EXEMESTANE WINADOL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Exemestane Winadol 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.

Contents of the pack:

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

1. What is Exemestane Winadol 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 the female sex hormones, estrogens, especially in postmenopausal women. The reduction of estrogen levels in the body is a way to treat hormone-dependent breast cancer.

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

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

Do not take Exemestane Winadol

• 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 menstrual 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 Winadol.

• Before starting treatment with exemestane, your doctor may ask you to have 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 want to evaluate 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 reduce the strength of your bones.

Taking Exemestane Winadol with other medicines

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

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

The following medicines should be used with caution while taking Exemestane Winadol. Tell your doctor if you are taking any of these medicines:

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

Taking Exemestane Winadol with food and drinks

Exemestane Winadol tablets should be taken after a meal, at approximately 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 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 being treated with Exemestane Winadol, do not drive or operate machinery.

Use in athletes

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

3. How to take Exemestane Winadol

Follow exactly the instructions of administration of Exemestane Winadol given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and elderly

Exemestane Winadol tablets should be taken orally after a meal, at approximately the same time every day. Your doctor will inform you how and for how long to take the medicine. 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 Winadol, inform the medical staff what medication you are taking.

Use in children

Exemestane Winadol is not suitable for use in children.

If you take more Exemestane Winadol than you should

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

If you forget to take Exemestane Winadol

If you accidentally forget to take a tablet, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Exemestane Winadol can cause side effects, although not everybody gets them.

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

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

• Difficulty sleeping
• Headache
• Hot flashes
• Feeling unwell
• Increased sweating
• Pain in muscles and joints (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, 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, 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):

• Numbness
• Muscle weakness

There may be inflammation of the liver (hepatitis). The symptoms include general feeling of being unwell, 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.

If you have a blood test, you may have 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 (reduced lymphocytes in the blood).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. Storage of Exemestane Winadol

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging 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 Winadol

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients are: colloidal anhydrous silica, crospovidone, hypromellose, mannitol, microcrystalline cellulose, sodium carboxymethyl starch (potato starch), magnesium stearate, and polysorbate 80. The tablet coating contains Opadry White Y-1-7000 (which is composed of hypromellose, macrogol 400, and titanium dioxide (E171)).

Appearance and packaging

Exemestane Winadol are film-coated tablets, white, round, biconvex, and marked with "E" on one side.

Exemestane Winadol 25 mg is available in blister packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Farmalider, S.A.

C/ La Granja, 1 3ª Planta

1. Alcobendas. Madrid

Manufacturer

FARMALIDER S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

This leaflet was approved in August 2024

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/.