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Initial Proposed Smpc Plus Proposed Revisions

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Initial Proposed Smpc Plus Proposed Revisions 1. NAME OF THE MEDICINAL PRODUCT Leticia 28 150 micrograms/30 microgram film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 white or almost white film-coated tablets: Each film-coated tablet contains 150 micrograms desogestrel 30 micrograms ethinylestradiol. Excipient with known effect: 64.3 mg lactose (as lactose monohydrate). 7 green placebo (inactive) film-coated tablets: The tablet does not contain active substances. Excipients with known effect: 37.26 mg lactose anhydrous and 0.003 mg sunset yellow. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The active tablet is white, or almost white, round shaped, biconvex film-coated tablets of 6 mm diameter, with P8 sign on one side and RG sign on other side. The placebo tablet is green, round, biconvex film-coated tablet, diameter about 6 mm, without engraving. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Oral contraception The decision to prescribe Leticia 28 should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Leticia 28 compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 Posology and method of administration Posology How to take Leticia 28 The tablets must be taken in the order directed on the package every day at about the same time of the day. Tablet taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started after the last tablet of the previous pack. During the intake of the 7 placebo tablets bleeding usually occurs. This usually starts on day 2-3 after intake of the placebo tablets and may not have finished before the next pack is started. How to start Leticia 28 No preceding hormonal contraceptive use [in the past month] 1 The tablet intake should be started on the first day of the woman’s natural cycle (i.e. on the first day on which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable. Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), combined contraceptive vaginal ring or transdermal patch) The woman should start taking Leticia 28 on the day after the last active tablet (the last tablet containing the active substance) of her previous COC, but at the latest on the day following the usual tablet-free interval or following the last placebo tablet (tablet containing no active substance) of her previous COC. In case a vaginal ring or a transdermal patch has been used, , it is preferable to start using Leticia 28 on the day of its removal. The woman may also start using Leticia 28 on the day the new vaginal ring or a transdermal patch would have been due, but no later that this day. If the woman has used her previous contraception method regularly and correctly and if the woman is not pregnant she may also change from her previous hormonal contraception on any day during the cycle. The hormone-free period from the previous contraception method must not be extended for longer than recommended. Not all adrministration methods of hormonal contraception (transdermal patch, vaginal ring) are necessarily marketed in all EU countries. Changing from progestogen only products (progestogen-only-pills, injection, implant, a progestogen- releasing intrauterine system (IUS) The woman can change from progestogen-only pills on any day (changing from implant or IUS on the day of its removal; changing from injection when the next injection should have been given) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet- taking. After abortion in the 1st trimester Tablet intake should start immediately. In this case no further contraceptive measures are necessary. After delivery or abortion in the 2nd trimester For breast-feeding women - see section 4.6. The woman should be advised to start the pill on day 21-28 after delivery or abortion in the 2nd trimester. She should be advised to use a barrier method concurrently during the first 7 days of tablet intake if she starts the pill later. In case she has already had intercourse, pregnancy should be excluded before she starts taking Leticia 28, or she should wait for her first menstrual bleeding. Forgotten tablets Missed green pills are placebo tablets and thus can be disregarded. However, they should be discarded to avoid unintentionally prolonging the placebo tablet phase. The following advice only refers to missed active tablets (white tablets). If the tablet intake is forgotten for less than 12 hours, contraceptive protection is not reduced. The woman should take the forgotten tablet as soon as she remembers, and the remaining tablets are taken as usual. If the tablet intake is forgotten for more than 12 hours, contraceptive protection may be reduced. The following two basic rules should be considered in case of forgotten tablets: 1. Continuous tablet intake must not be interrupted for longer than a period of 7 days. 2. 7 days of uninterrupted tablet intake are required to achieve sufficient suppression of the hypothalamus-pituitary-ovarian-axis. 2 Thus, the following advice may be given for daily practice: Week 1 The woman should take the last forgotten tablet as soon as she remembers, even if this means that she has to take 2 tablets at the same time. Then, she continues taking the tablets at the usual time of the day. She should concurrently use a barrier method, e.g. a condom, for the next 7 days. If intercourse has taken place during the preceding 7 days, the possibility of pregnancy should be considered. The more tablets are forgotten and the closer they are to the regular placebo tablet period, the higher the risk of pregnancy is. Week 2 The woman should take the last forgotten tablet as soon as she remembers, even if this means that she has to take 2 tablets at the same time. Then, she continues taking the tablets at the usual time of the day. Provided that the tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive measures. However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to use another contraceptive method for 7 days. Week 3 The risk of reduced contraceptive protection is imminent due to the forthcoming 7-day placebo tablet period. However, this risk may be prevented by adjusting tablet intake. Thus, it is not necessary to take further contraceptive measures if one of the two alternatives below is followed, provided that all tablets have been taken in a correct manner during the 7 days preceding the forgotten tablet. If this is not the case, the woman should be advised to follow the first of the two alternatives and concurrently use another contraceptive method for the next 7 days. 1. The user should take the last forgotten tablet as soon as she remembers even if it means that she has to take 2 tablets at the same time. Then she continues taking the tablets at the usual time of the day until she has taken all the active tablets. The 7 green tablets (placebo tablets) must be discarded. The next blister pack must be started right away after the last active tablet from the present package has been taken, thus no placebo tablets are taken. It is not very likely that the user will have her menstrual bleeding until the end of the second pack, but she may experience spotting or break-through bleeding on the days she is taking tablets. 2. The woman may also be advised to stop taking active tablets from the present pack. In that case she should then take the green tablets (placebo tablets) for up to 7 days, including those days when she forgot tablets, and then continue with the next pack. Week 4 The contraceptive effect is not reduced and the subsequent tablets should be taken at the usual time. In case the woman has forgotten tablets and then does not have her menstrual bleeding in the placebo tablet period, the possibility of pregnancy should be considered. Advice in case of gastrointestinal disturbances In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the active tablets, the advice concerning missed tablets, as given above, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack. How to induce or postpone a withdrawal bleed There is no indication for this product to postpone menstruation. However, in extraordinary cases, if postponing menstruation is required the woman should continue with another blister pack of Leticia 28 without taking the placebo tablets from the first pack. The extension can be carried on for as long as 3 wished until the end of the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Leticia 28 is then resumed after the usual 7-day placebo tablet interval To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming placebo tablet interval by as many days as she likes.
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