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EVEROLIMUS TEVA 7.5 MG TABLETS

Active substance(s): EVEROLIMUS / EVEROLIMUS

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Package leaflet: Information for the patient
EVEROLIMUS 2.5 mg, 5 mg, 7.5 mg AND 10 mg TABLETS
Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Everolimus Tablets are and what they are used for
2.
What you need to know before you take Everolimus Tablets
3.
How to take Everolimus Tablets
4.
Possible side effects
5.
How to store Everolimus Tablets
6.
Contents of the pack and other information
1.

What Everolimus Tablets are and what they are used for

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.
Everolimus is used to treat adult patients with:
 Advanced tumours called neuroendocrine tumours that originate from the stomach, bowels,
lung. It is given if the tumours are inoperable and do not overproduce specific hormones or
other related natural substances.

Everolimus which is contained in Everolimus 2.5 mg, 5 mg, 7.5 mg and 10 mg Tablets may also
be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or
pharmacist if you have further questions.
2.

What you need to know before you take Everolimus Tablets

Everolimus 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 Everolimus or why it has been prescribed for you, ask
your doctor.
Do NOT take Everolimus:
 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 Everolimus 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 Everolimus.
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 have diabetes (high level of sugar in your blood). 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.
 need to receive a vaccine while taking Everolimus.
 have high cholesterol. Everolimus may elevate cholesterol and/or other blood fats.
 have had recent major surgery, or if you still have an unhealed wound following surgery.
Everolimus may increase the risk of problems with wound healing.
 have an infection. It may be necessary to treat your infection before starting Everolimus.
 have previously had hepatitis B, because this may be reactivated during treatment with
Everolimus (see section 4 ‘Possible side effects’).
Everolimus may also:
 weaken your immune system. Therefore, you may be at risk of getting an infection while you
are taking Everolimus.
 impact your kidney function. Therefore, your doctor will monitor your kidney function while
you are taking Everolimus.
 cause shortness of breath, cough and fever.
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 Everolimus 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 Everolimus.
Children and adolescents
Everolimus is NOT to be used in children or adolescents (age below 18 years).
Other medicines and Everolimus
Everolimus may affect the way some other medicines work. If you are taking other medicines at the
same time as Everolimus, your doctor may need to change the dose of Everolimus 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 Everolimus:
 ketoconazole, itraconazole, voriconazole or fluconazole and other antifungals used to treat
fungal infections
 clarithromycin, telithromycin or erythromycin, antibiotics used to treat bacterial infections
 ritonavir and other medicines used to treat HIV infection/AIDS
 verapamil or diltiazem, used to treat heart conditions or high blood pressure
 dronedarone, a medicine used to help regulate your heart beat
 ciclosporin, a medicine used to stop the body from rejecting organ transplants
 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 may reduce the effectiveness of Everolimus:
 rifampicin, used to treat tuberculosis (TB).
 efavirenz or nevirapine, used to treat HIV infection/AIDS.
 St. John’s Wort (Hypericum perforatum), a herbal product used to treat depression and other
conditions

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 dexamethasone, a corticosteroid used to treat a wide variety of conditions including
inflammatory or immune problems
 phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or
fits.
These medicines should be avoided during your treatment with Everolimus. If you are taking any of
them, your doctor may switch you to a different medicine, or may change your dose of Everolimus.
Everolimus Tablets with food and drink
You should take Everolimus at the same time every day, consistently either with or without food.
Avoid grapefruit and grapefruit juice while you are on Everolimus as taking these together can
increase the risk of side effects.
Pregnancy, breast-feeding and fertility
Pregnancy
Everolimus could harm an 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. If, despite these measures, you think you may have become pregnant, ask your doctor for
advice before taking any more Everolimus.
Breast-feeding
Everolimus could harm a breast-fed baby. You should NOT breast-feed during treatment. Tell your
doctor if you are breast-feeding.
Female fertility
Absence of menstrual periods (amenorrhoea) has been observed in some female patients receiving
everolimus.
Everolimus may have an impact on female fertility. Talk to your doctor if you wish to have children.
Male fertility
Everolimus 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.
Everolimus Tablets contains lactose
Everolimus Tablets 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.

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3.

How to take Everolimus Tablets

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
Everolimus to take.
If you have liver problems, your doctor may start you on a lower dose of Everolimus (2.5, 5 or 7.5 mg
per day).
If you experience certain side effects while you are taking Everolimus (see section 4), your doctor may
lower your dose or stop treatment, either for a short time or permanently.
Take 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 Everolimus than you should
 If you have taken too much Everolimus, or if someone else accidentally takes your tablets, see a
doctor or go to a hospital immediately. Urgent treatment may be necessary.
 Take the carton and this leaflet, so that the doctor knows what has been taken.
If you forget to take Everolimus
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 Everolimus
Do NOT stop taking Everolimus unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Everolimus and seek medical help 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 a red rash or raised bumps.
Serious side effects of Everolimus include:
Very common: may affect more than 1 in 10 people
 increased temperature, chills (signs of infection)
 fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known
as pneumonitis).
Common: may affect up to 1 in 10 people
 excessive thirst, high urine output, increased appetite with weight loss, tiredness (signs of
diabetes)
 bleeding (haemorrhage), for example in the gut wall
 severely decreased urine output (sign of kidney failure).
Uncommon: may affect up to 1 in 100 people
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 fever, skin rash, joint pain and inflammation, as well as tiredness, loss of appetite, nausea,
jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools, dark urine (may
be signs of hepatitis B reactivation)
 breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of heart
failure)
 swelling and/or pain in one of the legs, usually in the calf, redness or warm skin in the affected
area (signs of blockade of a blood vessel (vein) in the legs 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 arteries in your lungs become
blocked)
 severely decreased urine output, swelling in the legs, feeling confused, pain in the back (signs
of sudden kidney failure)
 rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of serious allergic
reaction, also known as hypersensitivity).
Rare: may affect up to 1 in 1,000 people
 shortness of breath or rapid breath (signs of acute respiratory distress syndrome).
If you experience any of these side effects, tell your doctor immediately as this might have lifethreatening consequences.
Other possible side effects of Everolimus include:
Very common: may affect more than 1 in 10 people
 high level of sugar in the blood (hyperglycaemia)
 loss of appetite
 disturbed taste (dysgeusia)
 headache
 nose bleeds (epistaxis)
 cough
 mouth ulcers
 upset stomach including feeling sick (nausea) or diarrhoea
 skin rash
 itching (pruritus)
 feeling weak or tired
 tiredness, breathlessness, dizziness, pale skin, signs of low level of red blood cells (anaemia)
 swelling of arms, hands, feet, ankles or other part of the body (signs of oedema)
 weight loss
 high level of lipids (fats) in the blood (hypercholesterolaemia).
Common: may affect up to 1 in 10 people
 spontaneous bleeding or bruising (signs of low level of platelets, also known as
thrombocytopenia)
 breathlessness (dyspnoea)
 thirst, low urine output, dark urine, dry flushed skin, irritability (signs of dehydration)
 trouble sleeping (insomnia)
 headache, dizziness (sign of high blood pressure, also known as hypertension)
 fever, sore throat, mouth ulcers due to infections (signs of low level of white blood cells,
leukopenia, lymphopenia and/or neutropenia)
 fever
 inflammation of the inner lining of the mouth, stomach, gut
 dry mouth
 heartburn (dyspepsia)
 being sick (vomiting)
 difficulty in swallowing (dysphagia)
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abdominal pain
acne
rash and pain on the palms of your hands or soles of your feet (hand-foot syndrome)
reddening of the skin (erythema)
joint pain
pain in the mouth
menstruation disorders such as irregular periods
high level of lipids (fats) in the blood (hyperlipidaemia, raised triglycerides)
low level of potassium in the blood (hypokalaemia)
low level of phosphate in the blood (hypophosphataemia)
low level of calcium in the blood (hypocalcaemia)
dry skin, skin exfoliation, skin lesions
nail disorders, breaking of your nails
mild loss of hair
abnormal results of liver blood tests (increased alanine and aspartate aminotransferase)
abnormal results of renal blood tests (increased creatinine)
discharge from the eye with itching, redness and swelling
protein in the urine.

Uncommon: may affect up to 1 in 100 people
 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)
 loss of sense of taste (ageusia)
 coughing up blood (haemoptysis)
 menstruation disorders such as absence of periods (amenorrhoea)
 passing urine more often during daytime
 chest pain
 abnormal wound healing
 hot flushes
 pink eye or red eye (conjunctivitis).
Rare: may affect up to 1 in 1,000 people
 tiredness, breathlessness, dizziness, pale skin (signs of low level of red blood cells, 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 the
tongue and difficulty breathing or swallowing (also known as angioedema), may be signs of an
allergic reaction.
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 via Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Everolimus Tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister foil. The expiry
date refers to the last day of that month.
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Store in the original package in order to protect from light. This medicine does not require any special
temperature storage conditions.
Open the blister just before taking the tablets. Do not use this medicine if any pack is damaged or
shows signs of tampering.
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.
6.

Contents of the pack and other information

What Everolimus 2.5 mg, 5 mg, 7.5 mg and 10 mg Tablets contains:
The active substance is everolimus.


Everolimus 2.5mg Tablets contains 2.5 mg everolimus.



Everolimus 5mg Tablets contains 5 mg everolimus.



Everolimus 7.5mg Tablets contains 7.5 mg everolimus.



Everolimus 10mg Tablets contains 10 mg everolimus.

The other ingredients are butylhydroxytoluene (E 321), hypromellose, lactose monohydrate, lactose
anhydrous, crospovidone and magnesium stearate.
What Everolimus 2.5 mg, 5 mg, 7.5 mg and 10 mg Tablets looks like and contents of the pack
 Everolimus 2.5 mg Tablets are white, oblong, flat, bevelled edge tablets, approximately 10mm
long and 4mm wide, marked with ‘EV’ on one side and ‘2.5’ on the other.


Everolimus 5 mg Tablets are white, oblong, flat, bevelled edge tablets, approximately 12mm long
and 5mm wide, marked with ‘EV’ on one side and ‘5’ on the other



Everolimus 7.5 mg Tablets are white, oblong, flat, bevelled edge tablets, approximately 14mm
long and 5.5mm wide, marked with ‘EV’ on one side and ‘7.5’ on the other.



Everolimus 10 mg Tablets are white, oblong, flat, bevelled edge tablets, approximately 15mm
long and 6mm wide, marked with ‘EV’ on one side and ‘10’ on the other.

Everolimus Tablets are available in blister packs containing 10, 30, 30x1, 50x1, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer: TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen, 4042, Hungary
Or
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Kraków, 31-546, Poland
Or

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Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143, Germany
Or
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, Zagreb 10000, Croatia

This leaflet was last revised in 06/2017

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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