Aromasil 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aromasil 25 mg coated tablets

exemestane

Read the entire 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

5 Storage of Aromasil

1. Contents of the pack and other information

1. What Aromasil is and what it is used for

This medicine is called Aromasil. Aromasil belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed 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.

Aromasil is used to treat early-stage hormone-dependent breast cancer 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 another form of hormonal treatment has not been sufficiently effective.

2. What you need to know before starting Aromasil

Do not take Aromasil

• if you are or have previously been allergic to exemestane (the active substance in Aromasil) 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, think you might be pregnant, or are breastfeeding.

Warnings and precautions

• Consult your doctor, pharmacist, or nurse before starting to take Aromasil.
• Before starting treatment with Aromasil, your doctor may perform a blood test to confirm that you have reached menopause.
• Your vitamin D levels will also be periodically 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, inform your doctor if you have any liver or kidney problems.
• Inform your doctor if you have a history of, or currently suffer from, any condition affecting bone strength. Your doctor may evaluate your bone density before and during treatment with Aromasil. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could reduce bone strength.

Taking Aromasil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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. 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), or preparations containing it.

Pregnancy and breastfeeding

Do not take Aromasil 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 you could become pregnant.

Driving and use of machines

If you experience dizziness, drowsiness, or fatigue while being treated with Aromasil, do not drive or operate machinery.

Aromasil contains sucrose, sodium, and methyl parahydroxybenzoate

• If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.
• Aromasil contains a small amount of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed); if this occurs, contact your doctor.
• Use in athletes
• This medicine contains exemestane, which may result in a positive doping test.

3. How to take Aromasil

Adult and elderly patients

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

Aromasil tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will advise you on how to take Aromasil and for how long.

The recommended dose is one 25 mg tablet per day.

If you need to go to hospital while being treated with Aromasil, inform the medical staff about the 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, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the container and the package 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 almost time for your next dose, take the next dose 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts causing yellowing of the skin (cholestatic 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 as soon as possible if you think you are experiencing any of these symptoms.

In general, Aromasil is well tolerated, and the following adverse effects observed in patients treated with Aromasil are mainly mild or moderate. Most of these adverse effects are associated with reduced estrogen levels (for example, hot flushes).

Very common: 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)
• Tiredness
• Reduction in white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in the blood
• Elevated levels of blood enzymes 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 affecting the entire hand except the little finger) or skin tingling/tingling sensations
• Nausea (feeling unwell), vomiting, 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
• Reduction in blood platelet count
• Feeling of weakness

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 liver's bile ducts causing yellowing of the skin

Frequency not known: 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 (low lymphocyte count in the blood).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aromasil

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.
• This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aromasil

• The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other components are colloidal hydrated silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethylstarch (type A), polysorbate, polyvinyl alcohol, simethicone, macrogol, sucrose, light magnesium carbonate, methylparahydroxybenzoate (E218), cetyl ester wax, talc, carnauba wax, ethyl alcohol, shellac, titanium dioxide (E171) and iron oxides (E172).

Appearance of the product and contents of the pack

Aromasil is a round, biconvex, film-coated tablet, white to off-white in colour, marked with "7663" on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in 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 the most recent revision of this leaflet: 07/2025.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)