Ortho Tri-Cyclen is a combination birth control pill containing the female hormones ethinyl estradiol and norgestimate. These hormones prevent ovulation (the release of an egg from an ovary).

Ortho Tri-Cyclen 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.

Ortho Tri-Cyclen is used as contraception to prevent pregnancy.

Ortho Tri-Cyclen is also used to treat moderate acne vulgaris in females who are at least 15 years old. This medicine should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Do not use Ortho Tri-Cyclen if you are pregnant or if you have recently had a baby.

You should not use Ortho Tri-Cyclen if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take Ortho Tri-Cyclen if you smoke and are over 35 years old.

Take Ortho Tri-Cyclen exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms with spermicide, when you first start using Ortho Tri-Cyclen. Follow your doctor's instructions.

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 take one pill daily.

Ortho Tri-Cyclen packs contain seven dark green "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.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need major surgery with long-term bed rest, 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 Ortho Tri-Cyclen.

While taking Ortho Tri-Cyclen, you will need to visit your doctor regularly.

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

Usual Adult Dose of Ortho Tri-Cyclen for Contraception:

1 tablet orally once a day

Usual Adult Dose for Acne:

1 tablet orally once a day

Comments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Usual Pediatric Dose for Acne:

15 years or older: 1 tablet orally once a day

-Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no know contraindications to oral contraceptive therapy and who have achieved menarche.

Taking Ortho Tri-Cyclen 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 taking birth control pills. Your risk is also high when you restart birth control pills after not taking them 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 take combination birth control pills if you smoke and are over 35 years old.

Do not use Ortho Tri-Cyclen if you are pregnant. Stop using this medicine and 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.

You should not take Ortho Tri-Cyclen if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);

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

• circulation 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 (aura, numbness, vision changes), especially if you are older than 35; or

• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

To make sure Ortho Tri-Cyclen is safe for you, tell your doctor if you have ever had:

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

• high cholesterol or triglycerides, or if you are overweight;

• depression;

• a seizure or migraine headache;

• diabetes, gallbladder disease, underactive thyroid;

• liver or kidney disease;

• jaundice caused by pregnancy or birth control pills;

• irregular menstrual cycles; or

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

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

Follow the instructions provided with your medicine. Missing an Ortho Tri-Cyclen pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then 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 in a row in Week 3, throw out the pack and start a new pack 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 pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out 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 pack that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

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

Do not smoke while taking Ortho Tri-Cyclen, especially if you are older than 35 years of age.

Ortho Tri-Cyclen 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.

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

Stop using Ortho Tri-Cyclen and call your doctor at once if you have:

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot - sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems - loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• severe headache, pounding in your neck or ears;

• swelling in your hands, ankles, or feet;

• changes in the pattern or severity of migraine headaches;

• a breast lump; or

• symptoms of depression - sleep problems, weakness, tired feeling, mood changes.

Common Ortho Tri-Cyclen side effects may include:

• stomach pain, gas, nausea, vomiting;

• breast tenderness;

• acne, darkening of facial skin;

• headache, nervousness, mood changes;

qa

• problems with contact lenses;

• changes in weight;

• breakthrough bleeding;

• vaginal itching or discharge; or

• rash.

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.

Other drugs interact with ethinyl estradiol and norgestimate, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all your current medicines and any medicine you start or stop using.