Exemestane Winadol 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Exemestano Winadol 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

Exemestano Winadol 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.

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

2. What you need to know before starting to take Exemestano Winadol

Do not take Exemestano Winadol

• if you are or have previously been allergic to exemestane or to 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 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 Winadol.

• Before starting treatment with exemestane, your doctor may request a blood test to confirm that you have reached menopause.
• Before taking exemestane, 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 wish to evaluate your bone mineral density before and during treatment with exemestane. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could decrease bone strength.

Taking Exemestano Winadol with other medicines

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

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

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

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

Taking Exemestano Winadol with food and drink

Exemestano Winadol tablets should be taken after a meal, approximately at the same time each day.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or 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.

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

Driving and using machines

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

Use in athletes

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

3. How to take Exemestano Winadol

Follow exactly the administration instructions for Exemestano Winadol provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients

Exemestano Winadol tablets should be taken orally after a meal, approximately at 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 daily.

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

If you need to go to the hospital while being treated with Exemestano Winadol, inform the medical staff about the medication you are taking.

Use in children

Exemestano Winadol is not suitable for use in children.

If you take more Exemestano Winadol than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. Show the Exemestano Winadol packaging.

If you forget to take Exemestano Winadol

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

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

4. Possible adverse effects

Like all medicines, Exemestane Winadol may cause adverse effects, although not everyone will experience them.

Overall, Exemestane Winadol is well tolerated, and the following adverse effects observed in patients treated with Exemestane Winadol are mainly mild or moderate. Most of these adverse effects are associated with reduced estrogen levels (for example, hot flushes).

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

• Difficulty sleeping
• Headache
• Hot flushes
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue

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

• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the whole hand except the little finger)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhoea
• Skin rash, hair loss
• Decreased bone density, which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

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

• Numbness
• Muscle weakness

Liver inflammation (hepatitis) may occur. Symptoms include general feeling of 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.

If a blood test is performed, changes in liver function may be observed.

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 (low lymphocyte count in the blood).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist as soon as possible.

5. Storage of Exemestane Winadol

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging 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 empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestano Winadol

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

Appearance of the product and contents of the container

Exemestano Winadol are film-coated tablets, white in colour, round, biconvex, marked on one side with "E".

Exemestano Winadol 25 mg is supplied in blister packs containing 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La Granja, 1 3rd Floor

Alcobendas, Madrid

Manufacturer

FARMALIDER S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

This leaflet was last approved in August 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.