Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol; Norethisterone acetate
Novo Nordisk Ltd
G03CA53
Estradiol; Norethisterone acetate
1mg ; 500microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5017954000746
1 _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER KLIOVANCE ® 1 MG/0.5 MG FILM-COATED TABLETS Estradiol/norethisterone acetate 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 Kliovance ® is and what it is used for 2. What you need to know before you take Kliovance ® 3. How to take Kliovance ® 4. Possible side effects 5. How to store Kliovance ® 6. Contents of the pack and other information 1. WHAT KLIOVANCE ® IS AND WHAT IT IS USED FOR Kliovance ® is a continuous combined Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestagen. Kliovance ® is used in postmenopausal women with at least 1 year since their last natural period. Kliovance ® is used for: RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Kliovance ® alleviates these symptoms after menopause. You will only be prescribed Kliovance ® 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 Kliovance ® to prevent osteoporosis after menopause. Kliovance ® is prescribed for women who have not had their womb removed, and whose periods stopped more th Прочетете целия документ
OBJECT 1 KLIOVANCE Summary of Product Characteristics Updated 16-Mar-2016 | Novo Nordisk Limited 1. Name of the medicinal product Kliovance 1 mg/0.5 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the Apis bull on the other. 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. The experience treating women older than 65 years is limited. 4.2 Posology and method of administration Kliovance 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 also section 4.4) should be used. A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief. In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Kliovance 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 h Прочетете целия документ