Depressed mood and depression may occur. Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [see Warnings and Precautions (5.10)].
What is the most important information I should know about Rosyrah?
Do not use Rosyrah if you smoke cigarettes and are over 35 years old.
Smoking increases your risk of serious cardiovascular side effects from 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 Rosyrah?
Rosyrah is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.
How does Rosyrah work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.
Based on the results of a single clinical study lasting 12 months, 2 to 4 women out of 100 women may get pregnant during the first year they use Rosyrah.
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 to you while you are taking Rosyrah, stop taking Rosyrah right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spermicide) when you stop taking Rosyrah.
What should I tell my healthcare provider before taking Rosyrah?
Tell your healthcare provider if you:
Tell your healthcare provider if you have ever had any of the conditions listed in, "Who should not take Rosyrah" above. Your healthcare provider may recommend another method of birth control.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Rosyrah may affect the way other medicines work, and other medicines may affect how well Rosyrah 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 most serious risks of taking birth control pills?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
Women who take birth control pills may get:
All of these events are uncommon in healthy women.
Call your healthcare provider right away if you have:
What are common side effects of birth control pills?
The most common side effects of birth control pills are:
These side effects are usually mild and usually disappear with time.
Less common side effects are:
This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
What else should I know about taking Rosyrah?
Birth control pills do not protect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.
Do not skip any pills, even if you do not have sex often.
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
You should stop Rosyrah at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Rosyrah, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.
Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and spermicide, until you check with your healthcare provider.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Rosyrah for a condition for which it was not prescribed. Do not give Rosyrah to anyone else.
If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals.
Do birth control pills cause cancer?
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 Rosyrah?
When you take Rosyrah, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 3-4 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with each additional cycle. Do not stop taking Rosyrah because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.
What if I miss my scheduled period when taking Rosyrah?
You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow pills). Because scheduled periods are less frequent when you are taking Rosyrah, notify your healthcare provider that you have missed your period and that you are taking Rosyrah. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Rosyrah if it is determined that you are pregnant.
White to off-white tablets, light peach tablets, bluish green tablets: levonorgestrel and ethinyl estradiol
White to off-white tablets: lactose monohydrate, polacrilin potassium and magnesium stearate.
Light peach tablet: lactose monohydrate, polacrilin potassium, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate.
Bluish green tablets: lactose monohydrate, polacrilin potassium, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate.
Yellow tablets: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, lactose monohydrate, povidone K-25 and dl-α-tocopherol.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg, 0.15 mg/0.025 mg and 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg
Tray 2 contains 2 rows of 7 white to off-white pills (a total of 14 white to off-white pills) followed by 2 rows of 7 light peach pills (a total of 14 light peach pills).
Tray 3 contains 1 row of 7 light peach pills, followed by three rows of 7 bluish green pills (a total of 21 bluish green pills), followed by the last row, which contains 7 yellow pills.
3. Also find:
4. Be sure you have another kind of birth control (such as condoms and spermicides) ready at all times, to use as a back-up in case you miss pills.
When to start Rosyrah
If you are switching from another birth control method:
If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), wait for your next period and begin taking Rosyrah on the Sunday after your period starts as instructed in steps 1 and 2 in, "When to start Rosyrah" above. You need to use another method of birth control (such as condoms and spermicides) each time you have sex after stopping your old method of birth control until you have taken Rosyrah for 7 days.
If you have recently given birth and have not yet had a period, use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken Rosyrah for 7 days.
How to take Rosyrah
1. Take one pill at the same time every day until you have taken the last pill in the Extended-Cycle Tablet Blister Pack.
2. When you finish a tablet Blister Pack
3. If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking Rosyrah.
Finally, if you are still not sure what to do about the pills you have missed
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.