Leaflet: information for the user

Exemestano Desgen25 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 similar symptoms to 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.

1. What Exemestano Desgen 25mg is and what it is used for

2. What you need to know before taking Exemestano Desgen 25mg

3. How to take Exemestano Desgen 25mg

4.Possible side effects

5.Storage of Exemestano Desgen 25mg

6.Contents of the pack and additional information

Exemestano belongs to a group of medications known as aromatase inhibitors.

These drugs 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 is used to treat

• early hormone-dependent breast cancer in postmenopausal women when they have completed 2-3 years of treatment with tamoxifen

advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Exemestano Desgen 25mg

• if you areallergicto exemestano or to any of the other ingredientsof this medication (listed in section 6).
• if you have not yet reached menopause, that is, if you still have your period,
• if you arepregnant orbelieve you may be pregnant
• if you are inlactation

Warnings and precautions

Consult with your doctor before taking Exemestano Desgen 25mg

• Before starting treatment with Exemestano Desgen 25mg, your doctor may perform a blood test to ensure that you have reached menopause.

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

• Inform your doctor if you have any liver or kidney problems.
• Inform your doctor if you haveany history or condition that affects your bone resistance. Your doctor may analyze your bone density before and during treatment with Exemestano. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content and reduced resistance.

Use of other medications and Exemestano Desgen 25 mg

Inform your doctor or pharmacistif you are using, have used recently, or may be using any other medication.

Other medications may be affected by exemestano. These, in turn, may affect the proper functioning of exemestano.

Exemestanoshould 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. Inform your doctor if you are taking any of these medications:

• rifampicin(an antibiotic),
• carbamazepineorphenytoin(antiepileptic medications used to treat epilepsy),
• the medicinal herbSt. John's Wort(Hypericum perforatum), used to treat depression and general inflammation, or preparations containing it.

Taking Exemestano Desgen 25mg with food and beverages

Exemestano should be taken after meals.

Pregnancy and lactation

Do not take Exemestano desgen if you are pregnant or in lactation.

Inform your doctor if you are pregnant or may be pregnant.

Discuss contraceptive measures with your doctor if there is any possibility

Driving and operating machinery

If you experience dizziness, drowsiness, fatigue, or general discomfort while taking exemestano, do not drive or operate machinery until you feel better.

Warnings about excipients

Exemestano Desgen 25mg contains glucose and sodium.

If your doctor has already informed you that you haveintolerance to certain sugars, contact your doctor before taking this medication.

This medication contains less than 23mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”

Adult and Elderly Patients

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Exemestano tablets must be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take exemestano and for how long.

The recommended dose is one 25 mg tablet per day .

If you need to go to the hospital while taking exemestano, inform the medical staff what medication you are taking.

Use in Children

Exemestano is not suitable for use in children.

If you take more Exemestano Desgen 25mg than you should

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 taken.

If you forget to take Exemestano Desgen 25mg

Do not take a double dose to compensate for the missed tablets.

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 Desgen 25mg

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 may cause side effects, although not everyone will experience them.

Side effects observed in patients treated with exemestane are mainly mild or moderate.

Some side effects are associated with the reduction of estrogens (such as hot flashes).

Liver inflammation (hepatitis) may occur. Symptoms include a general feeling of discomfort, nausea, jaundice (yellow skin and eyes), itching, pain in the right upper abdomen, and loss of appetite.

Contact your doctor immediately if you think you are experiencing any of these symptoms.

Side effectsvery common(may affect more than 1 in 10 people):

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• General feeling of discomfort
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduced white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown in the blood
• Elevated levels of blood enzymes due to liver damage
• Pain

Side effectscommon(may affect up to 1 in 10 people):

• Loss of appetite
• Carpal tunnel syndrome (a combination of numbness, tingling, and pain affecting the entire hand except the little finger) or tingling/numbness in the skin
• Nausea (general feeling of discomfort)
• Constipation
• Indigestion,
• Diarrhea
• Hair loss
• Skin rash, urticaria, and itching
• Decreased bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking)
• Swelling of hands and feet
• Reduced platelet count in the blood
• Muscle weakness

Side effectsuncommon(may affect up to 1 in 100 people):

• Hypersensitivity

Side effects rare (may affect up to 1 in 1,000 people):

• Appearance of small blisters on a skin rash
• Numbness
• Liver inflammation Inflammation of the bile ducts of the liver causing yellowing of the skin

Side effects of unknown frequency (cannot be estimated from available data):

• Low levels of certain white blood cells in the blood.

You may also experience changes in the number of certain blood cells (lymphocytes) and platelets 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 for 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.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the blister or the

package.

The expiration date is the last day of the month indicated.

Do not dispose of the medication through the drains or in the trash. Deposit the containers and the

medications that you do not need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and the medications that you do not need. By doing so, you will help protect the environment.

     Contents of the packaging and infor Composition of Exemestane Desgen 25mg

• The active ingredient is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other components are mannitol (E421), hypromellose, crospovidone (type B), polysorbate 80, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica.
• The coating components are sodium carmellose (E466), maltodextrin, glucose monohydrate, titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172).

     Appearance of Exemestane Desgen 25mg and contents of the packaging

     Exemestane are yellow, biconvex, round, coated tablets marked on one face with “E9MT” and on the other face with “25”.

     Exemestane tablets are available in blister pack sizes of 30, 90, and 100 tablets; unit dose of 30 tablets.

     Only some packaging sizes may be marketed.

     Holder of the marketing authorization and responsible manufacturer

     Holder

GENERFARMA, S.L.

Isaac Peral 6 - Parque Tecnológico

46980– Paterna (Valencia)

Spain

Responsible manufacturer

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Synthon Hispania, S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Spain

Last review date of this leaflet: May 2021

     Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gov.es/