IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ORTHO TRI-CYCLEN® Lo?
Do not use ORTHO TRI-CYCLEN® Lo if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots, or stroke.
This risk increases with age and the number of cigarettes you smoke.
Who should not take ORTHO TRI-CYCLEN® Lo?
Do not take ORTHO TRI-CYCLEN® Lo if you:
If any of these conditions happen while you are taking ORTHO TRI-CYCLEN® Lo, stop taking ORTHO TRI-CYCLEN® Lo right away and talk to your healthcare professional. Use nonhormonal contraception when you stop taking ORTHO TRI-CYCLEN® Lo.
What are the possible serious side effects of ORTHO TRI-CYCLEN® Lo?
- smoke and are over 35 years of age
- had blood clots in your arms, legs, lungs, or eyes
- had a problem with your blood that makes it clot more than normal
- have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
- had a stroke
- had a heart attack
- have high blood pressure that cannot be controlled by medicine
- have diabetes with kidney, eye, nerve, or blood vessel damage
- have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
- have liver problems, including liver tumors
- have any unexplained vaginal bleeding
- are pregnant
- had breast cancer or any cancer that is sensitive to female hormones
- Like pregnancy, ORTHO TRI-CYCLEN® Lo may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.
Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
Call your healthcare professional or go to a hospital emergency room right away if you have:
- first start taking birth control pills
- restart the same or different birth control pills after not using them for a month or more
Other serious side effects include:
- leg pain that will not go away
- sudden severe shortness of breath
- sudden change in vision or blindness
- chest pain
- a sudden, severe headache unlike your usual headaches
- weakness or numbness in your arm or leg
- trouble speaking
What are the most common side effects of ORTHO TRI-CYCLEN® Lo?
- Liver problems, including:
- rare liver tumors
- jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare professional if you have yellowing of your skin or eyes
- High blood pressure. You should see your healthcare professional for a yearly check of your blood pressure.
- Gallbladder problems
- Changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
- New or worsening headaches including migraine headaches
- Irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking ORTHO TRI-CYCLEN® Lo.
- Possible cancer in your breast and cervix
- Swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare professional if you have a swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
- Dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking ORTHO TRI-CYCLEN® Lo. Use sunscreen if you have to be in the sunlight.
- headache (including migraine)
- nausea and vomiting
- breast problems
- tenderness, pain, and discomfort
- enlargement and swelling
- nipple pain
- stomach pain
- pain with your periods (menstrual cycle)
- mood changes, including depression
- vaginal infections
- weight gain
These are not all the possible side effects of ORTHO TRI-CYCLEN® Lo. For more information, ask your healthcare professional or pharmacist. You may report side effects to the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
What should I tell my healthcare professional before using ORTHO TRI-CYCLEN® Lo?
Tell your healthcare professional if you:
- are pregnant or think you may be pregnant. If you become pregnant, stop taking ORTHO TRI-CYCLEN® Lo.
- are depressed now or have been depressed in the past
- had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
- are breastfeeding or plan to breastfeed. ORTHO TRI-CYCLEN® Lo may decrease the amount of breast milk you make; this is less likely to occur if breastfeeding is well established. A small amount of the hormones in ORTHO TRI-CYCLEN® Lo may pass into your breast milk. Talk to your healthcare professional about the best birth control method for you while breastfeeding.
- Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ORTHO TRI-CYCLEN® Lo may affect the way other medicines work, and other medicines may affect how well ORTHO TRI-CYCLEN® Lo works.
- Especially tell your healthcare professional if you take any of the following medicines:
- barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and over-the-counter medicines containing St. John’s wort. Using these medicines with ORTHO TRI-CYCLEN® Lo may lead to irregular or unusual vaginal bleeding and/or spotting between your menstrual periods, and may make your contraceptive less effective. Talk to your doctor about using a back-up or alternative method of contraception when these medicines are used with ORTHO TRI-CYCLEN® Lo.
- HIV protease inhibitors such as: nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir.
Know the medicines you take. Keep a list of them to show your healthcare professional and pharmacist when you get a new medicine. Ask your healthcare professional if you are not sure if any of your medicines are listed above.
What else should I know about taking ORTHO TRI-CYCLEN® Lo?
If you are scheduled for any lab tests, tell your healthcare professional you are taking
ORTHO TRI-CYCLEN® Lo. Certain blood tests may be affected by ORTHO TRI-CYCLEN® Lo.
ORTHO TRI-CYCLEN® Lo does not protect against HIV infection (AIDS) and other sexually transmitted infections.
What should I know about my period when taking ORTHO TRI-CYCLEN® Lo?
Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking ORTHO TRI-CYCLEN® Lo, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.
If you miss two or more of your periods in a row tell your healthcare provider because you may be pregnant.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Scientific Affairs, LLC at 1-800-526-7736.
Please see the full Product Information including BOXED WARNING.