Melodia

Drospirenone, ethinylestradiol.

Melodia is round, yellow film-coated tablets.
Each film-coated tablet contains two active ingredients: Drospirenone 3 mg; Ethinylestradiol 0.03 mg.
Melodia contains lactose as an excipient.

Pharmacology: Pharmacodynamics: Melodia is a combined oral contraceptive ("the combined Pill"). Each tablet contains a small amount of two different female hormones. These are drospirenone (a progestogen) and ethinylestradiol (an estrogen). Because of the small amounts of hormones, Melodia is considered a low-dose oral contraceptive. As all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
Melodia act to suppress gonadotropins. This is achieved through inhibition of ovulation and alterations to both the cervical mucus and the endometrium. Improvement in symptoms like bloating, swelling or weight-gain, related to fluid retention. Improvement in acne and reduction in greasiness of the skin and hair.
Pharmacokinetics: The absolute bioavailability of drospirenone is 76% and ethinyl estradiol is 40%. Volume of distribution is 4 liters per kilogram for drospirenone, 4-5 liters for ethinyl estradiol.
Drospirenone bind to serum proteins 97% and ethinyl estradiol bind to serum proteins highly but non-specifically.
Half-life: Drospirenone 30 hours and ethinyl estradiol 24 hours.
Drospirenone and ethinyl estradiol are well metabolized in the liver and conjugated with glucuronide and sulfate.
Drospirenone excretion is nearly complete after 10 days and amounts excreted were slightly higher than in feces compared to urine.
Ethinyl estradiol is excreted in the urine and feces as glucuronide and sulfate conjugates and undergoes enterohepatic circulation.

Prevention of pregnancy.

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 1^st, 2^nd or 3^rd 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 1^st row and end of week 3-3^rd 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.

Patients in whom intentional overdose is known or suspected should be referred for phychiatric consultation.
The symptoms are nausea and vomiting. Serum concentrations of potassium and sodium, and evidence of metabolic acidosis, should be monitored. Nausea or vomiting is treated for symptomatic relief.

Hypersensitivity to drospirenone or ethinylestradiol.
This medication should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the first time during use, the product should be stopped immediately: Adrenal insufficiency; Hepatic function or renal impairment or in patients with conditions that predispose to hyperkalemia; Known or suspected breast carcinoma, or endometrium carcinoma; Known or suspected estrogen-dependent neoplasia; Cardiac insufficiency; Active or history of cerebrovascular disease/coronary artery disease; Cholestatic jaundice of pregnancy or jaundice with prior pill use; Cholestatic hepatic disease; History of benign or malignant hepatic tumors; Pregnancy; If the patient has (or has in the past) thrombophlebitis, thrombosis or thromboembolic disorder; Abnormal or undiagnosed uterine bleeding; Hypertension; Diabetes mellitus.

Do not use in the presence of thrombosis and hepatic disease.
Should not be used in women who have a higher risk of thrombosis, such as a history of thrombophlebitis, obesity, diabetes and hypertension.
Should not use in presence or history of liver tumors, known or suspected sex hormones related cancer such as breast cancer or genital organs cancer.
Use carefully in cigarette smoking women, especially women older than 35 years of age should consult the physician before using this medication.
Use other than contraceptive, consult the physician.
Consult the physician if any abnormal symptoms occur while using this medication.

Regular visits to physician at least every 6 to 12 months to check progress.
Stop medication immediately and check with physician if pregnancy is suspected.
If scheduled for laboratory tests, tell the physician if taking birth control pills; certain blood test may be affected by oral contraceptives.
Not refilling an old prescription for oral contraceptives without having a physical examination by physician, especially after pregnancy.
Stop using Melodia and immediately go to the doctor if the patient has possible signs of thrombosis, such as: Extreme pain and/or inflammation of one of the legs; Intense and sudden chest pain, which may reach the left arm; Sudden difficulty in breathing; Sudden cough without clear cause; Unusual headache, intense or prolonged, or worsening of a migraine; Partial or complete vision loss, or double vision; Difficulty or inability to speak; Vertigo or fainting; Weakness, abnormal sensations, or numbness of any part of the body.
Melodia and cancer: Women who take combined contraceptives have a slightly higher rate of breast cancer than women who don't, but it is not known if this is due to the medication. For example, it is possible that more tumors are detected in women who take contraceptives because they are examined by their doctor more frequently. The breast cancer rate reduces gradually after the patient decides to stop taking combined hormonal contraceptives.
It is important to regularly examine the breast and go to the doctor if the patient finds any lump.
Benign liver tumors have been found in women who use combined contraceptives on rare occasions and malignant tumors are even rarer. Go to the doctor if the patient experiences sudden intense abdominal pain.

Pregnancy: If the patient is pregnant, she should not take Melodia. If the patient is pregnant when taking Melodia, she should stop taking it immediately and contact the doctor.
Lactation: It is generally not recommended to take Melodia when breast-feeding. If the patient wants to use the contraceptive while breast-feeding, she should consult the doctor.

The following undesirable effects have been reported by users of the Pill, although they need not be caused by the Pill. These undesirable effects may occur in the first few months that the patient is using the Pill and usually lessen with time. (See table.)

Click on icon to see table/diagram/image

If the patient has hereditary angioedema; exogenous estrogens may induce or exacerbate symptoms of angioedema.
If the patient notices any side effects not mentioned in this monograph, inform the doctor or pharmacist.

Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); tuberculosis (e.g. rifampicin, rifabutin) and HIV infections (e.g. ritonavir, nevirapine); antibiotics (e.g. penicillins, tetracyclines, griseofulvin) for some other infectious diseases; and the herbal remedy St. John's wort (primarily used for the treatment of depressive moods). Some medicines (e.g. ketoconazole, erythromycin, cyclosporine) may inhibit the metabolism of Melodia.
The Pill may also interfere with the working of other medicines. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).
There is a theoretical potential for an increase in serum potassium if the patient is taking Melodia with other drugs that may increase serum potassium levels. Such drugs include angiotensin-II-receptor antagonists, diuretics that may increase the potassium in the blood, and aldosterone antagonists. However in studies in women taking drospirenone (combined with estradiol) together with an ACE inhibitor or indomethacin no significant difference in the potassium blood level could be observed.
Inform the doctor or pharmacist if taking or have recently taken any other medicines or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that the patient uses Melodia. They can tell if the patient needs to take additional contraceptive precautions and if so, for how long.
Certain laboratory tests may be affected by oral contraceptives.

Store below 30°C.

Oral Contraceptives

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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