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EXEMESTANE 25 MG FILM-COATED TABLETS

Active substance(s): EXEMESTANE

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PACKAGE LEAFLET: INFORMATION FOR THE USER




Exemestane 25 mg film-coated tablets
exemestane

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 is and what it is used for
2. Before you take Exemestane 25 mg
3. How to take Exemestane 25 mg
4. Possible side effects
5. How to store Exemestane 25 mg
6. Further information

1. WHAT EXEMESTANE 25 MG IS AND WHAT IT IS
USED FOR
Exemestane belongs 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 hormones, oestrogens,
especially in postmenopausal women. Reduction in oestrogen levels
in the body is a way of treating hormone dependent breast cancer.
Exemestane is used for treating
• hormone dependent early breast cancer in postmenopausal
women after they have completed 2-3 years of treatment with
the medicine tamoxifen
• hormone dependent advanced breast cancer in postmenopausal
women when a different hormonal drug treatment has not
worked well enough.

2. BEFORE YOU TAKE EXEMESTANE 25 MG
Do not take Exemestane 25 mg
• if you are or have previously been allergic (hypersensitive) to
exemestane or to any of the other ingredients of
Exemestane 25 mg (see section 6, ‘What Exemestane 25 mg
contains’ for a full list of ingredients).
• if you have not yet gone through the menopause i.e. if you
still have periods.
• if you are pregnant or likely to get pregnant.
• if you are breast-feeding.
Take special care with Exemestane 25 mg
• if you have problems with your liver or kidneys, you will need to
inform your doctor about it.
• 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 of
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.

Before treatment with Exemestane 25 mg your doctor may want to
take blood samples to make sure you have reached the menopause.
Taking other medicines
Other medicines may be affected by exemestane. They, in turn, may
affect how well exemestane works.
Exemestane 25 mg should not be given at the same time as
hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking
exemestane. Let your doctor know if you are taking medicines
such as:
• rifampicin (an antibiotic),
• carbamazepine or phenytoin (medicines used to treat fits),
• the herbal remedy St Johns Wort (Hypericum perforatum),
which is used to treat depression and general inflammation, or
preparations containing it.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Exemestane 25 mg with food and drink
Exemestane 25 mg should be taken after a meal.
Pregnancy and breast-feeding
Exemestane 25 mg should not be taken during pregnancy and
breast-feeding as it may harm your baby.
Contact your doctor immediately if you think you are pregnant.
Discuss contraception with your doctor if there is any possibility that
you may become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy, tired, drowsy or generally unwell, do not drive or
operate any tools or machines until you feel normal again.
Important information about some of the ingredients of
Exemestane
Exemestane tablets contain glucose monohydrate. If you have
previously been told that you have intolerance to some sugars,
contact your doctor before taking this medicine.

3. HOW TO TAKE EXEMESTANE 25 MG
Always take Exemestane 25 mg exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly
Exemestane tablets should be taken by mouth after a meal at
about the same time each day. Your doctor will tell you how to take
exemestane and for how long.
The recommended dose is one 25 mg tablet daily.
If you need to go to the hospital whilst taking exemestane, let the
medical staff know what medication you are taking.
Children
Exemestane 25 mg is not suitable for use in children.
If you take more Exemestane 25 mg than you should
If you have taken too much Exemestane 25 mg, or if someone else
accidentally took your tablets, contact your doctor, pharmacy or
hospital for advice immediately.
Show them the pack of Exemestane 25 mg.
If you forget to take Exemestane 25 mg
Do not take a double dose to make up for a forgotten dose. 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 25 mg
Do not stop taking Exemestane 25 mg even if you are feeling well,
unless your doctor tells you. Your doctor will advise you on how long
you should continue to take your tablets.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, exemestane can cause side effects, although not
everybody gets them.
Most of the side effects are mild to moderate. Some of these side
effects, such as hot flushes may be due to the lack of oestrogens in
your body.
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 immediately if you think you have any of
these symptoms.
Very common side effects (affects more than 1 user in 10)
• Difficulty sleeping • Headache • Hot flushes • Feeling sick
• Increased sweating • Muscle and joint pain (including
inflammation of the joints, back pain, and joint stiffness) • Tiredness
Common side effects (affects 1 to 10 users in 100)
• Loss of appetite • Depression • Dizziness • a combination of
pins and needles, numbness and pain affecting all of the hand
except the little finger (carpal tunnel syndrome) • Stomach ache,
being sick (vomiting), constipation, indigestion, diarrhea • 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 (affects 1 to 10 users in 1,000)
• 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 reduction of
lymphocytes in the blood (lymphopenia).
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.

5. HOW TO STORE EXEMESTANE 25 MG
Keep out of the reach and sight of children.
This medicinal product does not require any special storage
conditions.
Do not use Exemestane 25 mg after the expiry date which is stated
on the blister and carton after EXP. The first two digits indicate the
month and the last four digits indicate the year. The expiry date
refers to the last day of that month.
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.

6. FURTHER INFORMATION
What Exemestane 25 mg contains
• The active substance is exemestane. Each film-coated tablet
contains 25 mg exemestane.
• The other ingredients are mannitol (E421), hypromellose,
crospovidone, polysorbate 80, microcrystalline cellulose, sodium
starch glycolate type A, magnesium stearate, colloidal anhydrous
silica.
• The ingredients in the tablet coating are carmellose sodium
(E466), maltodextrin, glucose monohydrate, titanium dioxide
(E171), stearic acid (E570), iron oxide yellow (E172).
What Exemestane 25 mg looks like and contents of the pack
Exemestane 25 mg is a yellow film-coated biconvex round tablet,
debossed with ‘E9MT’ on one side and ‘25’ on the other side.
Exemestane 25 mg tablets are available in blister packs of
30, 90 and 100 tablets; unit-dose of 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder: Synthon BV,
Microweg 22, 6545 CM Nijmegen, The Netherlands.
Manufacturers:
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands.
Synthon Hispania S.L. Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat, Spain.
Distributed by: Consilient Health (UK) Ltd, No.1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in January 2015

P0327

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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