EXEMESTANE VIATRIS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

Your medicine is called Exemestane Viatris. Exemestane belongs to a group of medicines called aromatase inhibitors. These medicines interfere with an enzyme called aromatase, which is needed to produce the female sex hormones, estrogens, especially in post-menopausal women. The reduction of estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane is used to treat early hormone-dependent breast cancer in post-menopausal women after completing 2-3 years of treatment with tamoxifen.

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

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

Do not take Exemestane Viatris:

• If you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6).
• If you have not yet reached menopause, i.e., if you still have your menstrual period.
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Exemestane Viatris.

• Before starting treatment with Exemestane Viatris, your doctor may perform a blood test to ensure you have reached menopause.
• If you have any liver or kidney problems.
• If you have a history of or suffer from any disease that affects bone strength (e.g., osteoporosis). Your doctor may check your bone density before and during treatment with Exemestane Viatris. This is because medicines in this group reduce female hormone levels, which help bone growth, and may lead to a loss of bone mineral content and reduced bone strength.
• If you know you have low vitamin D levels (e.g., you are unable to spend time in the sun). Your doctor may want to check your vitamin D levels before treatment and, if necessary, give you vitamin D supplements.

Taking Exemestane 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.

Exemestane Viatris should not be taken at the same time as hormone replacement therapy (HRT) or medicines containing estrogen (including combined oral contraceptives).

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

Tell your doctor if you are taking medicines such as:

• Rifampicin (an antibiotic).
• Antiepileptics 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 Exemestane Viatris if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

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

Use in athletes

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

Exemestane Viatris 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 Viatris

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients

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

Use in children and adolescents

Exemestane Viatris is not suitable for use in children and adolescents under 18 years.

If you take more Exemestane Viatris than you should

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

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

If you forget to take Exemestane 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 it at the scheduled time.

If you stop taking Exemestane Viatris

Do not stop treatment without consulting your doctor first. If you stop treatment, your symptoms may come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In general, Exemestane Viatris is well tolerated, and the following side effects observed in patients treated with Exemestane Viatris are mild or moderate. Most side effects are related to the lack of estrogens (e.g., hot flashes).

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

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

• Bone loss that can reduce bone strength (osteoporosis), and may lead to fractures (breaks or cracks).
• Carpal tunnel syndrome (a combination of numbness, tingling, and pain that affects the entire hand, except the little finger).

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

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

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

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

The following side effects have also been reported:

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

• Depression.
• Difficulty sleeping.
• Headache.
• Hot flashes.
• Dizziness.
• Nausea.
• Increased sweating.
• Muscle and joint pain, including swelling, cracking, stiffness, and pain in one or more joints.
• Fatigue.
• Decreased white blood cell count (leukopenia).
• Stomach pain.
• Increased liver enzyme levels.
• Increased breakdown of hemoglobin in the blood.
• Increased levels of a certain enzyme in the blood due to liver damage.
• Pain.

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

• Loss of appetite, weight loss.
• Nausea (vomiting), constipation, indigestion, diarrhea.
• Skin rash, hives, itching.
• Hair loss.
• Swelling of hands and feet.
• Pins and needles.
• Decreased platelet count in the blood (thrombocytopenia).
• Muscle weakness.

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

• Drowsiness.

Unknown frequency side effects(cannot be estimated from the available data):

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

If you have any blood tests, you may see changes in liver function (increased liver enzymes and bilirubin). There may be changes in the number of white blood cells (called leukocytes and lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (decreased lymphocytes in the blood). This may cause more bruising and bleeding easily or more infections (with symptoms, for example, sore throat, fever, and chills).

In clinical studies, the following side 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 increased levels of cholesterol and other fats in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System 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 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.
• 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 other information

Composition of Exemestane Viatris

The active substance is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

The other ingredients are:

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

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

Appearance and packaging

Exemestane Viatris are white, round, and biconvex film-coated tablets.

They are available in blister packs of 14, 15, 20, 30, 60, 90, 100, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet:December 2018

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/