Package Leaflet: Information for the User

Exemestane Stada 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 give it to others even if they have the same symptoms as you, 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.

This medication is called Exemestano Stada. Exemestano belongs to a group of medications known as 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 Stada 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 Stada is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Exemestano Stada

• if you are or have been 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, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Exemestano Stada

-if you have any liver or kidney problems.

• if you have a history of or suffer from any disease that affects your bone resistance. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content, and may decrease your resistance. Your doctor may analyze your bone density before and during treatment. Your doctor may prescribe a medication to prevent or treat bone loss.
• if you have vitamin D deficiency.

Before starting treatment with exemestano, your doctor may perform a blood test to ensure that you have reached menopause.

Important information for athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical control for doping as positive.

Use of Exemestano Stada with other medications

Inform your doctor if you are using, have used recently, or may need to take 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.

Notify your doctor if you are taking any of the following medications:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants 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. Inform your doctor if you are pregnant or may be pregnant.

Discuss contraceptive measures with your doctor if there is any possibility of becoming pregnant.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

If you experience dizziness, drowsiness, or fatigue while taking exemestano, do not drive or operate machinery.

Exemestano Stada contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. Your doctor will tell you how to take exemestano and for how long.

Adults and elderly patients

The recommended dose is one 25 mg tablet per day.

Exemestano tablets should be taken orally after a meal, approximately at the same time every day.

Use in children and adolescents

Exemestano is not suitable for use in children and adolescents.

If you take more Exemestano Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Exemestano Stada

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 Stada

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. In general, exemestane is well tolerated, and the following side effects observed in patients treated with exemestaneare 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

• Difficulty sleeping
• Headache
• Hot flashes
• Unpleasant sensation
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue

Common: may affect up to 1 in 10 people

• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger), tingling (paresthesia)
• Stomach pain, vomiting (unpleasant sensation), constipation, indigestion, diarrhea
• Skin rash, hair loss, urticaria, 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

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity
• Numbness
• Acute generalized exanthematous pustulosis (skin eruption characterized by pustules and may be accompanied by fever)
• Muscle weakness

It may cause inflammation of the liver (hepatitis). Symptoms include general unpleasant sensation, nausea, jaundice (yellow color of the skin and eyes), itching, pain in the right upper abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you are experiencing any of these symptoms.

If you have had a blood test, you may have seen changes in liver function. There may be changes in the number of certain blood cells (lymphocytes) and platelets (blood cells responsible for coagulation) 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 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 of 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications 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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Exemestane Stada

• The active ingredient is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

• The other components are:

Tablet core:

Manitol, copovidone, crospovidone, microcrystalline cellulose silicified, sodium carboxymethylcellulose (Type A) (from potato), magnesium stearate.

Coating:

Hydroxypropyl methylcellulose, macrogol 400, titanium dioxide.

Appearance of the product and contents of the package

Round, white to off-white film-coated tablet, marked with “25” on one side and smooth on the other.

Exemestane Stada is available in blister packs of:

10, 30, 60, 90, 100, and 120 (blister packs of 10) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

EirGen Pharma Ltd.

Westside Business Park,

Old Kilmeaden Road, Waterford

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

Pharmacare Premium Ltd

HHF003 Hal Far Industrial Estate

Birzebbugia, BBG3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany:Exemestan Stada 25 mg Filmtabletten

Denmark:Exemestan Stada

Spain:Exemestano Stada 25 mg film-coated tablets EFG

France:EXEMESTANE EG 25 mg, coated tablet

Hungary:Funamel 25 mg film-coated tablet

Italy:Exemestane EG 25mg film-coated tablets

Netherlands:Exemestaan CF 25 mg, film-coated tablets

Portugal:Exemestano Stada

Romania:Memelin 25mg, film-coated tablets

Sweden:Exemestan Stada 25 mg film-coated tablets

Slovakia:Exemestan Stada 25 mg

Last review date of this leaflet:August 2020

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