Getting Started With ORTHO TRI-CYCLEN® Lo

 

If you think ORTHO TRI-CYCLEN® Lo may be right for you, set up an appointment with your gynecologist or healthcare professional to discuss whether you are a good candidate. Be sure to honestly discuss your health and lifestyle, so your healthcare professional can determine what’s most appropriate for you.

Get more tips on how to prepare for an OB/GYN visit

Need an ORTHO TRI-CYCLEN® Lo prescription?

If you and your healthcare professional decide on ORTHO TRI-CYCLEN® Lo, he or she will write you a prescription. Don’t forget to ask your healthcare professional for instructions on how to start taking it. You can get your prescription filled at a local or online pharmacy. Or check to see if your insurance company has a mail-order prescription program. It is important to remember to refill your prescription on time each month so you have a pack in time for your start date. Be sure you have ready at all times an extra full pill pack of ORTHO TRI-CYCLEN® Lo and another kind of birth control, such as a condom or spermacide, to use as a back-up method in case you miss pills.

Get tips on how to remember your birth control pills refills

Starting the Pill

The correct way to take ORTHO TRI-CYCLEN® Lo is to take one pill each day, at the same time each day. Pick a time that’s convenient and easy to remember (get birth control reminder tips ). Missed pills may not only increase the risk of pregnancy but also may increase your chance of experiencing some side effects, such as bleeding between periods.

You have 2 choices:

Starting your pill on the Sunday after your period starts or on the first day of your period. The ORTHO DIALPAK® Tablet Dispenser is preset for a Sunday Start, but you also can select a Day 1 Start by turning the dial to the first day of your period.

Sunday Start

Take the first “active”* white pill of the first pack on the Sunday after your period starts —even if you are still bleeding. If your period begins on a Sunday, start your pack on the same day. With a Sunday Start, you MUST use a backup birth control method (such as condoms or spermicide ) if you have sex for the first 7 days.

Day 1 Start

Take the first “active” white pill of the first pack within 24 hours of starting your period . If you choose a Day 1 Start, you will not need to use a backup method of birth control because you are starting the Pill at the beginning of your period.

*The 28-pill pack contains 21 “active” pills (7 white, 7 light blue, and 7 dark blue; all with hormones ) to take for 3 weeks. This is followed by 1 week of placebo pills (7 green; all without hormones).

Want to Change Your Start Date?

You should ask your healthcare professional for guidance before you change your start date. What type of information will you need to provide? Read on so you’ll be fully prepared for your next OB/GYN appointment.

 
IMPORTANT SAFETY INFORMATION
What is ORTHO TRI-CYCLEN® Lo?

ORTHO TRI-CYCLEN® Lo is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

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:

  • 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
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?
  • 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:

  • 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 professional 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 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.
  • Depression
  • 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.
What are the most common side effects of ORTHO TRI-CYCLEN® Lo?
  • headache (including migraine)
  • nausea and vomiting
  • breast problems
    • tenderness, pain, and discomfort
    • enlargement and swelling
    • discharge
    • nipple pain
  • stomach pain
  • pain with your periods (menstrual cycle)
  • mood changes, including depression
  • acne
  • vaginal infections
  • bloating
  • weight gain
  • fatigue

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.
    • Colesevelam
    • 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.

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