December 18, 2014
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Marvelon

(desogestrel - ethinyl estradiol)

DIN (Drug Identification Number)

02042487 MARVELON 21 TABLET
02042479 MARVELON 28 TABLET

What side effects are possible with Marvelon?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal cramping or bloating
  • acne (usually less common after 3 months of treatment, and may improve if acne already exists)
  • breast pain, tenderness, or swelling
  • brown, blotchy spots on exposed skin
  • dizziness
  • gain or loss of body or facial hair
  • increased or decreased interest in sexual intercourse
  • increased sensitivity of skin to sunlight
  • nausea
  • swelling of ankles and feet
  • unusual tiredness or weakness
  • vomiting
  • weight gain or loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • breast lumps (for women with a history of breast disease)
  • changes in the uterine bleeding pattern during or between menstrual periods, such as:
    • breakthrough bleeding or spotting between periods
    • complete stop of menstrual bleeding for several months in a row, or stop of menstrual bleeding that only occurs sometimes
    • decreased bleeding during periods
    • prolonged bleeding during periods
  • depression
  • for women who smoke tobacco:
    • pains in stomach, side, or abdomen
    • yellow eyes or skin
  • for women with diabetes: mild increase of blood sugar (faintness, nausea, pale skin, or sweating)
  • headaches or migraines (for many users, headaches may lessen but for others, they may increase frequency or severity)
  • increased blood pressure
  • swelling, pain, or tenderness in upper abdominal area
  • vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • abdominal or stomach pain (sudden, severe, or continuing)
  • coughing up blood
  • convulsions
  • crushing chest pain or chest heaviness
  • headache (severe or sudden)
  • loss of coordination (sudden)
  • loss of vision or change in vision (sudden)
  • pains in chest, groin, or leg (especially in the calf of the leg)
  • shortness of breath (sudden or unexplained)
  • slurring of speech (sudden)
  • weakness, numbness, or pain in arm or leg (unexplained)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.





Are there any other precautions or warnings for Marvelon?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: As with any hormonal contraceptives, there is a risk of developing blood clots. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Let your doctor know if you are planning an upcoming surgery or if you will be immobilized or inactive for a prolonged period of time (i.e. through accident or illness), as there is an increased risk of blood clot formation when using oral contraceptives.

If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision changes or speech changes, sudden severe headache, weakness or numbness in an arm or leg, or are coughing blood, get immediate medical attention as these symptoms could indicate a possible blood clot.

Blood pressure: If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

You may need to visit your doctor more frequently to have your blood pressure checked while using this medication. Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping this medication.

Breast cancer: The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.

Some women who use birth control pills may be at increased risk of developing breast cancer before menopause. These women may be long-term users of birth control pills (more than 8 years) or women who started using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small; however, a yearly breast examination is recommended for all women.

Cervical cancer: Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

Chronic infection with the human papillomavirus (HPV) is believed to be the most important risk factor for cervical cancer. Women who use combination oral contraceptives (COCs) for a long time may have a slightly higher chance of getting cervical cancer. This finding may not be caused by the contraceptive itself but may be related to sexual behavior and other factors.

Cigarette smoking and heart disease: Cigarette smoking is known to increase the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as a woman gets older. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use the birth control pill.

All women are urged not to smoke while taking this medication. Other factors that increase your risk of heart disease include diabetes, high blood pressure, high cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk.

For women who have a low risk of heart disease and do not smoke, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease, regardless of age. These women may continue to use birth control pills up to the age of menopause.

Depression: If you have a history of depression or other emotional problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have a history of depression or other emotional problems you may be more likely to have a recurrence while taking oral birth control medications.

Diabetes: If you have diabetes, or have a family history of diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have diabetes, it may be necessary to test your blood sugar more often to detect any worsening of blood sugar control after starting birth control pills.

Eye disorders: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye that may cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

Gallbladder disease: If you use hormonal contraceptives you have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after 4 or 5 years of use. Talk to your doctor if you have any concerns.

Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems, including liver tumours. See your doctor as soon as possible if you develop signs of liver problems such as yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Serious warnings and precautions: The use of oral contraceptive pills is associated with increased risk of several serious conditions including myocardial infarction (heart attack), thromboembolism (blood clot that breaks loose and travels to another part of the body), stroke, liver cancer, and gallbladder disease, although the risk of serious morbidity and mortality is small in healthy women without underlying risk factors.

Sexually transmitted infections (STIs): Birth control pills do not protect against HIV/AIDS and other sexually transmitted infections (STIs; formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with this medication to protect against these infections.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: The hormones in this medication pass into breast milk. These hormones may reduce the quantity and quality of the breast milk. Breast-feeding women should use another form of birth control until they are no longer breast-feeding. Talk to your doctor about your options.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age.

What other drugs could interact with Marvelon?

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

  • acetaminophen
  • alcohol
  • aminocaproic acid
  • ampicillin
  • antacids (use 2 hours before or after)
  • anticonvulsants (e.g., phenytoin, primidone, barbiturates)
  • antidiabetic medications (e.g., glyburide, insulin)
  • antihypertensive medications (medications that are used to treat high blood pressure)
  • ASA
  • barbiturates (e.g., phenobarbital)
  • benzodiazepines (e.g., lorazepam, diazepam)
  • beta-blockers (e.g, propranolol, metoprolol)
  • caffeine
  • carbamazepine
  • chloral hydrate
  • chloramphenicol
  • clofibrate
  • clomipramine
  • clonidine
  • corticosteroids (e.g. prednisone)
  • cotrimoxazole (trimethoprim - sulfamethoxazole)
  • cyclosporin
  • ethosuximide
  • folic acid
  • glutethimide
  • griseofulvin
  • meperidine
  • meprobamate
  • metronidazole
  • neomycin
  • nitrofurantoin
  • penicillin
  • phenothiazines (chlorpromazine)
  • phenytoin
  • primidone
  • protease inhibitors (e.g., ritonavir, nelfinavir)
  • rifabutin
  • rifampin
  • ritonavir
  • St. John's wort
  • succinylcholine
  • sulfonamides
  • tetracyclines
  • theophylline
  • topiramate
  • vitamin B12
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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