Exemestane 25mg Film Coated Tablets
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Exemestane 25 mg 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.
- This medicine has been prescribed for you. 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 anyside 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 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 hormone, oestrogen, especially in postmenopausal women. Reducing 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.
It 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 Exemestane or any of the other ingredients of Exemestane(Please see section 6).
• 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 if you are_breast-feeding.
Warning and precautions
Talk to your doctor or pharmacist before taking 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.
• If you have a history or are suffering from any condition which affects the strength of your bones. 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. You may have to undergo tests to measure your bone density before and during treatment. Your doctor can give you medicine to prevent or treat the bone loss.
Other medicines and Exemestane
Tell your doctor if you are taking, have recently taken or might take 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 (anti-convulsants used to treat epilepsy),
• the herbal remedy St John’s wort (Hypericumperforatum), or preparations containing it.
Pregnancy, breast-feeding and fertility
Do not take Exemestane if you are pregnant or breast-feeding.
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
Always take Exemestane exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure. Your doctor will tell you how to take Exemestane and for how long.
Adults and older people
The usual dose is one 25 mg film-coated tablet daily.
Exemestane film-coated tablets should be taken by mouth after a meal at approximately the same time each day.
Use in children and adolescents
Exemestaneis not suitable for use in children and adolescents.
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 film-coated tablets.
If you forget to take Exemestane
Do not take a double dose to make up for a forgotten dose.
If you forget to take your film-coated 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 taking your film-coated tablets even if you are feeling well, unless your doctor tells you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
4.
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, (may affect more than 1 in 10people):
• 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, (may affect 1 in 10 people):
• 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,(may affect up to 1 in 100people):
• 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 (blood cells which cause clotting) 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 or pharmacist. 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 Exemestane
Keep this medicine out of the sight and reach of children.
Do not use Exemestane after the expiry date which is stated on the carton after <EXP>. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines 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 film coated tablet contains 25 mg exemestane. The other ingredients are:
Tablet core:
Mannitol, Copovidone, Crospovidone, Silicified Microcrystalline Cellulose, Sodium Starch Glycolate (Type A), Magnesium Stearate
Film coating:
Hypromellose, Macrogol 400,Titanium Dioxide.
What Exemestane looks like and contents of the pack
White to off-white, round compound cup tablet, with “25” on one side and plain on the reverse.
Exemestane is available in blister packs of:
10, 14, 20, 30, 60, 90 and 100 (Blisters of 10 or 14) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder PharOS Generics,
4 Pikioni str., 3075-Limassol,
Cyprus
Manufacturer
EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford Ireland
DEPO-PACK S.N.C. DI DEL DEO SILVIO E C.
Morandi Street 28 21047 Saronno (VA)
Italy
&
Siegfried Generics (Malta) Ltd
HHF070 Hal Far Industrial Estate, Hal Far BBG3000
Malta
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Exemestane 25mg Film-coated tablets
CZ: Exemestane Farmia 25mg
EL: AROMESTAN 25mg Emra^npeva gs ^snxo npsvio Siaria
ES: Exemestano Urquima 25mg comprimidos recubiertos con pelicula EFG
HU: Exemestane Farmia 25mg filmtabletta
IT: Exemestane PharOS Generics 25mg compresse rivestite con film
SK: Exemestane Farmia 25mg