Package Insert: Information for the Patient

Exemestane Sandoz 25 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Exemestano belongs to a group of medicines called aromatase inhibitors.

These medicines interfere with a substance called aromatase, necessary for producing female sex hormones, estrogens, especially in postmenopausal women. The reduction of estrogen levels in the body is a form of treatment for hormone-dependent breast cancer.

Exemestano is used to treat hormone-dependent breast cancer in early stages in postmenopausal women after they have completed 2-3 years of treatment with the tamoxifen medication.

Exemestano is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Exemestano Sandoz

• if you are or have been allergic to exemestane or any of the other ingredients of this medicine (listed in section 6),
• if you have not yet reached menopause, that is, if you still have your period,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Exemestano Sandoz.

• This medicine contains exemestane which may provide a positive result in doping control tests,
• before starting treatment with exemestane, your doctor may perform a blood test to ensure that you have reached menopause,
• before taking exemestane, inform your doctor if you have any liver or kidney problems,
• inform your doctor if you have a history or suffer from any disease that affects your bone resistance. Your doctor may analyze your bone density before and during treatment with Exemestano Sandoz. This is because medicines in this group reduce female hormone levels, which can lead to a loss of bone mineral content, and may decrease your resistance,
• your doctor may consider that you should receive vitamin D supplementation because there is a high prevalence of severe deficiency in women with early breast cancer.

Important information for athletes

It is informed to athletes that this medicine contains a component that may establish a positive analytical result in doping control as positive.

Taking Exemestano Sandoz with other medicines

Inform your doctor if you are using, have recently taken, or may need to take any other medicine.

Exemestane should not be administered at the same time as hormone replacement therapy (HRT).

Inform your doctor if you are taking any of the following medicines:

• rifampicin (an antibiotic),
• antiepileptic medicines used to treat epilepsy (carbamazepine or phenytoin),
• herbal medicines used as antidepressants, St. John's Wort (Hypericum perforatum).

Taking Exemestano Sandoz with food and drinks

Exemestano Sandoz tablets should be taken after a meal, approximately at the same time every day.

Pregnancy and breastfeeding

Do not take Exemestano Sandoz if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Discuss contraceptive measures with your doctor if there is any possibility of becoming pregnant.

Driving and operating machines

If you experience dizziness, drowsiness, or fatigue while taking Exemestano Sandoz, do not drive or operate machines.

Exemestano Sandoz contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per coated tablet; that is, it is essentially "sodium-free".

Exemestane Sandoz should be taken orally after a meal, approximately at the same time every day.

Follow exactly the administration instructions for this medication as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while taking Exemestane Sandoz, inform the healthcare professionals what medication 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 take too many tablets by accident, contact your doctor immediately or go directly to the nearest hospital emergency department. Show the Exemestane Sandoz packaging.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Exemestane Sandoz

Do not take a double dose to compensate for the missed doses.

If you forget to take a tablet, take it as soon as you remember. If it is close to the time of the next dose, take it at your usual time.

If you interrupt treatment with Exemestane Sandoz

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Exemestane is well tolerated, and the following side effects observed in patients treated with this medicine are mainly of mild or moderate nature. Most side effects are associated with estrogen reduction (such as hot flashes).

Inform your doctor immediately if you experience the following:

• severe allergic reactions. Symptoms include rash, itching, urticaria, difficulty breathing or swallowing, dizziness,
• inflammation of the liver (hepatitis). Symptoms include general feeling of illness, nausea, jaundice (yellow discoloration of the skin and eyes), itching, abdominal pain on the right side, and loss of appetite.

The following side effects have been reported by people taking exemestane.

Very common side effects(may affect more than 1 in 10 people)

• difficulty sleeping,
• headache,
• hot flashes,
• feeling unwell,
• increased sweating,
• muscle and joint pain (including arthritis, back pain, and joint stiffness),
• fatigue.

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

• loss of appetite,
• depression,
• dizziness,
• tingling or numbness of hands and feet,
• carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger),
• stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea,
• skin rash, itching, hair loss,
• decrease in bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking),
• pain, swelling of hands and feet.

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

• decrease in the number of white blood cells in the blood, which increases the risk of infection. Symptoms may include fever, mouth or throat ulcers due to infections,
• acute generalized pustular rash,
• numbness,
• muscle weakness.

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

• low platelet count (with a higher risk of bleeding and hematomas).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Exemestane Sandoz

The active ingredient is exemestane. Each film-coated tablet contains 25 mg of exemestane.

The other components are:

• mannitol, microcrystalline cellulose, crospovidone, sodium carboxymethyl starch (Type A) from potato, hypromellose E5, polysorbate 80, anhydrous colloidal silica, and magnesium stearate,

hypromellose 6cp (E 464), titanium dioxide (E 171), and macrogol 400.

Appearance of the product and contents of the package

Exemestane Sandoz are film-coated tablets, round, biconvex, white or almost white, marked on one side with E25 and smooth on the other.

Exemestane Sandoz 25 mg is presented in carton packs containing opaque white PVC/PVdC-Alu blisters of 15, 20, 28, 30, 90, 98, 100, and 120 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Cemelog BRSLtd

2040 Budaors,

Vasut u.13,

Hungary

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr.

7A, RO-540472

Targu-Mures

Romania

or

Salutas Pharma GmbH

Otto-von-Guericke-Alle

1 39179 Barleben

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names

This leaflet was revised in 09/2019

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/