Drospirenone; Estetrol Tablets

What is this medication?

DROSPIRENONE; ESTETROL (dro SPY re nown; ES te trol) prevents ovulation and pregnancy. It belongs to a group of medications called oral contraceptives. It is a combination of the hormones estrogen and progestin.

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

COMMON BRAND NAME(S): NEXTSTELLIS

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

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

• Adrenal gland disease
• Blood clots
• Blood vessel conditions
• Breast cancer
• Cervical, endometrial, ovarian, liver, or uterine cancer
• Diabetes
• Gallbladder disease
• Having surgery
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol or triglycerides
• High levels of potassium in the blood
• History of irregular heartbeat or heart valve problems
• Kidney disease
• Liver disease
• Lupus
• Migraine headaches
• Protein C or S deficiency
• Recently had a baby, miscarriage, or abortion
• Stroke
• Tobacco use
• Unusual vaginal bleeding
• An unusual or allergic reaction to estrogens, progestins, or other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Follow the directions on the prescription label. Take this medication at the same time each day and in the order directed on the package. You can take it with or without food. If it upsets your stomach, take it with food. 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:

• Amprenavir
• Anastrozole
• Atazanavir
• Boceprevir
• Dasabuvir; ombitasvir; paritaprevir; ritonavir
• Letrozole
• Ombitasvir; paritaprevir; ritonavir
• Tranexamic acid

This medication may also interact with the following:

• Antiviral medications for HIV or hepatitis
• Aprepitant or fosaprepitant
• Armodafinil
• Barbiturates, such as phenobarbital, primidone
• Bile acid sequestrants, such as cholestyramine or colesevelam
• Bosentan
• Carbamazepine
• Certain antibiotics, such as rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines
• Certain diuretics, such as amiloride, spironolactone, triamterene
• Certain medications for blood pressure or heart disease, such as ACE-inhibitors, Angiotensin-II receptor blockers, eplerenone
• Certain medications for fungal infections, such as griseofulvin, ketoconazole, itraconazole
• Clobazam
• Corticosteroids, such as hydrocortisone, prednisolone, prednisone
• Cyclosporine
• Dantrolene
• Elagolix
• Exemestane
• Felbamate
• Grapefruit juice
• Heparin
• Lamotrigine
• Medications for diabetes
• Metyrapone
• Mifepristone
• Modafinil
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Oxcarbazepine
• Phenytoin
• Potassium supplements
• Pyrimethamine
• Raloxifene
• Rufinamide
• St. John's wort
• Sulfasalazine
• Tamoxifen
• Thyroid hormones
• Topiramate
• Ulipristal
• 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?

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.

Use an additional method of contraception, such as a condom, during the first cycle of this medication.

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

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are 35 years or older.

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

This medication 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 sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

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

This medication can cause tooth and gum problems. Tenderness, swelling, or minor bleeding of the gums may occur. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any medications you are taking.

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.

Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs).

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
• 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
• 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
• 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
• 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 and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.