Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk
Laboratorios Leon Farma, S.A. C/La Vallina s/n, Pol. Ind. 24008 NAVATEJERA (SPANJE)
G02BB01
ETHINYLESTRADIOL 3,5 mg/stuk ; ETONOGESTREL 11 mg/stuk
Hulpmiddel voor vaginaal gebruik
COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat) ; POLYURETAAN,
Vaginaal gebruik
Vaginal Ring With Progestogen And Estrogen
Hulpstoffen: COPOLYMEER VAN ETHYLEEN-VINYLACETAAT (28 pCt. vinylacetaat); POLYURETAAN;
2017-09-11
1 LF-ETOEE-NL-NLH.3722.001.IA.032-D0 PACKAGE LEAFLET: INFORMATION FOR THE USER ETONOGESTREL/ETHINYLESTRADIOL LEON FARMA 0,120 MG/0,015 MG PER 24 UUR, HULPMIDDEL VOOR VAGINAAL GEBRUIK etonogestrel/ethinylestradiol IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): • They are one of the most reliable reversible methods of contraception if used correctly. • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks. • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA 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. • 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. Your medicine is available as the above name but will be referred to as Etonogestrel/ Ethinylestradiol Leon Farma throughout this leaflet WHAT IS IN THIS LEAFLET 1. WHAT ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA IS AND WHAT IS IT USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA 2.1 When you should not use Etonogestrel/ Ethinylestradiol Leon Farma 2.2 Warnings and precautions Blood clots Cancer 2.3 Children and adolescents 2.4 Other medicines and Etonogestrel/ Ethinylestradiol Leon Farma Laboratory tests 2.5 Pregnancy and breast-feeding 2.6 Driving and using machines 3. HOW TO USE ETONOGESTREL/ ETHINYLESTRADIOL LEON FARMA 3.1 How to insert and remove Etonogestrel/ Ethinylestradiol Leon Farma 3.2 Three weeks in, one week out 3.3 When to start with the first ring Baca dokumen lengkap
1 SPC-ETOEE-CC-NL.H. 3722.001.IB.028-D0 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etonogestrel/Ethinylestradiol Leon Farma 0,120 mg/0,015 mg per 24 uur, hulpmiddel voor vaginaal gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Etonogestrel/ Ethinylestradiol Leon Farma contains 11.0 mg etonogestrel and 3.474 mg ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal delivery system. Etonogestrel/ Ethinylestradiol Leon Farma is flexible, transparent, and colourless to almost colourless ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception. Etonogestrel/ Ethinylestradiol Leon Farma is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The decision to prescribe Etonogestrel/ Ethinylestradiol Leon Farma should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Etonogestrel/ Ethinylestradiol Leon Farma compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To achieve contraceptive effectiveness, Etonogestrel/ Ethinylestradiol Leon Farma must be used as directed (see ‘How to use Etonogestrel/ Ethinylestradiol Leon Farma’ and ‘How to start Etonogestrel/ Ethinylestradiol Leon Farma’). Paediatric Population The safety and efficacy of Etonogestrel/ Ethinylestradiol Leon Farma in adolescents under the age of 18 have not been studied. Method of administration HOW TO USE Etonogestrel/ Ethinylestradiol Leon Farma 2 SPC-ETOEE-CC-NL.H. 3722.001.IB.028-D0 The woman herself can insert Etonogestrel/ Ethinylestradiol Leon Farma in the vagina. The physician should advise the wo Baca dokumen lengkap