MESTANE 25 mg Tabletki Powlekane

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1. MESTANE 25 mg coated tablets
   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

MESTANE 25 mg coated tablets

Exemestane
Generic medicine

Read this leaflet carefully before 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 category of medicines known as aromatase inhibitors.
These drugs interfere with a substance called aromatase, which is necessary for the
production of female sex hormones, estrogens, especially in postmenopausal women. Reducing the level of
estrogens in the body is a way to treat hormone-dependent breast cancer.
Mestane is used in the treatment of hormone-dependent breast cancer in the early stages in
postmenopausal women who have completed 2-3 years of therapy with the medicine tamoxifene.
Mestane is also used in the treatment of hormone-dependent breast cancer in the advanced stages in
postmenopausal women when hormonal therapy with another medicine has not
worked well enough.

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 ingredient of Mestane) or to any of the other ingredients of this medicine (listed in section 6).
• If you are notalready postmenopausal, i.e. you have a regular menstrual cycle.
• If you are pregnant, if you might be pregnant or if you are breastfeeding.

Warnings and precautions

• Before treatment with Mestane, your doctor may request blood samples to ensure that you have reached menopause.
• Before treatment, routine checks of your vitamin D levels will also be performed, as they can be very low in the early stages of breast cancer. If the levels are below normal, you will be given a vitamin D supplement.
• Before taking Mestane, tell your doctor if you have liver or kidney problems.
• Tell your doctor if you have suffered or are suffering from any condition that affects bone strength. Your doctor may need to measure your bone density before and during treatment with Mestane. This is because medicines belonging to this class lower the level of female hormones and this can lead to a loss of bone mineral content which can become less resistant.

Other medicines and Mestane
Tell your doctor if you are taking or have recently taken or might take any other
medicinal product.
Mestane must not be administered together with hormone replacement therapy (HRT).
The following medicines must be used with caution when taking Mestane. Tell 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 those who participate in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Pregnancy and breastfeeding
Do not take Mestane during pregnancy or breastfeeding.
Tell your doctor if you are pregnant or if you think you might be pregnant.
Women who could become pregnant during treatment are advised to 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, do not drive vehicles or
use machines.

Mestane contains sucrose and methyl-parahydroxybenzoate
 If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine. Mestane tablets contain sucrose (a type of sugar), which can
cause problems in a small number of patients with hereditary intolerance to certain sugars
(glucose-galactose malabsorption, fructose intolerance or sucrase-
isomaltase deficiency).
 Mestane contains a small amount of methyl-parahydroxybenzoate, which can cause allergic
reactions (possibly delayed); if this happens to you, contact your doctor.

3. HOW TO TAKE MESTANE

Adults and the elderly
Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor.
Mestane tablets must be taken by mouth every day after meals at approximately the same time. The
doctor will inform you on how to take Mestane and for how long.
The recommended dose is one 25 mg tablet once a day.
If you need to go to hospital during treatment with Mestane, inform the medical staff about the
medicines you are taking.

Use in children
The use of Mestane is not indicated in children.

If you take more MESTANE than you should
If you have accidentally taken too many tablets, contact your doctor immediately or go to the Emergency
Room of the nearest hospital and show them the MESTANE tablets packaging.

If you forget to take MESTANE
Do not take a double dose to make up for a missed tablet.
If you forget to take a tablet, take it as soon as you remember. If it is almost time to take the
next dose, take it at the usual time.

If you stop taking MESTANE
Do not stop taking the tablets even if you feel well, unless your doctor tells you to.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Mestane can cause side effects, although not everybody gets them.
Mestane is well tolerated and the side effects listed below observed in patients treated with
exemestane are mainly mild or moderate in severity. Most side effects are
associated with estrogen deficiency (e.g. hot flushes).
Hypersensitivity, liver inflammation (hepatitis) and inflammation of the bile ducts of the
liver, which can cause yellowing of the skin (cholestatic hepatitis), may occur. Symptoms include a feeling of
general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain on the right
side of the abdomen and loss of appetite. If you think you have any of these symptoms, contact your
doctor immediately for urgent medical assistance.

Very common side effects(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 hemoglobin degradation product in the blood
 Elevated level 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
 Carpal tunnel syndrome (pins and needles, numbness and pain in the
hand except for the little finger) or tingling/pins and needles sensation of the skin
 Stomach pain, vomiting (nausea), constipation, indigestion, diarrhea
 Hair loss
 Skin rash, hives and itching
 Thinning of the bones which may weaken (osteoporosis), leading in some cases
to bone fractures (breaks or cracks)
 Pain, swelling in hands and feet
 Decreased number of platelets in the blood
 Muscle weakness

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

Rare side effects(may affect up to 1 in 1000 people):
 Appearance of a skin rash with small blisters
 Drowsiness
 Liver inflammation
 Inflammation of the bile ducts of the liver which can cause yellowing of the skin

Side effects with unknown frequency(frequency cannot be estimated based on available data):
 Low level of a certain type of white blood cells in the blood
Changes in the number of some blood cells (lymphocytes) and
circulating platelets may also be observed, especially in patients with pre-existing lymphopenia (reduced number of lymphocytes in the
blood).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa. Reporting side effects helps to 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 package and on the 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 any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Mestane contains
 The active ingredient is exemestane. Each coated tablet contains 25 mg of exemestane.
 The other ingredients 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 contents of the pack
Mestane tablets are coated, round, biconvex, and whitish in color.
Mestane is available in blister packs of 30 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sophos Biotech S.r.l.
Via Latina, 20
00179 Rome
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

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Netherlands: Exemestaan Sophos
Italy: Mestane

This leaflet was last updated in