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SPRINTEC (norgestimate and ethinyl estradiol) kit [Teva Pharmaceuticals USA, Inc.]


SPRINTEC (norgestimate and ethinyl estradiol) kit [Teva Pharmaceuticals USA, Inc.]

What is the most important information I should know about Sprintec?

Do not use Sprintec 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.

What is Sprintec?

Sprintec is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Sprintec work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Sprintec.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

If any of these conditions happen while you are taking Sprintec, stop taking Sprintec right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Sprintec.

What should I tell my healthcare provider before taking Sprintec?

Tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Sprintec may affect the way other medicines work, and other medicines may affect how well Sprintec works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What are the possible serious side effects of Sprintec?

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:

Call your healthcare provider or go to a hospital emergency room right away if you have:

Other serious side effects include:

General information about the safe and effective use of Sprintec.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Sprintec for a condition for which it was not prescribed. Do not give Sprintec to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Sprintec. You can ask your pharmacist or healthcare provider for information about Sprintec that is written for health professionals.

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Sprintec?

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 Sprintec, 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.

What are the ingredients in Sprintec?

Active ingredients: Each blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients:

Blue pills: anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch.

White pills: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose.

If you start taking Sprintec and you have not used a hormonal birth control method before:

If you start taking Sprintec and you are switching from another birth control pill:

If you start taking Sprintec and previously used a vaginal ring or transdermal patch:

If you start taking Sprintec and you are switching from a progestin-only method such as an implant or injection:

If you start taking Sprintec and you are switching from an intrauterine device or system (IUD or IUS):

Sprintec comes in a blister pack tablet dispenser. Read the instructions below for using your blister pack tablet dispenser

How to Use Blister Cards for the 28 Tablets

There are two ways to start taking birth-control pills, Sunday Start or Day 1 Start. Your healthcare professional will tell you which to use.

Three Ways to Remember in What Order to Take the Pills

If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:

If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps:

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

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