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PACKAGE LEAFLET: INFORMATION FOR THE USER

Exemestane 25 mg film-coated tablets (exemestane)

What is in this leaflet:

1.    What Exemestane tablets are and what they are used for

2.    What you need to know before you take Exemestane tablets

3.    How to take Exemestane tablets

4.    Possible side effects

5.    How to store Exemestane tablets

6.    Contents of the pack and other information

1. What Exemestane tablets are and what they are used for

Exemestane tablets contain exemestane which 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.

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

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

2. What you need to know before you take Exemestane tablets Do not take Exemestane tablets:

•    If you are or have previously been 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, likely to be pregnant or breastfeeding.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Exemestane tablets.

Take special care with Exemestane tablets:

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

•    Before treatment with Exemestane tablets, tell your doctor if you have problems with your liver or kidneys;

•    Tell your doctor if you have a history or are suffering from any condition which affects the strength of your bones. Your doctor may want to measure your bone density before and during the treatment with Exemestane tablets. 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.

Children and adolescents

This medicine is not suitable for use in children.

Other medicines and Exemestane tablets

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

Exemestane tablets should not be given at the same time as hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking Exemestane tablets. Let your doctor know if you are taking medicines such as:

•    rifampicin (an antibiotic),

•    carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),

•    the herbal remedy St. Johns Wort (Hypericum perforatum), or preparations containing it.

Exemestane tablets with food and drink

Exemestane tablets should be taken after a meal at approximately the same time each day. See also information in Section 3 “How to take Exemestane tablets”.

Pregnancy, breast-feeding and fertility

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

Do not take Exemestane tablets if you are pregnant or breastfeeding.

Discuss contraception with your doctor if there is any possibility that you may become pregnant.

Driving and using machines

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and the older people

The recommended dose is one tablet daily.

Exemestane tablets should be taken by mouth after a meal at approximately the same time each day. Your doctor will tell you how to take your medicine and for how long.

If you need to go to the hospital whilst taking Exemestane tablets, let the medical staff know what medication you are taking.

Use in Children and adolescents

This medicine is not suitable for use in children.

If you take more Exemestane tablets than you should:

If you accidentally take too many tablets, contact your doctor immediately or go straight to your nearest hospital. Take your tablets and pack with you.

If you forget to take Exemestane tablets:

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Exemestane tablets:

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

In general, Exemestane tablets are well tolerated and the following side effects observed in patients treated with Exemestane tablets are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).

Inflammation of the liver (hepatitis) may occur. Symptoms include feeling unwell, nausea, jaundice (yellowing of skin and eyes), itching, right sided abdominal pain and loss of appetite. Contact your doctor promptly if you think you are having any of these symptoms.

Other side effects may include:

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

•    Difficulty sleeping

•    Headache

•    Hot flushes

•    Feeling sick

•    Increased sweating

•    Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)

•    Tiredness

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

•    Loss of appetite

•    Depression

•    Dizziness, carpal tunnel syndrome (a combinations of pins and needles, numbness and pain affecting all of the hand except the little finger)

•    Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea

•    Skin rash, hair loss

•    Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases

•    Pain, swollen hands and feet

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

•    Drowsiness

•    Muscle weakness

If you have any blood tests done, it may be noticed that there are changes in your liver function. Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. How to store Exemestane tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

•    The active substance is exemestane. Each tablet contains 25 mg exemestane.

•    The other ingredients are: microcrystalline cellulose, silica colloidal anhydrous, crospovidone, hypromellose, mannitol, sodium starch glycolate, magnesium stearate and polysorbate 80. The tablet coating contains Opadry white OYS 9622 (which consists of: hypromellose, propylene glycol and titanium dioxide (E171)).

What Exemestane tablets look like and contents of the pack

Exemestane tablets are white, round, biconvex, film-coated tablets embossed with an ‘E’ on one side.

Your medicine is supplied in blister packs containing 15, 20, 30, 90, 100 or 120 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Ranbaxy (UK) Limited,

Building 4, Chiswick Park,

566 Chiswick High Road,

London W4 5YE,

United Kingdom

Manufacturer:

Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece

This medicinal product is authorised in the Member States of the EEA under the

following names:

United Kingdom: Exemestane 25 mg film-coated tablets France: Exemestane Ranbaxy 25 mg comprime pellicule Romania: Exemestan Terapia 25 mg comprimate filmate

This leaflet was last revised in September 2014.