Posology : מינונים

4.2     Posology and method of administration

Posology
Take regularly and without omission, one tablet daily at the same time of the day, for 28 consecutive days (one pale-yellow, active tablet during the first 24 days, one white, inactive tablet during the 4 following days) with no free interval between each blister pack. A withdrawal bleed usually starts on day 2-3 after the last active tablet and may not have finished before the next pack is started.

How to start Minesse
 No preceding hormonal contraceptive use in the past month:
Take the first tablet on the first day of menstrual bleeding.

 Changing from another combined oral contraceptive (COC):
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The woman should start Minesse on the day after the last active tablet of her previous COC.
       Changing from a progestin-only method (minipill, injection, implant): The woman may switch any day from the minipill and should begin Minesse the next day. She should start Minesse on the day of an implant removal or, if using an injection, the day the next injection would be due. In all of these situations, the woman should be advised to additionally use a nonhormonal back-up method for the first 7 days of tablet-taking.

       Following first-trimester abortion:
The woman may start Minesse immediately. Additional contraceptive measures are not needed.

       Following delivery or second-trimester abortion:
Since the immediate post-partum period is associated with an increased risk of thromboembolism, COCs should be started no earlier than days 21 to 28 after delivery or second-trimester abortion. The woman should be advised to additionally use a nonhormonal back-up method for the first 7 days of tablet-taking. 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.

Omission of one or more tablets
Contraceptive reliability may be reduced if pale-yellow tablets are missed, and particularly if tablets are missed during the first days of the pack.

•   If the woman becomes aware of the omission of a pale-yellow tablet within 12 hours of the normal time of intake, the tablet should be taken immediately and treatment pursued normally, the next tablet being taken at the usual time.

•   If the woman becomes aware of the omission of a pale-yellow tablet more than 12 hours after the normal time of intake, contraception is no longer assured. The last forgotten tablet should be taken immediately, even if this means taking two tablets in one day, and oral contraceptive treatment pursued to the end of the blister pack, together with a nonhormonal back-up method of contraception (condoms, spermicides, etc.) which should be used for the next seven days. If the seven days where a back-up method is required run beyond the last active tablet in the current pack, the next pack must be started on the day following the intake of the last active tablet in the current pack and all inactive tablets should be discarded. The user is unlikely to have a withdrawal bleed until the inactive-tablet interval of the second pack, but she may experience spotting or breakthrough bleeding. If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be excluded before resuming tablet-taking.

Errors in taking one or more white tablets have no consequence, provided the interval between the last pale-yellow tablet of the current pack and the first pale-yellow tablet of the following pack does not exceed four days.

In case of gastrointestinal upset:
The onset of intercurrent digestive disorders within four hours after taking the tablet, such as vomiting or severe diarrhoea, may cause transient inefficacy of the method by reducing COC hormone absorption and such events should be dealt with in the same way as the case where a tablet has been forgotten for less than 12 hours. The extra tablet should be taken from a back-up pack. If these episodes recur over several days, a nonhormonal back-up contraceptive method should then be used, (condom, spermicide, etc.) until the beginning of the next blister pack.
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Paediatric population
Safety and efficacy was evaluated in subjects aged 18 years and above.
Limited data available for use in adolescents below 18 years.

Elderly patients
Minesse is not indicated after menopause.

Patients with hepatic impairment
Minesse is contraindicated in women with severe hepatic diseases. See also section ‘Contraindications’.

Patients with renal impairment
Minesse has not been specifically studied in renally impaired patients.

Method of administration
Oral use.