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drospirenone and estetrol

Pronunciation: droe SPYE re none and ES te trol

Brand: Nextstellis

What is the most important information I should know about drospirenone and estetrol?

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use this medicine if you smoke and are older than 35 years of age.

What is drospirenone and estetrol?

Drospirenone and estetrol is a combination hormonal birth control that is used to prevent pregnancy.

Drospirenone and estetrol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking drospirenone and estetrol?

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use this medicine if you smoke and are over 35 years old.

You should not use hormonal birth control if you have:

  • untreated or uncontrolled high blood pressure;
  • high blood pressure with blood vessel problems;
  • heart problems (heart valve disorder or heart rhythm disorder);
  • a history of heart attack, stroke, or blood clot;
  • an increased risk of having blood clots due to a hereditary blood disorder;
  • diabetes (and you've had diabetes longer than 20 years, or if diabetes has caused damage to your kidneys, eyes, nerves, or blood vessels);
  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
  • unusual vaginal bleeding that has not been checked by a doctor;
  • adrenal gland problems;
  • liver disease or liver cancer;
  • kidney disease or kidney failure;
  • severe migraine headaches with aura;
  • if you are overweight and have a BMI (body mass index) of 35 or higher; or
  • if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Viekira), with or without dasabuvir.

Tell your doctor if you have ever had:

  • diabetes;
  • high cholesterol or triglycerides;
  • depression; or
  • jaundice caused by pregnancy.

Do not use if you are pregnant and stop taking drospirenone and estetrol if you become pregnant.

Drospirenone and estetrol can slow breast milk production. Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take drospirenone and estetrol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

This medicine comes in pills of 2 different colors. Take a pink (active) pill every day for 24 days in a row, and then take a white (inactive) pill for the next 4 days in a row. Then start a new pack and repeat this daily cycle.

Take the medicine at the same time each day.

When you first start using drospirenone and estetrol, you may need to use back-up birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

You may have breakthrough bleeding, especially during the first 4 months. Tell your doctor if this bleeding continues or is very heavy.

Your blood pressure will need to be checked often.

Tell your doctor if you have a planned surgery.

Store at room temperature away from moisture and heat. Remove a pill from the pack only when you are ready to take your daily dose.

What happens if I miss a dose?

If you miss 1 active (pink) pill, take the pill as soon as you remember and take the next pill at your regular time (you may take 2 pills in 1 day). Then take 1 pill per day for the rest of the pack.

If you miss 2 or more active pills during Week 1 or 2, take a missed pill as soon as possible and also take the pill scheduled for that day (2 pills in 1 day). Throw away the other missed pills and take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss 2 active pills during Week 3, take a missed pill as soon as possible and also take the pill scheduled for that day (2 pills in 1 day). Throw away the other missed pills and take 1 pill per day until all pink pills are gone. Throw away the white inactive pills and start a new pack that day.

Skip any missed inactive (white) pills and keep taking 1 pill per day until the pack is finished.

Call your doctor if you miss 2 or more periods in a row, or if you miss a period after a month when you did not take this medicine daily.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause nausea, vomiting, severe headache, vaginal bleeding, sudden numbness or weakness, leg pain or swelling, or problems with vision or speech.

What should I avoid while taking drospirenone and estetrol?

Do not smoke while taking this medicine, especially if you are older than 35 years of age.

Drospirenone and estetrol may cause dark patches on the skin of your face. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of drospirenone and estetrol?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg pain or swelling, feeling short of breath.

Call your doctor at once if you have:

  • unusual vaginal bleeding, irregular or missed periods;
  • jaundice (yellowing of the skin or eyes);
  • a change in the pattern or severity of migraine headaches;
  • a breast lump;
  • symptoms of depression --sleep problems, weakness, tired feeling, mood changes;
  • high blood potassium --nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
  • low blood potassium --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • irregular or painful periods;
  • breast pain or tenderness;
  • mood changes;
  • headache;
  • acne;
  • weight gain; or
  • decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect drospirenone and estetrol?

Tell your doctor about all your current medicines. Many drugs can affect drospirenone and estetrol, especially:

  • aprepitant;
  • bosentan;
  • phenobarbital or other barbiturates;
  • lamotrigine;
  • St. John's wort;
  • an antibiotic --clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;
  • antifungal medicine --fluconazole, griseofulvin, itraconazole, ketoconazole, voriconazole;
  • antiviral medicine for HIV or hepatitis C --boceprevir, boceprevir, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, ritonavir, telaprevir;
  • cancer medicine --apalutamide, enzalutamide, mitotane;
  • a diuretic or "water pill" --amiloride, eplerenone, Spironolactone;
  • seizure medicine --carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate; or
  • steroid medicine --dexamethasone, prednisone.

This list is not complete and many other drugs may affect drospirenone and estetrol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about drospirenone and estetrol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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