms include breathlessness or pain when breathing
• bleeding from the stomach or intestines – symptoms include vomiting blood or presence of blood in stool
• intestinal obstruction, especially of the small intestine. Obstruction prevents the movement of intestinal contents to the lower part of the digestive tract (large intestine); symptoms include bloating, vomiting, severe constipation, loss of appetite and intestinal cramps
• haemolytic-uraemic syndrome – a condition characterised by destruction of red blood cells (haemolysis), which may occur with or without kidney failure
• pancytopenia – low count of all types of blood cells (red and white blood cells and platelets) shown in blood tests
• large purple skin discolourations (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• chest pain
• adrenal dysfunction – this may cause weakness, fatigue, loss of appetite, changes in skin pigmentation
• pituitary gland dysfunction – this may cause low levels in blood of certain hormones affecting the function of male or female sex organs
• hearing disorders

Frequency not known: frequency cannot be estimated from the available data

• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (visible in blood test)
• some patients have also reported feeling disoriented after taking posaconazole

If any of the adverse reactions listed above occur, consult your
doctor, pharmacist or nurse.
Reporting of adverse reactions
If you experience any adverse reactions, including any unlisted
symptoms not mentioned in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Posaconazole Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label following “EXP” or “Expiry date (EXP)”. The expiry date refers to the last day of the stated month.
Do not store in a refrigerator and do not freeze.
If any suspension remains after 30 days from the first opening of the bottle, do not use it. Return the bottle containing unused suspension to a pharmacy that accepts unused medicines.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Posaconazole Teva contains

• The active substance in Posaconazole Teva is posaconazole. Each millilitre of oral suspension contains 40 milligrams of posaconazole.
• The other ingredients of the suspension are: citric acid monohydrate, disodium citrate anhydrous, sodium benzoate (E 211), sodium lauryl sulphate, simethicone emulsion 30% (containing simethicone, methylcellulose, sorbic acid and purified water), glycerol, xanthan gum, liquid glucose, titanium dioxide (E 171), cherry flavour (PHL-142355) and purified water.

What Posaconazole Teva looks like and contents of the pack
Posaconazole Teva is a white to yellowish oral suspension with a cherry flavour, packed in amber glass bottles of type III, containing 105 ml of oral suspension, closed with a child-resistant plastic screw cap, and presented in a cardboard box. A measuring spoon is provided with the bottle, allowing measurement of volumes of 2.5 ml and 5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
TEVA B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturers:
Genepharm S.A.,
18 km Marathon Avenue
15351 Pallini Attikis, Greece
Rafarm S.A.,
Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki,
TK 19002, P.O. Box 37, Greece
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
For further information about this medicinal product and its trade names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
ul. Emilii Plater 53,
00-113 Warsaw,
tel. (22) 345 93 00