Package Insert: Information for the Patient

Exemestane Winadol 25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

Exemestano belongs to a group of medications known as aromatase inhibitors.

These medications interfere with a substance called aromatase, which is 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.

Exemestano 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 tamoxifen medication.

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.

Do not take Exemestano Winadol

• if you are or have been allergic to exemestano 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 Exemestano Winadol.

• Before starting treatment with exemestano, your doctor may ask you to have a blood test to ensure that you have reached menopause.
• Before taking exemestano, inform your doctor if you have any liver or kidney problems.
• Inform your doctor if you have a history or suffer from any disease that affects your bone resistance. Your doctor may want to evaluate your bone density before and during treatment with exemestano. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content, and may decrease your resistance.

Exemestano Winadol with other medications

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

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

The following medications should be used with caution while taking Exemestano Winadol. 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.

Exemestano Winadol with food and drinks

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

Pregnancy and breastfeeding

Do not take this medication if you are pregnant or breastfeeding.

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

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 Exemestano Winadol, do not drive or operate machinery.

Use in athletes

This medication contains exemestano, which may produce a positive result in doping control tests

Follow exactly the administration instructions for Exemestano Winadol indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly people

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 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 taking Exemestano Winadol, inform the medical staff what 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered. Show the Exemestano Winadol packaging.

If you forgot to take Exemestano Winadol

If you accidentally forgot to take a tablet, take the next dose at your usual time. Do not take a double dose to compensate for the missed doses.

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

Like all medications, Exemestano Winadol may produce adverse effects, although not everyone will experience them.

Generally, Exemestano Winadol is well tolerated, and the following adverse effects observed in patients treated with Exemestano Winadol are mainly mild or moderate. Most adverse effects are associated with estrogen reduction (such as hot flashes).

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Difficulty sleeping
• Headache
• Hot flashes
• Unpleasant sensation
• Increased sweating
• Muscle and joint pain (including arthritis, 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 entire hand except the little finger)
• Stomach pain, vomiting (unpleasant sensation), constipation, indigestion, diarrhea
• Skin rash, hair loss
• Bone density decrease that may reduce bone resistance (osteoporosis) and cause fractures in some cases (fractures or fissures)
• Pain, swelling of hands and feet

Rare Adverse Effects (may affect up to 1 in 100 people):

• Numbness
• Muscle weakness

It may cause liver inflammation (hepatitis). Symptoms include general unpleasant sensation, nausea, jaundice (yellow discoloration 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.

If a blood test is performed, it is possible to observe 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 (decreased lymphocytes in the blood).

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist as soon as possible.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Exemestano Winadol

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

Appearance of the product and content of the packaging

Exemestano Winadol are film-coated tablets, white in color, round, biconvex, and marked on one face with “E”.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for the manufacturing

Holder of the marketing authorization

Farmalider, S.A.

C/ La Granja, 1 3rd Floor

28108. Alcobendas. Madrid

Responsible for the manufacturing

FARMALIDER S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

This leaflet was approved in August 2024

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