What Evrolia is and what it is used for?
Evrolia is an anticancer medicine containing the active substance Everolimus.
Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Evrolia is used to treat adult patients with:
(so-called “VEGF-targeted therapy”) have not helped stop your disease.
What you need to know before you take Evrolia
Evrolia will only be prescribed for you by a doctor with experience in cancer treatment. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. If you have any questions about Evrolia or why it has been prescribed for you, ask your doctor.
Do not take Evrolia:
If you are allergic to Everolimus, to related substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor before taking Evrolia:
Evrolia may also:
Tell your doctor if you are planning to have radiation therapy in the near future, or if you have had radiation therapy before.
Tell your doctor if you experience these symptoms.
You will have regular blood tests during treatment. These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Evrolia is having an unwanted effect on these cells. Blood tests will also be carried out to check your kidney function (level of creatinine) and liver function (level of transaminases) and your blood sugar and cholesterol levels. This is because these can also be affected by Evrolia.
Children and adolescents
Evrolia is not to be used in children or adolescents (age below 18 years).
Other medicines and Evrolia
Evrolia may affect the way some other medicines work. If you are taking other medicines at the same time as Evrolia, your doctor may need to change the dose of Evrolia or the other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following may increase the risk of side effects with Evrolia:
The following may reduce the effectiveness of Evrolia:
These medicines should be avoided during your treatment with Evrolia. If you are taking any of them, your doctor may switch you to a different medicine, or may change your dose of Evrolia.
Evrolia with food and drink
Avoid grapefruit and grapefruit juice while you are on Evrolia. It may increase the amount of Evrolia in the blood, possibly to a harmful level.
Pregnancy, breast-feeding and fertility
Pregnancy
Evrolia could harm your unborn baby and is not recommended during pregnancy. Tell your doctor if you are pregnant or think that you may be pregnant. Your doctor will discuss with you whether you should take this medicine during your pregnancy.
Women who could potentially become pregnant should use highly effective contraception during treatment and for up to 8 weeks after ending treatment. If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Evrolia.
Breast-feeding
Evrolia could harm your breast-fed baby. You should not breast-feed during treatment and for 2 weeks after the last dose of Evrolia. Tell your doctor if you are breast-feeding.
Female fertility
Absence of menstrual periods (amenorrhoea) has been observed in some female patients receiving Evrolia.
Evrolia may have an impact on female fertility. Talk to your doctor if you wish to have children.
Male fertility
Evrolia may affect male fertility. Talk to your doctor if you wish to father a child.
Driving and using machines
If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.
Evrolia contains Lactose Monohydrate
Evrolia contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Evrolia?
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 10 mg, taken once a day. Your doctor will tell you how many tablets of Evrolia to take.
If you have liver problems, your doctor may start you on a lower dose of Evrolia (2.5, 5 or 7.5 mg per day).
If you experience certain side effects while you are taking Evrolia (see section 4), your doctor may lower your dose or stop treatment, either for a short time or permanently.
Take Evrolia once a day, at about the same time every day, consistently either with or without food.
Swallow the tablet(s) whole with a glass of water. Do not chew or crush the tablets.
If you take more Evrolia than you should
If you forget to take Evrolia
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for the forgotten tablets.
If you stop taking Evrolia
Do not stop taking Evrolia unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Evrolia and seek medical help immediately if you experience any of the following signs of an allergic reaction:
Serious side effects of Evrolia include:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
If you experience any of these side effects, tell your doctor immediately as this might have life-threatening consequences.
Other possible side effects of Evrolia include:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
If these side effects get severe please tell your doctor and/or pharmacist. Most of the side effects are mild to moderate and will generally disappear if your treatment is interrupted for a few days.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. By reporting side affects you can help provide more information on the safety of this medicine.
How to store Evrolia
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Further information
What Evrolia contains
The active substance of this medicine is Everolimus.
The other ingredients are:
What Evrolia looks like and contents of the pack
Evrolia 5 mg tablets are white to off-white, caplet flat faced uncoated tablets.
Evrolia 10 mg tablets are white to off-white, capsule shaped, bevel edged uncoated tablets with break line on one side.
Evrolia is available in the boxes of 4 blisters, each one containing 7 tablets. This gives a total of 28 tablets per pack.
Manufactured by:
Actero Middle East Pharmaceutical Company, Karaj, Iran