Everolimus stada

Package leaflet: Information for the user

Everolimus Stada, 5 mg, tablets
Everolimus Stada, 10 mg, tablets
Everolimus
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.

Contents of the leaflet

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

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

Everolimus Stada is an anticancer medicine containing the active substance everolimus.
Everolimus reduces blood supply to the tumour and slows down the growth and spread of cancer cells.
Everolimus Stada is used to treat adult patients with:

• advanced hormone receptor-positive breast cancer in postmenopausal women whose disease is no longer controlled by other medicines (so-called "non-steroidal aromatase inhibitors"). This medicine is given together with exemestane, a medicine known as a steroidal aromatase inhibitor, used in hormonal anticancer therapy.
• advanced tumours called pancreatic neuroendocrine tumours. This medicine is given when tumours are inoperable and do not secrete excessive amounts of specific hormones or other related natural substances.
• advanced kidney cancer (advanced renal cell carcinoma) when other medicines (called "anti-VEGF therapies") have not worked.

2. Important information before using Everolimus Stada

Everolimus Stada must only be prescribed by a physician experienced in the treatment of
cancer. All instructions from the doctor must be followed. These may differ from the general
information contained in this leaflet. If further information about Everolimus Stada is needed, or
an explanation as to why this particular medicine was chosen, the patient should contact their doctor.
When not to use Everolimus Stada

• if the patient is allergic to everolimus, substances similar to sirolimus or temsirolimus, or any of the other ingredients of this medicine (listed in section 6). If an allergy is suspected, the patient should consult their doctor for advice.

Warnings and precautions
Before starting treatment with Everolimus Stada, consult a doctor
if:

• the patient has liver problems or conditions that may have affected liver function. In such cases, the doctor may adjust the dose of Everolimus Stada.
• the patient has diabetes (high blood sugar levels). Everolimus Stada may increase blood sugar levels and worsen diabetes. This condition may require treatment with insulin and/or oral antidiabetic medicines. The patient should inform the doctor if they experience excessive thirst or increased frequency of urination.
• the patient needs to receive vaccinations during treatment with Everolimus Stada.
• the patient has high cholesterol levels. Everolimus Stada may increase cholesterol levels and/or other blood lipids.
• the patient has recently undergone major surgery or has unhealed surgical wounds. Everolimus Stada may impair wound healing.
• the patient has an infection. Existing infections may need to be treated before starting Everolimus Stada.
• the patient has previously had hepatitis B, as the disease may reactivate during treatment with Everolimus Stada (see section 4, “Possible side effects”).
• if the patient has received or is due to receive radiotherapy.

Everolimus Stada may also:

• suppress the immune system. Therefore, the patient may be at increased risk of infection while taking Everolimus Stada. If the patient develops fever or other signs of infection, they should consult their doctor. Some infections may be severe and potentially fatal.
• affect kidney function. Therefore, the doctor will monitor kidney function during treatment with Everolimus Stada.
• cause shortness of breath, cough, and fever.
• cause development of mouth ulcers and sores. The doctor may interrupt or discontinue treatment with Everolimus Stada. The patient may require treatment with mouthwashes, gels, or other products. Some mouthwashes and gels may worsen ulcers, so nothing should be used without consulting the doctor. The doctor may restart treatment with Everolimus Stada at the same or a lower dose.
• cause radiation therapy complications. Severe radiation-related reactions (such as shortness of breath, nausea, diarrhoea, skin rash, and pain in the mouth, gums, and throat), including fatal cases, have been observed in some patients receiving everolimus at the same time as radiotherapy or shortly after radiotherapy. In addition, patients previously treated with radiotherapy have reported so-called radiation recall reactions (including skin redness or lung inflammation in the area previously irradiated). The patient should inform their doctor about any planned radiotherapy in the near future or any previous radiotherapy.

The patient should inform their doctor if any of these symptoms occur.
During treatment, the patient will undergo regular blood tests to monitor blood cell counts (white blood cells, red blood cells, and platelets) and to check whether Everolimus Stada is having any adverse effects on blood cells. Blood tests will also be performed to monitor kidney function (creatinine levels), liver function (transaminase activity), and blood sugar and cholesterol levels, as Everolimus Stada may affect these parameters.
Children and adolescents
Everolimus Stada must not be used in children and adolescents (under 18 years of age).
Everolimus Stada and other medicines
Everolimus Stada may affect the action of other medicines. If the patient is taking other medicines concurrently with Everolimus Stada, the doctor may adjust the dose of Everolimus Stada or the other medicines.
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The following medicines, when taken with Everolimus Stada, may increase the risk of adverse effects:

• ketoconazole, itraconazole, voriconazole, or fluconazole, and other antifungal medicines used to treat fungal infections.
• clarithromycin, telithromycin, or erythromycin, antibiotics used to treat bacterial infections.
• ritonavir and other medicines used to treat HIV/AIDS.
• verapamil or diltiazem, used to treat heart disease or hypertension.
• dronedarone, a medicine that helps restore normal heart rhythm.
• cyclosporine, a medicine used to prevent organ transplant rejection.
• imatinib, which inhibits the growth of abnormal cells.
• angiotensin-converting enzyme (ACE) inhibitors (such as ramipril), used to treat hypertension or other cardiovascular conditions.
• nefazodone, used to treat depression.
• cannabidiol (used, among others, in the treatment of epileptic seizures).

The following medicines may reduce the effectiveness of Everolimus Stada:

• rifampicin, used to treat tuberculosis.
• efavirenz or nevirapine, used to treat HIV/AIDS.
• St John’s wort (Hypericum perforatum), a herbal product used to treat depression and other disorders.
• dexamethasone, a corticosteroid used to treat various conditions, including inflammatory or immunological disorders.
• phenytoin, carbamazepine, or phenobarbital, and other antiepileptic medicines used to prevent various types of seizures.

The patient should avoid taking these medicines during treatment with Everolimus Stada. If the patient is taking any of the above medicines, the doctor may switch to an alternative medicine or adjust the dose of Everolimus Stada.
Taking Everolimus Stada with food and drink
The patient should avoid eating grapefruit or drinking grapefruit juice during treatment with Everolimus Stada. This may increase the amount of Everolimus Stada in the blood, potentially to harmful levels.
Pregnancy, breastfeeding, and effects on fertility
Pregnancy
Everolimus Stada is not recommended during pregnancy, as it may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The doctor will inform the patient whether she can take this medicine during pregnancy.
Women of childbearing potential should use highly effective contraception during treatment and for 8 weeks after stopping treatment. If, despite these precautions, the patient suspects she may have become pregnant, she should contact her doctor before taking the next dose of Everolimus Stada.
Breastfeeding
Everolimus Stada may harm the breastfed infant. Breastfeeding must be avoided during treatment and for 2 weeks after the last dose of Everolimus Stada. If the patient is breastfeeding, she should inform her doctor.
Female fertility
In some patients taking everolimus, absence of menstrual periods (amenorrhoea) has been observed.
Everolimus Stada may affect female fertility. The patient should discuss with her doctor if she wishes to have children.
Male fertility
Everolimus Stada may affect male fertility. The patient should inform the doctor if he intends to father a child.
Driving and operating machinery
If the patient experiences unexplained fatigue (fatigue is a very common side effect), they should exercise particular caution when driving or operating machinery.
Everolimus Stada contains lactose
Everolimus Stada contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Everolimus Stada

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose is 10 mg taken once daily. Your doctor will determine how many Everolimus Stada tablets
you should take.
If you have liver problems, your doctor may start treatment with a lower dose of Everolimus Stada (2.5, 5, or 7.5 mg per day).
If certain adverse effects occur during treatment with Everolimus Stada (see section 4), your doctor may reduce the dose or
discontinue treatment temporarily or permanently.
Everolimus Stada should be taken once daily, at the same time each day, and always taken with food or always taken without food.
The tablet(s) should be swallowed whole with a glass of water. Tablets must not be chewed or crushed.

Taking more Everolimus Stada than prescribed

• If you take more Everolimus Stada than prescribed, or if someone else accidentally takes the tablets, you should immediately contact a doctor or go to a hospital. Urgent medical intervention may be necessary.
• You should show the doctor the outer carton and this leaflet so that it can be determined which medicine has been overdosed.

Missing a dose of Everolimus Stada
If you miss a dose, take the next planned dose as scheduled. Do not take a double dose to make up for the missed tablets.

Stopping Everolimus Stada
Do not stop taking Everolimus Stada unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOP taking Everolimus Stada and seek immediate medical help if any of the following symptoms of an allergic reaction occur:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with red rash or raised bumps

Serious side effects of Everolimus Stada include:
Very common (may affect more than 1 in 10 people)

• increased body temperature, chills (signs of infection)
• fever, cough, difficulty breathing, wheezing (signs of pneumonia)

Common (may affect up to 1 in 10 people)

• excessive thirst, increased urine production, increased appetite with weight loss, easy fatigue (signs of diabetes)
• bleeding (haemorrhage), for example in the intestinal wall
• severely reduced urine production (sign of kidney failure)

Uncommon (may affect up to 1 in 100 people)

• fever, skin rash, joint pain and inflammation, as well as easy fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right part of the abdomen, pale stools, dark urine (may be signs of reactivation of hepatitis B)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• swelling and (or) pain in one leg, usually the calf, with redness and warmth of the skin in the affected area (signs of blockage of a blood vessel (vein) in the leg due to blood clotting)
• sudden shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs become blocked)
• severely reduced urine production, swelling of legs, confusion, back pain (signs of acute kidney failure)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of a severe allergic reaction, also known as hypersensitivity)

Rare (may affect up to 1 in 1,000 people)

• breathlessness or rapid breathing (signs of acute respiratory distress syndrome)

You should immediately inform your doctor if any of the above-mentioned side effects occur,
as they may lead to life-threatening consequences.
Other possible side effects of Everolimus Stada include:
Very common (may affect more than 1 in 10 people)

• high blood sugar levels (hyperglycaemia)
• loss of appetite
• altered taste
• headache
• nosebleeds
• cough
• mouth ulcers
• stomach upset, including nausea and diarrhoea
• skin rash
• itching (pruritus)
• feeling weak or tired
• fatigue, breathlessness, dizziness, pale skin, symptoms of low red blood cell count (anaemia)
• swelling of arms, hands, feet, ankles or other parts of the body (signs of oedema)
• weight loss
• high levels of lipids (fats) in the blood (hypercholesterolaemia)

Common (may affect up to 1 in 10 people)

• sudden appearance of bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
• breathlessness (dyspnoea)
• feeling thirsty, low amount of urine passed, dark-coloured urine, dry red skin, irritability (signs of dehydration)
• sleep problems (insomnia)
• headache, dizziness (symptoms of high blood pressure, also known as hypertension)
• swelling of part or all of the hand (including fingers) or leg (including toes), feeling of heaviness, limited movement, discomfort (possible signs of lymphoedema)
• fever, sore throat, mouth ulcers due to infection (signs of low white blood cell count, leukopenia, lymphopenia and (or) neutropenia)
• fever
• inflammation of the tissue lining the mouth, stomach, intestine
• dry mouth
• heartburn (dyspepsia)
• vomiting
• difficulty swallowing (dysphagia)
• abdominal pain
• acne
• rash and pain in hands and soles of feet (hand-foot syndrome)
• redness of the skin (erythema)
• joint pain
• mouth pain
• menstrual disorders, such as irregular menstrual bleeding
• high levels of lipids (fats) in the blood (hyperlipidaemia, increased triglyceride levels)
• low potassium levels in the blood (hypokalaemia)
• low phosphate levels in the blood (hypophosphataemia)
• low calcium levels in the blood (hypocalcaemia)
• dry skin, peeling skin, skin lesions
• nail disorders, brittle nails
• mild hair loss
• abnormal liver function test results in blood (increased alanine aminotransferase and aspartate aminotransferase activity)
• abnormal kidney function test results in blood (increased creatinine levels)
• eyelid oedema
• protein in urine

Uncommon (may affect up to 1 in 100 people)

• weakness, unexpected bleeding or bruising and frequent infections, with symptoms such as fever, chills, sore throat or mouth ulcers (signs of low blood cell count, also known as pancytopenia)
• loss of taste (ageusia)
• coughing up blood (haemoptysis)
• menstrual disorders, such as absence of menstruation
• more frequent urination during the day
• chest pain
• problems with wound healing
• hot flushes
• eye discharge accompanied by itching and redness, pink eye or red eye (conjunctivitis)

Rare (may affect up to 1 in 1,000 people)

• fatigue, breathlessness, dizziness, pale skin (symptoms of low red blood cell count, possibly due to anaemia called pure red cell aplasia)
• swelling of the face, around the eyes, lips, inside the mouth and (or) throat, as well as the tongue, and difficulty breathing or swallowing (also known as angioedema), which may be symptoms of an allergic reaction

Frequency not known (cannot be estimated from the available data)

• reaction at the site of previous radiotherapy, e.g. skin redness or lung inflammation (so-called radiation recall syndrome)
• worsening of side effects of radiotherapy

If the above-mentioned side effects worsen, you should inform your doctor or pharmacist.
Most side effects are mild or moderate and should resolve after stopping treatment for a few days.
Reporting of side effects
If any side effects occur, including any not listed 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, additional information on the safety of this medicine can be collected.

5. How to store Everolimus Stada

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the stated month.
There are no special temperature storage requirements for this medicine. Store in the original packaging to protect from light.
Open the blister pack immediately before taking the tablet.
Do not use this medicine if there are any signs of damage or tampering.
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 will help protect the environment.

6. Contents of the pack and other information

What Everolimus Stada contains

• The active substance is everolimus. Each Everolimus Stada 5 mg tablet contains 5 mg of everolimus. Each Everolimus Stada 10 mg tablet contains 10 mg of everolimus.
• The other ingredients are: Butylhydroxytoluene (E321), Hypromellose 3 mPa·s (E464), Lactose, Crospovidone Type A (E1202), Magnesium stearate.

What Everolimus Stada looks like and contents of the pack
Everolimus Stada 5 mg tablets are oval, flat tablets, white or off-white in colour,
with "EVR" engraved on one side and "5" on the other, measuring 12 mm in length and 5 mm in width.
Everolimus Stada 10 mg tablets are oval, flat tablets, white or off-white in colour,
with "EVR" engraved on one side and "NAT" on the other, measuring 15 mm in length and 6 mm in width.
Everolimus Stada 5 mg and 10 mg are available in packs containing 10, 30, 90 tablets or
10x1, 30x1, 90x1 tablets (unit dose blisters).
Not all pack sizes and strengths may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria
Genepharm S.A.
18th Km Marathonos Avenue
153 51 Pallini Attiki
Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
PLA 3000 Paola
Malta
Pharmacare Premium Ltd
HHF003 Hal Far Industrial Estate
BBG3000 Birzebbugia
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Everolimus STADA 2.5 mg Tabletten
Everolimus STADA 5 mg Tabletten
Everolimus STADA 10 mg Tabletten
Belgium: Everolimus EG 2.5 mg tabletten
Everolimus EG 5 mg tabletten
Everolimus EG 10 mg tabletten
Czech Republic: Everolimus STADA
Germany: Everolimus AL 2.5 mg Tabletten
Everolimus AL 5 mg Tabletten
Everolimus AL 10 mg Tabletten
Denmark: Everolimus STADA
Spain: Everolimus STADA 2.5 mg comprimidos EFG
Everolimus STADA 5 mg comprimidos EFG
Everolimus STADA 10 mg comprimidos EFG
Finland: Everolimus STADA 2.5 mg/ 5 mg/ 10 mg tabletti
France: EVEROLIMUS EG 2.5 mg, comprimé
EVEROLIMUS EG 5 mg, comprimé
EVEROLIMUS EG 10 mg, comprimé
Croatia: Everolimus STADA 2.5/5/10 mg tablete
Italy: Everolimus EG
Luxembourg: Everolimus EG 2.5 mg comprimé
Everolimus EG 5 mg comprimé
Everolimus EG 10 mg comprimé
Netherlands: Everolimus CF 2.5 mg, tabletten
Everolimus CF 5 mg, tabletten
Everolimus CF 10 mg, tabletten
Poland: Everolimus STADA
Sweden: Everolimus STADA 2.5 mg/5 mg/10 mg tabletter
Slovakia: EVEROLIMUS STADA 2.5 mg
EVEROLIMUS STADA 5 mg
EVEROLIMUS STADA 10 mg