Posaconazole stada

Package leaflet: Information for the user

Posaconazole Stada, 40 mg/ml, oral suspension
posaconazole
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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Posaconazole Stada contains a medicine called posaconazole. It belongs to a group of antifungal medicines. This medicine is used to prevent and treat many types of fungal infections.
It works by killing or stopping the growth of fungi that can cause infections.
Posaconazole Stada 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 such as 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;
• previously untreated oral and throat infections (known as thrush), 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, namely:

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

2. Important information before using Posaconazole Stada

When not to use Posaconazole Stada:

• 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, any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine, or a statin medicine such as simvastatin, atorvastatin or lovastatin;
• if the patient has started treatment with venetoclax or the dose of venetoclax is being gradually increased as part of therapy for chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Stada if any of the above situations apply.
If in doubt, consult a doctor or pharmacist before taking Posaconazole Stada.
Additional information about other medicines that may interact with Posaconazole Stada can be found in the section “Posaconazole Stada with other medicines”.

Warnings and precautions

Before starting Posaconazole Stada, consult your doctor, pharmacist, or nurse if any of the following apply:

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

If any of the above statements apply to the patient (or are suspected), inform the doctor, pharmacist, or nurse before starting treatment with Posaconazole Stada.
If severe diarrhoea or vomiting occurs during treatment with Posaconazole Stada, inform your doctor, pharmacist, or nurse immediately, as this may reduce the effectiveness of the medicine. More information can be found in section 4.

During treatment, avoid exposure to sunlight. It is important to cover exposed skin areas with protective clothing and use a high sun protection factor (SPF) sunscreen, as increased sensitivity of the skin to UV (ultraviolet) radiation may occur.

Children

Posaconazole Stada must not be used in children and adolescents (under 18 years of age).

Posaconazole Stada and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Do not take Posaconazole Stada if you are taking any of the following medicines:

• terfenadine (used to treat allergies);
• astemizole (used to treat allergies);
• cisapride (used to treat gastrointestinal symptoms);
• 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 Stada may increase blood levels of these medicines, which may lead to serious heart rhythm disturbances.

• any medicines containing ergot alkaloids such as ergotamine or dihydroergotamine (used to treat migraine). Posaconazole Stada may increase blood levels of these medicines, leading to severe reduction in blood flow to fingers and toes and tissue damage;
• statin medicines such as simvastatin, atorvastatin or lovastatin (used to treat high cholesterol);
• venetoclax, used at the beginning of treatment for a type of cancer called chronic lymphocytic leukaemia (CLL).

Do not take Posaconazole Stada if any of the above situations apply. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines:

The list above includes medicines that must not be taken during treatment with Posaconazole Stada. In addition to the medicines listed above, other medicines may also carry a risk of heart rhythm disturbances, which may be increased when taken together with Posaconazole Stada. The patient should inform the doctor about all medicines being taken (both prescription and over-the-counter).

Some medicines may increase the risk of adverse effects of Posaconazole Stada by increasing blood levels of posaconazole.

The following medicines may reduce the effectiveness of Posaconazole Stada by decreasing blood levels of posaconazole:

• rifabutin and rifampicin (used to treat certain infections). Patients already taking rifabutin may require blood tests and monitoring for possible adverse effects of rifabutin;
• phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent epileptic seizures);
• efavirenz and fosamprenavir (used to treat HIV infection);
• medicines used to suppress gastric acid secretion, such as cimetidine, ranitidine or omeprazole and similar medicines classified as proton pump inhibitors;
• flucloxacillin (an antibiotic used to prevent bacterial infections).

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

• vincristine, vinblastine and other vinca alkaloids (used in the treatment of cancer);
• venetoclax (used in the treatment of cancer);
• cyclosporine (used during or after organ transplantation);
• tacrolimus and sirolimus (used after organ transplantation);
• rifabutin (used to treat certain infections);
• medicines used to treat HIV infection called protease inhibitors (including lopinavir and atazanavir, which are used 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);
• sulfonylurea derivatives such as glipizide (used to treat diabetes);
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If any of the above apply to the patient (or are suspected), inform the doctor or pharmacist before starting treatment with Posaconazole Stada.

Taking Posaconazole Stada with food and drink

To improve absorption of posaconazole, take it during or immediately after a meal or nutritional supplement (see section 3 “How to take Posaconazole Stada”). There are no available data on the effect of alcohol on posaconazole.

Pregnancy and breastfeeding

Women who are pregnant or suspect they may be pregnant must inform their doctor before using Posaconazole Stada. Posaconazole Stada must not be used during pregnancy unless specifically advised by the treating doctor.

Women of childbearing potential should use effective contraception during treatment with Posaconazole Stada. If pregnancy occurs during treatment with Posaconazole Stada, contact your doctor immediately.

Breastfeeding is not allowed during treatment with Posaconazole Stada, as small amounts of the medicine may pass into breast milk.

Driving and operating machinery

Dizziness, drowsiness or blurred vision may occur during treatment with Posaconazole Stada, 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 your doctor.

Posaconazole Stada contains glucose, sodium and sodium benzoate.

Glucose

Posaconazole Stada contains up to 2.1 g of glucose in 5 ml of oral suspension.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicinal product. It may be harmful to teeth.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of oral suspension, i.e. it is considered “sodium-free”.

Sodium benzoate

This medicine contains 10 mg of sodium benzoate (E211) per 5 ml of oral suspension.

3. How to use Posaconazole Stada

Posaconazole is available in other forms and strengths, but not under this brand name. Do not interchange posaconazole oral suspension with posaconazole tablets or posaconazole delayed-release tablets and oral suspension powder without consulting your doctor or pharmacist, as this may lead to ineffective treatment or an increased risk of adverse effects.
This medicine should always be taken exactly as prescribed 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 Stada should be continued and whether the daily dose needs adjustment.
The table below shows the recommended doses and duration of treatment, which depend on the type of infection the patient has 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 should be taken during or immediately after a meal or nutritional supplement.
Before administration, shake the oral suspension well for 5–10 seconds.

Use of a higher than recommended dose of Posaconazole Stada
If an excessive dose of the medicine is taken, contact a doctor or other healthcare professional immediately.
Missed dose of Posaconazole Stada
If a dose of the medicine is missed, take it as soon as possible, then continue taking the medicine as usual. However, if there is only a short time remaining before the next dose is due, take the dose according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 will experience them.

Serious side effects
If you notice any of the serious side effects listed below, contact your doctor, pharmacist, or nurse immediately, as immediate medical attention may be required:

• 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 side effects
If you notice any of the following side effects, inform your doctor, pharmacist, or nurse.

Common (may occur in up to 1 in 10 people):

• changes in blood electrolyte levels detected in blood tests (manifesting, among others, as confusion or weakness)
• abnormal skin sensations such as numbness, tingling, itching, burning, pricking, or stinging
• headache
• low potassium levels – detected in blood tests
• low magnesium levels – detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or upset stomach, flatulence, dry mouth, taste changes
• heartburn (a burning sensation in the chest rising up into 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, tiredness, or drowsiness
• rash
• itching
• constipation
• discomfort in the rectum

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

• anaemia – symptoms include headache, tiredness, dizziness, shortness of breath, paleness, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia), visible in blood tests, which may lead to bleeding
• low white blood cell count (leukopenia), visible in blood tests – this may increase the risk of infections
• increased eosinophil count, a type of white blood cell (eosinophilia) – this may occur during inflammatory conditions
• vasculitis (inflammation of blood vessels)
• heart rhythm disorders
• seizures (epileptic fits)
• nerve damage (neuropathy)
• heart rhythm disturbances – visible on electrocardiogram (ECG), palpitations, slow or rapid heartbeat, high or low blood pressure
• low blood pressure
• pancreatitis – may cause severe pain in the upper abdomen (stomach pain)
• interruption of blood supply to the spleen (splenic infarction) – may cause severe pain in the upper abdomen (stomach pain)
• serious kidney problems – symptoms include passing increased or decreased amounts of urine, or urine of unusual colour
• high blood creatinine levels – detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain during breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation, particularly affecting the skin
• tremor
• increased or decreased blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general malaise
• pain, back or neck pain, arm or leg pain
• fluid retention in the body (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• insomnia
• complete or partial loss of speech ability
• swollen lips
• unusual dreams or sleep problems
• problems with coordination or balance
• mucositis (inflammation of mucous membranes)
• nasal congestion
• breathing difficulties
• chest discomfort
• bloating sensation
• mild to severe nausea, vomiting, muscle cramps, diarrhoea (usually of viral origin), stomach pain
• belching
• feeling shaky

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

• pneumonia – symptoms include shortness of breath and coughing up discoloured sputum
• high blood pressure in the lung arteries (pulmonary hypertension), which may lead to serious lung and heart damage
• blood disorders, such as abnormal blood clotting parameters, prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• psychiatric problems, such as hearing voices or seeing things that are not real
• fainting
• disturbances in thinking or speech, abnormal tremor involving uncontrollable movements, mainly of the hands, that cannot be controlled
• stroke – symptoms include pain, weakness, numbness, or tingling in limbs
• blind spots or scotomas in the visual field
• heart failure or myocardial infarction (heart attack), which may lead to cardiac arrest and death, as well as rhythm disturbances with 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 shortness of breath or pain when breathing
• bleeding in the stomach or intestines – symptoms include vomiting blood or passing blood in stool
• intestinal blockage (intestinal obstruction); particularly affecting the ileum. The blockage prevents intestinal contents from passing to lower parts of the digestive tract; symptoms include bloating, vomiting, severe constipation, loss of appetite, and cramps
• haemolytic-uraemic syndrome – a condition characterised by the breakdown 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), visible in blood test results
• large purple skin discolourations (thrombotic thrombocytopenic purpura)
• facial and tongue swelling
• depression
• double vision
• chest pain
• adrenal gland dysfunction – may cause weakness, fatigue, loss of appetite, and skin pigmentation
• pituitary gland dysfunction – may cause low blood levels of certain hormones affecting the function of male and female reproductive organs
• hearing problems
• pseudoaldosteronism, which may contribute to high blood pressure with low potassium levels (detected in blood tests)

Frequency not known (frequency cannot be estimated from available data):

• some patients have also reported confusion after taking posaconazole
• skin redness

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

Reporting of side effects
If any side effects occur, including any unlisted adverse symptoms not mentioned in this leaflet, you should inform your doctor or pharmacist. Side effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Posaconazole Stada

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

6. Contents of the packaging and other information

What Posaconazole Stada contains

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

What Posaconazole Stada looks like and contents of the pack
Posaconazole Stada is a white to yellowish oral suspension with a cherry flavour, packed in amber glass bottles of type III, closed with a plastic screw cap (inner part made of LDPE) with child-resistant closure, and contained in a cardboard box. A measuring spoon is included with the bottle, allowing measurement of volumes of 2.5 ml and 5 ml.
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer/Importer:
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece
STADA Arzneimittel AG
Stadastrasse 2 - 18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Rafarm S.A
Thesi Pousi-Xatzi Agiou Louka
19002 Paiania Attiki,
Greece
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Posaconazol STADA 40 mg/ml Suspension zum Einnehmen
Denmark: Posaconazole Stada
Germany: Posaconazol AL 40 mg/ml Suspension zum Einnehmen
Finland: Posaconazole STADA 40 mg/ml oraalisuspensio
Poland: Posaconazole Stada
Sweden: Posaconazole STADA, 40 mg/ml oral suspension
Slovakia: Posakonazol STADA
United Kingdom: Posaconazole Thornton & Ross 40mg/ml oral suspension
Italy: Posaconazolo EG