Ossmiq

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 various fungal infections.
The action of this medicine involves killing or inhibiting the growth of certain types of fungi that can cause infections.
Ossmiq can be used in adults to treat fungal infections caused by fungi of the Aspergillus family.
Ossmiq may be used in adults and children over 2 years of age with a body weight above 40 kg to treat the following types of fungal infections:

• infections caused by fungi of the genus Aspergillus, for which treatment with antifungal medicines amphotericin B or itraconazole was ineffective or had to be discontinued;
• infections caused by fungi of the genus Fusarium, for which treatment with amphotericin B was ineffective or had to be discontinued;
• fungal infections known as "chromoblastomycosis" and "mycetoma", for which treatment with itraconazole was ineffective or had to be discontinued;
• infections caused by fungi of the genus Coccidioides, for which treatment with one or more of the following medicines: amphotericin B, itraconazole, or fluconazole, was ineffective or had to be discontinued.

This medicine may also be used to prevent fungal infections in the following adults and children over 2 years of age with a body weight above 40 kg who are at high risk of developing fungal infections:

• patients with impaired immune system function due to chemotherapy for acute myeloid leukemia or myelodysplastic syndrome;
• patients undergoing high-dose immunosuppression after hematopoietic stem cell transplantation.

2. Important information before taking Ossmiq

When not to take 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 (such as simvastatin, atorvastatin, or lovastatin).
• if the patient has just started taking venetoclax or their venetoclax dose is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL)

Do not take Ossmiq if any of the above situations apply to the patient.
In case of doubts before taking this medicine, consult a doctor or pharmacist.
More information on possible interactions with other medicines can be found in the subsection "Ossmiq and other medicines".

Warnings and precautions

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

• the patient has had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole;
• the patient has or has had liver disease; the doctor may recommend blood tests during treatment;
• the patient has severe diarrhea or vomiting, as they may reduce the effectiveness of the medicine;
• the patient has an abnormal heart rhythm on an electrocardiogram (ECG), indicating a condition called "prolonged QTc interval";
• the patient has weakened heart muscle or heart failure;
• the patient's heart rate is significantly slowed;
• the patient has heart rhythm disorders;
• the patient has abnormal levels of potassium, magnesium, or calcium in the blood;
• the patient is taking medicines containing vincristine, vinblastine, and other vinca alkaloids (anticancer medicines).
• the patient is taking venetoclax (a medicine used to treat cancer).

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

Children and

Ossmiq should not be used in children under 2 years of age

Ossmiq and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take.

If the patient is taking any of the following medicines, they should not take Ossmiq:

Ossmiq:

• terfenadine (a medicine used to treat allergies)
• astemizole (a medicine used to treat allergies)
• cisapride (a medicine used to treat stomach diseases)
• pimozide (a medicine used to treat symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (a medicine used to treat malaria)
• quinidine (a medicine used to treat irregular heart rhythm).

Ossmiq may increase the levels of the following medicines in the blood, which can lead to serious heart rhythm disorders:

• medicines containing ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used to treat migraines). Ossmiq may increase the levels of these medicines in the blood, which can lead to significant reduction of blood flow to the fingers and toes and their damage.
• statins, such as simvastatin, atorvastatin, or lovastatin (medicines used to lower high cholesterol levels in the blood).
• venetoclax used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL)

If the patient is taking any of these medicines, they should not take Ossmiq.
In case of doubts before taking this medicine, consult a doctor or pharmacist.
Other medicines
The above list includes medicines that should not be taken with Ossmiq.
In addition to these, there are other medicines that may increase the risk of heart rhythm disorders, especially when taken with Ossmiq. It is essential to tell the doctor about all medicines currently being taken (prescription or over-the-counter).
Some medicines may increase the risk of side effects of Ossmiq by increasing its levels in the blood.
The following medicines may reduce the effectiveness of Ossmiq by reducing its levels in the blood:

• rifabutin and rifampicin (medicines used to treat certain infections). If the patient is being treated with rifabutin, blood tests and monitoring for side effects of rifabutin may 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 of other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine, and other vinca alkaloids (anticancer medicines)
• venetoclax used at the start of treatment for a type of cancer
• cyclosporine (a medicine used during or after transplantation)
• tacrolimus and sirolimus (medicines used during or after 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, nizoldipine, 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 levels)
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If the patient is taking (or is unsure if they are taking) any of these medicines, they should consult their doctor or pharmacist before taking Ossmiq.

Pregnancy and breastfeeding

Women should inform their doctor if they think they are pregnant before starting treatment with Ossmiq.
Ossmiq should not be used during pregnancy unless the doctor decides otherwise.
During treatment with Ossmiq, women of childbearing age must use effective contraception.
If the patient becomes pregnant while taking Ossmiq, they should immediately contact their doctor.
Do not breastfeed while taking 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 their ability to drive or operate tools or machines. If these disturbances occur, the patient should not perform these activities and should contact their doctor.

Ossmiq contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant tablet, which means it is essentially "sodium-free".

3. How to take Ossmiq

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Do not switch from Ossmiq tablets to a posaconazole-containing oral suspension without consulting your doctor or pharmacist, as this may lead to reduced effectiveness or increased risk of side effects.

How much to take

The usual dose is 300 mg of posaconazole (3 gastro-resistant tablets of 100 mg) twice a day on the first day of treatment, and then 300 mg of posaconazole (3 gastro-resistant tablets of 100 mg) once a day.
The duration of treatment may depend on the type of infection in the patient and may be adjusted individually by the doctor. Do not change the dose of the medicine without consulting your doctor or pharmacist.

Taking the medicine

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

Taking more Ossmiq than prescribed

If the patient thinks they have taken too much of the medicine, they should immediately contact their doctor or go to the hospital.

Missing a dose of Ossmiq

• If the patient misses a dose, they should take it as soon as they remember.
• However, if it is almost time for the next dose, they should skip the missed dose and return to their regular dosing schedule.
• Do not take a double dose to make up for the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ossmiq can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should immediately contact their doctor, pharmacist, or nurse, as urgent medical attention may be necessary:

nausea or vomiting, diarrhea
symptoms of liver disorders (including yellowing of the skin or whites of the eyes, unusual darkening of urine or pale stools, unexplained nausea, stomach problems, loss of appetite, or unusual tiredness or weakness, increased liver enzyme activity in blood tests
allergic reaction

Other side effects

If the patient experiences any of the following side effects, they should tell their doctor, pharmacist, or nurse:
Frequent: the following may affect up to 1 in 10 people

• changes in electrolyte levels in the blood, as shown in blood tests (symptoms may include confusion or weakness)
• abnormal sensations in the skin, such as numbness, tingling, itching, shivering, pricking, or burning
• headache
• low potassium levels in the blood, as shown in blood tests
• low magnesium levels in the blood, as shown in blood tests
• high blood pressure
• loss of appetite, stomach pain, or indigestion, gas, dry mouth, changes in taste
• heartburn (a burning sensation in the chest that may spread to the throat)
• low neutrophil count, a type of white blood cell (neutropenia), as shown in blood tests, which may increase the risk of infections
• fever
• feeling of weakness, dizziness, tiredness, or drowsiness
• rash
• itching
• constipation
• discomfort in the rectal area

Uncommon: the following may affect up to 1 in 100 people

• anemia (symptoms include headache, tiredness, or dizziness, shortness of breath, or pale skin and low hemoglobin levels in blood tests)
• low platelet count (thrombocytopenia), as shown in blood tests, which may lead to bleeding
• reduced white blood cell count (leukopenia), as shown in blood tests, which may increase the risk of infections
• increased eosinophil count, a type of white blood cell (eosinophilia), which may accompany an inflammatory condition
• vasculitis
• heart rhythm disorders
• seizures
• nerve damage (neuropathy)
• abnormal heart rhythm on an electrocardiogram (ECG), irregular heartbeat, slow or fast heart rate, high or low blood pressure
• low blood pressure
• pancreatitis, which may cause severe abdominal pain
• interrupted blood flow to the spleen (splenic infarction), which may cause severe stomach pain
• severe kidney disorders with symptoms such as increased or decreased urine output or changes in urine color
• high creatinine levels in the blood, as shown in blood tests
• cough, hiccups
• nosebleeds
• severe sharp chest pain during inhalation (pain related to pleurisy)
• lymph node swelling (lymphadenopathy)
• reduced sensitivity, especially of the skin
• tremors
• high or low blood sugar levels
• blurred vision, increased sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of being unwell
• pains, back pain or neck pain, arm or leg pain
• fluid retention (edema)
• menstrual disorders (abnormal vaginal bleeding)
• insomnia
• complete or partial inability to walk
• swelling of the mucous membranes of the mouth
• unusual dreams or difficulty sleeping
• coordination or balance disorders
• mucous membrane inflammation
• nose congestion
• breathing difficulties
• discomfort in the chest
• bloating
• mild to severe nausea, vomiting, cramps, and diarrhea, usually of viral origin, stomach pain
• belching
• restlessness

Rare: the following may affect up to 1 in 1000 people

• pneumonia (symptoms include shortness of breath and production of discolored sputum)
• high blood pressure in the pulmonary blood vessels (pulmonary hypertension), which may cause severe lung and heart damage
• blood disorders, such as abnormal clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering and skin peeling
• psychiatric disorders, such as hearing voices or seeing things that do not exist
• fainting
• disorders of thinking or speech, uncontrolled tremors, especially of the hands
• stroke with symptoms including pain, weakness, numbness, or tingling of limbs
• blind spots or dark spots in the field of vision
• heart failure or heart attack, which may lead to cardiac arrest and death, heart rhythm disorders with sudden death
• formation of blood clots in the legs (deep vein thrombosis) with symptoms such as severe leg pain or swelling
• formation of blood clots in the lungs (pulmonary embolism) with symptoms such as shortness of breath or chest pain during breathing
• bleeding in the stomach or intestines with symptoms such as vomiting blood or blood in the stool
• intestinal obstruction, especially of the small intestine, which prevents the passage of intestinal contents to further sections (symptoms include bloating, vomiting, severe constipation, loss of appetite, and cramps)
• "hemolytic-uremic syndrome", which occurs as a result of red blood cell breakdown (hemolysis), with or without kidney failure
• "pancytopenia" - a decrease in the number of all types of blood cells (red, white, and platelets) shown in blood tests
• large purple discolorations on the skin (thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• chest pain
• abnormal adrenal gland function, which may cause weakness, tiredness, loss of appetite
• skin discoloration
• abnormal pituitary gland function, which may cause low levels of certain hormones in the blood and consequently affect the function of sexual organs in women and men
• hearing disorders
• pseudoaldosteronism, which results in high blood pressure with low potassium levels (visible in blood tests)
• Frequency not known: cannot be estimated from the available data
• some patients have also reported feeling confused after taking Ossmiq.

If the patient experiences any of the above side effects, they should tell their doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ossmiq

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label after EXP. The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ossmiq contains

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

What Ossmiq looks like and contents of the pack

Ossmiq gastro-resistant tablets are yellow, film-coated, capsule-shaped tablets with "100P" embossed on one side and a smooth surface on the other.
The tablets are packaged in blisters containing 24 or 96 tablets, single-dose blisters containing 24 x 1 and 96 x 1 tablets, or HDPE bottles containing 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

To obtain more detailed information on the medicine and its names in other EU member states, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of leaflet approval:09/2022
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