Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Bayer (Pty) Ltd, Reg. No.: 1968/011192/07, 27 Wrench Road, ISANDO, 1609
MELODENE is indicated for the prevention of pregnancy (oral contraception).
MELODENE, when taken correctly, has a failure rate of approximately 1% per year. The failure rate may increase when tablets are missed or taken incorrectly.
Tablets must be taken in the order directed by the arrows on the pack, every day at about the same time with some liquid as needed. One tablet is to be taken daily for 28 consecutive days. The first tablet should be taken from the silver section of the calendar pack by selecting the appropriate tablet for that day of the week (e.g. “MO” for Monday). Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts 2 to 3 days after starting the hormone-free pink tablets and may not have finished before the next pack is started. If a patient starts MELODENE during the latter part of the week, the very first cycle may be slightly shortened.
Tablet taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2 to 5 is allowed, but during the first cycle an additional barrier method is recommended in addition for the first 7 days of tablet-taking.
The woman should start with MELODENE preferably on the day after the last hormone-containing tablet of her previous combined oral contraceptive, but at the latest on the day following the usual hormone-free tablet interval of her previous combined oral contraceptive.
In case a vaginal ring or transdermal patch has been used, the woman should start using MELODENE preferably on the day of removal of the last ring or patch of a cycle pack, but at the latest when the next application would have been due.
The woman may switch on any day from the minipill (from an implant or the intrauterine system on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.
The woman may start immediately. When doing so, she does not need additional contraceptive measures.
For breastfeeding women see section 4.6. Women should be advised to start 21 to 28 days after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of MELODENE use, or the woman must wait for her first menstrual period.
The pink tablets are hormone-free tablets and missing these can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free tablet phase. The following advice only refers to missed hormone-containing white coated tablets:
If the user is less than 12 hours late in taking any hormone-containing tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:
Accordingly the following advice can be given in daily practice:
The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets that are missed and the closer they are to the hormone-free pink tablet phase, the higher the risk of a pregnancy.
The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
The risk of reduced reliability is imminent because of the forthcoming hormone-free pink tablet phase. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. If either of the following two options is adhered to, there is no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these two options, and also to use extra precautions for the next 7 days as well.
If the woman missed hormone-containing white tablets and subsequently has no withdrawal bleed in the hormone-free pink tablet phase, the possibility of a pregnancy should be considered.
In case of severe gastrointestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 3 to 4 hours after taking a white hormone-containing tablet, the advice concerning missed tablets is applicable. If the woman does not want to change her normal tablettaking schedule, she must take the extra tablet(s) needed from another pack.
To delay a period the woman should continue with another pack of MELODENE without taking the hormone-free pink tablets from her current pack. The extension can be carried on for as long as wished until the end of the white hormone-containing tablets in the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Regular intake of MELODENE is then resumed after the hormone-free pink tablet phase.
MELODENE is only indicated after menarche.
Not applicable. MELODENE is not indicated after menopause.
MELODENE is contraindicated in women with severe hepatic diseases as long as liver function values have not returned to normal. See also section 4.3
MELODENE has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population.
Oral use.
There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of white hormone-containing tablets are: nausea; vomiting; and withdrawal bleeding. The last may even occur in girls before their menarche, if they have accidently taken the medicine. There are no antidotes and further treatment should be symptomatic.
3 years.
Store at or below 30°C.
Protect from light.
MELODENE is packed in colourless transparent PVC/aluminium blisters containing 21 white hormone-containing tablets plus 7 pink hormone-free tablets per blister strip. The blister strip is packed into an outer cardboard carton.
Pack sizes: 28 tablets and 84 tablets.
Not all pack sizes are marketed.
No special requirements.
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