Oral contraceptives (By mouth)

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings While Using This Medicine

• Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Use a different kind of birth control during the first 3 weeks of oral contraceptive use to make sure you are protected from pregnancy.
• Make sure your doctor knows if you are breastfeeding, or if you have lupus, edema (fluid retention), seizure disorder, asthma, migraine headaches, or a history of depression. Tell your doctor if have breast lumps, high cholesterol, gallbladder disease, liver disease, kidney disease, or irregular monthly periods.
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.
• If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Check with your eye doctor if you wear contact lenses and you have vision problems or eye discomfort.
• You should see your doctor on a regular basis (every 6 months or 1 year) while taking birth control pills.
• If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• It is best to wait 2 or 3 months after stopping birth control pills before you try to get pregnant.

Brand Name(s)

Ortho Tri-Cyclen Lo, TriNessa, Tri-Sprintec 28, Aviane, Low-Ogestrel 28, Apri, Necon 1/35, Sprintec, Levora-28, Microgestin Fe 1/20, Necon 0.5/35, Microgestin Fe 1.5/30, Junel Fe 1/20, Junel Fe 1.5/30, Zovia 1/35e

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to oral contraceptives, or if you are pregnant. Do not use this medicine if you have breast cancer, cancer of the uterus, diabetes, heart disease, high blood pressure, or a history of blood clots, heart attack, or stroke. Do not use this medicine if you have problems with your liver (such as liver tumor), jaundice (yellowish eyes or skin), certain types of headaches, unusual vaginal bleeding, or if you are having a surgery that needs bedrest.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using antibiotics (such as ampicillin, rifampin, tetracycline, Omnipen®, Rimactane®) or antifungals (such as griseofulvin, Grifulvin V®), medicine for seizures (such as phenobarbital, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, primidone, Luminal®, Dilantin®, Tegretol®, Felbatol®, Trileptal®, Topamax®, Mysoline®), modafinil (Provigil®), or medicine to treat HIV or AIDS (such as ritonavir, Norvir®).
• Tell your doctor if you are also using St. John's Wort, atorvastatin (Lipitor®), vitamin C (ascorbic acid), acetaminophen (Tylenol®), itraconazole (Sporanox®), ketoconazole (Nizoral®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), prednisolone (Delta Cortef®, Prelone®), theophylline (Theo-Dur®, Slo-Phyllin®, Gyrocaps®), temazepam (Restoril®), morphine (Astramorph PF®, Duramorph®, Avinza®, MS Contin®, Roxanol®), or salicylic acid.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, shortness of breath, or coughing up blood.
• Heavy vaginal bleeding.
• Irregular or missed menstrual period.
• Lumps in breast.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Rapid weight gain.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Bloated feeling.
• Breast tenderness, pain, swelling, or discharge.
• Changes in appetite.
• Contact lens discomfort.
• Depression or mood changes.
• Mild headache.
• Mild skin rash or itching, or change in skin color.
• Sensitivity to sunlight.
• Stomach cramps.
• Tiredness.
• Vaginal spotting or light bleeding, itching, or discharge.
• Weight changes.

Introduction

Prevents pregnancy. Oral contraceptives are birth control pills.

How to Use This Medicine

Tablet, Chewable Tablet, Coated Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• You may take this medicine with food to lessen stomach upset.
• Keep your pills in the container you receive from the pharmacy. Take the pills in the order they appear in the container.
• Take your pill at the same time every day. Swallow the tablet whole. Do not crush, break, or chew it.
• If you are using the chewable tablets, you may chew the tablet completely before swallowing. Drink a full glass (8 ounces) of water right after swallowing.

If a dose is missed:

• If one dose is missed: Take the missed dose as soon as you remember. Take 2 tablets if you do not remember until the next day. Ask your doctor or pharmacist if you need to USE ANOTHER KIND OF BIRTH CONTROL until your period begins.
• If you miss more than one dose, read and follow the instructions on the package about missing doses carefully. Ask your doctor or pharmacist if you need more information.