Package leaflet: Information for the patient

Exemestane Sandoz 25 mg film-coated tablets

exemestane
Generic medicine
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 other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Exemestane Sandoz belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, which is involved in the production of female sex hormones (estrogens), particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.
Exemestane Sandoz is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of treatment with the medicine tamoxifen.
Exemestane Sandoz is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when treatment with another hormonal medicine has not produced the desired effects.

2. What you should know before taking Exemestane Sandoz

Do not take Exemestane Sandoz

if you are allergic or have had an allergic reaction 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 your monthly periods.
if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Exemestane Sandoz

This medicine contains a substance banned in sports that may cause a positive result in doping tests.
Before starting treatment with Exemestane Sandoz, your doctor may carry out blood tests to confirm that you have actually entered menopause.
Before taking Exemestane Sandoz, inform your doctor if you have liver or kidney problems.
Inform your doctor if you have a history of, or currently suffer from, a condition affecting bone strength. Your doctor may decide to measure your bone mineral density before and during treatment with Exemestane Sandoz, since drugs of this class reduce levels of female hormones, which may lead to loss of bone mineral content and consequently reduce bone strength.
Your doctor may consider giving you vitamin D supplements, as severe deficiency is highly prevalent in women with early-stage breast cancer.

Other medicines and Exemestane Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exemestane Sandoz must not be taken at the same time as hormone replacement therapy (HRT).
Inform your doctor if you are taking any of the following medicines:

rifampicin (an antibiotic)
medicines used to treat epilepsy (carbamazepine or phenytoin)
herbal remedies used as antidepressants (St. John's wort [ Hypericum perforatum ])

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in doping tests.

Exemestane Sandoz with food and drink
Exemestane Sandoz should be taken after a meal, approximately at the same time each day.

Pregnancy and breastfeeding
Do not take Exemestane Sandoz if you are pregnant or breastfeeding. If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. If there is any possibility you could become pregnant, discuss with your doctor the need to use an effective contraceptive method.

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

Exemestane Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Exemestane Sandoz

Exemestane Sandoz tablets should be taken after a meal, approximately at the same time each day.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 25 mg tablet daily.
If you need to be admitted to hospital while undergoing treatment with Exemestane Sandoz, inform the healthcare staff about the medicine you are taking.

Use in children
Exemestane Sandoz is not suitable for use in children.

If you take more Exemestane Sandoz than you should
If you have accidentally taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. Show the medical staff the Exemestane Sandoz packaging.

If you forget to take Exemestane Sandoz
Do not take a double dose to make up for a 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 tablet at your usual time.

If you stop taking Exemestane Sandoz
Do not stop taking the tablets (even if you feel well) unless instructed by your doctor.

If you have any further 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 everyone experiences them.
Exemestane Sandoz is well tolerated, and the following side effects observed in patients treated with this
medicine are mainly mild or moderate in severity. Most of the side effects (such as hot flushes) are associated with oestrogen deficiency.
Contact your doctor immediately if you think you are experiencing any of the following:

severe allergic reactions. Symptoms include skin rash, itching, hives, difficulty breathing or swelling, dizziness.
inflammation of the liver (hepatitis). Symptoms include general feeling of being unwell, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite.

The following additional side effects have been reported in people taking exemestane tablets.
Very common side effects (may affect more than 1 in 10 people):

sleep disorders
headache
hot flushes
nausea
increased sweating
muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
fatigue.

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

loss of appetite
depression
dizziness
tingling or numbness in the hands or feet
carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the whole hand except the little finger)
stomach discomfort, vomiting, constipation, indigestion, diarrhoea
skin rashes, itching, hair loss
thinning of the bones, which could reduce their strength (osteoporosis), in some cases leading to an increased risk of fractures (breaks or cracks)
pain, swelling of hands and feet.

Uncommon side effects (may affect up to 1 in 100 people):
to help provide more information on the safety of this medicine.

reduced number of white blood cells, leading to more frequent infections. Symptoms may include fever, sore throat, or mouth ulcers due to infections
generalised acute pustular rash (generalised acute pustular exanthema)
somnolence
muscle weakness.

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

low platelet count in the blood (with an increased risk of bleeding and bruising)

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 can help provide more information on the safety of this medicine.

5. How to store Exemestane Sandoz

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton 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 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 Sandoz contains
The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
The other components are:
mannitol, microcrystalline cellulose, crospovidone, sodium carboxymethyl starch (type A), hypromellose E5, polysorbate
80, anhydrous colloidal silica, magnesium stearate.
Coating: hypromellose 6 cp (E 464), titanium dioxide (E 171) and macrogol 400.
Description of the appearance of Exemestane Sandoz and package contents
Film-coated tablets, white to white/ivory in colour, round, biconvex, film-coated, marked with the imprint “E25” on one side and smooth on the other.
The film-coated tablets are packaged in white opaque PVC/PVdC-Alu blisters and placed in a cardboard carton.
Pack sizes:
15, 20, 28, 30, 90, 98, 100, 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz S.p.A. - Largo U. Boccioni,1 - 21040 Origgio (VA)
S.C. Sandoz, S.R.L. Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
This medicinal product is authorised in the European Economic Area countries under the following
names:
Belgium Exemestan Sandoz 25 mg filmomhulde tabletten
Denmark Exemestan "Sandoz"
Germany Exemestan HEXAL 25 mg Filmtabletten
Spain Exemestano Sandoz 25 mg comprimidos recubiertos con pelicula EFG
France EXÉMESTANE SANDOZ 25 mg, comprimé pelliculé
United Kingdom (Northern Ireland) EXEMESTAN/SANDOZ
Italy EXEMESTANE SANDOZ
Luxembourg Exemestan Sandoz 25 mg comprimés pelliculés
Netherlands Exemestaan Sandoz 25 mg, filmomhulde tabletten
Norway Exemestan Sandoz 25 mg filmdrasjerte tabletter
Portugal Exemestano Sandoz
Romania AROSTANIL 25 mg comprimate filmate
Sweden Exemestan Sandoz 25 mg, filmdragerade tablett