País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Norgestimate; Ethinylestradiol
Consilient Health Limited
G03AA; G03AA11
Norgestimate; Ethinylestradiol
250 / 35 microgram(s)
Tablet
oral use
3 or 6 blister strips of 21 tablets each
Product subject to prescription which may be renewed (B)
CYNDEA PHARMA, S.L
Progestogens and estrogens, fixed combinations
Progestogens and estrogens, fixed combinations; norgestimate and ethinylestradiol
Hormonal contraception
Marketed
2015-12-11
PACKAGE LEAFLET: INFORMATION FOR THE USER CILIQUE 250/ 35 MICROGRAM TABLETS norgestimate and ethinylestradiol 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 first 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 2.3 ‘The Pill and blood clots’, ‘How to recognise a blood clot’). 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 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 effects, talk to your doctor, family planning nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cilique is and what it is used for 2. What you need to know before you take Cilique 3. How to take Cilique 3.3 A missed pill 4. Possible side effects 5. How to store Cilique 6. Contents of the pack and other information 1. WHAT CILIQUE IS AND WHAT IT IS USED FOR Cilique is a combined hormonal contraceptive pill (‘the Pill’). YOU TAKE IT TO STOP GETTING PREGNANT. This contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones prevent an egg being released from your ovaries so you can’t get pregnant. Also, Cilique makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb. Cilique is a 21-day Pill - you take one each day for 21 days, followed by 7 days when you take no pills. THE BENEFITS OF TAKING THE PILL INCLUDE: • it is one of the most reli Llegiu el document complet
Health Products Regulatory Authority 23 November 2021 CRN00CLR8 Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cilique 250/35 micrograms tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms of norgestimate and 35 micrograms of ethinylestradiol. Excipients with known effect: Lactose 75.74 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Blue, round, biconvex tablets approximately 6mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormonal contraception. The decision to prescribe Cilique should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cilique compares with other Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. ADULTS: _How to use Cilique:_ One tablet is to be taken at around the same time of day on each of 21 consecutive days followed by a tablet-free interval of 7 days. Each subsequent pack is started after keeping a tablet-free interval. Withdrawal bleed occurs usually 2-3 days after the last tablet and may not finish before the next pack is started. _How to start Cilique:_ _No preceding hormonal contraceptive use in the last month_ Tablet-taking from the first pack of Ciliqueis started on the 1st day of the menstrual cycle, i.e. the first day of menstrual bleeding. If menstruation has already begun, Cilique may be commenced up to day 5 of the menstrual period, provided additional contraceptive precautions are taken for the first 7 days of tablet taking. - _Changing from a combined contraceptive (combined oral contraceptive (COC), vaginal ring or transdermal patch) to Cilique:_ The woman should start taking Cilique the next day after having taken the last active tablet of her previous pack of contraceptive pills – but no later than the day after the usual tablet-free or placebo-tablet period of her pre Llegiu el document complet