País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Exemestane
Morningside Healthcare Ltd
L02BG06
Exemestane
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401; GTIN: 5055132712241
1 ACCORD LOGO EXEMESTANE 25MG FILM-COATED TABLETS 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 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. - The full name of this medicine is Exemestane 25mg Film-coated Tablets but within the leaflet it will be referred to as Exemestane tablets. WHAT IS IN THIS LEAFLET: 1. What Exemestane tablets are and what they are used for 2. What you need to know before you take Exemestane tablets 3. How to take Exemestane tablets4. Possible side effects 5. How to store Exemestane tablets 6. Contents of the pack and other information 1. WHAT EXEMESTANE TABLETS ARE AND WHAT THEY ARE USED FOR Exemestane tablets belong 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 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 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 TABLETS DO NOT TAKE EXEMESTANE TABLETS IF YOU • are or have previously been ALLERGIC (hypersensitive) to exemestane (the active ingredient in Exemestane tablets) or any of the other ingredients of this medicine (listed in section 6). Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane 25 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 25 mg exemestane. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, round compound cup film coated tablet, with “25” on one side and plain on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy. Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult and elderly patients The recommended dose of Exemestane is one film-coated tablet (25mg) to be taken orally once a day, after a meal. In patients with early breast cancer, treatment with Exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane), or earlier if tumour relapse occurs. In patients with advanced breast cancer, treatment with Exemestane should continue until tumour progression is evident. No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2). Children and adolescents Not recommended for use in children and adolescents 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In pre-menopausal women and in pregnant or lactating women. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by asse Llegiu el document complet