Marvelon (Box)

Indications of Marvelon

This is used to avoid getting pregnant. Oral contraceptives are a highly efficient birth control strategy. When administered properly (no missing tablets), the chances of falling pregnant are extremely slim.

Pharmacology

The 'combined Pill' is a combination oral contraceptive pill. A modest amount of two separate female hormones is contained in each tablet. Desogestrel (a progestogen) and ethinylestradiol are the two (an estrogen). This is a low-dose oral contraceptive due to the little amount of hormones included. It is a monophasic combination oral contraceptive since all of the tablets in the pack contain the same hormones in the same dose.

Dosage & Administration of Marvelon

This pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually, it will start on day 2-3 after the last tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.

Starting your first pack of this tablet-

When no hormonal contraceptive has been used in the past month: Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the day's in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet taking in the first cycle.

When changing from another combined Pill: You can start taking this tablet the day after you take the last tablet from your present Pill pack (this means no tablet free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).

When changing from a progestagen-only Pill (minipill): You can stop taking the minipill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.

When changing from an injectable or implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.

After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet, you should discuss this first with your doctor.

After a miscarriage or an abortion: Your doctor will advise you.

If too many this tablet are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet, ask your doctor for advice.

When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control. If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.

If you forget tablets:

If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.

If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore you should follow the rules given below.

More than one tablet forgotten in a pack: Ask your doctor for advice.

1 tablet missed in week 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.

1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.

1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or

Stop taking tablets from your current pack, have a tabletfree break of 7 days or less (also count the day you missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.

You vomit: If you vomit within 3 to 4 hours after taking your this tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

You want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 day tablet-free break.

You want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

You have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

You have missed a period: If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

Interactions of Marvelon

There may be an interaction between desogestrel - ethinyl estradiol and any of the following:

acitretin

alpha agonists (e.g., clonidine, methyldopa)

ampicillin

anastrozole

angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)

angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)

antacids (use 2 hours before or after)

anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine,

Contraindications

• Do not use the combined Pill if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use this tablet. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.
• If you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body.
• If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
• If you have diabetes mellitus with blood vessel damage.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have had cancer of the breast or the genital organs.
• If you have or have had a benign or malignant tumour in the liver.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant.
• If you are allergic to any of the ingredients of this tablet.
• If any of these conditions appear for the first time while using the Pill, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

Side-Effects of Marvelon

Possible adverse effects: Users of the Pill have reported the following side symptoms, which are not necessarily caused by the Pill. These adverse effects may occur during the first few months of using the Pill, but they normally fade away over time.

Changes in sexual drive; melancholy moods; contact lens intolerance; nausea, vomiting, and feeling unwell; changes in vaginal secretion; varied skin reactions; fluid retention; changes in body weight; hypersensitivity reactions

Pregnancy & Lactation

Breastfeeding and the Pill: This tablet is not suggested for use while breastfeeding. If you want to use the Pill while breastfeeding, talk to your doctor first.

Pregnancy and the Pill: This tablet should not be taken by women who are pregnant or suspect they are pregnant.

Precautions & Warnings

Before you start to use this tablet: If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use this tablet

• you smoke;
• you have diabetes;
• you are overweight;
• you have high blood pressure;
• you have a heart valve disorder or a certain heart rhythm disorder;
• you have an inflammation of your veins (superficial phlebitis);
• you have varicose veins;
• anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
• you suffer from migraine;
• you suffer from epilepsy;
• you or someone in your immediate family have or had high blood levels of cholesterol or triglycerides (fatty substances);
• anyone in your immediate family has had breast cancer;
• you have liver or gallbladder disease;
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus eryhematosus (SLE; a disease affecting the skin all over the body);
• you have hemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
• you have sickle cell disease;
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face): if so, avoid too much exposure to the sun or ultraviolet radiation.

If any of the above conditions appear for the first time, recur or worsen while using the Pill, you should contact your doctor.

Thrombosis and the Pill: A thrombosis occurs when a blood clot forms and blocks a blood vessel. A thrombosis in the deep veins of the legs can happen at any time (deep venous thrombosis). If the blood clot breaks free from the veins where it forms, it can travel to the lungs' arteries and stop them, resulting in a "Pulmonary embolism." Deep venous thrombosis is a rather uncommon complication. It can happen whether you're on the Pill or not. It's also possible if you get pregnant. Pill users face a larger risk than non-users, but it is not as high as during pregnancy.

Breast cancer has been diagnosed slightly more frequently in women who take the Pill than in women of the same age who do not take it. During the ten years following the Pill's discontinuation, the tiny increase in the number of breast cancer diagnoses steadily fades away. It's unclear whether the Pill is to blame for the discrepancy. It's possible that the women were evaluated more frequently, allowing breast cancer to be detected earlier. In some cases, users of the Pill have developed benign liver tumors, and even more rarely, malignant liver tumors. Internal bleeding may occur as a result of these tumors. If you have severe discomfort in your stoma, see your doctor right once.

Storage Conditions

Store in a cool & dry place between 2-25° C, and protect from light. Keep out of the reach of children.