Everolimus Medac: detailed information

Patient Information Leaflet

Everolimus medac 5 mg tablets, 10 mg tablets

Everolimus
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

advanced hormone receptor-positive breast cancer in postmenopausal women in whom other treatments (known as “non-steroidal aromatase inhibitors”) are no longer effectively controlling the disease. It is given in combination with a 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 renal cell cancer (advanced kidney cancer) when other treatments (known as “anti-VEGF targeted therapies”) have not been effective in stopping the disease.

2. What you should know before taking Everolimus medac

Everolimus medac 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 medac or why it has been prescribed to you, consult your doctor.

Do not take Everolimus medac

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 medac:

if you have liver problems or have had any illness that may have affected your liver. In such cases, your doctor may need to prescribe a different dose of Everolimus medac.
if you have diabetes (high blood sugar levels). Everolimus medac 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 medac.
if you have high cholesterol levels. Everolimus medac can raise cholesterol levels and/or other blood fats.
if you have recently undergone surgery, or if you have a wound that has not yet healed following surgery. Everolimus medac may increase the risk of wound-healing complications.
if you have an infection. It may be necessary to treat the infection before starting Everolimus medac.
if you have previously had hepatitis B, as it may reactivate during treatment with Everolimus medac (see section 4, ‘Possible side effects’). Everolimus medac may also:
weaken your immune system. Therefore, you may be at increased risk of developing infections during treatment with Everolimus medac.
impair kidney function. Therefore, your doctor will monitor your kidney function during treatment with Everolimus medac.
cause shortness of breath, cough, and fever.

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 medac 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 sugar and cholesterol levels. These levels may also be affected by Everolimus medac.

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

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

ketoconazole, itraconazole, voriconazole, 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.
imatinib, used to inhibit the growth of abnormal cells.
angiotensin-converting enzyme (ACE) inhibitors (such as ramipril), used to treat high blood pressure or other cardiovascular problems.

The following substances may reduce the effectiveness of Everolimus medac:

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, phenobarbital, and other antiepileptic medicines used to prevent epileptic seizures.

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

Everolimus medac with food and drink
You must take Everolimus medac at the same time each day, regularly with or without food. Avoid grapefruit and grapefruit juice while being treated with Everolimus medac.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Pregnancy
Everolimus medac 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 a highly effective method of contraception during treatment. If, despite these precautions, you suspect you are pregnant, consult your doctor before taking any further doses of Everolimus medac.

Breastfeeding
Everolimus medac may harm the breastfed infant. You must not breastfeed during treatment. Inform your doctor if you are breastfeeding.

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

Male fertility
Everolimus medac 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 medac contains lactose
Everolimus medac 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 medac

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
tablets of Everolimus medac you should take.
If you have liver problems, your doctor may prescribe a lower dose of Everolimus medac.
If certain side effects occur while you are taking Everolimus medac (see section 4), your
doctor may reduce your dose or temporarily or permanently stop treatment.
Take Everolimus medac 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 medac than you should

If you have taken more Everolimus medac than you should, or if someone else has accidentally taken your tablets, contact a doctor immediately or go to hospital. Emergency treatment may be necessary.
Keep the packaging and this leaflet, so the doctor knows what has been taken.

If you forget to take Everolimus medac
If you forget to take a dose, take the next dose at your usual scheduled time. Do not take a double
dose to make up for forgotten tablets.
If you stop taking Everolimus medac
Do not stop treatment with Everolimus medac unless your doctor tells you to do so.
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 medac 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 skin itching, with red rash or skin swellings

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

Increased 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 users)

Excessive thirst, increased urine production, 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 users)

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 urine (may be signs of reactivation of hepatitis B)
Shortness of breath, breathing difficulties when lying down, swelling of the feet and 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 due to 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)
Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of severe allergic reactions, also called hypersensitivity)

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

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

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

Other possible side effects of Everolimus medac include:
Very common (may affect more than 1 in 10 users)

High blood sugar levels (hyperglycaemia)
Loss of appetite
Altered sense of taste (dysgeusia)
Headache
Nosebleeds (epistaxis)
Cough
Mouth ulcers
Stomach problems including feeling unwell (nausea) or diarrhoea
Rash
Itching
Tiredness or weakness
Fatigue, shortness of breath, dizziness, pale skin, signs of low red blood cell levels (anaemia)
Swelling of the 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 users)

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
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)
Eye discharge with itching, redness and swelling
Protein in the urine

Uncommon (may affect up to 1 in 100 users)

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 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
Red eyes (conjunctivitis)

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

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, pharmacist or nurse. You can also report side effects directly via the national reporting system at: 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 medac

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 after Exp..
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Open the blister pack only when it is time to take the tablets.
Do not use this medicine if you notice that the packaging is damaged or appears tampered with.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Everolimus medac contains

The active substance is everolimus. Each 5 mg tablet of Everolimus medac contains 5 mg of everolimus. Each 10 mg tablet of Everolimus medac contains 10 mg of everolimus.
The other components are: butylated hydroxytoluene (E 321), hypromellose 3 cPs, monohydrate lactose, anhydrous lactose, crospovidone type A, magnesium stearate.

Description of the appearance of Everolimus medac and package contents
Everolimus medac 5 mg tablets are white, oblong, flat tablets with bevelled edges, engraved with “EV” on one side and “5” on the other.
Everolimus medac 10 mg tablets are white, oblong, flat tablets with bevelled edges, engraved with “EV” on one side and “10” on the other.
Everolimus medac 5 mg and Everolimus medac 10 mg are available in packages containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
medac pharma s.r.l
Via Viggiano 90
00178 Rome
Italy

Manufacturer
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen 4042, Hungary
PLIVA Croatia Ltd., Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia