Patient Leaflet Updated 08-Mar-2019 | Glenmark Pharmaceuticals Europe Ltd
Exemestane 25 mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Exemestane 25 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Exemestane 25 mg film-coated tablets 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 25 MG FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
Your medicine is called Exemestane. 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EXEMESTANE
Do not take Exemestane:
Warnings and precautions
Other medicines and Exemestane
Please 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:
Pregnancy and breast-feeding
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
Adults and the elderly
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
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. The recommended dose is one 25 mg tablet daily.
If you need to go to the hospital whilst taking Exemestane, let the medical staff know what medication you are taking.
Use in children
Exemestane is not suitable for use in children.
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 taking your 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, 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).
Very common may affect more than 1 in 10 people
Common may affect up to 1 in 10 people
Uncommon may affect up to 1 in 100 people
Rare may affect up to 1 in 1000 people
Not known frequency cannot be estimated from the available data
Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood) may also be seen.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 this medicine 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.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Exemestane 25 mg film-coated tablets contain
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:
This leaflet was last revised in: September 2018
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