Exemestano viatris 25 mg comprimidos recubiertos con pelicula efg

Patient Information Leaflet: Package Leaflet

Exemestane Viatris 25 mg Film-Coated Tablets

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 they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Exemestane Viatris

3. How to take Exemestane Viatris

4. Possible side effects

5. Storage of Exemestane Viatris

6. Contents of the pack and additional information

Your medication is called Exemestano Viatris. Exemestano belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with an enzyme called aromatase, necessary for producing female sex hormones, estrogens, especially in postmenopausal women. The reduction of estrogen levels in the body is a way to treat 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 hormone treatments have not been effective.

Do not take Exemestano Viatris:

• If you are allergic to exemestano or 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 or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Warnings and precautions

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

• Before starting treatment with Exemestano Viatris, your doctor may perform a blood test to ensure that you have reached menopause.
• If you have any liver or kidney problems.
• If you have a history or condition that affects bone resistance (for example, osteoporosis).Your doctor may analyze bone density before and during treatment with Exemestano Viatris. This is because medications in this group reduce female hormone levels that help bone growth, which can lead to a loss of bone mineral content and decreased resistance.
• If you know you have low levels of vitamin D (for example, you cannot 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 Exemestano Viatris with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Exemestano Viatris should not be administered at the same time as hormone replacement therapy (HRT) or with medications containing estrogen (including combined oral contraceptives).

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

Inform your doctor if you are taking medications such as:

• Rifampicin (an antibiotic).
• Antiepileptic medications used to treat epilepsy (carbamazepine or phenytoin).
• 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Discuss possible use of contraceptive methods if there is any possibility of becoming pregnant.

Driving and operating machinery

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

Use in athletes

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

Exemestano Viatris contains sodium

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

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

Adults and elderly patients

The 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 old.

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 nearest hospital emergency department. Show them the packaging of the Exemestane Viatris tablets.

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 used.

If you forget to take Exemestane Viatris

Do not take a double dose to make up for the missed 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 usual time.

If you interrupt treatment with Exemestane Viatris

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

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them. Generally,Exemestano Viatrisis well tolerated and the following side effects observed in patients treated withExemestano Viatrisare of mild or moderate nature. Most side effects are associated with estrogen deficiency (e.g. hot flashes).

If you experience the following, stop taking the tablets and immediately contact your doctor or visit the nearest hospital emergency service:

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

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

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

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

Rare side effects(may affect a maximum of 1 in 1000 people):

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

The following side effects have also been reported:

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

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

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

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

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

• Drowsiness.

Unknown side effects(cannot be estimated from 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. There may be changes in the number of white blood cells (leukocytes and lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (decreased lymphocytes in the blood). It may cause more bruising and bleeding with greater ease or more infections (with symptoms, for example, sore throat, fever, and intense chills).

In clinical studies, the following side effects have been observed, but it has not been established whether these are related to the medication itself:

• Changes in the vagina and uterus, vaginal bleeding.
• Vision disturbances
• Obstruction of blood vessels due to blood coagulation, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 medication.

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

• This medication does not require special storage conditions.
• Do not useExemestano Viatrisafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Exemestane Viatris

The active ingredient is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

The other components are:

Core:Colloidal anhydrous 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 contents of the package

Exemestane Viatrisare white, round, and biconvex film-coated tablets.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyExemestan dura 25 mg filmtabletten

BelgiumExemestane Mylan 25 mg filmomhulde tabletten

SlovakiaExemestan Mylan 25 mg

SpainExemestano Viatris25 mg comprimidos recubiertos con película EFG

FranceExemestane Mylan 25 mg comprimés pelliculés

ItalyExemestane Mylan Generics

NorwayExemestane Generics

NetherlandsExemestaan Mylan 25 mg, filmomhulde tabletten

PolandExemestane Mylan

United KingdomExemestane 25 mg Film-coated tablets

Czech RepublicExemestan Mylan 25 mg

RomaniaExemestane Generics 25 mg comprimate filmate

Last review date of this leaflet:December 2018

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/