Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Exemestane
Originalis B.V.
L02BG06
Exemestane
25 milligram(s)
Coated tablet
exemestane
2019-07-19
WHAT IS IN THIS LEAFLET 1. What Aromasin is and what it is used for 2. What you need to know before you take Aromasin 3. How to take Aromasin 4. Possible side effects 5. How to store Aromasin 6. Contents of the pack and other information 1. WHAT AROMASIN IS AND WHAT IT IS USED FOR Your medicine is called Aromasin. Aromasin 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. Aromasin 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. Aromasin 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 AROMASIN DO NOT TAKE AROMASIN: • if you are or have previously been allergic to exemestane (the active ingredient in Aromasin) or any of the other ingredients of this medicine (listed in 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 breast-feeding. WARNINGS AND PRECAUTIONS • Talk to your doctor, pharmacist or nurse before taking Aromasin. • Before treatment with Aromasin, your doctor may want to take blood samples to make sure you have reached the menopause. • Routine checking of your vitamin D level will also be made before treatment, as your level may be very low in the early stages of breast cancer. You will be given vitamin D supplement if your levels are below normal. • Before taking Aromasin, 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 Przeczytaj cały dokument
Health Products Regulatory Authority 22 July 2019 CRN008VL3 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aromasin 25 mg coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 25 mg of exemestane. Excipients with known effect Sucrose Methyl parahydroxybenzoate (E218) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet _Product imported from Lithuania_ Round, biconvex, off-white coated tablet marked 7663 on one side. 4 CLINICAL PARTICULARS As per PA0822/111/001 5 PHARMACOLOGICAL PROPERTIES As per PA0822/111/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Silica, colloidal hydrated (E551) Crospovidone Hypromellose (E464) Magnesium stearate (E572) Mannitol (E421) Microcrystalline cellulose (E460) Sodium starch glycolate (type A) Polysorbate 80 (E433) Polyvinyl alcohol Simeticone Macrogol 6000 Sucrose Magnesium carbonate, light (E504) Methyl Parahydroxybenzoate (E218) Cetyl esters wax Talc Carnauba wax Ethyl alcohol Shellac Titanium Dioxide (E171) Black Iron Oxide (E172) Health Products Regulatory Authority 22 July 2019 CRN008VL3 Page 2 of 2 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product as marketed in the country of origin 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special storage conditions. 6.5 NATURE AND CONTENTS OF CONTAINER Blisters of 30 coated tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Originalis B.V. Joop Geesinkweg 901 1114 AB Amsterdam-Duivendrecht Netherlands 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA2306/015/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 th July 2019 10 DATE OF REVISION OF THE TEXT Przeczytaj cały dokument