PACKAGE LEAFLET: INFORMATION FOR THE USER

Exemestane Zentiva 25 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine.

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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

In this leaflet:

What Exemestane Zentiva is and what it is used for
Before you take Exemestane Zentiva
How to take Exemestane Zentiva
Possible side effects
How to store Exemestane Zentiva
Further information

1. What Exemestane Zentiva is and what it is used for

Exemestane Zentiva belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to produce female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.
Exemestane Zentiva is used to treat

early hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of treatment with tamoxifen, and
advanced hormone-dependent breast cancer in postmenopausal women when previous hormonal drug therapy has not been sufficiently effective.

2. Before taking Exemestane Zentiva

Do not take Exemestane Zentiva

if you are or have previously been allergic (hypersensitive) to exemestane or to any of the excipients of Exemestane Zentiva (see section 6, “What Exemestane Zentiva contains” for a complete list of excipients);
if you have not yet reached menopause, i.e. if you still have menstrual cycles;
if you are pregnant or think you might be pregnant;
if you are breastfeeding.

Take special care with Exemestane Zentiva

if you have problems with your liver or kidneys, you must inform your doctor.
if you have a history of or currently suffer from any condition affecting bone strength. Your doctor may wish to measure your bone mineral density before and during treatment with Exemestane Zentiva. This is because medicines of this class reduce levels of female hormones, which may lead to loss of bone mineral content and potentially reduce bone strength.

Before starting treatment with Exemestane Zentiva, your doctor may decide to take blood samples to confirm whether you have reached menopause.
For individuals engaged in sports, use of this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Taking other medicines
Other medicines may interact with Exemestane Zentiva. Likewise, they may affect the efficacy of Exemestane Zentiva.
Exemestane Zentiva must not be administered concomitantly with hormone replacement therapy (HRT).
The following medicines should be used with caution while taking Exemestane Zentiva. Inform your doctor if you are taking any of the following:

rifampicin (an antibiotic);
carbamazepine or phenytoin (medicines used to treat epileptic seizures);
St John’s wort (Hypericum perforatum), a herbal remedy used to treat depression and general inflammation, or products containing it.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.
Taking Exemestane Zentiva with food and drink
Exemestane Zentiva should be taken after a meal.
Pregnancy and breastfeeding
Exemestane Zentiva must not be taken during pregnancy or while breastfeeding, as it may harm the baby. Contact your doctor immediately if you think you may be pregnant. Discuss contraception with your doctor if there is any possibility you could become pregnant.

Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
If you experience dizziness, fatigue, drowsiness, or general malaise, do not drive or operate tools or machinery until you feel well again.
Important information about some of the excipients in Exemestane Zentiva
If you have previously been told that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Exemestane Zentiva

Always take Exemestane Zentiva exactly as instructed by your doctor.
If you are unsure, consult your doctor or pharmacist.

Adults and elderly
Exemestane Zentiva tablets should be taken orally after a meal, at approximately the same time each day. Your doctor will advise you on how to take Exemestane Zentiva and for how long.
The recommended dose is one 25 mg tablet daily.
If you need to go to hospital while taking Exemestane Zentiva, inform the medical staff about the medicine you are taking.

Children
Exemestane Zentiva is not suitable for use in children.

If you take more Exemestane Zentiva than you should
If you have taken too much Exemestane Zentiva, or if someone else has accidentally taken your tablets, contact your doctor, pharmacist, or hospital immediately for advice. Show them the Exemestane Zentiva packaging.

If you forget to take Exemestane Zentiva
Do not take a double dose to make up for the forgotten dose. If you forget to take your 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 Exemestane Zentiva
Do not stop taking Exemestane Zentiva even if you feel well, unless your doctor tells you to do so. Your doctor will advise you on how long you should continue taking the tablets.

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Exemestane Zentiva can cause side effects, although not everyone experiences them.
Most of the side effects are mild to moderate in severity. Some of these side effects, such as hot flushes, may be due to the lack of oestrogens in the body.
Inflammation of the liver (hepatitis) may occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, abdominal pain on the right side, and loss of appetite. Contact your doctor immediately if you think you have any of these symptoms.
Very common side effects (may affect more than 1 in 10 people)

Sleep disturbances ● Headache ● Hot flushes ● Nausea ● Increased sweating ● Muscle and joint pain (including joint inflammation, back pain, and joint stiffness) ● Fatigue.
Common side effects (may affect up to 1 in 10 people)
Loss of appetite ● Depression ● Dizziness ● Combination of tingling, numbness, and pain affecting the whole hand except the little finger (carpal tunnel syndrome) ● Stomach discomfort, feeling unwell (vomiting), constipation, indigestion, diarrhoea ● Skin rashes, hair loss ● Thinning of the bones which could reduce their strength (osteoporosis), leading to fractures (breaks or injuries), in some cases ● Pain, swelling in hands and feet.

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

Drowsiness ● Muscle weakness.

If you have had blood tests, you may notice changes in liver function. Changes in the levels of certain blood cells (lymphocytes) and circulating platelets may occur, especially in patients with pre-existing low lymphocyte counts (lymphopenia).
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. How to store Exemestane Zentiva

Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use Exemestane Zentiva after the expiry date which is stated on the blister and on the
packaging after EXP. The first two digits indicate the month and the last four digits
indicate the year. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Other information

What Exemestane Zentiva contains

The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
The excipients are mannitol (E421), hypromellose, crospovidone, polysorbate 80, microcrystalline cellulose, sodium starch glycolate type A, magnesium stearate, anhydrous colloidal silica.
The excipients in the tablet coating are sodium carmellose (E466), maltodextrin, monohydrate glucose, titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172).

Description of the appearance of Exemestane Zentiva and contents of the pack
Exemestane Zentiva is a yellow, round, biconvex film-coated tablet, with "E9MT" engraved on one side and "25" on the other.
Exemestane Zentiva film-coated tablets are available in blister packs containing 30, 90 and 100 tablets; 30 tablets in unit dose packaging.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturers responsible for batch release:
Synthon B.V.
Microweg 22
6545 CM Nijmegen (The Netherlands)
Synthon Hispania S.L.
Castellò 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Barcelona (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Exemestane Zentiva 25 mg comprimé pelliculé
Germany: Exemestan Winthrop 25 mg filmtabletten
Italy: Exemestane Zentiva
Netherlands: Exemestan Zentiva 25 mg, filmomhulde tabletten
United Kingdom: Exemestane 25 mg, film-coated tablets

This leaflet was last approved: December 2011