EXEMESTANE CINFA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestane Cinfa 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 Cinfa and what is it used for
2. What you need to know before you take Exemestane Cinfa
3. How to take Exemestane Cinfa
4. Possible side effects

5 Conservation of Exemestane Cinfa

1. Contents of the pack and further information

1. What is Exemestane Cinfa 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 necessary for producing female sex hormones, estrogens, especially in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane 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 medicine tamoxifen.

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

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

Do not take Exemestane Cinfa

• If you are 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 are still having your period.
• If you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Exemestane Cinfa.

• Before starting treatment with exemestane, your doctor may perform a blood test to ensure you have reached menopause.
• Periodically, your vitamin D levels will also be reviewed before starting treatment, as they may be too low in the early stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.
• 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 your bone density before and during treatment with exemestane. 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.

Taking Exemestane Cinfa with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

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

The following medicines should be used with caution if you are being treated with exemestane. Inform your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptics used to treat epilepsy),
• the herbal medicine St. John's Wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breast-feeding

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

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

Talk to your doctor about contraceptive measures if there is any chance you may become pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while taking exemestane, do not drive or operate machinery.

Exemestane Cinfa contains sodium.

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

Exemestane Cinfa contains glucose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Exemestane Cinfa

Follow exactly the instructions of administration of this medicine indicated by your doctor. If in doubt, consult your doctor again.

Adults and elderly patients

Exemestane tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take exemestane and for how long.

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while taking exemestane, inform the medical staff what medication you are taking.

Use in children

Exemestane is not suitable for use in children.

If you take more Exemestane Cinfa than you should

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 Cinfa

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 Cinfa

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.

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the bile ducts in the liver, which causes yellowing of the skin (cholestatic hepatitis), may occur. Symptoms include a feeling of general discomfort, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right upper abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you have any of these symptoms.

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

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

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased white blood cell count.
• Abdominal pain
• High levels of liver enzymes
• High levels of hemoglobin breakdown in the blood
• High levels of blood enzymes in the blood due to liver damage
• Pain

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

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger) or tingling/numbness in the skin
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Hair loss
• Rash, hives, and itching
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Decreased platelet count in the blood
• Muscle weakness

Uncommon(may affect up to 1 in 100 people):

• Hypersensitivity

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

• Appearance of small blisters in a skin rash
• Numbness
• Liver inflammation
• Inflammation of the bile ducts in the liver that causes yellowing of the skin

Frequency not known(cannot be estimated from the available data)

• Low levels of certain white blood cells in the blood

There may also be changes in the number of certain blood cells (lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (decrease in lymphocytes in the blood).

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 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. Conservation of Exemestane Cinfa

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 blister or 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 further information

Composition of Exemestane Cinfa

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients are mannitol (E-421), hypromellose, crospovidone, polysorbate 80, microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), magnesium stearate, colloidal anhydrous silica.
• The coating ingredients are sodium carmellose (E-466), maltodextrin, glucose monohydrate, titanium dioxide (E-171), stearic acid (E-570), yellow iron oxide (E-172).

Appearance of the product and pack contents

Exemestane Cinfa are yellow, biconvex, round film-coated tablets marked with "E9MT" on one face and "25" on the other face.

Exemestane Cinfa is presented in PVC-PVDC blisters. Each pack contains 30 (single dose) or 100 (clinical pack) film-coated tablets;

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Synthon Hispania, S.L.

Castello, 1 Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22, PO Box 7071

6545 CM Nijmegen

Netherlands

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:September 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76699/P_76699.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76699/P_76699.html