Package leaflet: Information for the user

MEXABREST 25 mg film-coated tablets

exemestane
Equivalent medicine
Please 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 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 of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MEXABREST is and what it is used for

MEXABREST belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed for the production of female sex hormones, estrogens, especially in postmenopausal women. Reducing the level of estrogens in the body is a way of treating hormone-dependent breast cancer.
MEXABREST is used to treat early hormone-dependent breast cancer in postmenopausal women, after completing 2–3 years of treatment with the medicine tamoxifen.
MEXABREST is also used to treat advanced hormone-dependent breast cancer in postmenopausal women, when prior hormonal therapy has not been sufficiently effective.

2. What you need to know before taking MEXABREST

Do not take MEXABREST

If you have a known allergy to exemestane or to any of the other ingredients of this medicine (listed in section 6).
If you have not yet reached menopause, i.e. if you are still having menstrual periods.
If you are pregnant or suspect you might be pregnant, or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking MEXABREST.

Before starting treatment with MEXABREST, your doctor may perform blood tests to confirm that you have reached menopause.
Routine checks of your vitamin D levels may also be carried out before treatment begins, as these levels can be very low in the early stages of breast cancer. If your vitamin D levels are below normal, you will be given a vitamin D supplement.
If you have liver or kidney problems, inform your doctor before taking MEXABREST.
Inform your doctor if you have or have had any medical condition affecting bone strength. Your doctor may wish to measure your bone mineral density before and during treatment with MEXABREST. This is because this class of medicines reduces levels of female hormones and may lead to a loss of bone mineral content, potentially reducing bone strength.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive outcome in anti-doping tests.

Other medicines and MEXABREST
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
MEXABREST must not be administered concurrently with hormone replacement therapy (HRT).
The following medicines should be used with caution when taking MEXABREST.
Inform your doctor if you are taking medicines such as:

rifampicin (an antibiotic);
carbamazepine or phenytoin (anticonvulsants used to treat epilepsy);
St. John’s wort (Hypericum perforatum) or preparations containing it.

Pregnancy and breastfeeding
Do not take MEXABREST if you are pregnant or breastfeeding. If you are pregnant or think you might be, inform your doctor.
If there is any possibility you could become pregnant, ask your doctor which contraceptive method you can use.

Driving and using machines
If you feel drowsy, dizzy, or weak while taking MEXABREST, you must not drive or operate machinery.

MEXABREST contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take MEXABREST

Adults and elderly
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
MEXABREST must be taken orally after meals, every day at approximately the same time. Your doctor will inform you
on how to take MEXABREST and for how long.
The recommended dose is one 25 mg tablet daily.
If you need to go to hospital during treatment with MEXABREST, inform the medical staff
which medicines you are taking.
Use in children
MEXABREST is not indicated for use in children.
If you take more MEXABREST than you should
If you accidentally take too many tablets, contact your doctor immediately or go straight to the nearest hospital emergency department, showing the MEXABREST packaging.
If you forget to take MEXABREST
Do not take a double dose to make up for the missed tablet.
If you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, take the next tablet at the usual time.
If you stop taking MEXABREST
Do not stop taking the tablets even if you feel well, unless your doctor has instructed you to do so.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
MEXABREST is well tolerated and the following adverse reactions observed in patients treated with MEXABREST
are mostly mild or moderate in intensity. Most of the adverse reactions (e.g. hot flushes)
are related to the reduction in estrogen levels.
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts may occur,
which can cause yellowing of the skin (cholestatic hepatitis). Symptoms include general feeling of malaise,
nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss
of appetite. If you think you have any of these symptoms, contact your doctor immediately to receive urgent
medical assistance.

Very common: may affect more than 1 in 10 people

Depression
Difficulty sleeping
Headache
Hot flushes
Dizziness
Nausea
Increased sweating
Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
Fatigue
Decreased number of white blood cells
Abdominal pain
Elevated liver enzymes
Elevated level of a haemoglobin breakdown product in the blood
Elevated level of an enzyme in the blood due to liver damage
Pain

Common: may affect up to 1 in 10 people

Loss of appetite
Carpal tunnel syndrome (a combination of pins and needles, numbness, and pain affecting the whole hand except the little finger) or skin tingling/itching
Vomiting (feeling sick), constipation, digestive problems, diarrhoea
Hair loss
Skin rashes, hives, and itching
Thinning of the bones which may reduce their strength (osteoporosis), with a possibility of bone fractures (breaks) in some cases
Swelling of hands and feet
Reduced number of platelets in the blood
Feeling of weakness

Uncommon: may affect up to 1 in 100 people

Hypersensitivity

Rare: may affect up to 1 in 1,000 people

Appearance of small blisters in the area of skin with a rash
Drowsiness
Liver inflammation
Inflammation of the liver's bile ducts which can cause yellowing of the skin

Not known: frequency cannot be estimated from the available data

Low level of a certain type of white blood cells in the blood

Changes in the number of certain blood cells (lymphocytes) and circulating
platelets may also occur, particularly in patients with pre-existing lymphopenia (reduced number of
lymphocytes in the blood).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or
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 MEXABREST

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.
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 MEXABREST contains
The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
The excipients are as follows:
Core: mannitol, microcrystalline cellulose, crospovidone, sodium glycolate starch (type A), hypromellose E5, polysorbate 80, anhydrous colloidal silica, magnesium stearate.
Coating:
hypromellose 6cp (E464), titanium dioxide (E171), macrogol 400
Description of the appearance of MEXABREST and the contents of the pack
MEXABREST tablets are white to almost white, round, biconvex, film-coated tablets with "E25" printed on one side and smooth on the other.
MEXABREST 25 mg tablets are available in opaque white PVC/PVdC-aluminium blisters containing 15, 20, 28, 30, 90, 98, 100 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Laboratori FUNDACIO DAU,
C/ De la letra C, 12-14,
Poligono Industrial de la Zona Franca,
08040 Barcelona,
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia, Schimatari, 32009,
Greece