EXEMESTANE DESGEN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestane Desgen25 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 Desgen 25mg and what is it used for
2. What you need to know before you take Exemestane Desgen 25mg
3. How to take Exemestane Desgen 25mg
4. Possible side effects
5. Storage of Exemestane Desgen 25mg
6. Contents of the pack and other information

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

Exemestane belongs to a group of medicines called 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.

Exemestane 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 other hormonal treatment has not been effective enough.

2. What you need to know before you take Exemestane Desgen 25mg

Do not take Exemestane Desgen 25mg

• if you are allergicto exemestane or any of the other ingredients of this medicine (listed in section 6).
• if you have not reached menopause, i.e., if you still have your period,
• if you are pregnant orthink you may be pregnant
• if you are breast-feeding

Warnings and precautions

Consult your doctor before taking Exemestane Desgen 25mg

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

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

• Before taking Exemestane, inform your doctor if you have any liveror kidneyproblems.
• Tell your doctor if you have a history of or suffer from any disease that affects bone strength. Your doctor may analyze your bone density before and during treatment with Exemestane. This is because drugs in this group reduce female hormone levels, which can lead to a loss of bone mineral content and may decrease bone strength.

Use of other medicines and Exemestane Desgen 25mg

Tell your doctor or pharmacistif you are taking, have recently taken, or might take any other medicines.

Other medicines may be affected by exemestane. These, in turn, may affect the proper functioning of exemestane.

Exemestane should notbe administered at the same time as hormone replacement therapy (HRT).

The following medicines should be used with caution if you are being treated with exemestane. Inform your doctor if you are taking any of these medicines:

• rifampicin(an antibiotic),
• carbamazepineor phenytoin(antiepileptics used to treat epilepsy),
• the herbal medicine St. John's Wort(Hypericum perforatum), used to treat depression and general inflammation, or preparations containing it.

Taking Exemestane Desgen 25mg with food and drinks

Exemestane should be taken after meals.

Pregnancy and breast-feeding

Do not take Exemestane Desgen if you are pregnant or breast-feeding.

Tell your doctor if you are pregnant or think you may be pregnant.

Talk to your doctor about birth control measures if there is any possibility of pregnancy.

Driving and using machines

If you feel dizzy, drowsy, tired, or unwell while being treated with exemestane, do not drive or operate machinery until you feel better.

Warnings about excipients

Exemestane Desgen 25mg contains glucose and sodium.

If you have been informed by your doctor that you have intolerance to certain sugars, contact your doctor before taking this medicine.

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

3. How to take Exemestane Desgen 25mg

Adult and elderly patients

Follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor again.

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

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while being treated with exemestane, inform the medical staff what medication you are taking.

Use in children

Exemestane is not suitable for use in children.

If you take more Exemestane Desgen 25mg than you should

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

If you forget to take Exemestane Desgen 25mg

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

If you forget to take a tablet, take it as soon as you remember. If it is near the time of your next dose, take it at the usual time.

If you stop taking Exemestane Desgen 25mg

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

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.

The 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).

There may be inflammation of the liver (hepatitis). Symptoms include a feeling of general discomfort, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right upper abdomen, and loss of appetite. Contact your doctor immediately if you think you have any of these symptoms.

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

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

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

• Lack of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger) or tingling/numbness in the skin
• Nausea (feeling unwell)
• Constipation
• Indigestion
• Diarrhea
• Hair loss
• Rash, hives, and itching
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Reduced platelet count in the blood
• Muscle weakness

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

• Hypersensitivity

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

• Appearance of small blisters in a skin rash
• Numbness
• Liver inflammation
• Inflammation of the bile ducts in the liver that causes yellowing of the skin

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

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

There may also be changes in the number of certain blood cells (lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (reduced lymphocytes in the blood).

Reporting of side effects

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

5. Storage of Exemestane Desgen 25mg

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister or carton.

The expiry date is the last day of the month stated.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Contents of the pack and information about Exemestane Desgen 25mg

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

Appearance of Exemestane Desgen 25mg and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GENERFARMA, S.L.

Isaac Peral 6 - Parque Tecnológico

46980– Paterna (Valencia)

Spain

Manufacturer

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Synthon Hispania, S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Spain

Date of last revision of this leaflet: May 2021

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

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