Exemestane Desgen 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Exemestane Desgen 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 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Exemestane belongs to a group of medicines called aromatase inhibitors.

These drugs interfere with a substance called aromatase, which is required to produce female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane is used to treat

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

advanced hormone-dependent breast cancer in postmenopausal women when other hormonal treatments have not been sufficiently effective.

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

Do not take Exemestane Desgen 25mg

• if you are allergic to exemestane or to any of the other ingredients of this medicine (listed in section 6),
• if you have not yet reached menopause, that is, if you still have menstrual periods,
• if you are pregnant or think you might be pregnant,
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor before taking Exemestane Desgen 25mg

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

• Periodically, your vitamin D levels may also be checked before starting treatment, as these 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 problems with your liver or kidneys.

• Inform your doctor if you have a personal or family history of, or currently suffer from, any disease affecting bone strength. Your doctor may evaluate your bone density before and during treatment with Exemestane. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could decrease bone strength.

Using other medicines and Exemestane Desgen 25 mg

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

Other medicines may be affected by exemestane. In turn, they may affect how well exemestane works.

Exemestane must not be taken 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),
• carbamazepine or phenytoin (antiepileptics used to treat epilepsy),
• the herbal remedy St. John’s wort (Hypericum perforatum), used for the treatment of depression and general inflammation, or preparations containing it.

Taking Exemestane Desgen 25mg with food and drink

Exemestane should be taken after meals.

Pregnancy and breastfeeding

Do not take Exemestane Desgen if you are pregnant or breastfeeding.

Inform your doctor if you are pregnant or think you might be pregnant.

Talk to your doctor about contraceptive measures if there is any possibility.

Driving and using machines

If you experience dizziness, drowsiness, fatigue, or general malaise while being treated with exemestane, do not drive or operate machinery until you feel better.

Information about excipients

Exemestane Desgen 25mg contains glucose and sodium.

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

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

3. How to take Exemestano Desgen 25mg

Adult and elderly patients

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor again.

Exemestane tablets must be taken orally after a meal, at approximately the same time each day. Your doctor will advise you on how to take exemestane and for how long.

The recommended dose is one 25 mg tablet daily.

If you need to go to the hospital while undergoing treatment with exemestane, inform the medical staff about the medication you are taking.

Use in children

Exemestane is not suitable for use in children.

If you take more Exemestano Desgen 25mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 make up for forgotten tablets.

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

If you stop treatment with Exemestano Desgen 25mg

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects,
although not everyone will experience them.

The adverse effects observed in patients treated with exemestane are mainly mild
or moderate. Some adverse effects are associated with reduced estrogen levels (such as hot flushes).

Liver inflammation (hepatitis) may occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor immediately if you think you are experiencing any of these symptoms.

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

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in the blood
• Elevated levels of blood enzymes in the blood due to liver damage
• Pain

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

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger) or skin tingling/tingling sensations
• Vomiting (feeling unwell)
• Constipation
• Indigestion
• Diarrhea
• Hair loss
• Skin rash, hives, and itching
• Decreased bone density, which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Reduced number of platelets in the blood
• Muscle weakness

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

• Hypersensitivity

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

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

Adverse effects of unknown frequency (cannot be estimated from 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if
they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Desgen 25mg

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister or the box.

The expiry date refers to the last day of the month indicated.

Do not dispose of medicines via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Contents of the pack and composition of Exemestane Desgen 25 mg

• The active substance 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 from potato starch (type A), magnesium stearate, colloidal anhydrous silica.
• The components of the coating are sodium carmellose (E466), maltodextrin, glucose monohydrate, titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172).

Appearance of Exemestane Desgen 25 mg and contents of the pack

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

Exemestane tablets are available in blister packs containing 30, 90, and 100 tablets;
unit dose packaging of 30 tablets.

Only certain 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
The Netherlands

Synthon Hispania, S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain

Date of the most recent review of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS)
http://www.aemps.gov.es/