Adco Everolimus 2,5 mg Tablets

ADCO EVEROLIMUS 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.

ADCO EVEROLIMUS is used to treat adult patients with:

• Advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.
• Subependymal giant cell astrocytoma (SEGA) (which is a low-grade brain tumour) associated with tuberous sclerosis (TS) (a rare multisystem genetic disease that causes benign tumours to grow in the brain and on other vital organs such as the kidneys, heart, liver, eyes, lungs and skin).
• Hormone receptor-positive advanced breast cancer in postmenopausal women, in whom other treatments (so called “non-steroidal aromatase inhibitors”) no longer keep the disease under control. It is given together with a medicine called exemestane, a steroidal aromatase inhibitor, which is used for hormonal anticancer therapy.
• Tuberous sclerosis complex (TSC), who have renal angiomyolipoma (a noncancerous tumour in the kidney(s)) not requiring immediate surgery.

Do not take ADCO EVEROLIMUS

• If you are hypersensitive (allergic) to everolimus, other rapamycin derivatives or any of the other ingredients of ADCO EVEROLIMUS (listed in section 6).
• If you are using live vaccines ( see, Take special care with ADCO EVEROLIMUS).
• If you are pregnant or breastfeeding your baby ( see Pregnancy and breastfeeding).

Warnings and precautions

Take special care with ADCO EVEROLIMUS

• If you have pneumonitis (inflammation of the lung), characterised by coughing up sputum, shortness of breath and fever. It may be necessary to treat your infection before starting treatment with ADCO EVEROLIMUS.
• If you are taking medicines for hypertension, called angiotensin-converting enzyme (ACE) inhibitors, it may cause swelling of the airways or tongue (angioedema) (see other medicines with ADCO EVEROLIMUS).
• If you have kidney problems, your doctor will monitor your kidney function.
• If you have diabetes (high level of sugar in your blood). ADCO EVEROLIMUS may increase blood sugar levels and worsen diabetes mellitus. This may result in the need for insulin and/or oral antidiabetic agent therapy. Tell your doctor if you experience any excessive thirst or increased frequency of urination.
• If you have high cholesterol. ADCO EVEROLIMUS may elevate cholesterol and/or other blood fats.
• If you experience unusual weakness or tiredness, shortness of breath or paleness, you may have a blood disorder. ADCO EVEROLIMUS may cause blood disorders and your doctor will perform regular blood tests during treatment.
• If you have a non-functional tumour in the stomach or lung, your doctor will determine the benefit- risk assessment for you before you start your treatment with ADCO EVEROLIMUS.
• If you are taking ADCO EVEROLIMUS in combination with pimozide (used to reduce uncontrolled movements), terfenadine (used to treat allergic reactions), quinidine (used to treat or prevent irregular heartbeats) or ergot alkaloid derivatives (used to treat migraine), as the side effects of these medicines may worsen.
• If you have any problems with your liver or if you have ever had any disease which may have affected your liver. If this is the case, your doctor may need to prescribe a different dose of ADCO EVEROLIMUS.
• If your liver is not functioning well.
• If you need to receive a vaccine while taking ADCO EVEROLIMUS. You should not receive any vaccine during treatment with ADCO EVEROLIMUS and close contact with those who have received vaccines should be avoided during treatment with ADCO EVEROLIMUS.
• If you recently had major surgery, or if you still have an unhealed wound following surgery, ADCO EVEROLIMUS may increase the risk of problems with wound healing.

ADCO EVEROLIMUS may also:

• Weaken your immune system. Therefore, you may be at risk of getting an infection while you are taking ADCO EVEROLIMUS. If you have fever or other signs of an infection, tell your doctor or healthcare professional right away. Some infections may be severe and may have fatal consequences.
• Cause an allergic reaction ( see section 4, SIDE EFFECTS for symptoms of an allergic reaction).
• Cause mouth ulcers and sores to develop. Treatment of mouth ulcers may include use of mouthwash. Since some mouthwashes can make ulcers worse, do not take any mouthwash without checking with your doctor or healthcare professional first.

Children and adolescents

ADCO EVEROLIMUS is not recommended for children and adolescents under the age of 18 years.

Other medicines with ADCO EVEROLIMUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

The following medicines may cause an interaction when used in combination with ADCO EVEROLIMUS:

• Ketoconazole, itraconazole, posaconazole, voriconazole or fluconazole (used to treat fungal infections).
• Telithromycin, clarithromycin or erythromycin (antibiotics used to treat bacterial infections).
• Nefazodone (used to treat depression).
• Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir, amprenavir, fosamprenavir, efavirenz or nevirapine (used to treat HIV infection/AIDS).
• Imatinib (used to treat certain cancers).
• Verapamil or diltiazem (used to treat heart conditions or high blood pressure).
• Ciclosporin (used to prevent rejection after organ transplantation).
• Dronedarone (used to help regulate your heartbeat).
• Rifampicin (used to treat tuberculosis (TB)).
• Dexamethasone (a corticosteroid used to treat a wide variety of conditions including inflammatory or immune problems).
• Phenytoin, carbamazepine or phenobarbital (used to treat epilepsy, seizures or fits).
• St John’s wort (Hypericum perforatum), a herbal product used to treat depression).
• Midazolam (used to produce sleepiness or drowsiness and to relieve anxiety before surgery).
• Octreotide (used to treat severe watery diarrhoea and sudden reddening of the face and neck, caused by certain types of tumours in the intestines).
• Angiotensin-converting enzyme (ACE) inhibitors (such as ramipril, used to treat high blood pressure or other heart conditions).
• Live vaccines (such as intranasal influenza, measles, mumps, rubella, oral polio, BCG (Bacillus Calmette-Guérin), yellow fever, varicella and TY21a typhoid vaccines).

Do not share medicines prescribed for you with any other person.

Always take ADCO EVEROLIMUS exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure.

The recommended dose is 10 mg, taken once a day. Your doctor will tell you how many tablets of ADCO EVEROLIMUS to take.

If you have liver problems, your doctor may start you on a lower dose of ADCO EVEROLIMUS (2,5; 5 or 7,5 mg per day).

If you experience certain side effects while you are taking ADCO EVEROLIMUS (see POSSIBLE SIDE EFFECTS), your doctor may lower your dose or stop ADCO EVEROLIMUS treatment, either for a short time or permanently.

Take ADCO EVEROLIMUS 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 ADCO EVEROLIMUS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Urgent treatment may be necessary. Take the carton and this leaflet with you, so that the doctor knows what has been taken.

If you forget to take ADCO EVEROLIMUS

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of ADCO EVEROLIMUS that has been prescribed for you in one day.

If you stop taking ADCO EVEROLIMUS

Do not stop taking ADCO EVEROLIMUS unless your doctor tells you to.

ADCO EVEROLIMUS can have side effects. Not all side effects reported for ADCO EVEROLIMUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO EVEROLIMUS, please consult your health care provider for advice.

If any of the following happens, STOP taking ADCO EVEROLIMUS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ADCO EVEROLIMUS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Side effects that may occur less frequently:

• Heart failure.
• Chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in your lungs become blocked).
• Acute respiratory distress syndrome (a life-threatening lung condition that prevents enough oxygen from getting to the lungs and into the blood, characterised by shortness of breath, low blood pressure or unusually fast breathing).
• Decreased urine, severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs of sudden kidney failure).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

Side effects that occur frequently:

• Tiredness, breathlessness, dizziness, pale skin, which may be signs of a low level of red blood cells (anaemia).
• Spontaneous bleeding or bruising (signs of a low level of platelets, also known as thrombocytopenia).
• Fever, sore throat, mouth ulcers due to infections (signs of a low level of white blood cells, leucopenia, lymphopenia and/or neutropenia).
• Decreased appetite.
• High level of sugar in the blood (hyperglycaemia).
• High level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides).
• Low level of phosphate in the blood (hypophosphataemia).
• Low level of potassium in the blood (hypokalaemia).
• Thirst, low urine output, dark urine, dry flushed skin, irritability (signs of dehydration).
• Low level of calcium in the blood (hypocalcaemia).
• Trouble sleeping (insomnia).
• Disturbed taste (dysgeusia).
• Headache.
• Swelling of the eyelid(s).
• Bleeding (haemorrhage), for example in the gut wall.
• High blood pressure.
• Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis).
• Nose bleeding, coughing.
• Inflammation of the inner lining of the mouth, stomach, gut.
• Diarrhoea, feeling sick (nausea), being sick (vomiting), dry mouth, stomach pain, mouth pain, heartburn, difficulty in swallowing (dysphagia).
• Abnormal results of liver blood tests (increased alanine and aspartate aminotransferase).
• Dry skin, skin exfoliation, skin lesions, nail disorders, breaking of nails, hair loss (temporary), acne, reddening of the skin (erythema).
• Rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome).
• Pain in the joints (arthralgia).
• Protein in the urine.
• Increased creatinine levels in the blood.
• Irregular menstrual periods.
• Unusual weakness or tiredness, lack of energy.

Side effects that may occur less frequently:

• Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (signs of low level of blood cells, also known as pancytopenia).
• Tiredness, breathlessness, dizziness, pale skin (signs of a low level of red blood cells, possibly due to a type of anaemia called pure red cell aplasia).
• Loss of sense of taste (ageusia).
• Pink eye or red eye (conjunctivitis).
• Flushing.
• Swelling and cramping in your foot, ankle or leg (deep vein thrombosis).
• Menstruation disorders such as absence of periods (amenorrhoea).
• Fever, chest pain, abnormal wound healing.
• Shingles (painful rash that may appear as a stripe of blisters in certain parts of the body such chest, back and abdomen).
• Ongoing or recurrent burning in the mouth with no obvious cause.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ADCO EVEROLIMUS. Adverse reactions can also be reported to the Adcock Ingram Pharmacovigilance department by e-mail to [email protected], fax to +27 86 533 0128 or call 011 635 0134.

• Store at or below 25 °C.
• Keep blister strips in outer carton until required for use in order to protect from light.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the label or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).