Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: myHealthbox
Norgestimate, ethinylestradiol
Janssen-Cilag Ltd
G03AA11
Norgestimate, ethinylestradiol
35/ 250 micrograms
Film-coated Tablet
Oral use
Blister strips of 21 tablets
POM - Prescription Only Medicine
Janssen Pharmaceutica NV
Hormonal Contraceptives for Systemic Use; Progestogens and estrogens, fixed combinations
Contraception and the recognised indications for such estrogen/progestogen combinations
Authorised
1995-07-01
GB - 10317400 GB - 10317400 © J-C 2014 READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. You may need to read it again. • If you have any further questions, ask your doctor, family planning nurse 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 EFF ECTS talk to your doctor, family planning nurse or pharmacist. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET: 1 WHAT CILEST DOES 2 MAKE SURE CILEST IS OK FOR YOU 3 TAKING CILEST 3.3 A MISSED PILL 4 POSSIBLE SIDE EFF ECTS 5 HOW TO STORE CILEST 6 WHAT IS IN CILEST AND WHO MAKES IT PACKAGE LEAFLET: INFORMATION FOR THE USER Ethinylestradiol/norgestimate Cilest is a registered trademark 35/250 micrograms film-coated tablets IMPORTANT THINGS TO KNOW ABOUT THE PILL (COMBINED HORMONAL CONTRACEPTIVES). • The Pill is one of the most reliable reversible methods of contraception if used correctly. • This medicine slightly increases your risk of having a blood clot in the veins and arteries (especially in the fi rst year or when restarting the Pill after 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 2.1 ‘The Pill and blood clots’, ‘How to recognise a blood clot’). • The Pill may reduce your risk of cancer of the ovary and womb if used for a long time, but increase your risk of breast cancer. • The Pill will not protect you against sexually transmitted diseases. • Some women should not take the Pill because of current medical problems or illnesses. Please read the leafl et to make sure Cilest is right for you. • To prevent pregnancy it is important to take Cilest as instructed and start each pack on time. Please make sure that you understand what to do if yo Đọc toàn bộ tài liệu
Cilest 35/ 250 micrograms filmcoated tablets Summary of Product Characteristics Updated 25Jun2015 | JanssenCilag Ltd 1. Name of the medicinal product Cilest 35/ 250 micrograms filmcoated tablets 2. Qualitative and quantitative composition Each filmcoated tablet contains norgestimate 0.25 mg and ethinylestradiol 0.035 mg. Excipients with known effects: Lactose monohydrate 57.065 mg, see section 4.4 For the full list of excipients, see section 6.1 3. Pharmaceutical form Filmcoated tablet Blue, round, biconvex, coated tablet, imprinted '0 250' on one side and '35' on the other side. 4. Clinical particulars 4.1 Therapeutic indications Contraception and the recognised indications for such oestrogen/progestogen combinations. The decision to prescribe Cilest should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cilest compares with other Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 Posology and method of administration For oral administration. 4.2.1 Adults _How to take Cilest_ One tablet is taken daily at the same time (preferably in the evening) without interruption for 21 days, followed by a break of 7 tabletfree days. Each subsequent pack is started after the 7 tabletfree days have elapsed. Additional contraceptive precautions are not then required. During the tabletfree period, bleeding can be expected, usually beginning 2 to 4 days after the last tablet. _Starting treatment_ It is preferable that tablet intake from the first pack is started up to and including day 5 of menstruation in which case no extra contraceptive precautions are necessary. Cilest can be started at any other time, if pregnancy can reasonably be excluded. In this c Đọc toàn bộ tài liệu