Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Litha Pharma (Pty) Ltd, 106 16, th Road, Midrand 1685
NOVYNETTE is indicated for the prevention of pregnancy (oral contraception).
One tablet daily should be taken (preferably always at the same time of the day) for 21 consecutive days. Each subsequent course is started after a 7-day tablet-free interval 4 weeks after intake of the first tablet on the same day of the week. During the 7 tablet-free days a menstruation-like withdrawal bleeding occurs.
The first tablet should be started on the first day of the menstrual cycle.
The first tablet of NOVYNETTE should be taken on the first day of the withdrawal bleeding after the end of the previous oral contraceptive course. Changing from a Progestogen-only-Pill (POP) or mini-pill, injection, implant From mini-pills it can be changed to NOVYNETTE on any day of the menstrual cycle, from implant on the day after its removal, from injection when the next one ought to be given.
In these cases additional contraceptive precautions are required for the first 7 days of tablet taking.
After abortion in the 1st trimester oral contraception may be started immediately. Additional contraceptive precautions are not required.
Oral contraception can be started by non-lactating women 21-28 days after a vaginal delivery or abortion in the 2nd trimester. If oral contraception is started later, one of the barrier methods as additional contraceptive precaution is also required for the first 7 days.
For use in lactation – see section 4.6.
If intercourse has already taken place, pregnancy should be excluded before tablet intake is started, or it should be delayed until the first menstrual bleeding.
If a tablet is delayed it should be taken as soon as possible and if it is taken within 12 hours of the correct time, contraceptive protection is not reduced and additional contraceptive precautions are not required. Further tablets should then be taken at the usual time.
If the delay exceeds 12 hours, contraceptive protection can be reduced. In this case the user should not take the forgotten tablet(s), but continue to take the tablets at the usual time. Additional contraceptive precautions are required for the next 7 days of tablet taking. If these seven days run beyond the end of the present pack, the next pack should be started at once without leaving a gap between the packs. This means that menstruation-like withdrawal bleeding will not occur until the end of the second pack, but spotting and break-through bleeding may occur on tablet taking days.
If no withdrawal bleeding occurs after finishing the second pack, the possibility of pregnancy should be excluded before continuing tablet intake from the next pack.
If vomiting occurs within 3-4 hours after tablet intake, the tablet may not be absorbed completely. In this case the precautions concerning forgotten tablets as described above should be applied. If the woman does not want to change her usual tablet intake, she has to take the necessary extra tablet(s) from another pack.
In order to induce the menstrual bleeding on an earlier day of the week than the usual with the present tablet intake, it is advised to shorten the forthcoming tablet-free interval by the desired number of days. The shorter the interval, the higher the risk that withdrawal bleeding will not occur, and break-through bleeding or spotting will be experienced while taking the tablets from the second pack (like in case of postponement of menstrual bleeding).
In order to postpone the menstrual bleeding, a new pack of NOVYNETTE should be started on the day after finishing the current pack, without leaving a gap between them. Postponement of menstrual bleeding may continue as long as required until the end of the second pack. During the use of the second pack break-through bleeding or spotting may occur. Regular intake of NOVYNETTE can be restored after the usual 7 tablet-free days.
For oral administration.
See section 4.8.
There is no known antidote and treatment should be symptomatic and supportive.
3 years.
Store at or below 25°C.
Protect from light. Do not remove from the outer carton until required for use.
Silver, imprinted hard aluminium/PVC/PVDC foil blister containing 21 tablets. Forming foil is hard PVC/PVDC foil and sealing foil is lacquered, printed, hard aluminium foil.
The blister is packed into a carton.
No special requirements.
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