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Overview: Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is a birth control medicine used to prevent pregnancy. It is also used to increase folate levels and treat premenstrual dysphoric disorder (PMDD) and acne in people who also want to prevent pregnancy. The blister pack has 21 or 24 tablets each containing drospirenone, ethinyl estradiol, and levomefolate calcium and four or seven tablets containing just levomefolate calcium. The most common side effects are headaches, nausea, and breast tenderness. Before taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, make sure to tell your health care provider about any health conditions or medicines you are taking. Get emergency help if you have trouble breathing, chest pain, vision changes, or trouble speaking.

Uses

What is drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium used for?

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is a birth control pill commonly used to prevent pregnancy. This medicine is also used to increase folate levels and treat premenstrual dysphoric disorder (PMDD) and acne in people who also want to prevent pregnancy. 

The blister packs have 28 tablets. There are 21 or 24 tablets that each contain drospirenone, ethinyl estradiol, and levomefolate calcium. There are also four or seven tablets that contain only levomefolate calcium. Ethinyl estradiol is an estrogen and drospirenone is a progestin. Levomefolate calcium is a B vitamin.

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may also be used for other conditions as determined by your health care provider.

How does drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium work (mechanism of action)?

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium contains three medicines. Drospirenone and ethinyl estradiol work mainly to stop the release of an egg from your ovaries. If this medicine is not used as directed, the chance of pregnancy increases. Levomefolate calcium works to increase the amount of folate in your body. 

How is drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium supplied (dosage forms)?

Brands and other names

  • Beyaz
  • Safyral
  • Tydemy

Dosage forms and strengths

  • 3 mg/0.02 mg/0.451 mg and 0.451 mg oral tablets
  • 3 mg/0.03 mg/0.451 mg and 0.451 mg oral tablets

How should I store drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you’re transporting it. Store it in a cool, dry place.

Only remove a tablet from the blister pack when you are ready to take it. 

Side Effects

What are the most common side effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

The most common side effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Premenstrual syndrome
  • Irregular periods
  • Headache or migraine (see below)
  • Breast tenderness, pain, or discomfort
  • Nausea or vomiting
  • Mood changes, including crankiness
  • Stomach pain, tenderness, or discomfort
  • Tiredness
  • Low sex drive
  • Weight gain

There may be other side effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

While less common, the most serious side effects of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium are described below, along with what to do if they happen.

Severe Allergic Reactions. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may cause allergic reactions, which can be serious. Stop taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Blood Clots. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), stroke, heart attack, a blood clot in the lungs (pulmonary embolism), or a blood clot in the eyes. Stop taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and get emergency help right away if you have any of the following signs of blood clots. 

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes 
  • Double vision

High Potassium Levels (Hyperkalemia). Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can cause a high potassium level (hyperkalemia), which can be serious and may lead to death. Your health care provider may check your potassium levels, especially if you take certain other medicines. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of a high potassium level. 

  • Muscle weakness or unusual tiredness
  • Slow heartbeat or feeling of skipped heartbeats 
  • Nausea or vomiting
  • Trouble breathing
  • Abnormal heart rhythm

Cancer. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is a combination birth control pill that contains two hormones. Certain cancers, including breast cancer and cervical cancer, are types of cancers that may be sensitive to hormones. Make sure you keep all appointments with your health care provider.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure rises while you take this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Gallbladder Problems. Taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can cause gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.

  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
  • Fever
  • Pain in your upper stomach area
  • Stool (poop) that is clay-colored

Headache/Migraine. Taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can cause new headaches or migraines to develop that keep coming back or cause you a lot of pain. Stop taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and call your health care provider right away if you get these symptoms. 

Warnings & Precautions

Who should not use drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

Allergies to Ingredients. People who are allergic to any of the following should not take drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium.

  • Drospirenone
  • Ethinyl estradiol 
  • Levomefolate calcium
  • Beyaz
  • Safyral
  • Tydemy
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium products they stock.

Drug Interactions. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken while you are using certain other medicines. Before taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details.

Kidney Problems. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium  should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your health care provider may do tests to see if they are working well enough to take this medicine.

Adrenal Problems. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have adrenal insufficiency, which is a condition where your adrenal glands stop making as much cortisol (the stress hormone). 

History of Blood Clots. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you currently have or have had a deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or heart attack.

Smoking. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you smoke and are 35 years of age or older, as this can increase your chances of having a heart attack, stroke, or blood clots.

Blood and Blood Vessel Problems. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have a condition that makes your blood more prone to getting blood clots, such as thrombophilia. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have or have had a history of plaque buildup in your blood vessels (coronary artery disease) or if you have or have had a condition that affects the blood flow to your brain (cerebrovascular disease).

Heart Problems. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have heart rhythm problems (such as atrial fibrillation) or heart valve problems, as this may increase your chances of having a blood clot.

Increased Blood Pressure (Hypertension). Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have high blood pressure that is not controlled. 

Diabetes. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have diabetes with a condition that affects your blood vessels (vascular disease).

Headaches/Migraines. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have migraines with vision or hearing changes, muscle weakness, tingling, or trouble speaking (aura) or certain types of headaches, as this can increase your risk of having a stroke. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you are 35 or older with migraine headaches (with or without aura).

Unusual Uterine Bleeding.  Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be used if you have bleeding from the uterus that is not part of your menstrual cycle or is unusual. Any unusual uterine bleeding needs to be checked out by your health care provider.

Cancer. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if you have or have had breast cancer.

Liver Problems. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium should not be taken if your liver is not working as well as it should be or if you have liver tumors. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.

What should I know about drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium before using it?

Do not take drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium with other people, even if they have the same condition as you. It may harm them.

Keep drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium out of the reach of children.

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted diseases (STDs).

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may not work well if you miss tablets. Take tablets in order (from left to right) at the same time every day until the pack is finished, and swallow the tablets whole. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack. 

If you throw up (vomit) or have diarrhea, this medicine may not work well. If you throw up (vomit) up to four hours after taking an active tablet, count this as a missed tablet. See the Missed Dose section for more details. You may need to use backup birth control. Talk to your health care provider about backup birth control options (condoms, spermicide). You also need to use backup birth control if you have sex during the first seven days after missing more than one dose of the active tablets.

When you start this medicine, you may skip a period or have irregular vaginal bleeding, such as spotting. If this continues or happens after you have normal monthly periods, call your health care provider right away. If you miss pills or think you may be pregnant, call your health care provider right away.

What should I tell my health care provider before using drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Gave birth within last month
  • Heart problems
  • High blood pressure
  • High potassium levels
  • Kidney or liver problems
  • High blood sugar or diabetes
  • High cholesterol or triglyceride levels 

Gallbladder Problems. Tell your health care provider if you have or have had gallbladder problems, including a history of cholestasis (slowed flow of bile from the liver) during pregnancy. Taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can increase your chances of having cholestasis again. 

Depression. Talk to your health care provider if you have a history of depression. Taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may worsen depression.

Major Surgeries. Tell your health care provider if you have any upcoming major surgeries. Your health care provider may ask you to stop taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium at least four weeks before your surgery and may wait at least two weeks after your surgery to start you on drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. If your health care provider decides to stop drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium because of an upcoming surgery, your health care provider will talk to you about other forms of contraception to use during that time.

Smoking. Tell your health care provider if you smoke. Smoking while taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can increase your risk of having a heart attack or stroke. 

Angioedema. Talk to your health care provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body, including your lips, face, tongue, or throat. Taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema.

Skin Darkening. Talk to your health care provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth (chloasma) during pregnancy because you may have an increased chance of having chloasma while taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. If you have had chloasma, avoid exposure to the sun and to ultraviolet (UV) rays from tanning booths or sun lamps.

Pregnancy. Do not take drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium right away and contact your health care provider.

Breastfeeding. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium may decrease the amount of breast milk you make. Your health care provider will let you know if you should take drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium while breastfeeding.

Interactions

Does drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium interact with foods or drinks?

Eating grapefruit or drinking grapefruit juice while taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium can increase the level of estrogens in your body. Talk to your health care provider if you eat grapefruit or drink grapefruit juice.

There are no known interactions between drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium and alcohol.

Does drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium.

  • A medicine for HIV, AIDS, or hepatitis C
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • A supplement or salt substitute containing potassium
  • Amiloride (Midamor), eplerenone (Inspra), spironolactone (Aldactone, Carospir), or triamterene (Dyrenium), which is a type of diuretic, also called a water pill
  • An angiotensin-converting enzyme (ACE) inhibitor, such as enalapril or lisinopril, which is a medicine for high blood pressure, heart failure, and certain kidney problems
  • An angiotensin II receptor blocker (ARB), such as losartan or valsartan, which is a medicine for high blood pressure, heart failure, and other heart conditions
  • Heparin, which is a medicine used to treat or prevent blood clots
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Lamotrigine (Lamictal), which is a medicine for seizures
  • A barbiturate, such as butalbital, phenobarbital, or primidone, which is a medicine that may be used to treat insomnia, migraines, or seizures
  • Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
  • Fluconazole (Diflucan), griseofulvin, itraconazole (Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend), which are medicines used to treat certain types of fungal infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • St. John’s wort, which is a supplement that may be used to treat depression
  • Atorvastatin (Lipitor), which is a medicine used for high cholesterol
  • Vitamin C (ascorbic acid) which is a medicine used to treat/prevent low vitamin C levels
  • Acetaminophen (Tylenol), which is used to treat pain and fever
  • An antibiotic, which is a medicine used for bacterial infections
  • Diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which are medicines used for high blood pressure or other conditions
  • Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
  • Pyrimethamine (Daraprim), which is a medicine commonly used to treat an infection called toxoplasmosis
  • Sulfasalazine (Azulfidine), which is a medicine used for certain inflammatory conditions, such as ulcerative colitis or rheumatoid arthritis
  • Cholestyramine (Prevalite), which is a medicine used to lower cholesterol

Some other medicines may alter the blood levels of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium. Always check with your health care provider.

Does interact with other drugs you are taking?

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Overdose/Missed Dose

What should I do if I accidentally use too much drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

If you or someone else has used too much drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium?

This medicine may not work well if you miss tablets. If you vomit within four hours after taking drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, this is considered a "missed tablet" because your body may not have fully absorbed the medicine. If you miss taking an active pill, take it as soon as you remember, even if that means taking two pills in one day. Then continue to take one pill every day until you finish the pack. 

If you miss two or more active pills, follow the directions in the Patient Labeling. What you need to do depends on how many tablets you have missed and which week(s) they were missed. You need to use backup birth control (condoms, spermicide) if you have sex during the first seven days after missing more than one dose of the active tablets.

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