Posology : מינונים

4.2   Posology and method of administration

Posology
One film-coated tablet must be taken every day at the same time (preferably in the evening) on 21 consecutive days, followed by a seven-day break in which no film-coated tablets are taken.
Menstruation-like withdrawal bleeding should occur two to four days after administration of the last film-coated tablet. After the seven-day medication-free interval, medication should be continued with the next pack of Belara, regardless of whether bleeding has ceased or not.

The film-coated tablets should be pressed out of the blister pack at the position marked with the corresponding weekday and swallowed whole, if necessary, with a little liquid. The film-coated tablets are to be taken daily following the direction of the arrow.
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Starting administration of the film-coated tablets

No previous administration of a hormonal contraceptive (during the last menstruation cycle) 
The first film-coated tablet should be taken on day one of the women’s natural cycle, i.e. on the first bleeding day of the next menstruation. If the first film-coated tablet is taken on the first day of menstruation, contraception starts on the first day of administration and also continues during the seven- day medication-free interval.

If menstruation had started more than five days earlier, then the woman should be instructed to wait until her next menstruation before starting to take Belara.

After a miscarriage or an abortion in the first trimester
After a miscarriage or an abortion in the first trimester administration of Belara can be started immediately. In this case no further contraceptive measures are necessary.

After childbirth or after a miscarriage or abortion after the third month of pregnancy After childbirth women who do not breast-feed can start administration 21-28 days after delivery in which case no additional mechanical contraceptive measures are required.

If administration starts more than 28 days after childbirth, additional mechanical contraceptive measures are necessary during the first seven days.

If a woman has already had sexual intercourse, pregnancy must be ruled out or she must wait until her next menstruation before starting administration.

Lactation (see section 4.6).
Belara should not be taken by breast-feeding women.

After discontinuation of Belara
After discontinuation of Belara the current cycle may be prolonged by about a week.
Irregular tablet administration

If a user has forgotten to take a film-coated tablet, but takes it within 12 hours no further contraceptive measures are necessary. Users should continue taking the film-coated tablets as usual.
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If the usual intake interval is exceeded by more than 12 hours, contraceptive protection may be reduced..
The last forgotten film-coated tablet should be taken immediately. The other film-coated tablets should be taken as usual. In addition other mechanical contraceptive measures, e.g. condoms, are also to be used for the next seven days. Normal withdrawal bleeding will probably not occur until the second pack has been used; however, breakthrough bleeding or spotting may often occur during tablet administration. If withdrawal bleeding does not occur after taking the second pack, then a pregnancy test should be carried out.
What to do in the event of vomiting or diarrhoea
If vomiting occurs within 4 hours after administration of the tablets or severe diarrhoea develops, absorption may be incomplete and reliable contraception is no longer ensured. In this case the instructions in "Irregular tablet administration" (see above) should be followed. Belara administration should be continued.

How to postpone a withdrawal bleed
To delay a period the woman should continue with another blister pack of Belara 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 Belara 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).

Paediatric population
Belara is only indicated after menarche. The safety and efficacy of chlormadinone acetate and ethinylestradiol in adolescents below 16 years has not been established. No data are available.

Elderly
Belara is not indicated after menopause.