Exemestane 25 mg coated tablets

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.

In this leaflet

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

Exemestane 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
• to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.

Do not take Exemestane

• if you are allergic (hypersensitive) to exemestane or any of the other ingredients of this medicine (listed in section 6).
• if you have not already been through 'the menopause', i.e. you are still having your monthly period,
• if you are pregnant, or are likely to be pregnant
• if you are breast-feeding.

Warnings and precautions

Before treatment with Exemestane, your doctor may want to take blood samples to make sure you have reached the menopause.

Before treatment, your Vitamin D level maybe routinely checked as in the early stages of breast cancer this may be very low. If your levels are lower than normal, you will be given a Vitamin D supplement.

Talk to your doctor or pharmacist before taking Exemestane:

• if you have problems with your liver or kidneys.
• if you have a history or are suffering from any condition which affects the strength of your bones (e.g. osteoprosis). Your doctor may want to measure your bone density before and during the treatment with Exemestane. This is because drugs of this class lower the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength. Your doctor may give you medicine to prevent or treat bone loss.

Please tell your doctor if one of these conditions applies to you.

Children and adolescents

Exemestane is not suitable for use in children and adolescents.

Anti-doping test

The active substance exemestane contained in this medication can produce a positive analytic result in an anti-doping test.

Other medicines and Exemestane

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Exemestane should not be given at the same time as oestrogen-containing medicines, for example hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking Exemestane:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (medicines used to treat epilepsy),
• the herbal remedy St Johns Wort (Hypericum perforatum), or preparations containing it.

Exemestane with food and drink

You should take Exemestane tablets after a meal.

Pregnancy, breast-feeding and fertility.

Do not take Exemestane if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should discuss contraception with your doctor if there is any possibility that you may become pregnant.

Driving and using machines

If you feel tired, drowsy, dizzy or weak whilst taking Exemestane, you should not drive or operate machinery.

Exemestane tablets contain sucrose (sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Exemestane tablets contain sucrose (a type of sugar), which may cause a problem in a small number of patients with hereditary intolerance to some sugars (glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase insufficiency).

Dosage

Adults and the elderly

The reccomended dose is one tablet daily after a meal, at approximately the same time each day.

Use in children and adolescents

Exemestane is not suitable for children and adolescents under the age of 18.

Method of administration

You should take Exemestane tablets by mouth. Do not chew the tablets. You can swallow the tablets with some liquid (e.g. a glass of water, 200ml).

Duration of treatment

Your doctor will tell you how long you should take Exemestane tablets.

If you take more Exemestane than you should

If you have taken too many tablets by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of Exemestane tablets.

If you forget to take Exemestane

Do not take a double dose to make up for a forgotten tablet.

If you forget to take your tablet, take it as soon as you remember. If it is nearly time for the next dose, take it at the usual time.

If you stop taking Exemestane

Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.

Seek advice from your doctor immediately if:

• you have signs of a decreased number of white blood cells called leucocytes. Symptoms can include frequent infections, fatigue, sleepiness, fever and headache.
• you have signs of a decreased number of blood cells called platelets. Symptoms can include brusing easily, prolonged bleeding from cuts, bleeding gums, nose bleeds, fatigue and yellowing of the skin and/or whites of the eyes (jaundice).
• your bones seem weaker and/or have been easily fracturered as this may indicate that your bones have thinned and weakend (osteoporosis). Your doctor may decide that you should stop using Exemestane.

Very common side effects (may affect more than 1 in 10 people)

• Depression
• Decreased number of white blood cells
• Headache
• Nausea (feeling sick)
• Abdominal pain
• Dizziness
• Increased sweating
• Muscle and joint pain (including inflammation of bones and joints, back pain, pain in limbs and joint stiffness)
• Hot flushes
• Tiredness
• Difficulty sleeping
• Pain
• Elevated levels of liver enzyme
• Elevated levels of haemoglobin breakdown products in the blood
• Elevated levels of a blood enzyme (due to liver damage)

Common side effects (may affect up to 1 in 10 people)

• Carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all of the hand except the little finger)
• Stomach ache, vomiting, constipation, indigestion, diarrhoea
• Skin rash, itchiness, hives
• Hair loss
• Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks)
• Loss of appetite
• Muscle weakness
• Pain, swollen hands and feet
• A reduction of the number of platelets in the blood

Uncommon side effects (may affect up to 1 in 100 people)

• Hypersensitivity

Rare side effects (may affect up to 1 in 1,000 people)

• Break out of small blisters on the skin
• Inflammation of the liver
• Yellowing of the skin caused by inflammation of the bile ducts in the liver
• Drowsiness

Not known (frequency cannot be estimated from the available data)

• Decrease in the level of certain white blood cells in the blood
• Changes in the levels of certain white blood cells (lymphocytes) and platelets in the blood - especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood) may also be seen

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

What Exemestane looks like and contents of the pack

Exemestane is a round, biconvex, white to off-white, coated tablet.

Pack sizes: 10, 15, 20, 30, 90, 105, 100, 120

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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