Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Morningside Healthcare Ltd., Unit C, Harcourt Way, Leicester, LE19 1WP, United Kingdom
Oral contraception.
The decision to prescribe Cimizt should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Cimizt compares with other CHCs (see sections 4.3 and 4.4).
Route of administration: Oral use.
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. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval; during which time a withdrawal bleeding usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her 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.
The woman should start taking Cimizt Tablets 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 a transdermal patch has been used, the woman should start using preferably on the day of removal, but at the latest when the next application would have been due.
The woman may switch any day from the progestogen-only pills (from an implant or the IUS on the day of its removal; from an injectable when the next injection would be due) but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
The woman may start immediately. When doing so, she need not take additional contraceptive measures.
The woman should be advised to start at day 21 to 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 COC use or the woman has to wait for her first menstrual period.
For breastfeeding women – see section 4.6.
If the user is less than 12 hours late in taking any tablet, contraceptive protection is not reduced.
The woman should take the tablet as soon as she remembers, and should take further tablets at usual time.
If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
The user should take the last missed tablet as soon as she remembers, 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 for the next 7 days. 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 regular tablet-free interval, the higher the risk of a pregnancy.
The user should take the last missed tablet as soon as she remembers, 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 for 7 days.
The risk of reduced reliability is imminent because of the forthcoming 7-day tablet-free interval. 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 for the next 7 days as well.
If the woman missed tablets and subsequently has no withdrawal bleed in the first normal tablet-free interval, 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 tablet-taking, a new (replacement) tablet should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than 12 hours elapse, the advice concerning missed tablets, under section “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 tablet(s) from another blister pack.
To delay a period the woman should continue with another blister pack of Cimizt Tablets without a tablet-free interval. The extension can be carried on for as long as wished until the end of the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Cimizt Tablets is then resumed after the usual 7- day tablet-free 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 tablet-free interval 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).
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.
3 years.
Do not store above 25°C and store in the original package in order to protect from moisture and light.
Clear transparent PVC/PVdC- Aluminium blister of 21 tablets per calender blister strip available in packs containing 1x21, 3x21 or 6x21 tablets. Each blister is packed in trilaminated pouch.
Clear transparent PVC/PVdC- Aluminium blister of 21 tablets per calender blister strip available in packs containing 1x21, 3x21 or 6x21 tablets. Each blister is packed in trilaminated pouch along with 2g molecular sieve.
Not all pack sizes may be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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