Aromasin

Package Leaflet: Information for the User

Aromasin 25 mg Film-coated Tablets

(Exemestane)
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aromasin is and what it is used for

Your medicine is called Aromasin. Aromasin belongs to a class of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed for the production of female sex hormones, the estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Aromasin is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have completed 2–3 years of therapy with the medicine tamoxifen.

Aromasin is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when hormone therapy with another medicine has not been sufficiently effective.

2. What you need to know before taking Aromasin

Do not take Aromasin

• If you are allergic to exemestane (the active substance in Aromasin) 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 still have regular menstrual periods.
• If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

• Talk to your doctor, pharmacist, or nurse before taking Aromasin.
• Before starting treatment with Aromasin, your doctor may request blood tests to confirm that you have reached menopause.
• Routine checks of your vitamin D levels may also be performed before starting treatment, as these levels can be very low in the early stages of breast cancer. If your vitamin D levels are below normal, you will be given a vitamin D supplement.
• Before taking Aromasin, inform your doctor if you have 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 consider it necessary to measure your bone mineral density before and during treatment with Aromasin. This is because medicines of this class reduce levels of female hormones, which may lead to loss of bone mineral content and cause bones to become weaker.

Other medicines and Aromasin

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

Aromasin must not be taken together with hormone replacement therapy (HRT).

The following medicines should be used with caution when taking Aromasin. Inform your doctor if you are taking:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• St John’s wort (Hypericum perforatum), or preparations containing it.

For those engaged in sports: Use of this medicinal product without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Pregnancy and breastfeeding

Do not take Aromasin during pregnancy or breastfeeding.

Inform your doctor if you are pregnant or think you might be pregnant.

Women who could become pregnant during treatment are advised to discuss with their doctor the use of an effective method of contraception.

Driving and using machines

If you experience drowsiness, dizziness, or weakness during treatment with Aromasin, you should not drive or operate machinery.

Aromasin contains sucrose, sodium, and methyl parahydroxybenzoate

• If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
• Aromasin contains a small amount of methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed). If this occurs, contact your doctor.

3. How to take Aromasin

Adults and elderly patients
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
Aromasin tablets should be taken orally once daily after meals, approximately at the same time each day. Your doctor will advise you on how to take Aromasin and for how long.
The recommended dose is one 25 mg tablet once daily.
If you need to go to hospital during treatment with Aromasin, inform the medical staff about the medicines you are taking.

Use in children
Aromasin is not indicated for use in children.

If you take more Aromasin than you should
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department and show them the Aromasin packaging.

If you forget to take Aromasin
Do not take a double dose to make up for a forgotten tablet.
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 Aromasin
Do not stop taking the tablets even if you feel well, unless otherwise instructed by your doctor.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aromasin can cause side effects, although not everyone experiences them.
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts may occur, which can lead to yellowing of the skin (cholestatic hepatitis). 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. If you think you are experiencing any of these symptoms, contact your doctor immediately to receive urgent medical assistance.

Aromasin is well tolerated, and the side effects listed below observed in patients treated with Aromasin are mainly mild or moderate in severity. Most of these side effects are related to estrogen deficiency (e.g., hot flushes).

Very common: may affect more than 1 in 10 people

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Nausea
• Increased sweating
• Muscle and joint pain (including: osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated level of a haemoglobin breakdown product in the blood
• Elevated level of an enzyme in the blood due to liver damage
• Pain

Common: may affect up to 1 in 10 people

• Loss of appetite
• Carpal tunnel syndrome (a sensation of pins and needles, numbness, and pain in the hand except the little finger), or skin tingling/prickling
• Vomiting (nausea), constipation, indigestion, diarrhoea
• Hair loss
• Skin rash, urticaria, and itching
• Thinning and weakening of the bones (osteoporosis), which in some cases may lead to bone fractures (breaks or cracks)
• Swelling of the hands and feet
• Reduced platelet count in the blood
• 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 a skin rash with small blisters
• Drowsiness
• Hepatitis (liver inflammation)
• Inflammation of the liver's bile ducts, which can cause yellowing of the skin

Not known: frequency cannot be estimated from the available data

• Low level of a certain type of white blood cells in the blood

Changes in the number of certain blood cells (lymphocytes) and circulating platelets may also occur, particularly in patients with pre-existing lymphopenia (reduced number of lymphocytes in the blood).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aromasin

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aromasin contains

• The active substance 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 carboxymethylstarch (type A), polysorbate, polyvinyl alcohol, simethicone, macrogol sucrose, light magnesium carbonate, methyl parahydroxybenzoate (E218), cetilic wax esters, talc, carnauba wax, ethyl alcohol, lacquer, titanium dioxide (E171) and iron oxides (E172).

Description of the appearance of Aromasin and contents of the pack
Aromasin tablets are film-coated, round, biconvex, white to off-white in colour,
marked with "7663" on one side.
Aromasin is available in blister packs containing 15, 20, 30, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Italia S.r.l., via Isonzo 71 – 04100 Latina
Manufacturer:
Pfizer Italia S.r.l
Località Marino del Tronto 63100 – Ascoli Piceno (AP)
Italy.

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Belgium, Denmark, Finland, Germany,
Greece, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Sweden, United Kingdom: Aromasin
France: Aromasine
Spain: Aromasil