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ALTAVERA- levonorgestrel and ethinyl estradiol kit


  1. Patient Information
  2. What Is The Most Important Information I Should Know About Altavera?
  3. What Is Altavera?
  4. How Does Altavera Work For Contraception?
  5. Do Not Take Altavera If You:
  6. Tell Your Healthcare Provider If You:
  7. How Should I Take Altavera?
  8. What Are The Possible Serious Side Effects Of Altavera?
  9. Call Your Healthcare Provider Or Go To A Hospital Emergency Room Right Away If You Have:
  10. Liver Problems, Including:
  11. What Else Should I Know About Taking Altavera?
  12. How Should I Store Altavera?
  13. Do Birth Control Pills Cause Cancer?
  14. What Should I Know About My Period When Taking Altavera?
  15. What Are The Ingredients In Altavera?
  16. Inactive Ingredients:

Patient Information 

ALTAVERA [all-tuh-VAIR-uh]
(levonorgestrel 0.15 mg and ethinyl estradiol 30 mcg tablets)

What Is The Most Important Information I Should Know About Altavera? 

Do not use Altavera 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 Altavera? 


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

How Does Altavera 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 to 5 out of 100 women may get pregnant during the first year they use Altavera.

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.

patient-guide-chart

Do Not Take Altavera 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
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
had breast cancer or any cancer that is sensitive to female hormones
have liver problems, including liver tumors
have any unexplained vaginal bleeding
are pregnant
take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme alanine aminotransferase (ALT) in the blood.

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

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. Altavera may decrease the amount of breast milk you make. A small amount of the hormones in Altavera 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.

Altavera may affect the way other medicines work, and other medicines may affect how well Altavera 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 Altavera? 

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

What Are The Possible Serious Side Effects Of Altavera? 


Like pregnancy, Altavera 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: 

leg pain that will not go awaysudden change in vision or blindness
sudden shortness of breathchest pain
a sudden, severe headache unlike your usual headachesweakness of numbness in your arm or leg
trouble speaking

Liver Problems, Including: 


rare liver tumors
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

nauseaweight gain
vomitingbreast tenderness
bleeding between menstrual periodsdifficulty wearing contact lenses

These are not all the possible side effects of Altavera. 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 Altavera? 


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

How Should I Store Altavera? 

Store Altavera at room temperature between 68 F to 77 F (20 C to 25 C).
Protect from light.

General information about the safe and effective use of Altavera.

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

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

For more information, call 1-844-XIROMED (844-947-6633).

Do Birth Control Pills Cause Cancer? 


Birth control pills do not
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 Altavera? 


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 Altavera, 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 Altavera? 

Active ingredients:Each peach pill contains levonorgestrel and ethinyl estradiol.

Inactive Ingredients: 


Peach pills: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, and titanium dioxide.

White pills: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, and titanium dioxide.

XIROMED, LLC.
Florham Park, NJ 07932

Rev. 04/2019



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