País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol; Norethisterone acetate
Viatris UK Healthcare Ltd
G03CA53
Estradiol; Norethisterone acetate
2mg ; 1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5012882007485
Package leaflet: Information for the user Elleste Duet TM Conti Tablets 2 MG/1 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 of the 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 Elleste Duet Conti Tablets are and what they are used for 2. What you need to know before you take Elleste Duet Conti Tablets 3. How to take Elleste Duet Conti Tablets 4. Possible side effects 5. How to store Elleste Duet Conti Tablets 6. Contents of the pack and other information 1. WHAT ELLESTE DUET CONTI TABLETS ARE AND WHAT THEY ARE USED FOR Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT). They contain two types of female hormones, an oestrogen (estradiol hemihydrate) and a progestogen (norethisterone acetate). Elleste Duet Conti Tablets are used in postmenopausal women with at least one year since their last natural period. Elleste Duet Conti Tablets are 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”). Elleste Duet Conti Tablets alleviate these symptoms after menopause. You will only be prescribed Elleste Duet Conti Tablets 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 med Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elleste Duet Conti Tablets 2 mg/1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2 mg estradiol (as estradiol hemihydrate) and 1 mg norethisterone acetate. Excipient with known effect: 60.8 mg lactose monohydrate. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Grey, round, biconvex tablets embossed with ‘P2’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women one 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 also Section 4.4). The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For initiation and continuation of treatment of post-menopausal symptoms the lowest effective dose for the shortest duration (see also Section 4.4) should be used. The product is a continuous combined HRT. One grey tablet is taken daily. The oestrogen and the progestogen are given every day without interruption. Therapy may start at any time in patients without prior hormone replacement therapy. Patients changing from another cyclical or continuous sequential preparation should complete the cycle and may then change to Elleste Duet Conti Tablets without a break in therapy. Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding. Missed Tablet: If a tablet is missed it should be taken within 12 hours of when normally taken; otherwise the tablet should be discarded, and the usual tablet should be taken the following day. If a tablet is missed there is an increased likelihood of breakthrough bleeding or spotting. _Elderly_ There are no spec Llegiu el document complet