EXEMESTANE VIR 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestane Vir 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. See section 4.

Contents of the pack:

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

1. What is Exemestane Vir 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 female sex hormones, oestrogens, especially in post-menopausal women. The reduction of oestrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane is used to treat hormone-dependent breast cancer in early stages in post-menopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.

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

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

Do not take Exemestane Vir

• if you are or have previously been allergic to exemestane (the active ingredient of Exemestane Vir) 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 are still having menstrual periods.
• if you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before starting to take exemestane.
• Before starting treatment with exemestane, your doctor may perform a blood test to make sure you have reached menopause.

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

• 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 assess 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.

Using Exemestane Vir with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

The following medicines should be used with caution if you are being treated with exemestane.

Tell your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anti-epileptics used to treat epilepsy)
• the herbal medicine St. John's Wort (Hypericum perforatum) or preparations that contain it.

Pregnancy and breast-feeding

Do not take exemestane if you are pregnant or breast-feeding.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Talk to your doctor about contraceptive measures if there is any chance you may become pregnant.

Driving and using machines

If you feel dizzy, drowsy or tired while being treated with exemestane, do not drive or operate machinery.

Exemestane Vir contains sodium

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

3. How to take Exemestane Vir

Adult and elderly patients

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

The exemestane tablets should be taken orally after a meal, at about 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.

If you need to go to the hospital while being treated with exemestane, let the medical staff know what medication you are taking.

Use in children

Exemestane is not suitable for use in children.

If you take more Exemestane Vir 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, stating the medicine and the amount taken. It is recommended to take the package and leaflet to the healthcare professional.

If you forget to take Exemestane Vir

Do not take a double dose to make up for forgotten doses.

If you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, take it at the usual time.

If you stop taking Exemestane Vir

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity, liver inflammation (hepatitis) and inflammation of the bile ducts of the liver, which causes yellowing of the skin (cholestatic hepatitis), may occur. The symptoms include a feeling of general discomfort, nausea, yellowing of the skin and eyes (jaundice), 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.

Generally, 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 related to the reduction of oestrogens (such as hot flushes).

Very common: may affect more than 1 in 10 people

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)
• Fatigue
• Reduced white blood cell count
• Abdominal pain
• High levels of liver enzymes
• High levels of haemolysis in the blood
• High levels of liver enzymes in the blood 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 that affects the whole hand except the little finger) or tingling/numbness of the skin
• Nausea (feeling sick), vomiting, constipation, indigestion, diarrhoea
• Hair loss
• Skin rash, hives and itching
• Reduced bone density that may reduce the strength of your bones (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet
• Reduced platelet count in the blood
• Feeling weak

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity

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

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

Frequency not known: cannot be estimated from the 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 that circulate in the blood, especially in patients with pre-existing lymphopenia (reduced lymphocytes in the blood).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the National Pharmacovigilance System of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Vir

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

Do not use this medicine after the expiry date which is stated on the outer carton and on the blister after EXP. The expiry date is the last day of the month stated.

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 further information

Composition of Exemestane Vir

• 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 starch glycolate (potato starch), magnesium stearate and polysorbate 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 pack contents

White, round, biconvex film-coated tablets, marked with "E" on one side.

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Industria Química y Farmacéutica VIR, S.A.

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

Manufacturer

Genepharm S.A.

18 Km Marathon Avenue

15351 Pallini, Greece

This medicine is authorised in the Member States of the European Economic Area under the following names

United Kingdom: Exemestane 25 mg film-coated tablets

Spain: Exemestano Vir 25 mg film-coated tablets EFG

Date of last revision of this leaflet: November 2021

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/.