Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Organon Pharma (UK) Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Oral contraception.
The decision to prescribe Marvelon should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Marvelon compares with other CHCs (see sections 4.3 and 4.4).
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 usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started.
It is preferable that tablet intake from the first pack is started on the first day of menstruation in which case no extra contraceptive precautions are necessary.
If menstruation has already begun, (that is 2, 3, or 4 days previously), tablet taking should commence on day 5 of the menstrual period. In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking.
If menstruation began more than 5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Marvelon.
All tablets in the old pack should be finished. The first Marvelon tablet is taken the next day i.e. no gap is left between taking tablets nor does the patient need to wait for her period to begin. Tablets should be taken as instructed in ‘How to take Marvelon’. Additional contraceptive precautions are not required. The patient will not have a period until the end of the first Marvelon pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days.
Marvelon should be started after taking the last active tablet from the ‘Every Day Pill’ pack (i.e. after taking 21 or 22 tablets). The first Marvelon tablet is taken the next day i.e. no gap is left between taking tablets nor does the patient need to wait for her period to begin. One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7 day tablet-free period. Each subsequent pack is started after the 7 day tablet-free period has elapsed. Additional contraceptive precautions are not required. Remaining tablets from the Every Day (ED) pack should be discarded. The patient will not have a period until the end of the first Marvelon pack, but this is not harmful, nor does it matter if she experiences some bleeding on tablet-taking days.
The first Marvelon tablet should be taken on the first day of the period, even if the patient has already taken a mini pill on that day. One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7 day tablet-free period. Each subsequent pack is started after the 7 day tablet-free period has elapsed. Additional contraceptive precautions are not then required. All the remaining Progestogen-only pills in the mini pill pack should be discarded.
If the patient is taking a (mini) pill, then she may not always have a period, especially when she is breast feeding. The first Marvelon tablet should be taken on the day after stopping the mini pill. All remaining pills in the mini pill packet must be discarded. Additional contraceptive precautions must be taken for the first seven days.
The woman may switch any day from an implant (or the IUS on the day of its removal, from an injectable when the next injection would be due). Additional contraceptive precautions must be taken for the first seven days.
Following childbirth hormonal contraceptive administration to non-breast feeding mothers should be started 21 days post-partum in which case no additional contraceptive precautions are required. If intercourse has taken place post-partum, hormonal contraceptive use should be delayed until the first day of the menstrual period.
If post-partum administration of Marvelon begins more than 21 days after delivery then additional contraceptive precautions are required for the first 7 days.
N.B. Mothers who are breast feeding should be advised not to use the combined pill since this may reduce the amount of breast-milk, but may be advised instead to use a progestogen-only pill (POP).
After miscarriage or abortion administration should start immediately in which case no additional contraceptive precautions are required.
When additional contraceptive precautions are required the patient should be advised either not to have sex, or to use a cap plus spermicide, or for her partner to use a condom.
Rhythm methods should not be advised as the pill disrupts the usual cyclical changes associated with the natural menstrual cycle e.g. changes in temperature and cervical mucus.
To skip a period, a new pack of Marvelon should be started on the day after finishing the current pack (the patient skips the tablet-free days). Tablet-taking should be continued in the usual way. During the use of the second pack she may experience slight spotting or breakthrough bleeding but contraceptive protection will not be diminished provided there are no tablet omissions. The next pack of Marvelon is started after the usual 7 tablet-free days, regardless of whether the period has completely finished or not.
The reliability of Marvelon may be reduced if tablets are forgotten:
If the forgotten tablet is taken within 12 hours, no further precautions are necessary, further tablets should be taken at the usual time.
If one or more tablets are forgotten for more than 12 hours, contraceptive protection will be reduced. The patient should take the last forgotten tablet, even if this means taking two tablets in one day, and then continue to take tablets at the normal time. Additional contraceptive precautions should be taken for the next seven days, and the patient should follow ‘the 7-day rule’.
If any one tablet is forgotten for more than 12 hours
If the patient has vomiting or diarrhoea for more than 12 hours
If the patient is taking any of the drugs listed under ‘Interactions’:
The patient should continue to take her tablets as usual and additional contraceptive precautions must be taken for the next 7 days.
But – if these 7 days run beyond the end of the current pack, the next pack must be started as soon as the current one is finished, i.e. no gap should be left between packs. (This prevents an extended break in tablet taking which may increase the risk of the ovaries releasing an egg and thus reducing contraceptive protection). The patient will not have a period until the end of 2 packs but this is not harmful nor does it matter if she experiences some bleeding on tablet taking days.
In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. Unless diarrhoea is extremely severe, it does not affect steroidal absorption.
If vomiting occurs within 3-4 hours after tablet taking, or in cases of severe or prolonged diarrhoea, the advice concerning missed tablets, as given in Section 4.2.3, is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
The safety and efficacy of desogestrel in adolescents below 18 years has not yet been established. No data are available.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are: nausea, vomiting and slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.
3 years.
Do not store above 25°C. Store blisters in the original pouches.
Push-through packs of 21 white tablets each. The pack is PVC/Al blister consisting of aluminium foil with a heat-seal coating and a PVC film. Each blister is packed in a printed aluminium pouch. The pouch is packed in a printed cardboard box together with the package leaflet (1, 3 or 50 pouches per box). Not all pack sizes may be marketed.
See Section 4.2.
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