EXEMESTANE SANDOZ 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Exemestane Sandoz 25 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Exemestane belongs to a group of medicines called aromatase inhibitors.

These medicines interfere with a substance called aromatase, which is needed to produce female sex hormones, estrogens, especially in post-menopausal women. The reduction of estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane is used to treat hormone-dependent breast cancer in early stages in post-menopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.

Exemestane is used to treat advanced hormone-dependent breast cancer in post-menopausal women when other hormonal treatment has not been effective enough.

2. What you need to know before you take Exemestane Sandoz

Do not take Exemestane Sandoz

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

Warnings and precautions

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

• This medicine contains exemestane, which may give a positive result in doping tests,
• before starting treatment with exemestane, your doctor may perform a blood test to ensure you have reached menopause,
• before taking exemestane, inform your doctor if you have any liver or kidney problems,
• tell your doctor if you have a history of or suffer from any disease that affects bone strength. Your doctor may analyze bone density before and during treatment with Exemestane 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 bone strength,
• 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

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Taking Exemestane Sandoz with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines.

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

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

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

Taking Exemestane Sandoz with food and drink

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

Pregnancy and breast-feeding

Do not take Exemestane Sandoz if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Talk to your doctor about contraceptive measures if there is any possibility of becoming pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while taking Exemestane Sandoz, do not drive or use machines.

Exemestane Sandoz contains sodium

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

3. How to take Exemestane Sandoz

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

Follow exactly the administration instructions of this medicine given 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 emergency department of the nearest hospital. Show the packaging of Exemestane Sandoz.

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

If you forget to take Exemestane Sandoz

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Exemestane Sandoz

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

If you have any further questions on 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 everybody gets them.

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

Tell your doctor immediately if you experience the following:

• severe allergic reactions. Symptoms include rash, itching, hives, difficulty breathing or swallowing, dizziness,
• liver inflammation (hepatitis). Symptoms include general feeling of being unwell, nausea, yellowing of the skin and eyes (jaundice), 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 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 of hands and feet,
• carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger),
• stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea,
• skin rash, itching, hair loss,
• decreased bone density which may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks),
• 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, which can increase the risk of infection. Symptoms may include fever, ulcers in the mouth or throat due to infections,
• acute generalized exanthematous pustulosis,
• numbness,
• muscle weakness.

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

• low platelet count (with an increased risk of bleeding and bruising).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Sandoz

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 after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestane Sandoz

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

The other ingredients are:

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

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

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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

Or

Lek Pharmaceuticals d.d.

Verovškova ulica 57

Ljubljana 1526,

Slovenia

This medicine is authorised in the Member States of the European Economic Area under the following names

This leaflet was last revised in 09/2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/