EXEMESTANE AUROVITAS SPAIN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestane Aurovitas Spain 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, 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

1. What Exemestane Aurovitas Spain is and what it is used for

This medicine is called Exemestane Aurovitas Spain. Exemestane belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to produce 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.

This medicine is used to treat early hormone-dependent breast cancer in postmenopausal women after completing 2-3 years of treatment with tamoxifen.

It is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when alternative hormonal treatments have not been effective.

2. What you need to know before you take Exemestane Aurovitas Spain

Do not take Exemestane Aurovitas Spain

• if you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6)
• if you have notreached menopause, e.g. if you still have your menstrual period
• if you are pregnant, could be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• Before starting treatment with this medicine, your doctor may decide to perform blood tests to ensure you have reached menopause.
• Before starting treatment with this medicine, tell your doctor if you have any liver or kidney disease.
• If you have had or have any condition that affects the strength of your bones. This is because this type of medicine reduces female hormone levels, which can cause a loss of bone mineral content, making your bones weaker. Your doctor may decide to monitor your bone density before and during treatment with exemestane. Your doctor may give you medication or vitamin D supplements to prevent bone loss.

Other medicines and Exemestane Aurovitas Spain

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

This medicine must not be taken at the same time as hormone replacement therapy (HRT). The following medicines should be used with caution when taken at the same time as exemestane. Tell your doctor if you are taking medicines such as:

• Rifampicin (an antibiotic).
• Carbamazepine or phenytoin (anticonvulsants used to treat epilepsy).
• St John's Wort (Hypericum perforatum), or preparations that contain it.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant or breastfeeding.

If you are pregnant, could be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Discuss with your doctor the possible use of contraceptive methods if there is any chance of becoming pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while taking exemestane, do not drive or operate machinery while taking this medicine.

Exemestane Aurovitas Spain contains sodium

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

3. How to take Exemestane Aurovitas Spain

Follow exactly the instructions for taking this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

Adults and elderly patients

Exemestane should be taken orally, after a meal, at approximately the same time each day. Your doctor will tell you how to take this medicine and for how long. The recommended dose is one 25 mg tablet per day.

Use in children

This medicine is not recommended for use in children.

If you take more Exemestane Aurovitas Spain than you should

If you accidentally take too many tablets, contact your doctor or go to the nearest hospital emergency department immediately. Show them the Exemestane Aurovitas Spain packaging.

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 used.

If you forget to take Exemestane Aurovitas Spain

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

If you stop taking Exemestane Aurovitas Spain

Do not stop taking exemestane unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the bile ducts in the liver, which causes yellowing of the skin (cholestatic hepatitis), may occur. 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 as soon as possible if you think you have any of these symptoms.

Generally, exemestane is well tolerated, and the following side effects observed in patients treated with this medicine are usually mild or moderate. Most side effects are related to the lack of estrogens (e.g., hot flashes).

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

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

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

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand, except the little finger) or tingling/numbness in the skin
• Vomiting (nausea), constipation, indigestion, diarrhea
• Hair loss
• Rash, hives, and itching
• Bone loss that can weaken bones (osteoporosis) and may lead to fractures (breaks or cracks)
• Swelling of hands and feet
• Decreased 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
• Drowsiness
• Liver inflammation
• Inflammation of the bile ducts in the liver, which causes yellowing of the skin

Frequency not known (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 (decreased lymphocytes in the blood).

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website www.notificaRAM.es

5. Storage of Exemestane Aurovitas Spain

This medicine does not require special storage conditions

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

Do not use Exemestane Aurovitas Spain after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestane Aurovitas Spain

The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.

The other ingredients are:

Tablet core:Mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate (Type A) potato, magnesium stearate.

Tablet coating:Hypromellose, polyethylene glycol 400, and titanium dioxide.

Appearance of the product and pack contents

White or almost white, round, film-coated tablets with "25" engraved on one side and smooth on the other.

Exemestane Aurovitas Spain is available in blister packs (10 tablets) with 30 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

EirGen Pharma Limited

Westside Business Park

Old Kilmeaden Road

Waterford (Ireland)

This medicine is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: Exemestane 25mg Film-coated tablets

Spain: Exemestano Aurovitas Spain 25 mg film-coated tablets EFG

Date of the last revision of this leaflet:April 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.