Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Norethisterone acetate; Estradiol
Theramex HQ UK Ltd
G03FB05
Norethisterone acetate; Estradiol
170microgram/24hour ; 50microgram/24hour
Transdermal patch
Transdermal
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101; GTIN: 5012946314153 5012946314290
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER EVOREL ® CONTI Estradiol hemihydrate, norethisterone acetate Evorel is a registered trademark 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 5. WHAT IS IN THIS LEAFLET 1. What Evorel Conti is and what it is used for 2. What you need to know before you use Evorel Conti 3. Safety of HRT 4. How to use Evorel Conti 5. Possible side effects 6. How to store Evorel Conti 7. Contents of the pack and other information 1. WHAT EVOREL CONTI IS AND WHAT IT IS USED FOR The name of your medicine is Evorel Conti. It belongs to a group of medicines called hormone replacement therapy (HRT). Evorel Conti contains two medicines: • An oestrogen (estradiol) • A progestogen (norethisterone) They are both female hormones. Evorel Conti comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight or twenty-four patches. The hormones are spread evenly in each patch. They pass slowly into your body through the skin. WHAT EVOREL CONTI IS USED FOR Evorel Conti is used: • For the symptoms of the menopause (see ‘What is the menopause?’). It is suitable for women who have not had a period (menstrual bleed) for at least 18 months • To prevent osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel Conti is only used if other medicines for osteoporosis have been tried first and they have not worked - 2 - WHAT IS THE MENOPAUSE? Women produce oestrogen hormones from their ovaries th Læs hele dokumentet
OBJECT 1 EVOREL CONTI Summary of Product Characteristics Updated 23-Jun-2016 | Janssen-Cilag Ltd 1. Name of the medicinal product EVOREL CONTI _International non-proprietary name_ estradiol norethisterone acetate 2. Qualitative and quantitative composition EVORELCONTI 3.2 mg of estradiol hemihydrate 11.2 mg of norethisterone acetate 3. Pharmaceutical form The EVOREL CONTI Transdermal Delivery System (TDS), or transdermal patch, is a flat two-layer laminate which is 0.1 mm in thickness. The first layer is a flexible, translucent, and nearly colourless backing film. The second layer is a monolayer adhesive film (matrix) composed of acrylic adhesive and guar gum and contains the hormones. This system is protected by a polyester foil release liner, which is affixed to the adhesive matrix and is removed prior to application of the patch to the skin. The polyester foil used is coated with silicone on both sides. The release liner has a S-shaped opening to facilitate its removal prior to use. Each TDS is enclosed in a protective, hermetically-sealed sachet. EVOREL CONTI has a surface area of 16 sq cm and contains 3.2 mg of estradiol corresponding to a nominal release of 50 micrograms of estradiol per 24 hours and 11.2 mg of norethisterone acetate corresponding to a nominal release of 170 micrograms of norethisterone acetate per 24 hours. Each TDS is marked in the centre of the lower margin on the outside of the backing film: CEN1 4. Clinical particulars 4.1 Therapeutic indications Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post-menopausal women more than 6 months post-menopause (or 18 months since last period). 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 treating women older than 65 years is limited. 4.2 Posology and method of administration _Adults_ Evorel Conti is a continuous combined HRT preparati Læs hele dokumentet