Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Oral contraception.
The decision to prescribe Drovelis should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Drovelis compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Oral use.
One tablet is to be taken daily for 28 consecutive days. The tablets must be taken every day at about the same time, if necessary, with a little liquid, in the order shown on the blister pack. Each pack starts with 24 pink active tablets, followed by 4 white placebo tablets. Each subsequent pack is started the day after the last tablet of the previous pack.
Stickers marked with the 7 days of the week are provided, and the relevant weekday sticker should be stuck on the tablet blister as an indicator of when the first tablet has been taken.
Withdrawal bleeding usually starts on day 2-3 after starting the white placebo tablets and may not have finished before the next pack is started. See ‘Cycle control’ in section 4.4.
Tablet-taking has to start on day 1 of the woman’s menstrual cycle, i.e., the first day of her menstrual bleeding, and when doing so, no additional contraceptive measures are necessary. If the first tablet is taken on days 2 to 5 of the woman’s menstruation, this medicinal product will not be effective until after the first 7 consecutive days of pink active tablet-taking. A reliable barrier method of contraception such as a condom must therefore be used additionally during these first 7 days. The possibility of pregnancy should be considered before starting Drovelis.
The woman should start with Drovelis preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
In case a vaginal ring or transdermal patch has been used the woman should start using Drovelis preferably on the day of removal, but at the latest when the next application would have been due.
The woman may start immediately. When doing so, she needs not take additional contraceptive measures.
Women should be advised to start between day 21 and 28 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of CHC use or the woman has to wait for her first menstrual period.
For breast-feeding women see section 4.6.
White placebo tablets from the last row of the blister can be disregarded. However, they should be discarded to avoid unintentionally prolonging the placebo tablet phase.
The following advice only refers to missed pink active tablets:
If the user is less than 24 hours late in taking any pink active tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as possible and should take further tablets at the usual time.
If she is more than 24 hours late in taking any pink active tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
1. The recommended hormone-free tablet interval is 4 days, tablet-taking must never be discontinued for longer than 4 days.
2. Seven days of uninterrupted pink active tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.
Accordingly, the following advice can be given in daily practice:
Day 1-7:
The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used until she has completed 7 days of uninterrupted pink active tablet-taking. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the placebo tablet phase, the higher the risk of a pregnancy.
Day 8-17:
The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions until she has completed 7 days of uninterrupted pink active tablettaking.
Day 18-24:
The risk of reduced reliability is imminent because of the forthcoming placebo tablet phase. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, she should follow the first of these two options and use extra precautions until she has completed 7 days of uninterrupted pink active tablet-taking as well.
1. The user should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time until the pink active tablets are used up. The 4 white placebo tablets from the last row must be discarded. The next blister pack must be started right away. The user is unlikely to have a withdrawal bleed until the end of the pink active tablets section of the second pack, but she may experience spotting or breakthrough bleeding on pink active tablet-taking days.
2. The woman may also be advised to discontinue pink active tablet-taking from the current blister pack. She should then take white placebo tablets from the last row for up to 4 days, including the days she missed tablets, and subsequently continue with the next blister pack.
If the woman missed tablets and subsequently has no withdrawal bleeding in the placebo tablet phase, the possibility of a pregnancy should be considered.
In case of severe gastro-intestinal disturbances (e.g., vomiting or diarrhoea), absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after pink active tablet-taking, a new (replacement) tablet should be taken as soon as possible. The new pink active tablet should be taken within 24 hours of the usual time of tablet-taking if possible. If more than 24 hours elapse, the advice concerning missed tablets, as given in section 4.2 “Management of missed tablets”, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra pink active tablet(s) from another blister pack.
To delay a period the woman should continue with another blister pack of Drovelis without taking the white placebo tablets from her current pack. The extension can be carried on for as long as wished until the end of the pink active tablets in the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Drovelis is then resumed after the placebo tablet phase. 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 phase by as many days as she likes. The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough-bleeding and spotting during the subsequent pack (just as when delaying a period).
Drovelis is not indicated after menopause.
Drovelis has not been specifically studied in patients with renal impairment. Drovelis is contraindicated in women with severe renal insufficiency (see section 4.3).
No clinical studies have been performed with Drovelis in patients with hepatic impairment. Drovelis is contraindicated in women with severe hepatic disease as long as liver function values have not returned to normal (see section 4.3).
Drovelis is only indicated after menarche. The safety and efficacy of Drovelis in adolescents aged under 16 years of age has not been established. No data are available.
There has not yet been any experience of overdose with Drovelis. On the basis of general experience with combined oral contraceptives, symptoms that may possibly occur in case of taking an overdose of pink active tablets are nausea, vomiting and withdrawal bleeding. Withdrawal bleeding may even occur in girls before their menarche, if they accidentally take the medicinal product. There are no antidotes and further treatment should be symptomatic.
4 years.
This medicinal product does not require any special storage conditions.
Transparent PVC/aluminium blister containing 28 film-coated tablets (24 pink active tablets and 4 white placebo tablets) in a carton with an etui storage bag and 1, 3, 6 or 13 self-adhesive weekday sticker(s).
Pack sizes: 28 (1 × 28), 84 (3 × 28), 168 (6 × 28) and 364 (13 × 28) film-coated tablets.
Not all pack sizes may be marketed.
Drospirenone containing medicinal products may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
