Source: Web Search Revision Year: 2020 Publisher: Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary
Oral contraception.
The decision to prescribe Rigevidon should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Rigevidon compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some liquid if necessary.
One tablet is to be taken daily for 21 consecutive days. Every subsequent blister pack is started after a 7-day tablet-free interval during which time a withdrawal bleeding usually occurs. This bleeding will usually start on the 2nd or 3rd day after the last tablet has been taken and it may not have stopped, before the next blister pack is started.
Tablet-taking is started on day 1 of the woman’s natural cycle (= the first day of her menstrual bleeding).
Take the first tablet the day after the dose of the last active tablet of the previous contraceptive or, at the latest, the day after the usual period of stopping the tablets.
In case of vaginal ring or transdermal patch, take the first tablet the day of removal or at the latest the day scheduled for application of the new device or ring.
Switching from the progestogen-only pill can be performed at any time in the cycle and Rigevidon coated tablet should be commenced the day after stopping.
Switching from an implant or IUS should occur on the day of removal and for an injectable contraceptive on the day scheduled for the new injection. In all cases, using an additional method of contraception for the 7 first days of treatment is recommended.
The woman may start the tablet intake immediately. In this case, it is not necessary to take further contraceptive precautions.
The woman should be advised to start on day 21-28 after delivery in non-lactating women or abortion in the 2nd trimester, because there is an increased risk of thromboembolic disorders during the post partum period. If she starts later than this, she should be advised to use a concomitant barrier method during the first 7 days of tablet intake. However, if she already has had intercourse, pregnancy must be excluded, before she starts the tablets, or she should wait for her first menstrual bleeding.
See section 4.6.
If the woman has forgotten tablet intake for less than 12 hours, the contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers this, and the remaining tablets should be taken at the usual time.
If the delay exceeds 12 hours, the contraceptive protection may be reduced. Handling of missed tablets may be managed by the following two basic rules:
Thus, the following advice may be given in daily practice:
Week 1:
The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time. Hereafter, she continues taking the tablets at the usual time point. She should use a barrier method concomitantly, e.g. a condom, for the next 7 days. If intercourse has taken place during the previous 7 days, the possibility of pregnancy must be considered. The more forgotten tablets, and the closer to the usual tablet-free interval this takes place, the greater the risk of pregnancy.
Week 2:
The woman should take the last missed tablet as soon as she remembers this, even if this means that she has to take 2 tablets at the same time. Hereafter, she continues taking the tablets at the usual time point. Provided that the tablets have been taken correctly during the 7 days preceding the first missed tablet, it is not necessary to take further contraceptive precautions. However, if this is not the case, or if more than 1 tablet has been forgotten, the woman should be advised to additionally use a barrier method (such as a condom) for 7 days.
Week 3:
The risk of contraceptive failure is imminent because of the ensuing tablet-free interval. The reduced contraceptive protection may, however, be prevented by adjusting the tablet intake. Therefore, by following one of the following two alternatives, it is not necessary to take further contraceptive precautions, provided that all tablets have been taken correctly during the 7 days preceding the first missed tablet. If this is not the case, the woman should be advised to follow the first of the two alternatives. Additionally a barrier method (such as a condom) should be used concomitantly for the next 7 days.
If the woman has missed tablets and does not get a withdrawal bleeding during the first, normal tabletfree interval, the possibility of pregnancy must be considered.
If case of severe gastro-intestinal symptoms (e.g. vomiting or diarrhoea), absorption of the active ingredients may not be complete and additional contraceptive measures should be taken.
If vomiting or severe diarrhea occurs within 3 to 4 hours after taking a tablet, a new tablet should be taken as a replacement as soon as possible. The new tablet should be taken if possible within 12 hours of the usual dose time.
If more than 12 hours elapse, the same instructions as those provided for missed tablets should apply (see section 4.2).
If the woman does not want to change her usual tablet intake, she should take the required extra tablet(s) from another blister pack.
In order to delay a withdrawal bleeding, the woman should continue the next blister pack of Rigevidon, after taking the last tablet in the current pack, without a tablet-free interval. The extension can be carried on for as long as desired until the end of the second blister pack. During the extension the woman may experience break through bleeding or spotting. Regular intake of Rigevidon is resumed after the usual 7 days tablet-free interval.
To shift her withdrawal bleeding to another day of the week, rather than the one the woman is used to with the present tablet intake, she may be advised to shorten the forthcoming tablet-free interval by as many days as she likes. The shorter the interval, the greater the risk that she will not have a withdrawal bleeding and that she may have breakthrough bleeding or spotting during the second blister pack (which is also the case when delaying a period). It is important to emphasise that the tablet-free interval should not be extended.
For oral administration.
Symptoms of overdose of oral contraceptive have been reported in adults, adolescents and children aged 12 and under. Symptoms of overdose can manifest by nausea, vomiting, breast pains, dizziness, abdominal pains, drowsiness/fatigue and vaginal bleeding in young girls. There is no antidote and treatment should only be symptomatic.
2 years.
Store below 25°C.
Aluminium-PVC/PVDC blister.
Pack sizes: 1×21, 3×21, 6×21 and 13×21 coated tablets.
Not all pack size may be marketed.
No special requirements.
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