Tri-Sprintec (Page 7 of 9)

Patient Information

Tri-Sprintec® [trī- sprin-tek]
(norgestimate and ethinyl estradiol tablets USP)

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

Do not use Tri-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 Tri-Sprintec?

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

Tri-Sprintec is also used to treat moderate acne vulgaris in females 15 years of age and older, who have no known history of allergies or problems taking birth control pills, and have started their menstrual cycle (“period”). Tri-Sprintec should only be used to treat acne in women who want to take birth control pills to prevent pregnancy.

How does Tri-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 Tri-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.

Chart
(click image for full-size original)

Who should not take Tri-Sprintec?

Do not take Tri-Sprintec 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 Tri-Sprintec, stop taking Tri-Sprintec right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri-Sprintec.

What should I tell my healthcare provider before taking Tri-Sprintec?

Tell your healthcare provider if you:

are pregnant or think you may be pregnant
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. Tri-Sprintec may decrease the amount of breast milk you make. A small amount of the hormones in Tri-Sprintec may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

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

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

How should I take Tri-Sprintec?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects Tri-Sprintec?

Like pregnancy, Tri-Sprintec 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 provider or go to a hospital emergency room right away if you have:

o
leg pain that will not go away
o
a sudden, severe headache unlike your usual headaches
o
sudden severe shortness of breath
o
weakness or numbness in your arm or leg
o
sudden change in vision or blindness
o
trouble speaking
o
chest pain

Other serious side effects include:

liver problems, including:
o
rare liver tumors
o
jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
high blood pressure. You should see your healthcare provider 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 Tri-Sprintec.
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 provider 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 is 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 Tri-Sprintec. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Tri-Sprintec?

headache (migraine)
breast pain or tenderness, enlargement or discharge
stomach pain, discomfort, and gas
vaginal infections and discharge
mood changes, including depression
nervousness
changes in weight
skin rash

These are not all the possible side effects of Tri-Sprintec. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Tri-Sprintec?

If you are scheduled for any lab tests, tell your healthcare provider you are taking Tri-Sprintec. Certain blood tests may be affected by Tri-Sprintec.
Tri-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Tri-Sprintec?

Store at 20° to 25°C (68° to 77°F).
Keep Tri-Sprintec and all medicines out of the reach of children.
Store away from light.

General information about the safe and effective use of Tri-Sprintec.

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

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

For more information, call 1-888-838-2872.

Do birth control pills cause cancer?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills 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 Tri-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 Tri-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 Tri-Sprintec?

Active ingredients: Each gray pill contains 0.18 mg norgestimate and 0.035 mg ethinyl estradiol. Each light blue pill contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol. Each blue pill contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol.

Inactive ingredients:

Grey pill: anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized corn starch.

Light blue pill: anhydrous lactose, FD&C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch

Blue pill: anhydrous lactose, FD&C blue no. 2 aluminum lake (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized corn starch

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

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