Ortho Cyclen

The active ingredient in Sprintec is ethinyl estradiol/norgestimate. Norgestimate (progestin) and ethinyl estradiol (estrogen) are the 2 hormones that work together to prevent pregnancy. Their mechanism of action works to prevent your ovaries from releasing eggs and thicken the cervical mucus to make it harder for sperm to enter the uterus making it difficult for a fertilized egg to implant. Essentially, it works to stop ovulation.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Sprintec. However, the following is a synopsis of the general guidelines for the use of Sprintec:

• Take this medication orally exactly as directed by your healthcare provider.
• Typical dose: take 1 active pill by mouth at the same time daily for 21 days, followed by 1 placebo tablet daily for the remaining 7 days. It is best to take tablets in the order directed on the blister pack.
• If you miss pills (including starting the pack late) you could get pregnant.

Some mild or common side effects of Sprintec seen in clinical trials as compared to placebo include:

• Headache.
• Mood changes.
• Breakthrough bleeding.
• Stomach pain
• Nausea.
• Vomiting.
• Breast tenderness.
• Weight changes.
• Irregular periods.
• Acne.
• Vaginal yeast infection or vaginal discharge.
• Tiredness.

Some individuals may experience serious side effects while using Sprintec. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reactions - hives, skin rash, itching, swelling, shortness of breath.
• Heart attack - chest pain, nausea, dizziness.
• Stroke.
• Deep vein thrombosis (blood clot in the leg).
• Pulmonary embolism (blood clot in the lung) - chest pain.
• Liver problems - yellowing of the skin (jaundice), tiredness, stomach pain.
• Severe headache.
• Increased blood pressure (hypertension).
• Depression.

These are not all of the possible side effects of Sprintec. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Sprintec, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart problems (coronary artery disease, heart valve issues).
• High blood pressure (hypertension).
• Prone to having blood clots.
• High cholesterol or triglycerides.
• History of a certain swelling disorder (angioedema).
• Depression.
• Wears contact lenses.
• Severe migraines.
• Diabetes.
• Gallbladder disease.
• Thyroid issues.
• Liver disease.
• Breast cancer.
• Kidney problems.
• Irregular menstrual cycles.

Boxed Warning

• Smoking causes an increased risk of serious cardiovascular events from combination oral contraceptives (COC) and hormonal birth control pills, including death from heart attack, blood clots or stroke.

• Previous hypersensitivity/allergic reaction to Sprintec and any of its ingredients.
• A high risk of arterial or venous thrombotic diseases.
• Liver disease.
• Unexplained vaginal bleeding that hasn't been diagnosed.
• Pregnancy.
• Breast cancer or other estrogen-or progestin-sensitive cancer.
• Co-administration with Hepatitis C drug combinations containing ritonavir with or without dasabuvir.
• Women over 35 years old who smoke.

For the first cycle of use only, use a backup form of non-hormonal birth control (condoms, spermicide) for the first 7 days to prevent pregnancy until the medication has enough time to work. If you start on the first day of your period, you do not need to use backup birth control the first week.

When Sprintec is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Medications for HIV, AIDS, or hepatitis C.
• Grapefruit juice.
• Phenytoin.
• Barbiturate.
• Carbamazepine.
• Bosentan.
• Ketoconazole.
• Topiramate.
• Rifabutin.
• Aprepitant.
• St. John’s wort (supplement used for depression).
• Atorvastatin.
• Vitamin C (ascorbic acid).
• Acetaminophen (Tylenol).
• Immunosuppressive medications.
• Prednisolone.
• Theophylline.
• Morphine.
• Temazepam.
• Thyroid medication.

Sprintec is available in a variety of dosage forms, including:

• 21 blue active tablets each containing 0.250 mg norgestimate and 0.035 mg ethinyl estradiol.
• 7 white inactive tablets.

Store this medication at room temperature and keep out of reach of children.

Teva Pharmaceutical Industries Ltd. is the pharmaceutical company that manufactures Sprintec.

There are lower-cost generic options available of the brand name Sprintec.

Do not stop or adjust your use of this medication without first consulting with your healthcare provider.

Do not take Sprintec if you are pregnant. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Sprintec is known to reduce breast milk production. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.