EXEMESTANE AUROVITAS 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

This medicine is called Exemestane Aurovitas. 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 hormone-dependent breast cancer in early stages 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 other hormonal treatment has not been effective enough.

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

Do not take Exemestane Aurovitas

• if you are or have been previously allergic to exemestane, soy, peanut, lecithin, or any of the other components of this medicine (listed in section 6),
• if you have not yet reached menopause, i.e., if you still have your period,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• Before starting treatment with this medicine, your doctor may perform a blood test to make sure you have reached menopause.
• Periodically, your vitamin D levels will also be checked 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 this medicine, tell your doctor if you have any liver or kidney problems.
• Tell your doctor if you have a history of or suffer from any disease that affects bone strength. Your doctor may check your bone density before and during treatment with exemestane. This is because medicines in this group reduce female hormone levels, which can lead to a loss of bone mineral content and may decrease bone strength.

Use in athletes

This medicine contains exemestane, which may produce a positive result in doping tests (see references in section 4.4 of the technical sheet).

Other medicines and Exemestane Aurovitas

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

This medicine should 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. Tell your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptics used to treat epilepsy),
• the herbal medicine 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.

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

Talk to your doctor about contraceptive measures if there is any chance you may become pregnant.

Driving and using machines

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

Exemestane Aurovitas contains sodium

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

Exemestane Aurovitas contains lecithin (soy)

This medicine contains lecithin derived from soy. Do not use this medicine in case of peanut or soy allergy (see section 2 "Do not take Exemestane Aurovitas").

3. How to take Exemestane Aurovitas

Adult and elderly patients

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

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.

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

Use in children

This medicine is not suitable for use in children.

If you take more Exemestane Aurovitas 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 used. It is recommended to take the packaging and the leaflet to the healthcare professional.

If you forget to take Exemestane Aurovitas

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

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

If you stop taking Exemestane Aurovitas

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

If you have any other 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 side of the 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 blood 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 reduce bone strength (osteoporosis) and may lead to fractures (breaks or cracks).
• Swelling of hands and feet.
• Decreased platelet count in the blood.
• Feeling of 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 that 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es

5. Storage of Exemestane Aurovitas

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestane Aurovitas

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

The other ingredients are:

Core of the tablet:pregelatinized starch, corn starch, microcrystalline cellulose (Grade-101), microcrystalline cellulose (Grade-102), crospovidone (Type A), sodium carboxymethyl starch (Type A) (potato), povidone (K 30), polysorbate 80, hydroxypropylcellulose (2.0 - 2.9 mPa.s), talc, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet:poly(vinyl alcohol), titanium dioxide (E171), talc, lecithin (soy) (E322), xanthan gum.

Appearance of the product and pack contents

White to off-white film-coated tablets, approximately 6 mm, round, biconvex, with beveled edges and "25" engraved on one side and smooth on the other side.

Exemestane Aurovitas 25 mg film-coated tablets EFG are available in PVC/PVdC opaque white aluminum blister packs of 28, 30, 60, 98, 100, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

You can ask for more information about this medicine by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany: Exemestan PUREN 25 mg Filmtabletten

Spain: Exemestano Aurovitas 25 mg comprimidos recubiertos con película EFG

France: Exemestane ARROW LAB 25 mg, comprimé pelliculé.

Italy: Exemestane Aurobindo Italia

Malta: Exemestane Eugia 25 mg film-coated tablets

Portugal: Exemestano Generis

Date of last revision of this leaflet:July 2024

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