OSSMIQ

Package leaflet: Information for the patient

Ossmiq, 100 mg, enteric-coated tablets
Posaconazole
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

1. What Ossmiq is and what it is used for

Ossmiq contains the active substance posaconazole. Posaconazole belongs to a group of antifungal medicines. It is used to prevent and treat a number of different fungal infections.
This medicine works by killing or inhibiting the growth of certain types of fungi that can cause infections.
Ossmiq can be used in adults for the treatment of fungal infections caused by Aspergillus species.
Ossmiq may be used in adults and children aged 2 years and older with a body weight above 40 kg for the treatment of the following types of fungal infections:

• Infections caused by Aspergillus species that have not responded to, or treatment with, amphotericin B or itraconazole had to be discontinued;
• Infections caused by Fusarium species that have not responded to amphotericin B or treatment with it had to be discontinued;
• Fungal infections known as "chromoblastomycosis" and "phaeohyphomycosis" that have not responded to itraconazole or treatment with it had to be discontinued;
• Infections caused by Coccidioides species that have not responded to, or treatment with one or more of the following medicines—amphotericin B, itraconazole, or fluconazole—had to be discontinued.

This medicine may also be used for the prevention of fungal infections in the following adults and children aged 2 years and older with a body weight above 40 kg who are at high risk of developing fungal infections:

• Patients with weakened immune systems due to chemotherapy for acute myeloid leukemia or myelodysplastic syndrome;
• Patients undergoing high-dose immunosuppressive therapy following hematopoietic stem cell transplantation.

2. Important information before using Ossmiq

When not to use Ossmiq

• 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 medicine containing ergot alkaloids (such as ergotamine or dihydroergotamine), or a statin medicine (such as simvastatin, atorvastatin or lovastatin);
• the patient has just started taking venetoclax or the dose of venetoclax is being gradually increased in the treatment of chronic lymphocytic leukaemia (CLL).

Ossmiq should not be taken if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before using this medicine.
More information about possible interactions with other medicines can be found in the subsection “Ossmiq and other medicines”.

Warnings and precautions

Before taking Ossmiq, discuss with your doctor, pharmacist or nurse if:

• the patient has previously had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole or voriconazole;
• the patient has or has ever had liver disease; your doctor may recommend blood tests during treatment;
• the patient has severe diarrhoea or vomiting, as these may reduce the effectiveness of the medicine;
• the patient has an abnormal heart trace on electrocardiogram (ECG), indicating a condition called “prolonged QTc interval”;
• the patient has been diagnosed with weakened heart muscle or heart failure;
• the patient’s heart rate is significantly slow;
• the patient has heart rhythm disorders;
• the patient has abnormal blood levels of potassium, magnesium or calcium;
• the patient is taking medicines containing vincristine, vinblastine or other vinca alkaloids (medicines used in cancer treatment);
• the patient is taking venetoclax (a medicine used in cancer treatment).

If any of the above conditions apply to the patient or if the patient is unsure, consult a doctor, pharmacist or nurse before using Ossmiq.
If the patient develops severe diarrhoea or vomiting while taking this medicine, contact a doctor, pharmacist or nurse immediately, as there is a risk that the medicine may not work properly. Further information can be found in section 4.

Children

Ossmiq must not be used in children. It should not be given to children under 2 years of age.

Ossmiq and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Ossmiq if the patient is taking any of the following medicines:

• terfenadine (a medicine used to treat allergies)
• astemizole (a medicine used to treat allergies)
• cisapride (a medicine used to treat stomach disorders)
• pimozide (a medicine used to treat symptoms of Tourette’s syndrome and psychiatric disorders)
• halofantrine (a medicine used to treat malaria)
• quinidine (a medicine used to treat irregular heartbeat).

Ossmiq may increase blood levels of the following medicines, which could lead to serious heart rhythm disturbances in the patient:

• medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraine). Ossmiq may increase blood levels of these medicines, which could lead to severely reduced blood flow to the fingers and toes and cause tissue damage.
• statins, such as simvastatin, atorvastatin or lovastatin (medicines used to lower high blood cholesterol levels).
• venetoclax, when starting treatment for a type of cancer, chronic lymphocytic leukaemia (CLL).

If the patient is taking any of these medicines, Ossmiq must not be taken.
If in doubt, consult a doctor or pharmacist before using this medicine.

Other medicines

The above list includes medicines that must not be taken together with Ossmiq.
In addition, there are other medicines that may carry a risk of heart rhythm disturbances, particularly when taken together with Ossmiq. Always inform your doctor about all medicines currently being taken (whether prescribed or available without prescription).

Some medicines may increase the risk of Ossmiq side effects by increasing its blood levels.

The following medicines may reduce the effectiveness of Ossmiq by decreasing its blood levels:

• rifabutin and rifampicin (medicines used to treat certain infections). If the patient is being treated with rifabutin, blood tests and monitoring for rifabutin side effects will be necessary.
• medicines used to treat or prevent seizures (including phenytoin, carbamazepine, phenobarbital or primidone).
• efavirenz and fosamprenavir (medicines used to treat HIV infection).

Ossmiq may increase the risk of side effects from other medicines by increasing their blood levels. These include:

• vincristine, vinblastine and other vinca alkaloids (anticancer medicines)
• venetoclax, when starting treatment for certain types of cancer
• cyclosporine (a medicine used during or after organ transplantation)
• tacrolimus and sirolimus (medicines used during or after organ transplantation)
• rifabutin (a medicine used to treat certain infections)
• medicines used to treat HIV infection, known as protease inhibitors (including lopinavir and atazanavir given with ritonavir)
• midazolam, triazolam, alprazolam or other benzodiazepines (sedatives or muscle relaxants)
• diltiazem, verapamil, nifedipine, nilvadipine or other calcium channel blockers (medicines used to treat high blood pressure)
• digoxin (a medicine used to treat heart failure)
• glipizide or other sulfonylureas (medicines used to treat high blood sugar)
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If the patient is taking (or is unsure whether they are taking) any of these medicines, consult a doctor or pharmacist before using Ossmiq.

Pregnancy and breastfeeding

Inform your doctor if the patient thinks she may be pregnant before starting Ossmiq.
Do not use Ossmiq during pregnancy unless your doctor decides otherwise.
Women of childbearing potential must use effective contraception during treatment with this medicine.
If the patient becomes pregnant while taking Ossmiq, she should contact her doctor immediately.

Do not breastfeed during treatment with Ossmiq, as small amounts of the medicine may pass into breast milk.

Driving and using machines

While taking Ossmiq, the patient may experience dizziness, drowsiness or vision disturbances, which may affect the ability to drive or operate tools or machinery. If such symptoms occur, these activities should not be performed; contact your doctor.

Ossmiq contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per enteric tablet, meaning the medicine is considered “sodium-free”.

3. How to use Ossmiq

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Do not substitute Ossmiq tablets with an oral suspension containing posaconazole without first consulting a doctor or pharmacist, as this may result in reduced effectiveness of the medicine or an increased risk of adverse effects.
Dosage
The usual dose is 300 mg of posaconazole (3 enteric-coated tablets of 100 mg each) twice daily on the first day of treatment, followed by 300 mg of posaconazole (3 enteric-coated tablets of 100 mg each) once daily.
The duration of treatment may depend on the type of infection in the individual patient and may be individually adjusted by the doctor. Do not change the dose of the medicine or alter the prescribed treatment regimen without prior consultation with a doctor.
Taking the medicine

• Swallow the tablets whole with water.
• Do not crush, chew, break, or dissolve the tablets.
• The tablets may be taken with food or independently of meals.

Accidental overdose of Ossmiq
If a patient suspects having taken an excessive dose of the medicine, seek immediate medical advice from a doctor or go to a hospital.
Missed dose of Ossmiq

• If a patient misses a dose, take it as soon as remembered.
• However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule.
• 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
If the patient experiences any of the serious side effects listed below, seek immediate medical advice from a doctor, pharmacist, or nurse, as urgent medical attention may be required:

• nausea or vomiting, diarrhoea
• symptoms of liver problems (including yellowing of the skin or whites of the eyes, unusually dark urine, pale stools, nausea without an obvious cause, stomach problems, loss of appetite, or unusual tiredness or weakness, increased liver enzyme activity detected in blood tests)
• allergic reaction

Other side effects
If the patient experiences any of the side effects listed below, inform a doctor, pharmacist, or nurse:

Common: may affect up to 1 in 10 people

• changes in blood electrolyte levels detected in blood tests (symptoms may include confusion or weakness)
• unusual skin sensations such as numbness, tingling, itching, chills, pricking, or burning
• headache
• low blood potassium levels detected in blood tests
• low blood magnesium levels detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or indigestion, gas, dry mouth, taste changes
• heartburn (a burning sensation in the chest radiating to the throat)
• low neutrophil count, a type of white blood cell (neutropenia), detected in blood tests, which may increase susceptibility to infections
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• discomfort in the rectal area

Uncommon: may affect up to 1 in 100 people

• anaemia (symptoms include headache, fatigue or dizziness, shortness of breath, or pale skin, and low haemoglobin levels detected in blood tests)
• low platelet count (thrombocytopenia) detected in blood tests, which may lead to bleeding
• reduced white blood cell count (leukopenia), a type of white blood cell, detected in blood tests, which may increase susceptibility to infections
• increased eosinophil count, a type of white blood cell (eosinophilia), which may accompany inflammatory conditions
• inflammation of blood vessels
• heart rhythm disturbances
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm visible on electrocardiogram (EKG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas, which may cause severe abdominal pain
• interrupted blood supply to the spleen (splenic infarction), which may cause severe stomach pain
• serious kidney function disorders with symptoms such as passing more or less urine than usual, or urine of different colour
• high blood creatinine levels detected in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during breathing (pain associated with pleuritis)
• swollen lymph nodes (lymphadenopathy)
• reduced sensitivity, especially of the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general malaise
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to walk
• swelling of the oral mucosa
• unusual dreams or difficulty falling asleep
• coordination or balance disturbances
• mucosal inflammation
• nasal congestion
• breathing difficulties
• chest discomfort
• bloating
• mild to severe nausea, vomiting, cramps, and diarrhoea, usually of viral origin, stomach pain
• belching
• feeling of restlessness

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

• lung inflammation (symptoms include shortness of breath and discoloured sputum)
• high blood pressure in the lung blood vessels (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood disorders such as abnormal clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering rash and skin peeling
• psychiatric disorders such as hearing voices or seeing things that are not real
• fainting
• disturbances in thinking or speaking, uncontrollable tremor, especially of the hands
• stroke with symptoms including pain, weakness, numbness, or tingling in limbs
• blind spots or dark spots in the visual field
• heart failure or myocardial infarction, which may lead to cardiac arrest and death, arrhythmias with sudden death
• blood clots in the legs (deep vein thrombosis) with symptoms such as severe leg pain or swelling
• blood clots in the lungs (pulmonary embolism) with symptoms such as shortness of breath or pain during breathing
• bleeding in the stomach or intestine with symptoms such as vomiting blood or blood in the stool
• intestinal obstruction, especially of the sigmoid colon, which blocks the passage of intestinal contents (symptoms include bloating, vomiting, severe constipation, loss of appetite, and cramps)
• "haemolytic-uraemic syndrome", occurring as a result of red blood cell destruction (haemolysis), with or without kidney failure
• "pancytopenia" – reduced number of all types of blood cells (red, white, and platelets) detected in blood tests
• large purple skin discolourations (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• chest pain
• adrenal gland dysfunction, which may cause weakness, fatigue, and loss of appetite
• skin depigmentation
• pituitary gland dysfunction, which may lead to low levels of certain hormones in the blood and consequently affect sexual organ function in both women and men
• hearing disturbances
• pseudoaldosteronism, resulting in high blood pressure with low potassium levels (detected in blood laboratory tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported feeling confused after taking Ossmiq.

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

Reporting of side effects
If any symptoms of side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 Ossmiq

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label following EXP. The expiry date refers to the last day of the specified month.
No special storage conditions apply.
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 Ossmiq contains

• The active substance is posaconazole. Each enteric-coated tablet contains 100 mg of posaconazole.
• The other ingredients are: methacrylic acid and ethyl acrylate copolymer (1:1) (type B), triethyl citrate, xylitol, hydroxypropyl cellulose, propyl gallate, microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, and iron oxide yellow (E 172).

What Ossmiq looks like and contents of the pack
Ossmiq enteric-coated tablets are yellow, film-coated, capsule-shaped tablets with the imprint
“100P” on one side and smooth on the other side.
The tablets are packed in blisters containing 24 or 96 tablets, unit dose blisters containing 24 x 1
and 96 x 1 tablets, or in HDPE bottles containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer:
Delorbis Pharmaceuticals Ltd
17, Athinon Street, Ergates Industrial Area
2643 Ergates
2081 Lefkosia, Cyprus
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For further information about the medicine and its names in other European Economic Area member states, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00