Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
tamoxifen (tamoxifen citrate)
CP Pharmaceuticals Ltd.
tamoxifen (tamoxifen citrate)
10mg
tablets film-coated
Prescription
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New Regulatory text • Updated Wockhardt logo • Strength blocks size changed to run to the margins only 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’. Oestrogen is a natural substance in your body known as a ‘sex hormone’. Tamoxifen Tablets work by blocking the effects of oestrogen. Tamoxifen Tablets are used to treat breast cancer. They are also used to treat infertility in women caused by a failure to produce and release eggs (ovulate) properly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN TABLETS DO NOT TAKE TAMOXIFEN TABLETS: • if you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6) • if you are pregnant or think you might be pregnant (see the section on ‘Pregnancy’ below) • if you are taking anastrozole • if you are taking any treatment for infertility Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tamoxifen 10mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tamoxifen Citrate BP 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _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. _OLDER 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 day. If no signs of ovulation are demonstrable, then a subsequent course of treatment may start 45 days later, with dosage increased as above. If a patient responds with menstruation, then the next course of treatment is commenced on the second day Lees het volledige document