Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, Isando 1609
Oral contraception.
Tablets must be taken every day at about the same time in the order directed on the package, and with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started on the day after taking the last tablet from the previous pack. A withdrawal bleed usually starts on days 2 to 3 after the last hormone-containing tablet and may not have finished before the next pack is started.
Tablet-taking should start on day 1 of the natural cycle (i.e. the first day of menstrual bleeding). Starting on days 2 to 5 is allowed, but during the first cycle a back-up method of birth control (such as condoms and spermicide) is recommended in addition for the first 7 days of tablet-taking.
The woman should start with MIRELLE preferably on the day after the last hormone-containing tablet of her previous combined oral contraceptive, but at the latest on the day following the usual tablet-free or hormone-free tablet interval of her previous combined oral contraceptive. In case a vaginal ring or transdermal patch has been used, the woman should start using MIRELLE preferably on the day of removal of the last ring or patch of a cycle pack, but at the latest when the next application would have been due.
The woman may switch any day from the minipill (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 does not need additional contraceptive measures.
For breastfeeding women, see section 4.6.
Women 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 of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of MIRELLE or the woman has to wait for her first menstrual period.
Missed hormone-free white coated tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free white tablet phase. The following advice only refers to missed hormone-containing pale yellow coated tablet.
If the user is less than 12 hours late in taking any hormone-containing pale yellow tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
Accordingly, the following advice can be given in daily practice:
Days 1 to 7
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 that are missed and the closer they are to the hormone-free white tablet phase, the higher the risk of a pregnancy.
Days 8 to 14
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 this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
Days 15 to 24
The risk of reduced reliability is imminent because of the forthcoming hormone-free white 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 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, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well.
If the woman missed tablets and subsequently has no withdrawal bleed in the hormone-free white tablet phase, the possibility of a pregnancy should be considered.
In case of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3 to 4 hours after taking a pale yellow hormone-containing tablet the advice concerning missed tablets as given in 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) needed from another pack.
To delay a period the woman should continue with another pack of MIRELLE without the hormone-free white tablets from her current pack. The extension can be carried on for as long as wished until the end of the pale yellow tablets in the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of MIRELLE is then resumed after the usual 4 day hormone-free white 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 hormone-free white 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 second pack (just as when delaying a period).
MIRELLE is only indicated after menarche.
MIRELLE is not indicated after menopause.
MIRELLE is contraindicated in women with severe hepatic diseases. See also section 4.3.
MIRELLE has not been specifically studied in renally impaired patients.
Oral use.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in cases of taking an overdose of hormone-containing pale yellow tablets are nausea, vomiting and withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidentally taken the medicine. There are no antidotes and further treatment should be symptomatic.
2 years.
Store below 25°C.
Protect from moisture and light.
MIRELLE is packed in colourless transparent PVC/aluminium blisters containing 24 pale yellow hormonecontaining tablets plus 4 white hormone-free tablets per blister strip.
The blister strip is packed into an outer cardboard carton.
Pack sizes: 28 tablets.
No special requirements.
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