Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Theramex HQ UK Ltd
G03FB05
Not applicable
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 06040101; GTIN: 5012946314160
Package Leaflet: Information for the User EVOREL ® SEQUI TRANSDERMAL PATCHES (ESTRADIOL/NORETHISTERONE ACETATE) 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 Sequi is and what it is used for 2. What you need to know before you use Evorel Sequi 3. Safety of HRT 4. How to use Evorel Sequi 5. Possible side effects 6. How to store Evorel Sequi 7. Contents of the pack and other information The name of your medicine is Evorel Sequi. It belongs to a group of medicines called hormone replacement therapy (HRT). Evorel Sequi contains two medicines: An oestrogen (estradiol) A progestogen (norethisterone) They are both female hormones. Evorel Sequi comes in a ‘memory pack’. This can be used to help you remember when to change your patches. Each pack contains eight patches: Four ‘Evorel 50’ patches marked CE50 (containing estradiol only) Four ‘Evorel Conti’ patches marked CEN1 (containing estradiol and norethisterone) The hormones are spread evenly in each patch. They pass slowly into your body through the skin. WHAT EVOREL SEQUI IS USED FOR Evorel Sequi is used: For the symptoms of the menopause (see ‘What is the menopause?’). It is only used in women who still have a womb. It is suitable for women who have had the menopause (postmenopausal) or who are around the time of the menopause (perimenopausal) To prevent osteoporosis (fragile bones) in women who have had the menopause and are most likely to have bone problems. Evorel Sequi is only used if other m Přečtěte si celý dokument
OBJECT 1 EVOREL SEQUI Summary of Product Characteristics Updated 24-Jun-2016 | Janssen-Cilag Ltd 1. Name of the medicinal product EVOREL SEQUI _International non-proprietary names_ estradiol norethisterone acetate 2. Qualitative and quantitative composition EVOREL SEQUI is a transdermal therapy comprising a) 4 EVOREL 50 TDSs, each containing: 3.2 mg of estradiol hemihydrate b) 4 EVOREL CONTI TDSs, each containing: 3.2 mg of estradiol hemihydrate 11.2 mg of norethisterone acetate 3. Pharmaceutical form EVOREL SEQUI is composed of EVOREL 50 and EVOREL CONTI. Both EVOREL 50 and EVOREL CONTI are a Transdermal Delivery System (TDS), or transdermal patch, composed of 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 an 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 EVOREL Conti patch is marked in the centre of the lower margin on the outside of the backing film: CENI. EVOREL 50 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. The release liner of EVOREL 50 is aluminised on one side. Each EVOREL 50 patch is marked in the centre of the lower margin of the outside of the backing film: CE50. 4. Clinical particulars 4.1 The Přečtěte si celý dokument