Belara Dosage/Direction for Use

Recommended Dosage: One film-coated tablet must be taken every day at the same time (preferably in the evening) for 21 consecutive days, followed by a seven-day break during which no film-coated tablets are taken; menstruation-like withdrawal bleeding should occur two to four days after taking 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 the bleeding has stopped or not.
Method of administration: The film-coated tablets should be pressed out of the blister pack at the position marked with the corresponding day of the week and swallowed in whole, if necessary with some liquid as needed. The film-coated tablets are to be taken daily following the direction of the arrow.
Starting administration of the film-coated tablets: No preceding hormonal contraceptive use (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 menstrual bleeding. 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.
The first film-coated tablet can also be taken on the 2nd - 5th day of menstruation, irrespective of whether bleeding has stopped or not. In this case additional mechanical contraceptive measures must be taken during the first seven days of administration.
If the menstruation had started more than five days earlier, then it should be pointed out that starting to take Belara will have to be delayed until the next menstruation.
Changing from another hormonal contraceptive to Belara: Changing from another combined hormonal contraceptive: The woman should start taking Belara on the day following the usual tablet-free or placebo tablet interval of the previous combined hormonal contraceptive.
Switching from a progestogen-only pill ("POP"): The first Belara film-coated tablet should be taken on the day after stopping the progestogen-only medicinal product. During the first seven days of use additional mechanical contraceptive measures must be applied.
Switching from a contraceptive hormone injection or implant: Administration of Belara can be started on the day of the removal of the implant or on the day of the next originally planned injection. During the first seven days additional mechanical contraceptive measures must be applied.
Following a first-trimester miscarriage or abortion: After a miscarriage or an abortion in the first trimester, the use of Belara can be started immediately, and, in this case no further contraceptive measures are necessary.
Following second-trimester delivery, miscarriage or abortion: Women who do not breast-feed can start administration 21-28 days after delivery, and in this case no additional contraceptive measures are required.
If the tablet-taking starts more than 28 days after delivery, additional mechanical contraceptive measures are necessary during the first seven days.
However, if intercourse has already occurred, pregnancy must be ruled out or the woman must wait until the next menstruation before starting administration.
Lactation (see Use in Pregnancy & Lactation): Belara should not be taken by breast-feeding women.
After discontinuation of Belara: After discontinuation of Belara the current cycle may be delayed by about a week.
Irregular tablet administration: If the user has forgotten to take a film-coated tablet, but takes one within 12 hours no further contraceptive measures are necessary. The user should continue taking the film-coated tablets as usual.
If the user is more than 12 hours late in taking the film-coated tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules: 1. tablet-taking must never be discontinued for longer than 7 days.
2. 7 days of uninterrupted tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian axis.
The last forgotten film-coated tablet should be taken immediately, even if this means taking two tablets at the same time. The following film-coated tablets should be taken as usual. Additionally other mechanical contraceptive measures, e.g. condoms, are also to be used for the next seven days. If tablets were missed in week 1 of the cycle and intercourse occurred during the seven days prior to missing the tablets (including the tablet-free interval) the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the regular tablet-free interval, the higher the risk of a pregnancy.
If the current pack contains less than seven tablets, the next pack of Belara must be started as soon as the current pack is finished i.e. there should be no interval between the packs. Normal withdrawal bleeding will probably not occur until the second pack has been used; however, breakthrough bleeding or spotting may often occur during tablet taking. If withdrawal bleeding does not occur after conclusion of the second pack, then a pregnancy test should be carried out.
Instructions in case of vomiting or diarrhoea: If vomiting occurs within 4 hours after taking the tablets or severe diarrhoea develops, absorption may be incomplete and reliable contraception is no longer ensured. In this case, instructions "Irregular tablet administration" (see previously mentioned) should be followed. The use of Belara 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 continued for as long as preferred until taking the last pill of the second pack. During the extension breakthrough-bleeding or spotting may be experienced. Following the usual 7-day tablet-free period, regular use of Belara may be resumed.
In order to shift the menstruation to another day of the week different from the one occurring according to the current regimen, shortening of the next tablet-free interval is advised, by as many days as preferred. The shorter the interval, the higher the risk of not having a withdrawal bleed, and of the occurrence of breakthrough-bleeding and spotting during the subsequent pack (just as when delaying the 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.
Route of Administration: For oral use.