PATIENT INFORMATION LEAFLET

Exemestane Mylan Generics 25 mg film-coated tablets

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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Exemestane Mylan Generics is and what it is used for

Your medicine is called Exemestane Mylan Generics. Exemestane Mylan Generics belongs
to a group of medicines known as aromatase inhibitors. These medicines interfere with an
enzyme called aromatase, which is required for the production of female sex hormones, the
estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a
treatment approach for hormone-dependent breast cancer.
Exemestane Mylan Generics is used to treat early-stage hormone-dependent breast cancer in
postmenopausal women who have completed 2–3 years of therapy with the medicine tamoxifen.
Exemestane Mylan Generics is also used to treat advanced hormone-dependent breast cancer in
postmenopausal women when hormonal treatment with another medicine has not been sufficiently effective.

2. What you need to know before taking Exemestane Mylan Generics

Do not take Exemestane Mylan Generics

If you are allergic to exemestane or to any of the other ingredients of this medicine (listed in section 6).
If you have not yet reached menopause, meaning you still have regular menstrual periods.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Exemestane Mylan Generics.

Before starting treatment with Exemestane Mylan Generics, your doctor may request blood tests to confirm that you have reached menopause.
If you have liver or kidney problems.
If you have a history of, or currently suffer from, any condition affecting bone strength (e.g. osteoporosis). Your doctor may want to measure your bone density before and during treatment with Exemestane Mylan Generics. This is because medicines in this class reduce levels of female hormones that contribute to bone growth. This may lead to loss of bone mineral content, making bones weaker.
If you know you have low levels of vitamin D (for example, if you are unable to spend time in natural sunlight). Your doctor may decide to check your vitamin D levels before treatment and, if necessary, prescribe vitamin D supplements.

Other medicines and Exemestane Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Exemestane Mylan Generics must not be taken together with hormone replacement therapy (HRT) or with medicines containing estrogens (including combined oral contraceptives).
The following medicines should be used with caution when taking Exemestane Mylan Generics. Inform your doctor if you are taking any of the following:

Rifampicin (an antibiotic)
Anticonvulsants used to treat epilepsy (carbamazepine or phenytoin)
The herbal remedy St John’s wort (Hypericum perforatum) or preparations containing it.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Pregnancy and breastfeeding
Do not take Exemestane Mylan Generics if you are pregnant, think you may be pregnant, or are breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Discuss contraception with your doctor if there is any chance you could become pregnant.
Driving and using machines
If you experience drowsiness, dizziness, or weakness during treatment with Exemestane Mylan Generics, you must not drive or operate machinery.
Exemestane Mylan Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Exemestane Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and elderly
Exemestane Mylan Generics tablets should be taken orally every day after meals, at approximately the same time each day. Your doctor will tell you how and for how long to take Exemestane Mylan Generics. The recommended dose is one 25 mg tablet daily.
Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.
If you are admitted to hospital while being treated with Exemestane Mylan Generics, inform the hospital staff that you are taking this medicine.
Use in children and adolescents
Exemestane Mylan Generics is not intended for use in children and adolescents under 18 years of age.
If you take more Exemestane Mylan Generics than you should
If you take too many tablets by mistake, contact your doctor immediately or go to the nearest Emergency Department. Show the doctor the Exemestane Mylan Generics tablet pack.
If you forget to take Exemestane Mylan Generics
Do not take a double dose to make up for the forgotten dose.
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, take the next dose at your usual time.
If you stop taking Exemestane Mylan Generics
Do not stop treatment without first consulting your doctor. Symptoms may return after stopping treatment.
If you have any questions about 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. Exemestane Mylan Generics is generally well tolerated and the side effects listed below observed in patients treated with Exemestane Mylan Generics are mainly mild to moderate in severity. Most of these side effects are related to oestrogen deficiency (e.g. hot flushes).
If you experience any of the following, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:
Common side effects (may affect up to 1 in 10 people)

Thinning of the bones which could reduce their strength (osteoporosis), possibly leading in some cases to bone fractures (breaks or cracks)
Carpal tunnel syndrome (a combination of tingling, numbness and pain affecting the whole hand, except the little finger)

Uncommon side effects (may affect up to 1 in 100 people)

Sudden allergic reactions such as rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing (anaphylaxis)

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

Inflammation of the liver (hepatitis) or blockage of the bile duct, which may cause yellowing of the skin or eyes, general feeling of illness, nausea, itching, abdominal pain on the right side, and loss of appetite
Rapid appearance on the skin of a rash, red and swollen areas or patches covered with small fluid-filled blisters, skin inflammation, peeling and shedding of the skin over the body, which may be associated with fever.

The following side effects have also been reported:
Very common side effects (may affect more than 1 in 10 people)

Depression
Difficulty sleeping
Headache
Hot flushes
Dizziness
Feeling unwell (nausea)
Increased sweating
Pain in muscles and joints, swelling, creaking, stiffness and pain in one or more joints
Fatigue
Decreased number of white blood cells (leucopenia)
Stomach ache
Elevated liver enzymes
Elevated levels of a haemoglobin breakdown product in the blood
Elevated levels of an enzyme in the blood due to liver damage
Pain

Common side effects (may affect up to 1 in 10 people)

Loss of appetite, weight loss
Feeling unwell (vomiting), constipation, indigestion, diarrhoea
Skin rash, hives and itching
Hair loss
Swelling of hands and feet
Tingling
Reduced number of platelets in the blood (thrombocytopenia)
Muscle weakness

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

Drowsiness

Side effects with unknown frequency (frequency cannot be estimated from the available data):

Low levels of a certain type of white blood cells (lymphocytes) in the blood

If you have blood tests, changes in liver function (increased liver enzymes and bilirubin) may be observed. Changes in the number of white blood cells (leucocytes and lymphocytes) and circulating platelets may occur, particularly in patients with pre-existing lymphopenia (reduced number of lymphocytes in the blood). You may experience increased bruising and bleeding or become more susceptible to infections (with symptoms such as sore throat, fever and severe chills).
The following adverse events have been observed in clinical studies, but it has not been established whether they are related to the medicine:

Changes in the vagina and uterus, vaginal bleeding
Visual disturbances
Blockage of blood vessels due to blood clotting, heart attack, increased blood pressure, heart failure
Changes or increases in cholesterol and other blood fats

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Exemestane Mylan Generics

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage precautions.
Do not use this medicine after the expiry date stated on the outer carton and blister after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Exemestane Mylan Generics contains
The active substance is exemestane (as exemestane).
Each film-coated tablet contains 25 mg of exemestane (as exemestane).
The other ingredients are:
Tablet core: Anhydrous colloidal silica, crospovidone, hypromellose 5cP, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, and sodium starch glycolate (type A).
Tablet coating: Hypromellose 5cP, macrogol, talc, and titanium dioxide (E171).

Description of the appearance of Exemestane Mylan Generics and pack sizes
Exemestane Mylan Generics is available as white, round, biconvex, film-coated tablets.
Exemestane Mylan Generics is available in blister packs containing 14, 15, 20, 30, 60, 90, 100 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers
Remedica Limited, Limassol Industrial Estate, PO Box 51706, CY-3508, Limassol, Cyprus
Chanelle Medical, Loughrea, Co Galway, Ireland
McDermott Laboratories Ltd., trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom

This medicinal product is authorized in EEA Member States under the following names:
Belgium Exemestane Mylan 25 mg filmomhulde tabletten
Czech Republic EXEMESTAN MYLAN 25 mg, potahované tablety
Germany Exemestan dura 25 mg Filmtabletten
France Exemestane Mylan 25mg, comprimé pelliculé
Italy Exemestane Mylan Generics
Spain Exemestano MYLAN Pharmaceuticals 25 mg comprimidos recubiertos con película EFG
United Kingdom Exemestane 25mg film-coated tablets
Norway Exemestane Generics 25 mg tablett, filmdrasjert
Netherlands Exemestaan Mylan 25 mg, filmomhulde tabletten
Poland Exemestane Mylan
Portugal Exemestano Mylan
Romania Exemestan Generics 25mg, comprimate filmate
Slovakia Exemestan Mylan 25 mg