Posology : מינונים

4.2     Posology and method of administration

Posology
HOW TO TAKE MINULET
Regular daily intake of tablets for 21 consecutive days is important for the preservation of contraceptive efficacy.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. 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 bleed occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.

HOW TO START MINULET
No hormonal contraceptive use within the preceding month

The user should begin taking Minulet on Day 1 of her natural menstrual cycle (i.e. the first day of menstrual bleeding). Beginning Minulet use on days 2-7 of the menstrual cycle is allowed; however a non-hormonal back-up method of birth control [e.g. condoms and spermicide] is recommended during the first 7 days of Minulet use.

Switching from another combined hormonal contraceptive (CHC)


Minulet use should begin preferably on the day after the last active tablet of the previous CHC, but no later than the day following the usual tablet-free or inactive tablet interval of the previous CHC.

Switching from a progestin only method of birth control (pill, implant, intrauterine device {IUD}, injection)

•   The user may discontinue use of a progestin only pill on any day; use of Minulet should begin the following day.
•   Minulet use should begin on the same day that a progestin-only implant or a progestin- only IUD is removed.
•   Minulet use should begin on the day that the next progestin-only injection is scheduled.

In each of these situations, the user should be advised to use a non-hormonal back-up method of birth control during the first 7 days of Minulet use.

Following first trimester abortion
The woman may start immediately. When doing so, she does not need to take additional contraceptive measures.

Postpartum
Because the immediate post-partum period is associated with an increased risk of thromboembolism, Minulet should begin no sooner than day 28th postpartum day after delivery or second-trimester abortion. The woman should be advised to additionally use a 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 Minulet use or the woman has to wait for her first menstrual period before beginning Minulet use (see sections 4.4 and 4.6).

MANAGEMENT OF MISSED TABLETS
Contraceptive protection may be reduced if tablets are missed and particularly if the missing of tablets extends the tablet-free interval. If tablets were missed in the first week of the cycle and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

Provided that the user is less than 12 hours late in taking any tablet, she should take it as soon as she remembers and further tablets should be taken at the usual time.

If she is more than 12 hours late in taking any tablet, contraceptive protection may be reduced. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets in one day. She then continues to take tablets at her usual time. In addition, a back-up method such as the condom should be used for the next 7 days.

If these 7 days run beyond the last tablet in the current pack, the next pack must be started as soon as the current pack is finished; no gap should be left between packs. This prevents an extended break in tablet taking, thereby reducing the risk of escape ovulation. The user is unlikely to have a withdrawal bleed until the end of the second pack but she may experience spotting or breakthrough bleeding on tablet taking days.

If the user does not have a withdrawal bleed at the end of the second pack, the possibility of pregnancy must be ruled out before resuming tablet taking from the next pack.

IN CASE OF GASTROINTESTINAL UPSET
If vomiting or diarrhoea occurs within 4 hours after the tablet taking, tablet absorption may be incomplete. Use of tablets from a backup pack is required, as outlined in the section Management of missed tablets (see above in section 4.2).


        HOW TO DELAY A PERIOD
To delay a period the woman should continue with another pack of Minulet 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 Minulet is then resumed after the usual 7 day tablet-free interval.

PAEDIATRIC POPULATION
Paediatric data are not available. Safety and efficacy of CHCs have been established in adult women of reproductive age.

ELDERLY POPULATION
CHCs are not indicated for use in postmenopausal women.

Method of administration
Minulet tablets are taken orally.