Package Leaflet: Information for the user

Exemestane Normon 25 mg film-coated tablets

Exemestane

Read this 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Exemestano Normon belongs to a group of medications known as aromatase inhibitors. These drugs interfere with a substance called aromatase, 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 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 tamoxifen medication.

Exemestano Normon is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Exemestano Normon

• if you are allergic (hypersensitive) to exemestano or to any of the other components of this medication (listed in section 6).
• if you have not yet reached menopause, that is, if you still have your period.
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

• Before starting treatment with this medication, your doctor may perform 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 analyze 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.

Other medications and Exemestano Normon

Inform your doctor if you are using or have recently used other medications, including those purchased without a prescription.

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

The following medications should be used with caution if you are being treated with exemestano.

Inform your doctor if you are taking any of the following medications:

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

Taking Exemestano Normon with food and drinks

Exemestano 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, or think you may be 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 being treated with Exemestano Normon, do not drive or operate machinery.

Use in athletes

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

Exemestano Normon contains sodium

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

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

Your doctor will tell you how to take exemestane and for how long. The recommended dose is one 25 mg tablet per day.

Adults and elderly people

The tablets of this medication 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 taking exemestane, inform the medical staff 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Exemestane Normon

Do not take a double dose to compensate for the missed doses.

If you forgot to take a tablet, take it as soon as you remember. If it is close to the time of the next dose, take it at the usual time.

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

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

Generally, 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 associated with estrogen reduction (such as hot flashes).

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

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

Common(may affect up to 1 person in 10):

• 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 (feeling unwell), constipation, indigestion, diarrhea
• Skin rash, hair loss
• Decreased bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking)
• Pain, swelling of hands and feet

Rare(may affect up to 1 person in 100):

• Numbness
• Muscle weakness

There may be an inflammation of the liver (hepatitis). Symptoms include general feeling of unwellness, 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 are experiencing any of these symptoms.

If you have had a blood test, you may have seen 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 side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist as soon as possible.

Reporting side effects

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

This medication does not require special conditions for conservation.

Keep this medication out of the 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.

Medications 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Exemestano Normon

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

Appearance of the product and content of the container

Exemestano Normon are white or almost white, round, biconvex, and printed with “E” on one face (engraved with a punch).

Exemestano Normon is presented in containers with blisters of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of thisleaflet:January 2022