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AROMASIN 25MG TABLETS

Active substance(s): EXEMESTANE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

AROMASIN 25mg TABLETS / EXEMESTANE 25mg TABLETS
(exemestane)
This product is available using any of the above names but will be referred to as
Aromasin throughout the following leaflet.
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 Aromasin is and what it is used for
2. Before you take Aromasin
3. How to take Aromasin
4. Possible side effects
5. How to store Aromasin
6. Further information
1. WHAT AROMASIN IS AND WHAT IT IS USED FOR
Your medicine is called Aromasin. Aromasin 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.
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.
2. BEFORE YOU TAKE AROMASIN
Do not take Aromasin
• if you are or have previously been allergic (hypersensitive) to exemestane (the active
ingredient in Aromasin) or any of the other ingredients of Aromasin. See section 6
(“What Aromasin contains”) for full list of other ingredients.
• 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.
Take special care with Aromasin
• Before treatment with Aromasin, your doctor may want to take blood samples to
make sure you have reached the menopause.
• Before taking Aromasin, 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 of Aromasin. 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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Aromasin should not be given at the same time as hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking Aromasin. 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 John’s Wort (Hypericum perforatum), or preparations containing it.
Pregnancy and breast-feeding
Do not take Aromasin if you are pregnant or breastfeeding.
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 Aromasin, you should not attempt to
drive or operate machinery.
Important information about some of the ingredients of Aromasin
If you have previously been told that you have intolerance to some sugars, contact
your doctor before taking this medicine. Aromasin 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
sucrose-isomaltase insufficiency).
• Aromasin contains a small amount of methyl parahydroxybenzoate, which may cause
allergic reactions (possibly delayed), if this should happen please contact your doctor.


3. HOW TO TAKE AROMASIN
Adults and the elderly
Aromasin tablets should be taken by mouth after a meal at approximately the same
time each day. Your doctor will tell you how to take Aromasin and for how long. The
recommended dose is one 25 mg tablet daily.
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
If you need to go to the hospital whilst taking Aromasin, let the medical staff know what
medication you are taking.

Children
Aromasin is not suitable for use in children.
If you take more Aromasin 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 Aromasin tablets.
If you forget to take Aromasin
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Aromasin can cause side effects, although not everybody gets them.
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 side effects, (affecting more than 1 person in 10):
• 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, (affecting between 1 to 10 people in 100):
• 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, (affecting between 1 to 10 people in 1000):
• 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.
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 AROMASIN
• Do not store your tablets above 30°C and keep them in the original pack.
• Before use, check the expiry date printed on the pack. Do not use after this date.
Return all unused tablets to your pharmacist for disposal.
• Keep out of the sight and reach of children.
• If your doctor tells you to stop taking the tablets, please take them back to the
pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show signs of any deterioration, you should seek
the advice of your pharmacist who will advise you what to do.
6. FURTHER INFORMATION
What Aromasin contains
Your medicine is called Aromasin. Each off-white, coated tablet marked 7663 on one
side contains 25 mg of the active ingredient, exemestane. It also contains black printing
ink, silica colloidal hydrated (E551), crospovidone, hypromellose (E464), magnesium
stearate (E572), mannitol (E421), microcrystalline cellulose (E460), sodium starch
glycollate (A), polysorbate 80 (E433), polyvinyl alcohol, simethicone, macrogol 6000,
sucrose, magnesium carbonate, light (E504), methyl-p-hydroxybenzoate (E218), cetyl
esters wax, talc, carnauba wax, ethyl alcohol, shellac, titanium oxides (E171) and iron
oxides (E172).
Aromasin is available in blister packs of 30 tablets.
POM

PL No: 15814/0509

Manufactured by Pfizer Italia, S.r.l., Via del Comercio, Zona industriale, 63100 Marino
del Tronto (Ascoli Piceno), Italy and procured from within the EU and repackaged by
the Product Licence holder: O.P.D. Laboratories Ltd, Unit 6 Colonial Way, Watford,
Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 01.04.2015.
Aromasin is a registered Trade Mark of Pfizer Enterprises Sarl.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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