Exemestane 25 Mg Film-Coated Tablets
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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 your pharmacist.
In this leaflet:
1. What Exemestane is and what it is used for
2. Before you take Exemestane
3. How to take Exemestane
4. Possible side effects
5. How to store Exemestane
6. Further information
1. What Exemestane is and what it is used for
Your medicine is called Exemestane. 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 to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.
Exemestane 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 Exemestane Do not take Exemestane
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane) or any of the other ingredients of Exemestane. See section 6 (“What Exemestane 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 Exemestane
• Before treatment with Exemestane, your doctor may want to take blood samples to make sure you have reached the menopause.
• Before taking Exemestane, 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. 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 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 (anticonvulsants used to treat epilepsy),
• herbal remedy St Johns Wort (Hypericum perforatum), or preparations containing it.
Pregnancy and breast-feeding
Do not take Exemestane 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, you should not attempt to drive or operate machinery.
3. How to take Exemestane 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 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 Exemestane, let the medical staff know what medication you are taking.
Children and adolescents below 18 years
Exemestane is not suitable for use in children and adolescents below 18 years.
If you take more Exemestane 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
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 stop taking Exemestane
Do not stop treatment without consulting your doctor. If you stop the treatment your symptoms might reappear.
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. In general, Exemestane is well tolerated and the following side effects observed in patients treated with Exemestane 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 teste 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 get serious or if you notice any side effect not listed on this leaflet, please tell your doctor or your pharmacist as soon as possible.
5. How to store Exemestane
Keep out of the reach and sight of children.
• This medicinal product does not require any special storage conditions.
• Do not use Exemestane after expiry date which is stated on the outer carton and the blister after EXP. The expiry date refers to the last day of the month.
• Exemestane 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 contains:
The active ingredient is Exemestane. Each film-coated tablet contains 25 mg of Exemestane.
The other ingredients are:
Tablet Core: Silica, colloidal anhydrous, Crospovidone, Hypromellose 5cP, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polysorbate 80 and Sodium Starch Glycolate (Type A).
Film-coatina: Hypromellose 5cP, Macrogol, Talc and Ttanium Dioxide (E171).
What Exemestane looks like and contents of the pack
Exemestane 25 mg Film-coated Tablets are white, round biconvex film-coated tablets
Exemestane 25 mg Film-coated Tablets are available in blister packs of 14,15,20,30,60,90,100 and 120.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
Remedies Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
This leaflet was prepared in: December 2013
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