Leaflet: information for the user

Exemestane Vir 25 mg film-coated tablets EFG

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 give it to others even if they have similar symptoms, as 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.

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

2. What you need to know before you start taking Exemestane Vir

3. How to take Exemestane Vir

4. Possible side effects

5. Storage of Exemestane Vir

6. Contents of the pack and additional information

Exemestano belongs to a group of medications called aromatase inhibitors. These medications 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 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 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 ExemestanoVir

• If you are or have been allergic to exemestano (active ingredient of Exemestano Vir) or to 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, pharmacist, or nurse before starting to take exemestano.
• Before starting treatment with exemestano, your doctor may perform a blood test to ensure that you have reached menopause.

• Your vitamin D levels will also be checked periodically before starting treatment, as they may be too low in the initial stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.

• Inform your doctor if you have any liver or kidney problems before taking exemestano.
• Inform your doctor if you have a history or condition that affects your bone resistance. Your doctor may want to evaluate your bone density before and during exemestano treatment. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content and decreased resistance.

Use of Exemestano Vir with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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.

Pregnancy and breastfeeding

Do not take exemestano if you are pregnant or breastfeeding.

If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor 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, do not drive or operate machinery.

Exemestano Vir contains sodium

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

Adult and Elderly Patients

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Exemestano tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take exemestano and for how long.

The recommended dose is 1 tablet of 25 mg per day.

If you need to go to the hospital while taking exemestano, inform the medical staff what medication you are taking.

Use in Children

Exemestano is not suitable for use in children.

If You Take More Exemestano Vir 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. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If You Forget to Take Exemestano Vir

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

If you forget 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 Interrupt Treatment with Exemestano Vir

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

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

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

It may cause hypersensitivity, liver inflammation (hepatitis) and inflammation of the liver's bile ducts, which causes yellowing of the skin (cholestatic hepatitis). Symptoms include general feeling of discomfort, 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.

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

Very common: may affect more than 1 in 10 people

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• General feeling of discomfort
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduction in white blood cell count
• Abdominal pain
• Elevated liver enzyme levels
• Elevated levels of hemoglobin breakdown in the blood
• Elevated levels of certain blood enzymes due to liver damage
• Pain

Common: may affect up to 1 in 10 people

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger) or tingling/numbness in the skin
• Vomiting (feeling of discomfort), constipation, indigestion, diarrhea
• Hair loss
• Skin rash, urticaria, and itching
• Decreased bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking)
• Pain, swelling of hands and feet
• Reduction in platelet count in the blood
• Feeling of weakness

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity

Rare: may affect up to 1 in 1,000 people

• Appearance of small blisters on a skin rash
• Numbness
• Liver inflammation
• Inflammation of the liver's bile ducts that causes yellowing of the skin

Frequency not known: cannot be estimated from available data

• Low levels of certain white blood cells in the blood

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).

Reporting of side effects

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

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the outer box and on the blister 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. Ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition of Exemestano Vir

• 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 glycolate starch (potato starch), magnesium stearate, and polisorbate 80. The tablet coating contains Opadry white OYS 9622 (which is composed of hypromellose, propylene glycol, and titanium dioxide (E171)).

Appearance of the product and contents of the packaging

Film-coated tablets, white in color, round, biconvex, marked with “E” on one face.

This medicine is presented in blister packs with 15, 20, 30, 90, 100, or 120 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II, 28923 Alcorcón (Madrid) – Spain

Responsible for manufacturing

Genepharm S.A.

18 Km Marathon Avenue

15351 Pallini, Greece

This medicine is authorized in the Member States of the European Economic Area with the following names

United Kingdom: Exemestane 25 mg film-coated tablets

Spain: Exemestano Vir 25 mg film-coated tablets EFG

Last review date of this leaflet: November 2021

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/.