I

EXEMESTANE

25 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1. What Exemestane 25 mg Film-Coated Tablets are and what they are used for

2. Before you take Exemestane 25 mg Film-Coated Tablets

3. How to take Exemestane 25 mg Film-Coated Tablets

4. Possible side effects

5. How to store Exemestane 25 mg Film-Coated Tablets

6. Further information

OWHAT EXEMESTANE 25 mg

FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Your medicine is called Exemestane 25 mg Film-Coated Tablets.

Exemestane 25 mg Film-Coated Tablets belong to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make the female sex hormone, oestrogen, especially in postmenopausal women. Reducing oestrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane 25 mg Film-Coated 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.

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

©BEFORE YOU TAKE EXEMESTANE 25 mg FILM-COATED TABLETS

Do not take Exemestane 25 mg Film-Coated Tablets

if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane 25 mg Film-Coated Tablets or any of the other ingredients of Exemestane 25 mg Film-Coated Tablets (Please see 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 if you are breast-feeding.

Take special care with Exemestane 25 mg Film-Coated Tablets

•    Before treatment with Exemestane 25 mg Film-Coated Tablets, your doctor may want to take blood samples to make sure you have reached the menopause.

•    Before taking Exemestane 25 mg Film-Coated Tablets, tell your doctor 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. 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. You may have to undergo tests to measure your bone density before and during treatment. Your doctor can give you medicine to prevent or treat the bone loss.

Taking other medicines

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

Exemestane 25 mg Film-Coated Tablets should not be given at the same time as hormone replacement therapy (HRT). The following medicines should be used cautiously when taking Exemestane 25 mg Film-Coated Tablets. Let your doctor know if you are taking medicines such as:

•    rifampicin (an antibiotic)

•    carbamazepine or phenytoin (anti-convulsants used to treat epilepsy)

•    the herbal remedy St John's wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breast-feeding

Do not take Exemestane 25 mg Film-Coated Tablets if you are pregnant or breast-feeding. If you are pregnant or think you might be, tell your doctor.

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 25 mg Film-Coated Tablets, you should not attempt to drive or operate machinery.

©HOW TO TAKE EXEMESTANE 25 mg FILM-COATED TABLETS

Always take Exemestane 25 mg Film-Coated Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how to take Exemestane 25 mg Film-Coated Tablets and for how long.

Adults and the elderly

The usual dose is one 25 mg film-coated tablet daily.

Exemestane 25 mg Film-Coated Tablets should be taken by mouth after a meal at approximately the same time each day.

Children and adolescents

Exemestane 25 mg Film-Coated Tablets are not suitable for use in children and adolescents.

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If you take more Exemestane 25 mg Film-Coated Tablets than you should

If too many tablets are taken by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of Exemestane 25 mg Film-Coated Tablets.

If you forget to take Exemestane 25 mg Film-Coated Tablets

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

If you forget to take your film-coated 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 25 mg Film-Coated Tablets

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

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 (blood cells which cause clotting) circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).

If any side effects gets serious or if you notice any side effect not listed on this leaflet, please tell your doctor or your pharmacist as soon as possible.

©HOW TO STORE EXEMESTANE 25 mg FILM-COATED TABLETS

POSSIBLE SIDE EFFECTS

Keep out of the reach and sight of children.

Do not use Exemestane 25 mg Film-Coated Tablets after the expiry date which is stated on the carton after <EXP>.

The expiry date refers to the last day of that month.

Like all medicines, Exemestane 25 mg Film-Coated Tablets can cause side effects, although not everybody gets them. In general, Exemestane 25 mg Film-Coated Tablets are well tolerated and the following side effects observed in patients treated with Exemestane 25 mg Film-Coated Tablets 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 side effects, (occurring in 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.

This medicine does not require any special storage conditions.

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.

FURTHER INFORMATION

What Exemestane 25 mg Film-Coated Tablets contain

The active substance is exemestane. Each film-coated tablet contains 25 mg exemestane.

Common side effects, (occuring in more than 1 in 100 but less than 1 in 10 people):

•    Loss of appetite

•    Depression

•    Dizziness, carpal tunnel syndrome (a combination 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, (occurring in more than 1 in 1000 but less than 1 in 100 people):

•    Drowsiness

•    Muscle weakness.

Inflammation of the liver (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 if you think you have any of these symptoms.

The other ingredients are:

Tablet core:

Mannitol, Copovidone, Crospovidone, Silicified Microcrystalline Cellulose, Sodium Starch Glycolate (Type A), Magnesium Stearate.

Film coating:

Hypromellose, Macrogol 400,Titanium Dioxide.

What Exemestane 25 mg Film-Coated Tablets look like and contents of the pack

White to off-white, round compound cup tablet, debossed with "25" on one side and plain on the reverse.

Exemestane 25 mg Film-Coated Tablets are available in blister packs of:

10, 14, 20, 30, 50x1,60, 90, 100 (Blisters of 10 or 14) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorsiation Holder is TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom.

Manufacturer is EirGen Pharma Ltd. 64/65 Westside Business Park, Old Kilmeaden Road, Waterford, Ireland.

This leaflet was last revised in August 2011.

PL 00289/1498

90013-B

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TEVA UK LIMITED    000000