Exemestane 25mg Film Coated Tablets
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Exemestane 25mg Film-coated Tablets
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.
• The full name of this medicine is Exemestane 25mg Film-coated Tablets but within the leaflet it will be referred to as Exemestane tablets.
In this leaflet:
j What Exemestane tablets are and what they are used for Before you take How to take
^ Possible side effects How to store
"6 Further information
j What Exemestane tablets are and what they are used for
Exemestane 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 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.
Before you take
Do not take Exemestane tablets if you
• are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane tablets) or any of the other ingredients of Exemestane tablets. See section 6 ("What Exemestane tablets contain”) for full list of other ingredients.
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• have not already been through 'the menopause', i.e. you are still having your monthly period.
• are pregnant, likely to be pregnant or breastfeeding.
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 taking 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 of 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.
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 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.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Exemestane tablets 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 Exemestane tablets, you should not attempt to drive or operate machinery.
Howto take
Adults and the elderly
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 Exemestane tablets and for how long. The recommended dose is one 25mg tablet daily.
Do not stop taking your tablets even if you are feeling well, unless your doctor
te||s you. Continued overpage
If you need to go to the hospital whilst taking Exemestane tablets, let the medical staff know what medication you are taking.
Children
Exemestane tablets are not suitable for use in children.
if you take more Exemestane 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 tablets.
if you forget to take Exemestane tablets
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 have any further questions on the use of this product, ask your doctor or pharmacist.
□ Possible side effects
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).
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.
B How to store
Keep out of the reach and sight of children.
Do not store above 25"C.
Do not use Exemestane tablets after the expiry date which is stated on the carton and blister after EXP. 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.
Like all medicines, Exemestane tablets can cause side effects, although not everybody gets them. In general, Exemestane tablets is 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).
Very common side effects, (affecting more than 1 person in 10):
• Difficulty sleeping
• Headache
• Hot flushes
• Feeling sick (nausea)
• 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 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
B Further information
What Exemestane tablets contain
• The active substance is exemestane. Each film-coated tablet contains 25mg exemestane.
• The other ingredients are: core: povidone K30; maize starch (bleached), starch, pregelatinized (partially), sodium starch glycolate type A, cellulose microcrystalline type 101, talc, silica colloidal anhydrous, magnesium stearate and polysorbate 80; film-coating: polyvinyl alcohol partially Hydrolyzed, talc, macrogol 3350 and titanium dioxide (E171).
What Exemestane tablets look like and contents of the pack
Exemestane 25mg film-coated tablet is white, round, lenticular, with uniform appearance and intact edges.
Pack sizes:
30 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf Rekjavikurvegur 76-78,
220 HafnarfjorSur Iceland
Manufacturer
S.C. Sindan-Pharma SRL 11, Ion Mihalache Blvd.,
011171 Bucharest Romania
This leaflet was last revised in July 2013
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 would like a leaflet with larger text, please contact 01271 311257.
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^actavis
Actavis, Barnstaple, EX32 8NS, UK