Exemestane 25mg Film Coated Tablets
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Exemestane 25mg film-coated tablets (exemestane)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Exemestane is and what it is used for
2. What you need to know before you take Exemestane
3. How to take Exemestane
4. Possible side effects
5. How to store Exemestane
6. Contents of the pack and other information
1. What Exemestaneis 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. What you need to know before you take Exemestane
Do not take Exemestane
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestaneor any of the other ingredients of exemestane. See section 6 (“What Exemestanecontains”) 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, or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Warnings and precautions
• Before treatment with Exemestane, your doctor may want to take blood samples to make sure you have reached the menopause.
Talk to your doctor or pharmacist or nurse before taking Exemestane
• 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 (e.g. osteoporosis). 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.
• if you know you have low levels of vitamin D (for example you are unable to spend time in natural sunlight). Your doctor may want to check your Vit. D levels before treatment and, if needed, give you Vitamin D supplements.
• Exemestane contains a forbidden substance which is being able to provide a positive result in a doping control tests.
Children and adolescents
Do not give this medicine to children below 18 years because it is unlikely to be safe.
Other medicines and Exemestane
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription.
Exemestane should not be given at the same time as hormone replacement therapy (HRT) or with any oestrogen containing medicines (including combined oral contraceptive pills).
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.
Exemestane contains lactose and sucrose
If you have previously been told that you have intolerance to some sugars, contact your doctor before taking this medicine.
Pregnancy, breast-feeding and fertility
Do not take Exemestane if you are pregnant or breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 drowsy, dizzy or weak whilst taking Exemestane, you should not attempt to drive or operate machinery.
3. How to take Exemestane
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and the elderly
Exemestane 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. You should check with your doctor or pharmacist if you are not sure. 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.
Use in 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.
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 or nurse.
4. Possible side effects
Like all medicines, this medicine 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).
If you experience the following, stop taking tablets and tell your doctor immediately or go to the casualty department of your nearest hospital:
Uncommon side effects (may affect up to 1 in 100 people):
Sudden signs of allergy such as rash, itching or hives on the skin, welling of the face, lips, tongue or other parts of the body, shortness of breath , wheezing or trouble breathing (anaphylaxis)
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.
Very common (may affect 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
Common (may affect up to 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), tingling or numbness of the hands or feet (paraesthesia )
• Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea
• Skin rash, hair loss, hives and itchy rash
• 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 (may affect up to 1 in 100 people):
• Drowsiness
• Muscle weakness
• Low number of white blood cells (leukopenia)
• Liver disease
A generalised skin reaction that can occur anywhere on the body - the skin may be red with numerous small pus-filled blisters.
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). You may have increased bruising and bleeding or more infections (e.g. sore throat).
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.
In clinical studies the following side effects have been noted but it has not been established if these are related to the medicine itself: changes in vagina and womb, vaginal bleeding, changes in vision, blockage of blood vessel due to blood clotting, heart attack, increased blood pressure, heart failure, changes in or increased levels of cholesterol and other fats in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
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 Exemestane
Keep this medicine out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Exemestane contains
- The active substance is exemestane. Each tablet contains 25 mg of exemestane.
- The other ingredients are:
For core: hypromellose 2910, polysorbate 80, butylhydroxyanisole, butylhydroxytoluene, lactose monohydrate, sucrose, cellulose microcrystalline 102, crospovidove (type A), sodium lauryl sulphate, sodium starch glycolate (Type A), magnesium stearate, silica colloidal anhydrous.
For coating: magnesium carbonate, hypromellose 2910, lactose monohydrate, macrogol 3350/ 400, triacetin, sodium bicarbonate, titanium dioxide (E171).
What Exemestanelooks like and contents of the pack
Exemestane comes as a white film-coated (approximately 5.56 mm diameter), round, biconvex tablet debossed with “X” on one side of the tablet and “M” on the other side
Exemestane are available in Amber Aclar/Aluminium foil blisters 30 and 100 film-coated tablets in cardboard cartons and in Amber Aclar/Aluminium foil perforated unit dose blisters 30 x 1 and 100 x 1 film-coated tablets in cardboard cartons.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Potters Bar,
Hertfordshire, EN6 1TL United Kingdom
Manufacturer
McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road Dublin 13 Ireland
Mylan Hungary Kft ,
H-2900, Mylan utca 1,
Komarom
Hungary
Generics [UK] Ltd.
Station Close, Potters Bar,
Hertfordshire, EN6 1TL United Kingdom
This leaflet was last revised in
August 2014
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