re 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
If any of these conditions happen while you are taking ORTHO-CYCLEN or ORTHO TRI-CYCLEN, stop taking ORTHO-CYCLEN or ORTHO TRI-CYCLEN right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking ORTHO-CYCLEN or ORTHO TRI-CYCLEN.
What should I tell my healthcare provider before taking ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
Tell your healthcare provider if you:
are pregnant or think you may be pregnant
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-CYCLEN or ORTHO TRI-CYCLEN may decrease the amount of breast milk you make. A small amount of the hormones in ORTHO-CYCLEN or ORTHO TRI-CYCLEN may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
ORTHO-CYCLEN or ORTHO TRI-CYCLEN may affect the way other medicines work, and other medicines may affect how well ORTHO-CYCLEN or ORTHO TRI-CYCLEN works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
Read the Instructions for Use at the end of this Patient Information.
What are the possible serious side effects of ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
Like pregnancy, ORTHO-CYCLEN or ORTHO TRI-CYCLEN 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:
first start taking birth control pills
restart the same or different birth control pills after not using them for a month or more
Call your healthcare provider or go to a hospital emergency room right away if you have:
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
Other serious side effects include:
liver problems, including:
rare liver tumors
jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
high blood pressure. You should see your healthcare provider 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-CYCLEN or ORTHO TRI-CYCLEN.
depression
possible cancer in your breast and cervix
swelling of your skin especially around your mouth, eyes, and in your thr