AROMASIL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aromasil 25 mg Film-Coated Tablets

exemestane

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 Package Leaflet

1. What is Aromasil and what is it used for
2. What you need to know before you take Aromasil
3. How to take Aromasil
4. Possible side effects

5 Storage of Aromasil

1. Contents of the pack and other information

1. What is Aromasil and what is it used for

This medicine is called Aromasil. Aromasil 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. Reducing estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Aromasil is used to treat hormone-dependent breast cancer in early stages in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.

Aromasil is 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 Aromasil

Do not take Aromasil

• if you are or have previously been allergic to exemestane (the active substance of Aromasil) or to any of the other ingredients of this medicine (listed in section 6),
• if you have not yet reached menopause, i.e., if you are still having menstrual periods,
• if you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before you start taking Aromasil.
• Before starting treatment with Aromasil, 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 Aromasil, 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 Aromasil. 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.

Taking Aromasil with other medicines

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

Aromasil 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 Aromasil. 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 and breast-feeding

Do not take Aromasil 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 contraceptive measures if there is a possibility of becoming pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while being treated with Aromasil, do not drive or operate machinery.

Aromasil contains sucrose, sodium, and methyl parahydroxybenzoate

• If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".
• Aromasil contains a small amount of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed), so if this occurs, contact your doctor.
• Athletes
• This medicine contains exemestane, which may produce a positive result in doping tests.

3. How to take Aromasil

Adult and elderly patients

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor again.

Aromasil tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take Aromasil 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 Aromasil, let the medical staff know what medication you are taking.

Use in children

Aromasil is not suitable for use in children.

If you take more Aromasil than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet to the healthcare professional.

If you forget to take Aromasil

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 of the next dose, take it at the usual time.

If you stop taking Aromasil

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, 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 of 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.

In general, Aromasil is well tolerated, and the following side effects observed in patients treated with Aromasil are mainly mild or moderate. Most side effects are associated with the reduction of estrogens (such as hot flashes).

Very common: 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
• 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: 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
• Nausea (feeling sick), vomiting, 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
• Decreased platelet count in the blood
• Feeling weak

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity

Rare: 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 of 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 (decrease in lymphocytes in the blood).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aromasil

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the outer packaging and on the blister after EXP. The expiry date is the last day of the month shown.
• This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Aromasil

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients are colloidal hydrated silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethyl starch (type A), polysorbate, polyvinyl alcohol, simethicone, macrogol, sucrose, light magnesium carbonate, methyl parahydroxybenzoate (E218), cetylesters wax, talc, carnauba wax, ethanol, shellac, titanium dioxide (E171), and iron oxides (E172).

Appearance of the product and pack contents

Aromasil is a film-coated tablet, round, biconvex, white, marked with 7663 on one side.

Aromasil is available in blister packs of 15, 20, 30, 90, 100, and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Pfizer, S.L.

Avda. de Europa 20 B,

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pfizer Italia, S.r.l.

Via del Comercio, Zona Industriale

63100 Marino del Tronto (Ascoli Piceno)

Italy

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Denmark, Finland, Germany,

Greece, Iceland, Ireland, Italy, Luxembourg,

Netherlands, Portugal, United Kingdom (Northern Ireland): Aromasin

France: Aromasine

Spain: Aromasil

Date of last revision of this leaflet:07/2025.

Other sources of information

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/)