Exemestane Viatris 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Exemestano Viatris 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, 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 and must not be given to other people, even if they have the same symptoms, as 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. See section 4.

Contents of the leaflet

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

1. What Exemestano Viatris is and what it is used for

Your medicine is called Exemestano Viatris. Exemestano belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with an enzyme called aromatase, which is needed to produce female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestano is used to treat early hormone-dependent breast cancer in postmenopausal women after completing 2–3 years of treatment with tamoxifen.

Exemestano is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when alternative hormonal treatments have not been effective.

2. What you need to know before taking Exemestano Viatris

Do not take Exemestano Viatris:

• If you are allergic to exemestane or to any of the other ingredients of this medicine (listed in section 6).
• If you have not yet reached menopause, that is, if you still have menstrual periods.
• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Exemestano Viatris.

• Before starting treatment with Exemestano Viatris, your doctor may perform a blood test to confirm that you have reached menopause.
• If you have any liver or kidney problems.
• If you have a history of, or currently suffer from, any condition affecting bone strength (e.g., osteoporosis). Your doctor may assess your bone density before and during treatment with Exemestano Viatris. This is because medicines in this class reduce levels of female hormones that support bone growth, which may lead to loss of bone mineral content and potentially reduce bone strength.
• If you know you have low levels of vitamin D (for example, because you do not get enough sun exposure). Your doctor may wish to check your vitamin D levels before treatment and, if necessary, prescribe vitamin D supplements.

Taking Exemestano Viatris with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Exemestano Viatris must not be taken at the same time as hormone replacement therapy (HRT) or medicines containing estrogen (including combined oral contraceptive pills).

The following medicines should be used with caution if you are taking Exemestano Viatris.

Inform your doctor if you are taking medicines such as:

• Rifampicin (an antibiotic).
• Antiepileptic medicines used to treat epilepsy (carbamazepine or phenytoin).
• The herbal remedy St. John’s wort (Hypericum perforatum) or preparations containing it.

Pregnancy and breastfeeding

Do not take Exemestano Viatris if you are pregnant or breastfeeding.

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

Discuss with your doctor the use of contraceptive methods if there is any possibility of becoming pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while taking Exemestano Viatris, do not drive or operate tools or machinery.

Use in athletes

This medicine contains exemestane, which may result in a positive doping test.

Exemestano Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Exemestano Viatris

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients

Exemestano Viatris tablets should be taken orally after a meal, at approximately the same time each day. Your doctor will instruct you on how to take Exemestano Viatris 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 Exemestano Viatris, inform the medical staff about the medication you are taking.

Use in children and adolescents

Exemestano Viatris is not suitable for use in children and adolescents under 18 years of age.

If you take more Exemestano Viatris than you should

If you accidentally take too many tablets, contact your doctor immediately or go directly to the nearest hospital emergency department. Show them the packaging of the Exemestano Viatris tablets.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Exemestano Viatris

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

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

If you stop taking Exemestano Viatris

Do not stop treatment without first consulting your doctor. If you interrupt treatment, your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. In general, Exemestane Viatris is well tolerated, and the following adverse effects observed in patients treated with Exemestane Viatris are of mild or moderate nature. Most of the adverse effects are associated with estrogen deficiency (e.g., hot flashes).

If you experience any of the following, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:

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

• Loss of bone mass that may reduce bone strength (osteoporosis), and occasionally may lead to fractures (breaks or cracks).
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the whole hand, except the little finger).

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

• Sudden signs of allergy such as skin rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing (anaphylaxis).

Rare adverse effects (may affect up to 1 in 1,000 people):

• Inflammation of the liver (hepatitis) or blockage of the bile duct may occur, which can cause yellowing of the skin and eyes, general malaise, nausea, itching, abdominal pain on the right side, and loss of appetite.
• Rapid onset of skin rash, red and swollen areas or skin lesions with fluid-filled blisters, skin inflammation, peeling or shedding of the skin, which may also be associated with fever.

The following adverse effects have also been reported:

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

• Depression.
• Difficulty sleeping.
• Headache.
• Hot flashes.
• Dizziness.
• Feeling of dizziness (nausea).
• Increased sweating.
• Muscle pain and joint pain, including swelling, cracking, stiffness, and pain in one or more joints.
• Fatigue.
• Decrease in the number of white blood cells (leukopenia).
• Stomach pain.
• Increase in liver enzymes.
• Increase in the level of hemoglobin breakdown products in the blood.
• Increase in the level of certain liver enzymes in the blood due to liver damage.
• Pain.

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

• Loss of appetite, weight loss.
• Dizziness (vomiting), constipation, indigestion, diarrhea.
• Skin rash, hives, itching.
• Hair loss.
• Swelling of hands and feet.
• Prickling sensations.
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Muscle weakness.

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

• Somnolence.

Adverse effects with unknown frequency (cannot be estimated from the available data):

• Low levels of certain white blood cells (lymphocytes) in the blood.

If blood tests are performed, changes in liver function (increased liver enzymes and bilirubin) may be observed. Changes in the number of white blood cells (called leukocytes and lymphocytes) and platelets circulating in the blood may occur, especially in patients with pre-existing lymphopenia (low lymphocyte count). This may make you more prone to bruising and bleeding easily, or to infections (with symptoms such as sore throat, fever, and severe chills).

In clinical studies, the following adverse effects have been observed, but it has not been established whether they are related to the medicine itself:

• Changes in the vagina and uterus, vaginal bleeding.
• Vision disorders.
• Blockage of blood vessels due to blood clotting, heart attacks, increased blood pressure, heart failure.
• Changes or increases in cholesterol and other blood fats.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Viatris

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

• This medicine does not require any special storage conditions.
• Do not use Exemestane Viatris after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Exemestano Viatris

The active substance is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

The other components are:

Core: Anhydrous colloidal silica, crospovidone, hypromellose 5cP, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, and sodium starch glycolate (Type A) from potato.

Coating: Hypromellose 5cP, macrogol, talc, and titanium dioxide (E-171).

Appearance of the product and pack contents

Exemestano Viatris are white, round, biconvex film-coated tablets.

Available in blister packs containing 14, 15, 20, 30, 60, 90, 100, and 120 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Or

McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road (Dublin) - 13
Ireland

Or

Remedica Limited
Limassol Industrial Estate, P.O. Box 51706, CY-3508 Limassol
Cyprus

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

Germany: Exemestan dura 25 mg filmtabletten
Belgium: Exemestane Mylan 25 mg filmomhulde tabletten
Slovakia: Exemestan Mylan 25 mg
Spain: Exemestano Viatris 25 mg comprimidos recubiertos con película EFG
France: Exemestane Mylan 25 mg comprimés pelliculés
Italy: Exemestane Mylan Generics
Norway: Exemestane Generics
Netherlands: Exemestaan Mylan 25 mg, filmomhulde tabletten
Poland: Exemestane Mylan
United Kingdom: Exemestane 25 mg Film-coated tablets
Czech Republic: Exemestan Mylan 25 mg
Romania: Exemestane Generics 25 mg comprimate filmate

Date of the most recent review of this leaflet: December 2018

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