Melodia

Melodia Dosage/Direction for Use

ethinylestradiol + drospirenone

Manufacturer:

Exeltis

Distributor:

DKLL

Marketer:

Exeltis
Full Prescribing Info
Dosage/Direction for Use
One pack (blister) contains 21 tablets. The day of the week to take the tablet is printed at the side of each tablet. If, for example, the patient starts on Wednesday, she should take a tablet with "WED" at the side. Follow the arrow on the pack until the patient has used the 21 tablets.
The patient should then not take any tablet for 7 days. During these 7 days when the patient does not take any tablets (called drug-free interval), she should menstruate. Menstruation, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the drug-free interval.
On the eight day from taking the last Melodia tablet (that is after 7 days drug-free interval), start the following pack, even if the patient has not stopped menstruating. This means that the patient should start the following package on the same which she started the previous week and menstruation should occur during the same dates of every month.
If the patient uses Melodia as described, she is protected against pregnancy during the 7 days that she does not take any tablet.
When can the patient start the first pack: If the patient has not taken any hormonal contraceptive in the previous month: Start taking Melodia on the first day of the cycle (that is the first day of menstruation). If the patient starts taking Melodia on the first day of menstruation, she will be immediately protected against pregnancy. The patient can also start from the second to the fifth day of cycle, but she should use additional contraceptives (a condom for example) for the first 7 days.
Changing from another combined hormonal contraceptive, combined contraceptive vaginal ring or patch: The patient can start taking Melodia the next day after the drug-free interval of the previous contraceptive (or after taking the last inactive tablet). When changing from a combined contraceptive vaginal ring or patch, follow the doctor's recommendations.
Changing from a method based exclusively on progestogens (progestogen only tablets, injection, progestogen-releasing intrauterine device or implant): The patient can change from the progestogen only tablet whatever she likes (if she had an implant or an intrauterine device, use the new tablet the day she removes it; if the patient used injections, use the new tablet on the day when she would have injected again), but it is recommended, in all cases, that the patient uses additional protection (a condom for example) for the first 7 days of taking the tablets.
After an abortion: Follow the doctor's recommendations.
After having a child: The patient can start taking Melodia between 21 and 28 days after having her child. If the patient starts later, she should use a barrier contraceptive (a condom for example) for the first 7 days the patient takes Melodia. If, after having a child, the patient has already had sexual relations before starting Melodia (again), she must be sure that she is not pregnant or wait for her next period.
If the patient forgets to take Melodia: If the patient forgets to take a tablet in the 1st, 2nd or 3rd rows, she should follow these instructions: If the patient is less than 12 hours late in taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as the patient realizes and the following tablets at the usual time.
If the patient is more than 12 hours late in taking a tablet, protection from pregnancy may be reduced. The more tablets the patient has forgotten to take, the greater the risk of reducing the contraceptive effect.
The risk of reduced protection against pregnancy is highest if the patient forgets to take the tablet at the beginning 1st row and end of week 3-3rd row in the pack. Consequently, the patient should adopt the following measures (also see the figure as follows): Forgetting to take more than one tablet in a pack: Consult the doctor.
Forgetting to take one tablet in week 1: Take the tablet that the patient has forgotten as soon as she realizes, even if this means that she has to take two tablets at the same time. Continue taking the following tablets at the usual time and take additional precautions, for example a condom, for the next 7 days. If the patient has had sexual relations in the week before she forgets to take the tablet, there is a risk she may be pregnant. In this case, consult the doctor.
Forgetting to take one tablet in week 2: Take the tablet that the patient has forgotten as soon as she realizes, even if this means that she has to take two tablets at the same time. Continue taking the following tablets at the usual time. The contraceptive effect will not be reduced and the patient does not need to take additional precautions.
Forgetting to take one tablet in week 3: The patient can choose one of two possibilities: 1. Take the tablet that the patient has forgotten as soon as she realizes, even if this means that she has to take two tablets at the same time. Continue taking the following tablets at the usual time. Start taking the next pack as soon as the current pack is finished.
The patient will probably have period (withdrawal bleeding) at the end of the second pack, but she could also have some spots or bleeding when taking the second pack.
2. The patient can stop taking tablets from her current pack, have a tablet-free interval of 7 days (taking note that of the day she forgets to take the tablet) and start a new pack on her fixed start date.
If the patient follows one of these two recommendations, she will be protected against pregnancy, If she has forgotten to take tablets and she does not have a period during the tablet-free interval, she may be pregnant. In this case, the patient should consult the doctor before continuing with the second pack. (See figure.)

Click on icon to see table/diagram/image

WHAT TO DO IF: The patient suffers from gastro-intestinal disturbances (e.g. vomiting, severe diarrhea): If the patient vomits, or has severe diarrhea, the active ingredients of Melodia may not have been completely absorbed. If the patient vomits within 3 to 4 hours after taking the tablet, this is like missing a tablet. Therefore, follow the advice for missed tablets. If the patient has severe diarrhea, contact the doctor.
The patient has unexpected bleeding: With all pills, for the first few months, the patient can have irregular vaginal bleeding (spotting or breakthrough bleeding) between her periods. The patient may need to use sanitary protection, but continue to take the tablets as normal. Irregular vaginal bleeding usually stops once the body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell the doctor.
The patient has missed a period: If the patient has taken all of the tablets at the right time, and she has not vomited, nor had severe diarrhea or used other medicines then she is very unlikely to be pregnant.
Continue to take Melodia as usual.
If the patient misses her period twice in a row, she may be pregnant. Tell the doctor immediately. Do not start the next pack of Melodia until the doctor has checked the patient is not pregnant.
Changing the period: Before deciding to change the period, consult the doctor.
If unsure how to proceed, consult the doctor for an examination.
The patient wants to delay a period: If necessary, the patient can delay her period if she starts with the next pack of Melodia immediately after finishing her current pack. The patient can continue with this pack for as long as she wishes, until this pack is empty. When she wishes her period to begin, just stop tablet-taking. While using the second pack the patient may have some breakthrough bleeding or spotting on tablet-taking days. Start with the next pack after the usual 7-day tablet-free break.
The patient wants to change the starting day of the period: If the patient takes the tablets as directed, she will have her period on about the same day every 4 weeks. If the patient wants to change this, just shorten, (never lengthen) the next tablet-free break. For example, if the period usually starts on a Friday and in future the patient wants it to start on Tuesday (3 days earlier), she should now start the next pack 3 days sooner than she usually does. If the patient makes the tablet-free break very short (e.g. 3 days or less), she may not have a bleeding during the break. The patient may have some breakthrough bleeding or spotting during the use of the next pack.
The patient wants to stop using Melodia: The patient can stop using whenever she wants. If the patient doesn't want to be pregnant, she should consult the doctor about using other methods for prevention.
If the patient has any questions, contact the doctor.
More about the Pill: The combined pill may also have non-contraceptive health benefits.
The period may be lighter and shorter. As a result, the risk of anemia may be lower.
The period pains may become less severe or may completely disappear.
In addition, some serious disorders have been reported to occur less frequently in users of the Pills containing 50 micrograms of ethinylestradiol ("high-dose pills"). These are benign breast disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID), ectopic pregnancy (pregnancy in which the embryo implants outside the womb) and cancer of the endometrium (lining of the womb) and ovaries. This may also be the case for low-dose pills but so far this has only been confirmed for endometrial and ovarian cancer.
One of the hormones in Melodia, drospirenone, has special properties leading to beneficial effects in addition to contraception. Drospirenone can prevent weight-gain, and other symptoms like bloating and swelling, related to fluid retention caused by hormones both in oral contraceptives and at certain times in the menstrual cycle. Drospirenone also has antiandrogenic activity which can help to reduce acne (pimples) and greasiness of the skin and hair. These special properties make drospirenone similar to the natural progesterone hormone produced by the body.
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