Exemestane Cinfa 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Exemestane cinfa 25 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What exemestano cinfa is and what it is 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 postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane is used to treat early-stage hormone-dependent breast cancer 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 another hormonal treatment has not been sufficiently effective.

2. What you need to know before starting exemestano cinfa

Do not take exemestano cinfa

• If you are allergic to exemestano or to 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 menstrual periods.
• If you are pregnant, think you might be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take exemestano cinfa.

• Before starting treatment with exemestano, your doctor may perform a blood test to confirm that you have reached menopause.
• Your vitamin D levels will also be periodically checked 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 exemestano, inform your doctor if you have any liver or kidney problems.
• Inform your doctor if you have a history of, or currently suffer from, any condition affecting bone strength. Your doctor may assess your bone density before and during treatment with exemestano. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could reduce bone strength.

Taking exemestano cinfa with other medicines

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

Exemestano must 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 exemestano. Inform your doctor if you are taking any of these medicines:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take exemestano if you are pregnant or breastfeeding.

Talk to your doctor about contraceptive measures if there is any possibility you could become pregnant.

Driving and use of machines

If you experience dizziness, drowsiness, or fatigue while being treated with exemestano, do not drive or operate machinery.

exemestano cinfa contains sodium.

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

exemestano cinfa contains glucose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take exemestane cinfa

Follow exactly the instructions for administration of this medicine as given by your doctor. If in 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 advise you on how to take exemestane and for how long.

The recommended dose is one 25 mg tablet daily.

If you need to go to hospital while being treated with exemestane, inform the medical staff about the 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 almost time for your next dose, take the next dose 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 do so.

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

4. Possible adverse effects

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

Hypersensitivity, inflammation of the liver (hepatitis), and inflammation of the liver's bile ducts causing yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you are experiencing any of these symptoms.

In general, exemestane is well tolerated, and the following adverse effects observed in patients treated with exemestane are mainly mild or moderate. Most of these adverse effects are related to reduced estrogen levels (for example, hot flushes).

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

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduction in the number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in the blood
• Elevated levels of blood enzymes 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 affecting the entire hand except the little finger) or skin tingling/tingling sensations
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Hair loss
• Skin rash, hives, and itching
• Decreased bone density, which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Reduction in the number of blood platelets
• 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
• Inflammation of the liver
• Inflammation of the liver's bile ducts causing 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 (reduced lymphocytes in the blood).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of exemestane cinfa

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

Do not use this medicine after the expiry date stated on the blister or container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of exemestane cinfa

• The active substance 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 carboxymethylstarch (type A) (from potato), magnesium stearate, colloidal anhydrous silica.
• Components of the coating are sodium carmellose (E-466), maltodextrin, monohydrate glucose, titanium dioxide (E-171), stearic acid (E-570), yellow iron oxide (E-172).

Appearance of the product and contents of the pack

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

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

Only certain 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

The Netherlands

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: September 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es.

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

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