Estrostep Fe (contraception)

Estrostep Fe (contraception)

Estrostep Fe (contraception)

What is Estrostep Fe?

Estrostep Fe is used as a contraceptive to prevent pregnancy. Estrostep Fe is also used to treat moderate acne in women who are at least 15 years old and already have their period and want to take birth control pills. There are many brands of ethinyl estradiol and norethindrone available. Not all brands are listed in this brochure.

Estrostep Fe may also be used for purposes not listed in this medication guide.

Birth control pill side effects

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

This medicine can cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• Signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, vision or balance problems;

• Signs of a blood clot in the lungs – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;

• Signs of a blood clot deep in the body – pain, swelling or warmth in one leg;

• Heart attack symptoms – chest pain or feeling of pressure, pain spreading to the jaw or shoulder, nausea, sweating;

• Liver problems - swelling in the midsection, pain in the right upper abdomen, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased blood pressure – severe headache, blurred vision, throbbing in the neck or ears;

• Depression – mood swings, low self-esteem, loss of interest in things you used to enjoy, new sleep problems, thoughts about hurting yourself;

• swelling of the hands, ankles, or feet, or a lump in the breast; or

• a change in the pattern or severity of migraine headaches.

Common side effects of Estrostep Fe may include:

• nausea, vomiting;

• breast tenderness or breakthrough bleeding; or

• Headaches or problems with contact lenses.

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

Warnings

Do not use birth control pills if you are pregnant or have recently had a child.

You should not use birth control pills if you:uncontrolled high blood pressure, heart disease, coronary artery disease, circulatory problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraines, if you are also taking certain hepatitis C medications, if you are about to have major surgery, if you smoke and are over 35 years old, or if you have ever had a heart attack, stroke, blood clot, jaundice or breast cancer caused by pregnancy or birth control pills. had uterine/cervical or vaginal cancer.

Smoking, especially if you are over 35, or taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Before you take this medicine

Taking birth control pills can increase your risk of blood clots, strokes, or heart attacks. You are at even greater risk if you have high blood pressure, diabetes, high cholesterol or are overweight. Your risk of a stroke or blood clot is highest in the first year of taking birth control pills. Your risk is also high if you start taking birth control pills again after not taking them for four weeks or more.

Smoking can increase the risk of blood clots, strokes, or heart attacks from birth control pills, especially if you are older than 35.

Do not use if pregnant.Stop using Estrostep Fe and tell your doctor immediately if you become pregnant or miss two menstrual periods in a row. If you have recently had a child, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you:

• untreated or uncontrolled high blood pressure or heart disease (history of chest pain, coronary artery disease, heart attack, stroke, or blood clots);

• an increased risk of blood clots due to a heart problem or hereditary blood disorder;

• circulatory problems (especially if caused by diabetes);

• 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;

• liver disease or liver cancer;

• severe migraine headaches (with aura, numbness, weakness, or vision problems), especially if you are older than 35;

• a history of jaundice caused by pregnancy or birth control pills;

• if you smoke and are over 35 years old; or

• if you are taking hepatitis C medicines containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.

Tell your doctor if you have ever had:

• heart problems, high blood pressure or if you are prone to blood clots;

• high cholesterol or triglyceride levels or if you are overweight;

• Depression;

• a seizure or migraine headache;

• diabetes, gallbladder disease, hypothyroidism;

• liver or kidney disease; or

• irregular menstrual cycles or fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Ask a doctor whether breast-feeding is safe while using this medication.

How should I take birth control pills?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Use the medicine exactly as directed.

The first time you take this medication, you may need to use additional contraception, such as condoms containing spermicides. Follow your doctor's instructions.

Take one tablet every day, no more than 24 hours apart. When the pills are finished, start a new pack the next day. You may become pregnant if you do not take one tablet every day.

Some birth control packs contain “reminder pills” to help maintain your regular cycle. Your period usually starts while you are taking these reminder pills.

Use additional contraception if you experience severe vomiting or diarrhea.

Breakthrough bleeding may occur. Tell your doctor if the condition persists or is very severe.

If you need major surgery or need to stay in bed for a long time, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Estrostep Fe.

While you are taking birth control pills, you must visit your doctor regularly.

Store at room temperature, protected from moisture and heat.

What happens if I miss a dose?

Follow the instructions on your prescription label and read any medication guides or instructions for use. If you forget the pill, your risk of becoming pregnant increases.

If you miss an active pill, take two tablets on the day you remember. Then take 1 tablet per day for the remainder of the pack.

If you miss two active pills in a row in week 1 or 2, take two tablets a day for two days in a row. Then take 1 tablet per day for the remainder of the pack. Use additional contraception for at least seven days after the missed pill.

If you miss two active pills in a row in week 3, throw away the rest of the pack and start a new pack on the same day if you start on day one. If you start on Sunday, continue taking one tablet daily until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss three active pills in a row in week 1, 2, or 3, throw away the rest of the pack and start a new pack on the same day if you start on day one. If you start on Sunday, continue taking one tablet daily until Sunday. On Sunday, throw away the rest of the pack and start a new pack that day.

If you miss two or more active pills, you may not get a period during the month.If you miss your period for two months in a row, call your doctor because you may be pregnant.

If you forget a reminder pill, throw it away and continue taking 1 reminder pill per day until the pack is finished.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222. Overdose may cause nausea or vaginal bleeding.

What should I avoid when taking birth control pills?

Do not smoke while taking birth control pills.especially if you are over 35 years old.

Birth control pills do not protect you from sexually transmitted diseases – including HIV and AIDS. The only way to protect yourself from these diseases is to use a condom.

What other medications affect birth control pills?

Tell your doctor about all other medicines you are taking, especially:

• rifampin;

• troglitazone;

• atorvastatin;

• glecaprevir/pibrentasvir; or

• Anticonvulsants (antiepileptic drugs) such as phenobarbital, phenytoin and carbamazepine.

This list is not complete. Other medications can affect Estrostep Fe, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible drug interactions are listed here.

More information

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