Reclipsen

Generic Name: ethinyl estradiol and desogestrel (EH thih nill ess tra DYE ole and des oh JESS trel)

What is Reclipsen (ethinyl estradiol and desogestrel)?

Ethinyl estradiol and desogestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and desogestrel are used as contraception to prevent pregnancy.

Ethinyl estradiol and desogestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Reclipsen (ethinyl estradiol and desogestrel)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Reclipsen (ethinyl estradiol and desogestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

a history of a stroke or blood clot;

circulation problems (especially if caused by diabetes);

a hormone-related cancer such as breast or uterine cancer;

abnormal vaginal bleeding;

liver disease or liver cancer;

severe high blood pressure;

severe migraine headaches;

a heart valve disorder; or

a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have any of the following conditions. You may need a dosage adjustment or special tests to safely take birth control pills.

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

high cholesterol or if you are overweight;

a history of depression;

gallbladder disease;

diabetes;

seizures or epilepsy;

a history of irregular menstrual cycles; or

a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

How should I take Reclipsen (ethinyl estradiol and desogestrel)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor’s instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor’s instructions.

The 28-day birth control pack contains seven “reminder” pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. Follow the directions on the patient information sheet provided with your medicine. If you do not have an information sheet, call your doctor for instructions if you miss a dose.

If you miss one “active” pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two “active” pills in a row in week one or two, take two pills per day for two days in a row. Then take one 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 two “active” pills in a row in week 3, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three “active” tablets in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

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

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Reclipsen (ethinyl estradiol and desogestrel)?

Do not smoke while using this medication, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

This medication 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.

Reclipsen (ethinyl estradiol and desogestrel) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

a change in the pattern or severity of migraine headaches;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet;

a breast lump; or

symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach cramps;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Reclipsen (ethinyl estradiol and desogestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using this medication, tell your doctor if you are using any of the following drugs:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);

an antibiotic;

phenylbutazone (Azolid, Butazolidin);

St. John’s wort;

seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), topiramate (Topamax), and others;

a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

This list is not complete and there may be other drugs that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.