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Aromasin®

25 mg coated tablets.

Exemestane

Reference Market: Italy

PACKAGE LEAFLET

Package leaflet: Information for the user

Aromasin 25 mg 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.

What is in this leaflet

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

Your medicine is called Aromasin. Aromasin belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.

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

Aromasin is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity, inflammation of the liver (hepatitis) and inflammation of the bile ducts of the liver which cause yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include feeling generally unwell, nausea, jaundice (yellowing of the skin and eyes), itching, right sided abdominal pain and loss of appetite. Contact your doctor promptly to seek urgent medical advice if you think you have any of these symptoms.

In general, Aromasin is well tolerated and the following side effects observed in patients treated with Aromasin are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (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)
• Tiredness
• A reduction in the number of white blood cells
• Abdominal pain
• Elevated level of liver enzymes
• Elevated level of a haemoglobin breakdown in the blood
• Elevated level of a blood 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 combination of pins and needles, numbness and pain affecting all of the hand except the little finger) or tingling/prickling of the skin
• Vomiting (nausea), constipation, indigestion, diarrhoea
• Hair loss
• Skin rash, hives and itchiness
• Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases
• Swollen hands and feet
• A reduction in the number of platelets 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

• A breakout of small blisters on an area of the skin in a rash
• Drowsiness
• Inflammation of the liver
• Inflammation of the bile ducts of the liver which cause yellowing of the skin

Not known frequency cannot be estimated from the available data

• Low level of certain white blood cells in the blood

Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood) may also be seen.

• Keep this medicine out of the sight and reach of children.
• Store below 30°C
• Do not use Aromasin after the expiry date stated on the box and on the blister pack after "Exp." The expiry date refers to the last day of that month.
• This medicine does not require special precautions for storage.

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 to protect the environment.