Drospirenone Tablets

DROSPIRENONE (dro SPY re nown) prevents ovulation and pregnancy. It belongs to a group of medications called contraceptives. This medication is a progestin hormone.

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.

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
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• High potassium level—muscle weakness, fast or irregular heartbeat
• 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
• 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
• 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):

• Acne
• Breast pain or tenderness
• Headache
• Irregular menstrual cycles or spotting
• Menstrual cramps
• Nausea
• Weight gain

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

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
• Heart disease or recent heart attack
• High potassium level
• Kidney disease
• Liver disease
• Migraine headaches
• Stroke
• An unusual or allergic reaction to drospirenone, progestins, or other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Do not take this medication with any of the following:

• Atazanavir; cobicistat
• Bosentan
• Fosamprenavir

This medication may also interact with the following:

• Aprepitant
• Barbiturates, such as phenobarbital, primidone
• Carbamazepine
• Certain antibiotics, such as clarithromycin, rifampin, rifabutin, rifapentine
• Certain antivirals for HIV or hepatitis
• Certain diuretics, such as amiloride, spironolactone, triamterene
• Certain medications for blood pressure, heart disease
• Certain medications for fungal infections, such as griseofulvin, ketoconazole, itraconazole, voriconazole
• Cyclosporine
• Felbamate
• Heparin
• Medications for diabetes
• Modafinil
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Oxcarbazepine
• Phenytoin
• Potassium supplements
• Rufinamide
• St. John's Wort
• Topiramate

If you miss a dose, take it as soon as you can and 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.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You may need blood work done while you are taking this medication.

If you have any reason to think you are pregnant, stop taking this medication right away and contact your care team.

This medication does not protect you against HIV or any other sexually transmitted infections (STIs).

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