Mestane

PACKAGE LEAFLET: INFORMATION FOR THE USER

MESTANE 25 mg coated tablets

Exemestane
Generic medicine
Please read all of this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Mestane is and what it is used for
2. What you need to know before taking Mestane
3. How to take Mestane
4. Possible side effects
5. How to store Mestane
6. Contents of the pack and other information

1. WHAT MESTANE IS AND WHAT IT IS USED FOR

Your medicine is called Mestane. Mestane belongs to a class of medicines known as aromatase inhibitors. These drugs act by interfering with a substance 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 way of treating hormone-dependent breast cancer.

Mestane 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.

Mestane is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when hormonal therapy with another medicine has not been sufficiently effective.

2. WHAT YOU NEED TO KNOW BEFORE TAKING MESTANE

Do not take Mestane

• If you are allergic or have previously been allergic to exemestane (the active substance in Mestane) or to any of the other ingredients of this medicine (listed in section 6).
• If you are not yet postmenopausal, i.e. if you still have regular menstrual cycles.
• If you are pregnant, think you might be pregnant, or are breastfeeding.

Warnings and precautions

• Before starting treatment with Mestane, your doctor may request blood tests to confirm that you have reached menopause.
• Routine checks of your vitamin D levels may also be performed before treatment begins, as these levels can be very low in early stages of breast cancer. If your vitamin D levels are below normal, you will be given a vitamin D supplement.
• Before taking Mestane, inform your doctor if you have liver or kidney problems.
• Inform your doctor if you have had or currently have any condition affecting bone strength. Your doctor may consider it necessary to measure your bone mineral density before and during treatment with Mestane. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and weakened bones.

Other medicines and Mestane
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Mestane must not be taken together with hormone replacement therapy (HRT).
The following medicines should be used with caution when taking Mestane. Inform your doctor if you are taking:
 rifampicin (an antibiotic),
 carbamazepine or phenytoin (anticonvulsants used in the treatment of epilepsy),
 St. John’s wort (Hypericum perforatum), or preparations containing it.
For athletes: using this medicine without a medical need constitutes doping and may lead to a positive doping test.

Pregnancy and breastfeeding
Do not take Mestane during pregnancy or while breastfeeding.
Inform your doctor if you are pregnant or think you might be pregnant.
Women who could become pregnant during treatment should discuss with their doctor the use of an effective method of contraception.

Driving and using machines
If you experience drowsiness, dizziness, or weakness during treatment with Mestane, you should not drive or operate machinery.

Mestane contains sucrose, methyl parahydroxybenzoate, and sodium
 If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
 This medicine can cause allergic reactions (including delayed reactions).
 This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE MESTANE

Adults and elderly
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Mestane tablets should be taken orally every day after meals, approximately at the same time. Your doctor will advise you on how to take Mestane and for how long.
The recommended dose is one 25 mg tablet once daily.
If you need to go to hospital during treatment with Mestane, inform the medical staff about the medicines you are taking.

Use in children
Mestane is not indicated for use in children.

If you take more Mestane than you should
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department and show them the Mestane tablet pack.

If you forget to take Mestane
Do not take a double dose to make up for the forgotten 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 dose at the usual time.

If you stop taking Mestane
Do not stop taking the tablets even if you feel well, unless otherwise instructed by your doctor.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Mestane can cause adverse reactions, although not everyone experiences them.
Mestane is well tolerated and the adverse reactions listed below, observed in patients treated with exemestane,
are mainly mild or moderate in severity. Most of these adverse reactions are associated with
estrogen deficiency (e.g., hot flushes).
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver bile ducts may occur, which can
lead to yellowing of the skin (cholestatic hepatitis). Symptoms include general 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 are experiencing any of these symptoms, contact your doctor immediately to receive urgent medical
assistance.

Very common adverse reactions (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 white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of a hemoglobin breakdown product in the blood
• Elevated levels of an enzyme in the blood due to liver damage
• Pain

Common adverse reactions (may affect up to 1 in 10 people):

• Loss of appetite
• Carpal tunnel syndrome (pins and needles sensation, numbness, and pain in the hand except the little finger) or skin tingling/itching
• Stomach discomfort, vomiting (nausea), constipation, indigestion, diarrhea
• Hair loss
• Skin rash, hives, and itching
• Thinning of the bones that may weaken (osteoporosis), leading in some cases to bone fractures (breaks or cracks)
• Pain and swelling in hands and feet
• Reduced platelet count in the blood
• Muscle weakness

Uncommon adverse reactions (may affect up to 1 in 100 people):

• Hypersensitivity

Rare adverse reactions (may affect up to 1 in 1000 people):

• Skin rash with small blisters
• Drowsiness
• Liver inflammation
• Inflammation of the liver bile ducts that may cause yellowing of the skin

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Low levels 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE MESTANE

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 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. PACK CONTENTS AND OTHER INFORMATION

What Mestane contains
• The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other components are: hydrated colloidal silica, hypromellose, magnesium stearate, mannitol, sodium
starch glycolate, polysorbate, sodium croscarmellose (type A), polyvinyl alcohol, simethicone, macrogol,
sucrose, magnesium carbonate, titanium dioxide (E171), methyl parahydroxybenzoate (E218), talc,
carnauba wax.

Description of the appearance of Mestane and packaging contents
Mestane tablets are coated, round, biconvex, white to off-white in colour.
Mestane is available in blister packs containing 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sophos Biotech S.r.l.
Via Modica 6
20143 Milano
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48, Quinto De’ Stampi
20089 Rozzano (MI), Italy
Doppel Farmaceutici S.r.l.
Via Martiri Delle Foibe, 1
29016 Cortemaggiore (PC), Italy
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA), Italy

This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy: Mestane

This leaflet was last updated on