Everolimus Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Everolimus Sandoz GmbH 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Generic medicine
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Everolimus Sandoz GmbH is and what it is used for
What you need to know before taking Everolimus Sandoz GmbH
How to take Everolimus Sandoz GmbH
Possible side effects
How to store Everolimus Sandoz GmbH
Contents of the pack and other information

1. What Everolimus Sandoz GmbH is and what it is used for

Everolimus Sandoz GmbH is an anticancer medicine containing the active substance called everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.
Everolimus Sandoz GmbH is used to treat adult patients with:
advanced hormone receptor-positive breast cancer in postmenopausal women, in whom other treatments (defined as “non-steroidal aromatase inhibitors”) are no longer able to control the disease.
It is administered in combination with a type of medicine called exemestane, a steroidal aromatase inhibitor, which is used for antihormonal cancer therapy.
advanced tumours called neuroendocrine tumours originating from the stomach, intestine, lung or pancreas. It is used when the tumours are inoperable and do not overproduce specific hormones or other related natural substances.
advanced kidney cancer (advanced renal cell carcinoma) where other treatments (defined as “anti-VEGF targeted therapies”) have not been effective in stopping it.

2. What you should know before taking Everolimus Sandoz GmbH

Everolimus Sandoz GmbH will only be prescribed by a doctor experienced in the treatment of cancer. Follow carefully all instructions given by your doctor. These instructions may differ from the general information contained in this leaflet. If you have any questions about Everolimus Sandoz GmbH or why it has been prescribed for you, consult your doctor.

Do not take Everolimus Sandoz GmbH
if you are allergic to everolimus, to similar 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, consult your doctor.

Warnings and precautions
Talk to your doctor before taking Everolimus Sandoz GmbH:

if you have liver problems or have had any illness that may have affected your liver. In this case, your doctor may need to prescribe a different dose of Everolimus Sandoz GmbH.
if you have diabetes (high blood sugar levels). Everolimus Sandoz GmbH can increase blood sugar levels and worsen diabetes mellitus. This may require treatment with insulin and/or oral antidiabetic agents. Inform your doctor if you experience excessive thirst or increased frequency of urination.
if you need to receive a vaccine while taking Everolimus Sandoz GmbH.
if you have high cholesterol levels. Everolimus Sandoz GmbH can increase cholesterol levels and/or other fats in the blood.
if you have recently undergone surgery, or if you have an unhealed surgical wound. Everolimus Sandoz GmbH may increase the risk of wound healing complications.
if you have an infection. It may be necessary to treat the infection before starting Everolimus Sandoz GmbH.
if you have previously had hepatitis B, as it may reactivate during treatment with Everolimus Sandoz GmbH (see section 4, 'Possible side effects').

Everolimus Sandoz GmbH may also:

weaken the immune system. Therefore, you may be at increased risk of developing an infection during treatment with Everolimus Sandoz GmbH. If you develop fever or other signs of infection, consult your doctor. Some infections may be severe and potentially fatal.
impair kidney function. Therefore, your doctor will monitor your kidney function during treatment with Everolimus Sandoz GmbH.
cause shortness of breath, cough, and fever.
cause mouth ulcers and the development of sores. Your doctor may need to interrupt or stop treatment with Everolimus Sandoz GmbH. Treatment with a mouthwash, gel, or other products may be required. Some mouthwashes and gels may worsen ulcers, so do not use any product without first consulting your doctor. Your doctor may restart treatment with Everolimus Sandoz GmbH at the same dose or at a lower dose.

Inform your doctor if you experience any of these symptoms.

You will have regular blood tests during treatment. These tests will monitor the number of blood cells in your body (white blood cells, red blood cells, and platelets) to check whether Everolimus Sandoz GmbH is having any unwanted effects on these cells. Blood tests will also be performed to monitor kidney function (creatinine levels) and liver function (transaminase levels), as well as blood glucose and cholesterol levels. These levels may also be affected by Everolimus Sandoz GmbH.

Children and adolescents
Everolimus Sandoz GmbH must not be used in children or adolescents (under 18 years of age).

Other medicines and Everolimus Sandoz GmbH
Everolimus Sandoz GmbH can affect the action of certain medicines. If you are taking other medicines at the same time as Everolimus Sandoz GmbH, your doctor may need to adjust the dose of Everolimus Sandoz GmbH or of the other medicines.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following substances may increase the risk of side effects with Everolimus Sandoz GmbH:

ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungal agents used to treat fungal infections.
clarithromycin, telithromycin, or erythromycin, antibiotics used to treat bacterial infections.
ritonavir and other medicines used to treat HIV/AIDS infection.
verapamil or diltiazem, used to treat heart conditions or high blood pressure.
dronedarone, used to help regulate heart rhythm.
ciclosporin, a medicine used to prevent rejection of transplanted organs by the body.
imatinib, used to block the growth of abnormal cells.
angiotensin-converting enzyme (ACE) inhibitors (such as ramipril), used to treat high blood pressure or other cardiovascular problems.
nefazodone, used in the treatment of depression.

The following substances may reduce the effectiveness of Everolimus Sandoz GmbH:

rifampicin, used to treat tuberculosis (TB).
efavirenz or nevirapine, used to treat HIV/AIDS infection.
St John's wort (Hypericum perforatum), a herbal product used to treat depression and other conditions.
dexamethasone, a corticosteroid used to treat a wide range of conditions including inflammatory or immune disorders.
phenytoin, carbamazepine, or phenobarbital and other antiepileptic medicines used to prevent epileptic seizures.

These medicines should be avoided during treatment with Everolimus Sandoz GmbH. If you are taking any of these medicines, your doctor may prescribe alternative medicines or adjust your dose of Everolimus Sandoz GmbH.

Everolimus Sandoz GmbH with food and drink
Avoid grapefruit and grapefruit juice while being treated with Everolimus Sandoz GmbH.

Pregnancy, breast-feeding and fertility
Pregnancy
Everolimus Sandoz GmbH may harm the unborn baby and is not recommended during pregnancy. Inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will discuss with you whether you should take this medicine during pregnancy.
Women who could become pregnant must use highly effective contraception during treatment and for 8 weeks after stopping treatment.
If, despite these measures, you suspect you may be pregnant, consult your doctor before taking any further doses of Everolimus Sandoz GmbH.

Breast-feeding
Everolimus Sandoz GmbH may harm the breastfed infant. You must not breast-feed during treatment and for 2 weeks after the last dose of Everolimus Sandoz GmbH. Inform your doctor if you are breast-feeding.

Female fertility
Menstrual cycle disturbances (amenorrhoea) have been observed in some patients treated with Everolimus Sandoz GmbH.
Everolimus Sandoz GmbH may affect female fertility. Inform your doctor if you wish to have children.

Male fertility
Everolimus Sandoz GmbH may affect male fertility. Talk to your doctor if you wish to father a child.

Driving and using machines
If you feel unusually tired (tiredness is a very common side effect), exercise particular caution when driving or operating machinery.

Everolimus Sandoz GmbH contains lactose
Everolimus Sandoz GmbH contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Everolimus Sandoz GmbH

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 10 mg taken once daily. Your doctor will tell you how many Everolimus Sandoz GmbH tablets you should take.
If you have liver problems, your doctor may prescribe a lower dose of Everolimus Sandoz GmbH (2.5, 5, or 7.5 mg/day).
If certain side effects occur while you are taking Everolimus Sandoz GmbH (see section 4), your doctor may reduce your dose or temporarily or permanently stop treatment.
Take Everolimus Sandoz GmbH once daily, approximately at the same time each day, regularly 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 Everolimus Sandoz GmbH than you should
If you have taken more Everolimus Sandoz GmbH than you should, or if someone else has accidentally taken your tablets, contact a doctor or go to hospital immediately. Emergency treatment may be necessary.
Keep the packaging and this leaflet with you so the doctor knows what has been taken.

If you forget to take Everolimus Sandoz GmbH
If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten tablets.

If you stop taking Everolimus Sandoz GmbH
Do not stop treatment with Everolimus Sandoz GmbH unless your doctor tells you to.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP treatment with Everolimus Sandoz GmbH and contact your doctor immediately if you experience any of the following signs of an allergic reaction:

Difficulty breathing or swallowing
Swelling of the face, lips, tongue or throat
Severe itching of the skin, with red rash or skin swellings

Serious side effects of Everolimus Sandoz GmbH 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 lung inflammation, also known as pneumonitis)

Common (may affect up to 1 in 10 people)

Excessive thirst, increased urination, increased appetite with weight loss, fatigue (signs of diabetes)
Bleeding (haemorrhage), for example in the intestinal wall
Severe decrease in urine production (signs of kidney failure)

Uncommon (may affect up to 1 in 100 people)

Fever, rash, joint pain and inflammation, as well as fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right part of the abdomen, pale stools, dark-coloured urine (may be signs of reactivation of hepatitis B)
Shortness of breath, breathing difficulties when lying down, swelling of feet or legs (signs of heart failure)
Swelling and/or pain in one of the legs, usually in the calf, redness or warmth of the skin in the affected area (signs of blockage of a blood vessel (vein) in the leg caused by blood clotting)
Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more pulmonary arteries become blocked)
Severe decrease in urine production, swelling of the legs, confusion, back pain (signs of sudden kidney failure)
Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of severe allergic reactions, also known as hypersensitivity)

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

Shortness of breath or rapid breathing (signs of acute respiratory distress syndrome)

If you experience any of these side effects, inform your doctor immediately, as they could be life-threatening.

Other possible side effects of Everolimus Sandoz GmbH include:

Very common (may affect more than 1 in 10 people)

High blood sugar levels (hyperglycaemia)
Loss of appetite
Altered sense of taste (dysgeusia)
Headache
Nosebleeds (epistaxis)
Cough
Mouth ulcers
Stomach disturbances including feeling unwell (nausea) or diarrhoea
Skin rash
Itching
Fatigue or weakness
Tiredness, shortness of breath, dizziness, pale skin, signs of low red blood cell levels (anaemia)
Swelling of arms, hands, feet, ankles or other body parts (signs of oedema)
Weight loss
High levels of lipids (fats) in the blood (hypercholesterolaemia)

Common (may affect up to 1 in 10 people)

Spontaneous bleeding or bruising (signs of low platelet count, also known as thrombocytopenia)
Shortness of breath (dyspnoea)
Thirst, low urine output, dark urine, dry and flushed skin, irritability (signs of dehydration)
Difficulty sleeping (insomnia)
Headache, dizziness (signs of high blood pressure, also known as hypertension)
Fever, sore throat, mouth ulcers due to infections (signs of low white blood cell count, leucopenia, lymphopenia and/or neutropenia)
Fever
Inflammation of the inner lining of the mouth, stomach and intestine
Dry mouth
Heartburn (dyspepsia)
Feeling unwell (vomiting)
Difficulty swallowing (dysphagia)
Abdominal pain
Acne
Skin rash and pain on the palms of the hands or soles of the feet (hand-foot syndrome)
Skin redness (erythema)
Joint pain
Mouth pain
Menstrual disorders such as irregular cycles
High levels of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
Low potassium levels in the blood (hypokalaemia)
Low phosphate levels in the blood (hypophosphataemia)
Low calcium levels in the blood (hypocalcaemia)
Dryness, peeling and skin lesions
Nail problems, nail breakage
Mild hair loss
Abnormal blood test results for liver function (increased alanine and aspartate aminotransferase)
Abnormal blood test results for kidney function (increased creatinine)
Eyelid swelling
Protein in the urine

Uncommon (may affect up to 1 in 100 people)

Weakness, spontaneous 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 sense of taste (ageusia)
Coughing up blood (haemoptysis)
Menstrual disorders such as absence of periods (amenorrhoea)
Need to urinate more often during the day
Chest pain
Problems with wound healing
Hot flushes
Eye discharge with itching and redness, red eyes (conjunctivitis)

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

Tiredness, shortness of breath, dizziness, paleness (signs of low red blood cell count, possibly due to a type of anaemia called pure red cell aplasia)
Swelling of the face, around the eyes, mouth and inside the mouth and/or throat, as well as of the tongue, and difficulty breathing or swallowing (also known as angioedema), which may be signs of an allergic reaction

If these side effects worsen, inform your doctor and/or pharmacist. Most side effects are mild or moderate in severity and usually resolve if treatment is interrupted for a few days.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Everolimus Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "Exp". The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep in the original packaging to protect the medicine from light and moisture.
Open the blister pack only when taking the tablets.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Everolimus Sandoz GmbH contains

The active substance is everolimus.

Everolimus Sandoz GmbH 2.5 mg tablets

Each tablet contains 2.5 mg of everolimus.

Everolimus Sandoz GmbH 5 mg tablets

Each tablet contains 5 mg of everolimus.

Everolimus Sandoz GmbH 10 mg tablets

Each tablet contains 10 mg of everolimus.
The other ingredients are: butylhydroxytoluene (E321), magnesium stearate, lactose, hypromellose, crospovidone Type A. See section 2 “Everolimus Sandoz GmbH contains lactose”.

Description of the appearance of Everolimus Sandoz GmbH and contents of the pack
Everolimus Sandoz GmbH 2.5 mg tablets
White to yellowish, elongated tablets, approximately 10.1 x 4.1 mm, with beveled edges and no break line, printed with “LCL” on one side and “NVR” on the other.
Everolimus Sandoz GmbH 5 mg tablets
White to yellowish, elongated tablets, approximately 12.1 x 4.9 mm, with beveled edges and no break line, printed with “5” on one side and “NVR” on the other.
Everolimus Sandoz GmbH 10 mg tablets
White to yellowish, elongated tablets, approximately 15.1 x 6.0 mm, with beveled edges and no break line, printed with “UHE” on one side and “NVR” on the other.
The tablets are packaged in aluminum/polyamide/aluminum/PVC blisters and contained in a carton box.
Pack sizes:
Blister packs: 10, 30 or 90 tablets
Not all pack sizes or strengths may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder:
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
Legal representative in Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany: Everolimus - 1 A Pharma 2.5 mg Tabletten
Everolimus - 1 A Pharma 5 mg Tabletten
Everolimus - 1 A Pharma 10 mg Tabletten
Italy: Everolimus Sandoz GmbH
Netherlands: Everolimus Sandoz 2.5 mg, tabletten
Everolimus Sandoz 5 mg, tabletten
Everolimus Sandoz 10 mg, tabletten