Exemestane 25 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Exemestane 25 mg 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.
0 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.
0 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 film-coated tablets are and what are they 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 25 MG FILM-COATED TABLETS ARE AND WHAT ARE THEY USED FOR
Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines 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 25 mg film-coated 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 25 mg film-coated 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.
Do not take Exemestane:
• If you are or have previously been allergic (hypersensitive) to exemestane or any of the other ingredients. See section 6 ('Further information') for full list of other ingredients;
0 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:
0 Before taking Exemestane your doctor may want to take blood samples to make sure you have reached the menopause;
0 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 with Exemestane. This is because drugs of this class lower the levels offemale hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength.
Using 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:
0 rifampicin (an antibiotic),
0carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
0 the herbal remedy St. Johns Wort (Hypericum perforatum), or preparations containing it.
Taking Exemestane with food and drink
Exemestane should be taken after a meal at approximately the same time each day.
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.
Always take Exemestane 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 should be taken by mouth after a meal at approximately the same time each day. Your doctor will tell you how to take your medicine and for how long. The recommended dose is one 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
Date: 27-02-15
Version: 01 (UK) - GPEL a7ws
Exemestane, let the medical staff know what medication you are taking.
This medicine is not suitable for use in children.
If you take more Exemestane than you should:
If you accidentally take too many tablets, contact your doctor immediately or go straight to your nearest hospital. Take your tablets and pack with you.
If you forget to take Exemestane
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
(lymphocytes) and platelets circulating in your blood may occur, especially in patients with a preexisting lymphopenia (reduced lymphocytes in the blood).
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.
Like all medicines Exemestane can cause side effects, although not everybody gets them. In general, your medicine is well tolerated and the following side effects have been observed in patients treated with Exemestane and 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 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
Uncommon side effects, (affecting between 1 to 10 people in 1000):
• Drowsiness
• Muscle weakness
Inflammation of the liver (hepatitis) may occur. Symptoms include feeling unwell, nausea, jaundice (yellowing of skin and eyes), itching, right sided abdominal pain and loss of appetite. Contact your doctor promptly if you think you are having 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
Keep out of the reach and sight of children.
Do not use Exemestane after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 film-coated tablets contain
• Each tablet contains 25 mg exemestane which is the active substance.
• Your medicine also contains the following inactive ingredients: silica colloidal anhydrous, crospovidone, hypromellose, mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate and polysorbate 80. The tablet coating contains Opadry white OYS 9622 (which consists of: hypromellose, propylene glycol and titanium dioxide (E171)).
What Exemestane 25 mg film-coated tablets look like and contents of the pack
White, round, biconvex, film-coated tablets embossed with an 'E' on one side.
Your medicine is supplied in blister packs containing 15,20, 30, 90,100 or 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:Glenmark
Pharmaceuticals Europe Ltd,
Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, UK
Manufacturer:
Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece
This medicinal product is authorised in the Member States of the EE A under the following names:
United Kingdom: Exemestane 25 mg film-coated tablets
Germany: Exemestan Medicopharm 25 mg Filmtabletten
Spain: Exemestano VIR 25 mg comprimidos
recubiertos con pelicula EF G
This leaflet was last revised in: March 2015
Date: 27-02-15
Version: 01 (UK) - GPEL a/ws