Aromasil 25 mg comprimidos recubiertos

Prospecto: information for the user

Aromasil 25 mg coated tablets

exemestane

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Aromasil and what it is used for

2.What you need to know before starting to take Aromasil

3.How to take Aromasil

4.Possible adverse effects

5Storage of Aromasil

6.Contents of the package and additional information

This medication is called Aromasil. Aromasil 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 form of treatment for 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 medication tamoxifen.

Aromasil is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Aromasil

• if you are or have been allergic to exemestane (the active ingredient in Aromasil) or to any of the other components of this medication (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

• Consult your doctor, pharmacist, or nurse before starting to take Aromasil.
• Before starting treatment with Aromasil, your doctor may perform a blood test to ensure that you have reached menopause.
• Your vitamin D levels will also be checked periodically before starting treatment, as they may be too low in the initial stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.
• Inform your doctor if you have any liver or kidney problems before taking Aromasil.
• Inform your doctor if you have a history or condition that affects your bone resistance. Your doctor may analyze your bone density before and during treatment with Aromasil. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content and reduced resistance.

Taking Aromasil with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Aromasil should not be taken at the same time as hormone replacement therapy (HRT).

The following medications should be used with caution if you are taking Aromasil. Inform your doctor if you are taking any of these medications:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptic medications used to treat epilepsy),
• 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 may be pregnant.

Discuss contraceptive measures with your doctor if there is any possibility of becoming pregnant.

Driving and operating machinery

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

Aromasil contains saccharose, sodium, and methyl parahydroxybenzoate

• If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• This medication contains less than 1 mmol of sodium (23 mg) per tablet; it 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.

Adults and Elderly Patients

Follow exactly the administration instructions for this medication as indicated 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 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 taking Aromasil, inform the medical staff 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 Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If You Forget to Take Aromasil

Do not take a double dose to compensate for the missed doses.

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

If You Interrupt Treatment with Aromasil

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

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

Like all medicines, this medicine may 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 a 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.

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 estrogen reduction (such as hot flashes).

Very common: may affect more than 1 person in 10

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• General feeling of discomfort
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduction in the number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown in the blood
• Elevated levels of blood enzymes due to liver damage
• Pain

Common: may affect up to 1 person in 10

• 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 of discomfort), constipation, indigestion, diarrhea
• Hair loss
• Skin rash, urticaria, and itching
• Decreased bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking)
• Swelling of hands and feet
• Reduction in the number of platelets in the blood
• Feeling of weakness

Uncommon: may affect up to 1 person in 100

• Hypersensitivity

Rare: may affect up to 1 person in 1,000

• Appearance of small blisters on a skin rash
• Numbness
• Liver inflammation
• Inflammation of the liver's bile ducts that causes 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 (decreased lymphocytes in the blood).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the outer box and on the blister pack after CAD. The expiration date is the last day of the month indicated.
• This medicationdoes not require special preservation conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aromasil

• The active principle is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other components are hydrated colloidal silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A) containing potato starch, polisorbate, polyvinyl alcohol, simethicone, macrogol, saccharose, light magnesium carbonate, methyl parahydroxybenzoate (E218), cetyl ester wax, talc, carnauba wax, ethanol, shellac, titanium dioxide (E171), and iron oxide (E172).

Appearance of the product and content of the container

Aromasil is a coated, round, biconvex tablet, white in color, marked on one of its faces with 7663.

Aromasil is presented in containers with blisters of 15, 20, 30, 90, 100, and 120 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa 20 B,

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Pfizer Italia, S.r.l.

Via del Comercio, Zona Industriale

63100 Marino del Tronto (Ascoli Piceno)

Italy

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with 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 last review of this leaflet:01/2022.

Other sources of information

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/)