国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Estradiol; Norethisterone acetate
Novo Nordisk A/S
G03FA; G03FA01
Estradiol; Norethisterone acetate
2 mg/1 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Progestogens and estrogens, fixed combinations; norethisterone and estrogen
Marketed
1987-11-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER KLIOGEST 2 MG/1 MG FILM-COATED TABLETS estradiol/norethisterone acetate READ THIS ENTIRE 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 Kliogest is and what it is used for 2. What you need to know before you take Kliogest 3. How to take Kliogest 4. Possible side effects 5. How to store Kliogest 6. Contents of the pack and other information 1. WHAT KLIOGEST IS AND WHAT IT IS USED FOR Kliogest is a continuous combined Hormone Replacement Therapy (HRT) which is taken every day without interruption. Kliogest is used in postmenopausal women with at least 1 year since their last natural period. The tablets contain 2 hormones: estradiol 2 mg (an oestrogen identical to the one made in the ovaries) and norethisterone acetate 1 mg (a progestagen that acts in a similar way to the body’s own hormone progesterone). Kliogest is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Kliogest alleviates these symptoms after menopause. You will only be prescribed Kliogest if your symptoms seriously hinder your daily life. _ _ PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Kliogest to prevent 阅读完整的文件
Health Products Regulatory Authority 16 January 2024 CRN00F27K Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kliogest 2 mg/1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg. Excipient with known effect: lactose monohydrate. Each white film-coated tablet contains lactose monohydrate 36.3 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White, film-coated, biconvex tablets, engraved with NOVO 281. Diameter 6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of or contraindicated for other medicinal products approved for the prevention of osteoporosis (see section 4.4). The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kliogest is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see section 4.4) should be used. In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Kliogest may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended. If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increase the likelihood of breakthrough bleeding an 阅读完整的文件