Isturisa 10 mg film coated tablets

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Isturisa is a medicine that contains the active substance osilodrostat.

Isturisa is used in adults to treat endogenous Cushing’s syndrome, a condition in which the body produces too much of a hormone called cortisol. Too much cortisol may lead to a variety of symptoms such as weight gain (particularly around the waist), a moon-shaped face, bruising easily, irregular periods, excessive body and facial hair, and generally feeling weak, tired or unwell.

Isturisa blocks the main enzyme that makes cortisol in the adrenal glands. The effect of this is to decrease the over-production of cortisol and improve the symptoms of endogenous Cushing’s syndrome.

• if you are allergic to osilodrostat or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor or pharmacist before taking Isturisa.

If any of the following apply to you, tell your doctor before taking Isturisa:

• if you have a heart disorder or a heart rhythm disorder, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT interval prolongation).
• if you have a liver disease; your doctor may need to change your dose of Isturisa.

Contact your doctor immediately if you have two or more of these symptoms during your treatment with Isturisa. This may indicate that you have adrenal insufficiency (low cortisol levels):

• weakness
• light-headedness
• tiredness
• lack of appetite
• nausea (feeling sick)
• vomiting

After Isturisa discontinuation, these symptoms may persist for months. You should contact with your doctor since you may need additional monitoring and/or treatment.

Your doctor will test your blood and/or urine before you start treatment and regularly during treatment. This is to detect any possible abnormalities in your magnesium, calcium and potassium levels and also to measure the levels of cortisol. Depending on the results, your doctor may change your dose.

This medicine may have an unwanted effect (called QT prolongation) on the function of the heart. Your doctor will therefore also check for this effect by performing an electrocardiogram (ECG) before you start treatment and during treatment.

If your Cushing’s syndrome is caused by a benign tumour (called adenoma) in the pituitary gland, your doctor may consider stopping your treatment if a pituitary scan shows that the adenoma has expanded into neighbouring regions.

This medicine is not recommended for patients aged under 18 years. This is because there is a lack of data in these patients.

Tell your doctor if you are taking, have recently taken or might take any other medicines. It is particularly important that you mention any of the following medicines:

• medicines that may have an unwanted effect (called QT prolongation) on the function of the heart. These include medicines used for abnormal heart rhythm such as quinidine, sotalol and amiodarone; medicines used for allergies (antihistamines); antidepressants such as amitriptyline and drugs for mental health disorders (antipsychotics); antibiotics, including the following types: macrolides, fluoroquinolones or imidazole; and other medicines for Cushing’s disease (pasireotide, ketoconazole)
• theophylline (used to treat breathing problems) or tizanidine (used to treat muscle pain and muscle cramps)

This medicine should not be used during pregnancy or breast-feeding, unless your doctor has advised you to do so. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Women who could become pregnant should use an effective method of contraception during treatment and for at least one week after the last dose. Ask your doctor about the need for contraception before you start taking Isturisa.

Dizziness and tiredness may occur during treatment with Isturisa. Do not drive or operate machines if you get these symptoms.

If you have taken more Isturisa than you should and you feel unwell (for example if you feel weak, light-headed, tired or sick, or if you have to vomit), or if someone else accidentally takes your medicine, contact a doctor or hospital for advice immediately. Medical treatment may be needed.

Do not take a double dose to make up for a forgotten dose. Instead, just wait until it is time for your next dose and take that at the scheduled time.

Do not stop taking Isturisa unless your doctor tells you to. If you stop your treatment with Isturisa, your symptoms may come back.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system : Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is osilodrostat. Each film-coated tablet contains 1 mg osilodrostat, 5 mg osilodrostat or 10 mg osilodrostat.
• The other ingredients are:
  • In the tablet core: microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica.
  • In the film coating: hypromellose, titanium dioxide (E171), iron oxides (E172, see below), macrogol and talc.
    • Isturisa 1 mg film-coated tablets contain iron oxide yellow and iron oxide red.
    • Isturisa 5 mg film-coated tablets contain iron oxide yellow.
    • Isturisa 10 mg film-coated tablets contain iron oxide yellow, iron oxide red and iron oxide black.

Isturisa is available in packs containing 60 film-coated tablets.

The 1 mg tablets are pale yellow, round, unscored and debossed with ‘1’ on one side. The approximate diameter is 6.1 mm.

The 5 mg tablets are yellow, round, unscored and debossed with ‘5’ on one side. The approximate diameter is 7.1 mm.

The 10 mg tablets are pale orange brown, round, unscored and debossed with ‘10’ on one side. The approximate diameter is 9.1 mm.