EXEMESTANO 25 mg Film-Coated Tablets

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the User

Exemestane Normon 25 mg film-coated tablets EFG

Exemestane

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 and other information:

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

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

Exemestane Normon belongs to a group of medicines called aromatase inhibitors. These drugs interfere with a substance called aromatase, necessary for producing female sex hormones, estrogens, especially in postmenopausal women.

Reducing estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane Normon 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 Normon 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 Normon

Do not take Exemestane Normon

• if you are allergic (hypersensitive) 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

• Before starting treatment with this medicine, your doctor may perform a blood test to make sure you have reached menopause.
• Before taking exemestane, tell 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 the strength of your bones. Your doctor may check 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.

Other medicines and Exemestane Normon

Tell your doctor if you are using or have recently used other medicines, including those obtained without a prescription.

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

The following medicines should be used with caution if you are being treated with exemestane.

Tell 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 that contain it.

Taking Exemestane Normon with food and drink

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

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

If you feel dizzy, drowsy, or tired while being treated with Exemestane Normon, do not drive or operate machinery.

Use in athletes

This medicine contains exemestane, which may produce a positive result in doping tests.

Exemestane Normon contains sodium

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

3. How to take Exemestane Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly

These 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.

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

If you need to go to the hospital while being treated with exemestane, let the medical staff know what medication you are taking.

Use in children

Exemestane Normon is not suitable for use in children.

If you take more Exemestane Normon 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 Normon

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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very common(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(may affect up to 1 in 10 people):

• Loss of appetite
• Depression
• Dizziness, 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
• Rash, hair loss
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

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

• Numbness
• Muscle weakness

There may be inflammation of the liver (hepatitis). Symptoms include feeling unwell, nausea, jaundice (yellow color 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.

If you have had a blood test, you may have seen that there have been changes in liver function. There may 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).

If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Normon

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Exemestane Normon

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients are microcrystalline cellulose, mannitol, crospovidone, sodium carboxymethyl starch type A (potato), low-substituted hydroxypropylcellulose, hydroxypropylmethylcellulose, macrogol 6000, polysorbate 80, colloidal silica, magnesium stearate, titanium dioxide (E-171), and talc.

Appearance of the product and pack contents

Exemestane Normon are white or almost white, round, biconvex film-coated tablets, serigraphed with "E" on one face (punched).

Exemestane Normon is available in blister packs of 30 tablets.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos-Madrid (SPAIN)

Date of last revision of this leaflet:January 2022