País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Exemestane
Viatris UK Healthcare Ltd
L02BG06
Exemestane
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 08030401; GTIN: 5016695004372
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No . Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Myriad Pro 9 pt 9 pt Exemestane_25mg_30 Leaflet 1575315 803254 1575315 PL 04569/1276 Remedica Ltd (Limassol - CY) P18-0696/09E 1344 N/A 101168520/0170 2 United Kingdom N/A N/A 28 Jul 18 01:15 1 157 x 322 mm Black 1 / 2 3D Render ID N/A v3/Jul 2017 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 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. WHAT IS IN THIS LEAFLET: 1. What _Exemestane 25 mg film-coated tablets_ are and what they are used for 2. What you need to know before you take _Exemestane 25 mg film-coated tablets_ 3. How to take _Exemestane 25 mg film-coated _ _tablets_ 4. Possible side effects 5. How to store _Exemestane 25 mg film-coated _ _tablets_ 6. Contents of the pack and other information 1. WHAT EXEMESTANE 25 MG FILM-COATED TABLETS ARE AND WHAT IT IS USED FOR Your medicine is called _Exemestane 25 mg _ _film-coated tablets. Exemestane 25 mg film-coated _ _tablets_ belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with an enzyme called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduct Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exemestane 25mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 25 mg exemestane. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _ _ Film-coated Tablet White, round biconvex film-coated tablets 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 Posology _Adults and elderly patients _ _The recommended dose of exemestane is one 25 mg tablet to be taken orally once a _ _day, preferably 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). _Paediatric population _ Not recommended for use in children and adolescents. Method of administration For oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipient listed in section 6.1. Pre- menopausal women and in pregnant or breast-feeding 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 assessment Llegiu el document complet