Држава: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tamoxifen (tamoxifen citrate)
CP Pharmaceuticals Ltd.
L02BA01
tamoxifen (tamoxifen citrate)
10mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2018-09-24
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 name of your medicine is Tamoxifen 10mg, 20mg or 40mg Film-Coated Tablets. In the rest of this leaflet it is called Tamoxifen Tablets. WHAT IS IN THIS LEAFLET: 1. What Tamoxifen Tablets are and what they are used for 2. What you need to know before you take Tamoxifen Tablets 3. How to take Tamoxifen Tablets 4. Possible side effects 5. How to store Tamoxifen Tablets 6. Contents of the pack and other information 1. WHAT TAMOXIFEN TABLETS ARE AND WHAT THEY ARE USED FOR Tamoxifen Tablets contain a medicine called tamoxifen. This belongs to a group of medicines called ‘anti-oestrogens’. WHAT TAMOXIFEN TABLETS ARE USED FOR • Tamoxifen Tablets are used to treat breast cancer. • Tamoxifen Tablets also to treat infertility in women caused by a failure to produce and release eggs (ovulate) properly. • Tamoxifen Tablets can also reduce the risk of developing breast cancer occurring in those women who have an increased likelihood of developing breast cancer (your risk). It is important that your healthcare professional calculates your risk of developing breast cancer and discusses the result with you before commencing treatment. There are a number of specific tools available to calculate breast cancer risk, based on information such as your age, family history, genetics, reproductive factors (e.g. age when periods started and stopped, had children o Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 10mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tamoxifen Citrate 15.20mg, equivalent to 10mg of tamoxifen. Excipient with known effect Lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 'Tamoxifen' is indicated for: 1. The treatment of breast cancer. 2. The treatment of anovulatory infertility. 3. The primary prevention of breast cancer in women at moderate or high risk (see section 5.1) Women aged less than 30 years old were excluded from primary prevention trials so the efficacy and safety of tamoxifen treatment in these younger women is unknown. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _1._ _BREAST CANCER:_ ADULTS: The recommended daily dose of tamoxifen is normally 20mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with higher doses. Substantive evidence supporting the use of treatment with 30-40mg per day is not available, although these doses have been used in some patients with advanced disease. _ELDERLY PEOPLE:_ Similar dosing regimens of tamoxifen have been used in older people with breast cancer and in some of these patients it has been used as sole therapy. _2. ANOVULATORY INFERTILITY:_ Before commencing any course of treatment, whether initial or subsequent, the possibility of pregnancy must be excluded. In women who are menstruating regularly, but with anovular cycles, the initial course of treatment consists of 20 mg given daily on the second, third, fourth and fifth days of the menstrual cycle. If unsatisfactory basal temperature records or poor pre-ovulatory cervical mucus indicate that this initial course of treatment has been unsuccessful, further courses may be given during subsequent menstrual periods, increasing the dosage to 40mg and then 80mg daily. In women who are not menstruating regularly, the initial course may begin on any d Прочитајте комплетан документ