Leaflet: information for the user

Exemestane Aurovitas Spain 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 and should not be given to others, even if they have similar symptoms, 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.

In this leaflet:

1. What Exemestane Aurovitas Spain is and what it is used for
2. What you need to know before you start taking 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 additional information

This medication is called ExemestanoAurovitas Spain. 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 way to treat hormone-dependent breast cancer.

This medication 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 hormone treatments have not been effective.

Do not take Exemestano Aurovitas Spain

• if you are allergic to exemestano or any of the other components of this medication (listed in Section 6)
• if you have not reached menopause, for example if you still have your menstrual period
• if you are pregnant, may become pregnant, or are breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• Before starting treatment with this medication, your doctor may decide to perform blood tests to ensure that you have reached menopause.
• Before starting treatment with this medication, inform your doctor if you have any liver or kidney disease.
• If you have experienced or have any condition that affects the strength of your bones. This is because this type of medication decreases female hormone levels, which can cause a loss of mineral content in your bones, which can decrease their strength. Your doctor may decide to control bone density before and during treatment with exemestano. Your doctor may give you medication or Vitamin D supplements to prevent bone loss.

Other medications and Exemestano Aurovitas Spain

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication.

This medication should not be administered at the same time as hormone replacement therapy (HRT). The following medications should be used with caution when administered simultaneously with exemestano. Inform your doctor if you are taking medications such as:

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

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

Driving and operating machinery

If you feel dizzy, drowsy, or tired while taking exemestano, do not drive or operate machinery during treatment.

Exemestano Aurovitas Spain contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Adults and elderly patients

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

Use in children

This medication is not recommended for use in children.

If you take more Exemestano Aurovitas Spain than you should

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

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 used.

If you forget to take Exemestano Aurovitas Spain

Do not take a double dose to make up for missed doses.

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

If you interrupt treatment with Exemestano Aurovitas Spain

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

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

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

It may cause hypersensitivity, liver inflammation (hepatitis) and inflammation of the liver's bile ducts, which causes yellowing of the skin (cholestatic hepatitis). Symptoms include general feeling of discomfort, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you are experiencing any of these symptoms.

Exemestane is generally well tolerated, and the following side effects observed in patients treated with this medicine are of mild or moderate nature. Most side effects are associated with estrogen deficiency (for example, hot flashes).

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

• Depression
• Difficulty sleeping.
• Headache.
• Hot flashes.
• Dizziness.
• General feeling of discomfort.
• Increased sweating.
• Joint and muscle 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.

EffectsCommon side 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 tingling/numbness in the skin.
• Vomiting (dizziness), constipation, indigestion, diarrhea.
• Hair loss.
• Skin rash, urticaria, and itching.
• Bone loss that can reduce bone strength (osteoporosis) and, in some cases, may lead to fractures (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 on a skin rash.
• Drowsiness.
• Liver inflammation.
• Liver inflammation that causes yellowing of the skin.

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 (decreased lymphocytes in the blood).

Reporting of side effects

If you experience any type ofsideeffects, consult your doctor or pharmacist, even if it is a 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, Website:www.notificaRAM.es

This medication does not require special storage conditions

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

Do not use Exemestane Aurovitas Spain after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Exemestano Aurovitas Spain

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

The other components are:

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

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

Appearance of the product and content of the container

Film-coated round, white or off-white tablets with “25” engraved on one face and smooth on the other.

ExemestaneAurovitas Spainis available in blister packaging (10 tablets) with 30 and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Responsible for manufacturing:

EirGen Pharma Limited

Westside Business Park

Old Kilmeaden Road

Waterford (Ireland)

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom:Exemestane 25mg Film-coated tablets

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

Revision date of thisleaflet:April 2022

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