How does this medication work? What will it do for me?
This combination medication contains 3 medications: drospirenone, ethinyl estradiol and levomefolate. Drospirenone is a progestin and ethinyl estradiol is an estrogen. Both are female hormones that, when combined, they are used as a birth control pill to prevent pregnancy. Levomefolate is the active form of folic acid. Folic acid is needed for the body to produce blood cells. For women who take birth control pills, the body is not able to turn folic acid into levomefolate as easily as it could when she was not taking birth control. The levomefolate replaces the folic acid the body is not creating.
This medication works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix (making it difficult for sperm to penetrate into the uterus) and in the endometrium (making it difficult for an egg to implant).
Drospirenone - ethinyl estradiol - levomefolate may be used to treat moderate acne for women over 14 years of age who also want birth control and have started menstruating. This medication may also be used to improve folate levels for women who choose to use birth control pills.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each pink, round, convex, film-coated tablet embossed with the letters "Z+" in a regular hexagon contains drospirenone 3 mg, ethinyl estradiol 0.020 mg and levomefolate calcium 0.451 mg. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, ferric oxide red, hydroxypropylcelllulose 5 cP, hypromellose 5 cP, lactose monohydrate, macrogol 6000, magnesium stearate, talc, titanium dioxide and beta-cyclodextrin.
Each light-orange, round, convex, film-coated tablet embossed with the letters "M+" in a regular hexagon contains levomefolate calcium 0.451 mg. Nonmedicinal ingredients: cellulose microcrystalline, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hydroxypropylcelluslose 5 cP, hypromellose 5 cP, lactose monohydrate, macrogol 6000, magnesium stearate, talc and titanium dioxide.
How should I use this medication?
Take one pink hormone-containing tablet daily at the same time of day (e.g., with a meal or at bedtime) for 24 consecutive days, then take one light orange, hormone-free tablet daily for 4 days. When the light orange tablets are finished, start a new package. You will begin a new package on the same day of the week that you started the last one. You may still be menstruating when you start the new package.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 of your period.
It is a good idea to use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use to ensure prevention of pregnancy.
Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.
If you have vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or pharmacist.
It is important to take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases. If you experience vomiting or diarrhea within 3 to 4 hours after taking the pink tablet, take another tablet as soon as possible.
If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.
If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills on the day you remember and 2 pills the next day. Then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.
If you start your pills on Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.
If you start your pills on a day other than a Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills at any time during your cycle, safely dispose of the rest of the pill pack and start a new pack that same day. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.
If you miss any of the light orange "reminder" pills in week 4, safely dispose of the pills you missed and keep taking one pill each day until the pack is empty. Begin a new pack as you would normally.
See package insert for additional information on when to start and what to do if you forget to take a pill.
Store this medication in its original packaging at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take drospirenone - ethinyl estradiol - levomefolate if you:
- are allergic to drospirenone, ethinyl estradiol, levomefolate or any ingredients of this medication
- are or may be pregnant
- have active liver disease
- have any eye damage resulting from vascular (blood vessel) disease of the eye, such as partial or complete loss of vision or defect in visual fields
- have had a heart attack
- have had jaundice (yellowing of skin) with pregnancy or with prior pill use
- have, have had, or may have an endometrial cancer (cancer of the uterus lining) or another type of tumour that needs estrogen to grow
- have, have had, or may have breast cancer
- have heart valve disease with complications
- have or have had benign or malignant liver tumours
- have or have had cerebrovascular disorders (e.g., stroke) or a condition that may be the first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
- have or have had coronary artery disease (e.g., angina)
- have or have had migraines with aura
- have or have had pancreatitis associated with extremely high triglyceride levels
- have or have had thrombophlebitis or thromboembolic (blood clotting) disorders
- have reduced kidney function
- have reduced liver function
- have problems with the adrenal gland
- have severe or multiple risk factors for blood clots:
- diabetes with blood vessel involvement
- heavy smoking (more than 15 cigarettes per day) and over age 35
- inherited or acquired blood clotting disorders
- major surgery associated with an increased risk of blood clots after surgery
- prolonged bed rest
- severe high blood pressure
- severe high cholesterol
- have undiagnosed abnormal vaginal bleeding
What side effects are possible with this medication?
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 cramps
- back or abdominal pain
- breast enlargement or tenderness
- change in appetite
- changed interest in sexual activity
- cold and sinus symptoms (e.g., sinus pain, stuffy or runny nose, cough)
- difficulty wearing contact lenses
- flu-like symptoms (e.g., cough, fatigue, fever, sore throat)
- trouble sleeping
- weight changes
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- bleeding or spotting between menstrual periods
- breast lump
- darkening skin (particularly on the face)
- dramatic mood changes
- high blood pressure
- lack of menstrual bleeding
- painful menstrual periods
- signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
- symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
- unusual swelling of the arms or legs
- vaginal yeast infection
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
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 this medication?
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: All hormonal contraceptives can increase the risk of developing blood clots. Some studies show that birth control pills containing drospirenone have a higher risk of blood clots compared to other birth control pills. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots.
Tell your doctor 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 combination hormonal contraceptives.
If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision 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.
Cigarette smoking and heart disease: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as women get 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.
Electrolytes: This medication contains the progesterone drospirenone, which may increase potassium levels in women who are at high risk for this condition. Women with reduced kidney or liver function or inadequate production of adrenal hormones are at increased risk.
If you receive other medications that can increase your potassium you should have your potassium levels checked by your doctor when you first start this medication. Some of these medications include potassium supplements, ACE inhibitors, angiotensin-II receptor antagonists (e.g., candesartan, losartan), some diuretics, heparin, aldosterone antagonists (e.g., spironolactone), and nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen).
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.
Fibroid tumours: This medication may worsen fibroid tumours (noncancerous growths in the uterus), causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.
Gallbladder problems: The use of hormonal contraceptives increases the risk of gallbladder problems. If you experience symptoms of gallbladder problems such as severe stomach or back (between the shoulder blades) pain, nausea or vomiting, contact your doctor.
Kidney disease: If you have kidney disease, 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 have regular blood tests while taking this medication.
Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems. 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.
Migraine and headache: If you have migraines, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed. You should report the development of new types of headaches that are recurrent, persistent, or severe or worsening migraine headaches to your doctor.
Regular checkups: You should visit your doctor yearly for a physical examination and follow-up while you are taking this medication.
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.
Risk of cancer: The use of hormonal contraceptives may increase the risk of breast and cervical cancer in women before menopause (around age 50). If you have been using hormonal contraceptives for a long time (more than 8 years), started using them at an early age, or have a family history of cancer (mother or sister), you may be at an increased risk of developing cancer. Talk to your doctor about whether any special monitoring is needed.
If you are taking birth control pills, you should learn how to do a breast self-exam. Notify your doctor any time you detect a lump. In a few women, the use of birth control pills may speed up the growth of a breast cancer that has not yet been diagnosed. A yearly clinical breast examination is also recommended because, if breast cancer should develop, medications that contain estrogen may cause the cancer to grow quickly.
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. 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 14 years of age.
What other drugs could interact with this medication?
There may be an interaction between drospirenone - ethinyl estradiol - levomefolate and any of the following:
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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