Drospirenone; Ethinyl Estradiol; Levomefolate Tablets

What is this medication?

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE (dro SPY re nown; ETH in il es tra DYE ole; lee voe ME FOE late) is an oral contraceptive (birth control pill). This medicine combines two types of female hormones, an estrogen and a progestin. This medicine also has levomefolate, a B vitamin. It is used to prevent ovulation and pregnancy. It is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), to treat acne, and to raise folate levels in women who want to use birth control.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Beyaz, SAFYRAL, Tydemy

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal vaginal bleeding
• Adrenal gland disease
• Blood vessel disease or blood clots
• Breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Depression
• Diabetes (high blood sugar)
• Gallbladder disease
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol
• High potassium level
• Kidney disease
• Liver disease
• Migraine headaches
• Stroke
• Systemic lupus erythematosus (SLE)
• Thyroid disease
• Tobacco smoker
• An unusual or allergic reaction to estrogens, progestins, folates, or other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. To reduce nausea, this medication may be taken with food. Follow the directions on the prescription label. Take this medication at the same time each day and in the order directed on the package. Do not take your medication more often than directed.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your care team about the use of this medication in children. Special care may be needed. This medication has been used in children who have started having menstrual periods.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, refer to the patient information sheet you received with your medication for direction. If you miss more than one pill, this medication may not be as effective and you may need to use another form of contraception.

What may interact with this medication?

Do not take this medication with any of the following:

• Aminoglutethimide
• Amprenavir, fosamprenavir
• Atazanavir; cobicistat
• Anastrozole
• Bosentan
• Exemestane
• Letrozole
• Metyrapone
• Testolactone

This medication may also interact with the following:

• Acetaminophen
• Antiviral medications for HIV or AIDS
• Aprepitant
• Atorvastatin
• Barbiturates
• Certain antibiotics, such as rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines
• Certain diuretics, such as amiloride, spironolactone, triamterene
• Certain medications for fungal infections, such as griseofulvin, ketoconazole, itraconazole
• Certain medications for high blood pressure or heart conditions, such as ACE-inhibitors, Angiotensin-II receptor blockers, eplerenone
• Certain medications for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Cholestyramine
• Cobicistat
• Corticosteroids, such as hydrocortisone and prednisolone
• Cyclosporine
• Dantrolene
• Felbamate
• Grapefruit juice
• Heparin
• Lamotrigine
• Medications for diabetes, including pioglitazone
• Methotrexate
• Modafinil
• NSAIDs
• Potassium supplements
• Pyrimethamine
• Raloxifene
• St. John's wort
• Sulfasalazine
• Tamoxifen
• Topiramate
• Thyroid hormones
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Use an additional method of contraception during the first cycle that you take these tablets.

If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking birth control pills, especially if you are more than 35 years old. You are strongly advised not to smoke.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

If you are going to have elective surgery, you may need to stop taking this medicine before the surgery. Consult your health care professional for advice.

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual vaginal discharge, itching, or odor
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Irregular menstrual cycles or spotting
• Nausea
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.