ORTHO TRI-CYCLEN LO, Your Birth Control Pill

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Caution: patient labels may come in different sizes and shapes.

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Always be sure you know everything about a medicine before you take it. This information will help you get the full benefits from your medicine.

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Although it may sound strange, drinking water causes the body to release excess fluid. A recommended amount is 8-glasses a day.

Details, Details, Details...It's all in the details

Sometimes all it takes is reading instructions and ingredients. In this section you will learn how to understand the labels and how to differentiate the options on the market according to benefits, side effects and risks.

You've got the basics about the Pill, what's in it and how it works. But is it really right for you? To answer that question, it's important to know more about the specific benefits, and the risks, of taking the Pill. Armed with that knowledge, you can also have a more productive discussion with your healthcare professional – but more about that later.

To help you dive into the details, there's a document that comes packaged with your Pill and also can be found on Web sites – it's called the detailed patient labeling (aka patient labeling). Unlike other labels that you can read on the back of a can while you're standing in the store, the label that accompanies your medications, like the Pill, is much more detailed. So much so, that you may have seen it and immediately put it aside or even been a little intimidated. Well, don't be! We promise that you don't need to be a brainiac or chemistry major to sort it out. Full US Product Information

What's in a label?

There are 3 very important things that the patient label will tell you:

The benefits of using the Pill
The risks involved – this includes potential serious and nonserious side effects plus information about who should not take the Pill and why
How to take the Pill – to ensure that it is as effective as possible

"The benefits:" There are 2 sections of the label that talk about benefits – the first is about preventing pregnancy, which compares the effectiveness of the Pill against other birth control methods. You'll see that the Pill is among the most effective nonsurgical methods. This information is expressed in “failure rates” – the percentage of time in the first year that pregnancy can happen with each method. What's more, these are “real world” rates – so, for example, if the Pill is used perfectly (meaning taken every day around the same time) its failure rate is less than 1%; in the real world, its failure rate is 5%. So, you see why it is important to take it every day at the same time!
"The risks:" Like we said up front, any medication carries risks as well as benefits. With help from your healthcare professional, it is important to understand these risks so that you can better weigh them against the benefits. The hard thing about understanding risk is that the numbers often seem stated in ways that make it difficult to apply to you. Or, in ways that can seem scary. Let's break it down on the label. There are 4 key sections:
- Who should not take the Pill – For most women, the Pill is safe when used according to the US FDA-approved label. However, there are women who, because of their health status, should not take the Pill. That includes – and it's a big red flag – women who smoke. That's because the most serious risks associated with taking the Pill are made a lot worse if you smoke. You've heard it a million times, but seriously, don't smoke. Life's a lot easier if you don't.
- Risks – There several health risks called out on the label. They can all be serious, but most of them are rare. The most serious risks are blood clots, heart attacks and strokes – and they can be fatal. These are the “cardiovascular” side effects that are worse if you smoke. Many of the risks can increase with age and smoking. But, even if you are over 40, if you don't smoke and are in good health, the benefits of taking the Pill (at the lowest possible effective dose) may outweigh the possible risks. If you are taking the Pill, the label also gives you a list of warning signs, like specific types of pain or other sudden events. If you experience any of these, it may be a signal of something serious; and, definitely a signal for you to call your healthcare professional.
- Side Effects – There are side effects with all medications, whether they are over the counter or prescription. Many of the side effects of the Pill are not serious, and may go away after the first few months of use. It's a great irony of life that one of the most common side effects is irregular bleeding such as spotting, especially for women who go on the Pill expecting a more regular period. Not only is it embarrassing, it can also make you stop taking your Pill if you think you're getting your period. Don't do that! If it persists, especially past the third month on your Pill, call your healthcare professional instead. It may be time for an alternative “Pill experience”.
- Precautions – These aren't risks like side effects, but they do spell out some more general health-related situations that you should be aware of if you are on the Pill or want to begin taking it, for example, if you are breast-feeding or taking other medications that may interact with the Pill.
"Additional potential benefits:" There is a second section about the potential “noncontraceptive” health benefits, many of which relate to period control – for example, making them more regular and lighter, or reducing the pain that many women have during their periods. If you're interested in these benefits, you should certainly bring them up with your healthcare professional when you are discussing which pill may be best for you.
"How to take the Pill:" Because it is so important to take the Pill correctly, the label includes a lot of detail on how to do this, from when to start your first pack to what to do if you do miss a pill, or two, or even three or more. If this happens to you, and it can happen to the best of us, don't panic. You might be able to make it up. But, if you can't make up the missed pills because you missed too many or if you have any doubt, just use a backup method until you can be sure again.

Try these helpful tips for how to remember to take your Pill every day.

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What is ORTHO TRI-CYCLEN^® LO?

ORTHO TRI-CYCLEN^® LO is a prescription oral contraceptive used for the prevention of pregnancy.
ORTHO TRI-CYCLEN^® LO does not protect against HIV (AIDS) or other sexually transmitted diseases.
ORTHO TRI-CYCLEN^® LO is not indicated for use in emergency contraception.

Important Safety Information

What is the most important information I should know about ORTHO TRI-CYCLEN^® LO?

Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age, with heavy smoking (15 or more cigarettes per day) and in women over 35 years of age. Women who use hormonal contraceptives are strongly advised not to smoke.

Who should not use ORTHO TRI-CYCLEN^® LO?

You should not use ORTHO TRI-CYCLEN^® LO if you are pregnant or think you may be pregnant or if you have any of the following conditions:

A history of heart attack or stroke, blood clots in the legs, lungs, or eyes, a history of blood clots in the deep veins of your legs, chest pain, known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, unexplained vaginal bleeding (until your doctor reaches a diagnosis), yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, liver tumor (benign or cancerous), or if you plan to have surgery with prolonged bed rest.

Tell your healthcare professional if you have ever had any of these conditions, he/she can recommend a safer method of birth control.

What are the possible side effects of ORTHO TRI-CYCLEN^® LO?

Irregular vaginal bleeding or spotting. If bleeding occurs in more than one cycle or lasts for more than a few days call your healthcare professional
Problems wearing contact lenses such as change in vision or inability to wear your lenses. If these occur, contact your healthcare professional
Fluid retention with swelling of the fingers or ankles and may raise your blood pressure. Contact your healthcare professional if you experience fluid retention.
Spotty darkening of the skin (particularly the face). This may persist after you stop using ORTHO TRI-CYCLEN^® LO
Other side effects include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, vaginal infections and allergic reactions.

Call your doctor immediately if you experience any of these side effects while you are using ORTHO TRI-CYCLEN^® LO:
Sharp chest pain, coughing blood or sudden shortness of breath, pain in the calf, crushing chest pain or tightness in the chest, sudden, severe, headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg, sudden or complete loss of vision, breast lumps, severe pain or tenderness in the stomach area, difficulty in sleeping, weakness, lack of energy, fatigue or change in mood, yellowing of the skin or whites of the eye along with fever, fatigue, loss of appetite, dark-colored urine or light-colored bowel movements.

What should I tell my healthcare professional before using ORTHO TRI-CYCLEN^® LO?

Tell your healthcare professional if you: Smoke, are breast-feeding, or are taking any other medications.
Also, tell your healthcare professional if you have or have had:
Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, a family history of breast cancer, diabetes, elevated cholesterol or triglycerides, high blood pressure, migraine or other headaches or epilepsy, depression, gallbladder, liver, heart or kidney disease, history of light or irregular menstrual periods.
Tell your healthcare professional about all of the medicines you are taking, before starting and while you are using ORTHO TRI-CYCLEN^® LO including prescription and non-prescription medicines, vitamins, herbal and dietary supplements such as:

Barbiturates, bosentan, carbamazepine, phenybutazone, drugs used to treat HIV or AIDS, antibiotics, phenytoin, rifampin, topiramate, St. John’s Wort (a herbal supplement).

Also, tell your healthcare professional

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Ask your healthcare provider if you are not sure if any of your medicines are listed above.

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.

Please see the Detailed Patient Labeling from the full Product Information.

Details, Details, Details...It's all in the details

Sometimes all it takes is reading instructions and ingredients. In this section you will learn how to understand the labels and how to differentiate the options on the market according to benefits, side effects and risks.

What's in a label?

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