Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2017 Publisher: Bayer New Zealand Limited, 3 Argus Place, Hillcrest, North Shore, AUCKLAND 0627 Free Phone: 0800 233 988
Oral contraception.
The pregnancy rate of progestogen-only pills is slightly higher than that of combined oral progestogen-oestrogen combinations. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.
The dosage of MICROLUT is one tablet daily without any break, taken at the same time each day with some liquid as needed.
Tablets must be taken in the order directed on the package for the full 28 days without regard to bleeding. This means that after the first pack has been finished, the next should be started without interruption. The days of the week are printed on the pack for convenience.
It is important to maintain an interval of exactly 24 hours between tablets. This interval should by no means be exceeded by more than 3 hours. If, for example, the patient chooses 7 a.m. as the time for taking her tablets, she should try to always take them at this time. Whenever this is impossible, the tablet must be taken by 10 a.m. at the very latest, otherwise protection against conception may decline. The greatest possible reliability of MICROLUT can be assured only by adhering as closely as possible to the 24-hour-intervals.
Tablet taking has to start on the first day of the menstrual bleeding.
The woman should start with MICROLUT immediately on the day after the last hormonal tablet of her previous COC and omit the pill-free interval of this COC.
When switching from another progestogen-only Minipill, the woman may start with MICROLUT on any day, without any break between tablets.
The woman may switch from an implant on the day of its removal, from an injectable when the next injection would be due, but should in both cases be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking.
The woman may start immediately.
For breast-feeding women, Microlut may be initiated 6 weeks post-partum, (see section 4.6). Women who are not breast-feeding should be advised to start in the fourth week after delivery. When starting later, the woman should be advised to additionally use a barrier contraceptive method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before starting MICROLUT use or the woman has to wait for her first menstrual period.
If even 1 tablet is taken late (i.e. if it is more than 27 hours since the last tablet was taken, i.e. more than three hours later than it should have been taken) or if even 1 tablet is missed, protection against conception may be impaired. The user should take the last missed tablet as soon as she remembers, even if this means taking 2 tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method 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, the higher the risk of a pregnancy.
If vomiting and/or diarrhoea occur within 3-4 hours after tablet taking, absorption may not be complete and additional contraceptive measures should be taken. In such an event, the advice concerning 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.
There have been no reports of serious deleterious effects from overdose.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
Symptoms that may occur in this case are nausea, vomiting and slight vaginal bleeding.
There are no antidotes and further treatment should be symptomatic.
5 years.
Store below 25°C.
PVC/Aluminium blisters. Pack sizes of 1 × 28 or 3 × 28 tablets.
Not all pack sizes may be marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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