Leaflet: information for the user

Exemestane cinfa 25 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What exemestane cinfa is and what it is used for

2.What you need to know before you start taking exemestane cinfa

3.How to take exemestane cinfa

4.Possible side effects

5Storage of exemestane cinfa

6.Contents of the pack and additional information

Exemestane belongs to a group of medicines called aromatase inhibitors. These medicinesmedicinesinterfere 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.

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 tamoxifen medicine.

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

Do not take exemestane cinfa

• If you are allergic to exemestane or any of the other components of this medication (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 breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take exemestane cinfa.

• Before starting treatment with exemestane, your doctor may perform a blood test to ensure that you have reached menopause.
• Your vitamin D levels will also be checked periodically before starting treatment, as they may be too low in the initial stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.
• Inform your doctor if you have any liver or kidney problems before taking exemestane.
• Inform your doctor if you have a history or condition that affects your bone resistance. Your doctor may analyze your bone density before and during exemestane treatment. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content and decreased resistance.

Taking exemestane cinfa with other medications

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

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

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

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take exemestane if you are pregnant or breastfeeding.

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

Driving and operating machinery

If you experience dizziness, drowsiness, or fatigue while taking exemestane, do not drive or operate machinery.

exemestane cinfa contains sodium.

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

exemestane cinfa contains glucose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Adults and elderly patients

Exemestane tablets must 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 tablet of 25 mg 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take exemestane cinfa

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

If you forgot 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 the usual time.

If you interrupt treatment with exemestane cinfa

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

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

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

It may cause hypersensitivity, liver inflammation (hepatitis) and inflammation of the bile ducts of the liver, which causes yellowing of the skin (cholestatic hepatitis). Symptoms include general feeling of 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 are experiencing any of these symptoms.

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

Most common(may affect more than 1 in 10 patients):

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• General feeling of discomfort
• Increased sweating
• Muscle and joint pain (includingosteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduced white blood cell count.
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown in the blood
• Elevated levels of blood enzymes due to liver damage
• Pain

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

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

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

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

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

Frequency not known(cannot be estimated from 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 (decreased lymphocytes in the blood).

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 Spanish System for 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 blister pack or on the container after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at theSIGREcollection point of the pharmacy. In case of doubtaskyour pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of exemestane cinfa

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

Appearance of the product and contents of the package

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

Exemestane cinfa is presented in PVC-PVDC blisters. Each package contains 30 (unit dose) or 100 (clinical package) film-coated tablets;

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Synthon Hispania, S.L.

Castello, 1 Industrial Estate Las Salinas

08830 Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22, PO Box 7071

6545 CM Nijmegen

Netherlands

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:September 2020

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your 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