DailyMed - RIVELSA kit levonorgestrel/ethinyl estradiol and ethinyl estradiol (2023)

PATIENT INFORMATION

RIVELSA®

(tablet levonorgestrel/ethinylestradiol and ethinylestradiol)

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

Do not use RIVELSA if you smoke cigarettes and are over 35 years old.Smoking increases the risk of serious cardiovascular side effects from birth control pills, including death from a heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes smoked.

What is RIVELSA?

RIVELSA 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 RIVELSA work for birth control?

Your chance of getting pregnant depends on how closely you follow the directions for taking your birth control pill. The more closely you follow the instructions, the less chance you have of becoming pregnant.

Based on the results of a single 12-month clinical study, between 2 and 4 out of 100 women may become pregnant in the first year of taking RIVELSA.

The graph below shows the chances of pregnancy for women who use different birth control methods. Each box on the card contains a list of birth control methods with similar effectiveness. The most effective methods are in the table above. The box at the bottom of the table shows the chances of pregnancy for women who are not using birth control and are trying to conceive.

Who should not use RIVELSA?

Do not take RIVELSA if you:

• smoke and are older than 35 years
• if you have had blood clots in your arms, legs, eyes or lungs
• have certain heart valve problems or abnormal heart rhythms that can cause blood clots to form in the heart
• had a stroke
• had a heart attack
• if you have a hereditary problem with your blood that causes it to clot more than normal
• have liver disease, including liver tumours
• if you have high blood pressure that cannot be controlled with medication
• Take a combination of hepatitis C medicines containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir. This can increase the level of the liver enzyme "alanine aminotransferase" (ALT) in the blood
• if you have diabetes with damage to the kidneys, eyes, nerves or blood vessels
• have certain types of severe migraine headaches with aura, numbness, weakness or blurred vision, or have migraine headaches if you are over 35 years of age
• if you have unexplained bleeding from the vagina
• had breast cancer, which may be sensitive to female hormones

If you get any of these conditions while taking RIVELSA, stop taking RIVELSA immediately and talk to your doctor. Use non-hormonal contraceptives (such as condoms and spermicide) when you stop taking RIVELSA.

What should I tell my doctor before taking RIVELSA?

Tell your doctor if you:

• are pregnant or think you may be pregnant
• are depressed now or have been depressed in the past
• yellowing of your skin or eyes caused by pregnancy (jaundice) (pregnancy cholestasis)
• You are breastfeeding or planning to breastfeed. RIVELSA may reduce the amount of breast milk you produce. A small amount of the hormones in RIVELSA may pass into your breast milk. Talk to your doctor about the best birth control method for you while breastfeeding.

Tell your doctor if you have ever had any of the diseases listed.“Who should not use RIVELSA” above.Your doctor may recommend another method of birth control for you.

Tell your doctor about all medications you are taking.including prescription and over-the-counter medications, vitamins, and herbal supplements.

RIVELSA can affect the way other medicines work, and other medicines can affect the way RIVELSA works.

Find out about the medications you are taking. Keep a list to show your doctor and pharmacist when you are given a new medicine.

How should I take RIVELSA?

read thisinstructionsat the end of this patient information.

What are the biggest 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 or obesity, or are over 35 years old. This increased risk is highest when you first start birth control pills and when you start taking the same or different birth control pills after not taking them for a month or more.

It's possible to die from a problem caused by a blood clot, such as a heart attack or stroke. Some examples of serious blood clots are blood clots in:

• Legs (deep vein thrombosis)
• lung (pulmonary embolism)
• eyes (loss of sight)
• heart (heart attack)
• Hirninfarkt)

Women who take birth control pills can get:

• high blood pressure
• Gallbladder problems
• Rare cancerous or non-cancerous liver tumors

All of these events are uncommon in healthy women.

Call your doctor at once if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or total
• Severe chest pain or pressure
• A sudden, severe headache, unlike your usual headache
• Weakness or numbness in an arm or leg, or difficulty speaking
• Yellowing of the skin or the whites of the eyes

What are common side effects of birth control pills?

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
• nausea
• tenderness of the breasts
• Headache

These side effects are usually mild and usually go away over time.

Less common side effects are:

• Acne
• Less sexual desire
• bloating or fluid retention
• Mottled darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High level of fats (cholesterol, triglycerides) in the blood
• Depression, especially if you have suffered from depression in the past. Call your doctor at once if you think about harming yourself.
• Problems with the tolerance of contact lenses
• weight gain

This is not a complete list of possible side effects. If you get any side effects that worry you, talk to your doctor. You can report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported related to birth control pill overdose, even when accidentally ingested by children.

What else should I know about taking RIVELSA?

contraceptive pills donotprotect against sexually transmitted diseases, including HIV, the virus that causes AIDS.

Don't miss a single pill even if you don't have sex often.

Contraceptive pills should not be taken during pregnancy. However, birth control pills accidentally taken during pregnancy are not known to cause birth defects.

You should stop taking RIVELSA at least four weeks before major surgery and wait at least two weeks before restarting it, as the risk of blood clots is increased.

If you are breastfeeding, consider using another method of birth control until you are ready to stop breastfeeding. Birth control pills that contain estrogen, such as B. RIVELSA, can reduce the amount of milk you produce. A small portion of the hormones in the pill passes into breast milk.

Tell your doctor about all medications and herbal products you use. Some drugs and herbal products can make birth control pills less effective, including:

• Barbiturate
• Bosentan
• carbamazepine
• felbamaat
• Griseofulvin
• Oxcarbazepin
• Phenytoin
• Rifampin
• Johannis herbs
• Topiram

Use a backup or alternative method of birth control if you are taking medications that may make birth control pills less effective.

If you vomit or have diarrhea, your birth control pills may not work as well. Use another method of birth control such as condoms and spermicide until you contact your doctor.

Birth control pills can interact with lamotrigine, an anticonvulsant drug for epilepsy. This can increase the risk of seizures, so your doctor may need to adjust your lamotrigine dose.

Women undergoing thyroid hormone replacement therapy may need increased thyroid hormone doses.

How should I store RIVELSA?

• Store RIVELSA at room temperature between 20°C and 25°C (68°F to 77°F).
• Keep RIVELSA and all medicines out of the reach of children.

General information about RIVELSA

Sometimes medicines are prescribed for purposes other than those stated in the leaflet. Do not use RIVELSA for conditions for which it is not prescribed. Do not give RIVELSA to third parties.

If you have any concerns or questions, please consult your doctor. You can also ask your doctor for a more detailed healthcare professional label.

Do birth control pills cause cancer?

It is not known whether hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there may be a small increase in the risk of breast cancer in current users with prolonged 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 take birth control pills may have a slightly higher risk of developing cervical cancer. However, this can also have other reasons, for example because you have more sexual partners.

What if I want to get pregnant?

You can stop taking the pill at any time. Before you stop taking the pill, you should visit your doctor for a check-up.

What should I know about my period while taking RIVELSA?

If you are taking RIVELSA, which has an extended dosing cycle of 91 days, you can expect 4 planned periods per year (bleeding if you are taking the 7 yellow pills). Each period is expected to last about 3-4 days. However, you will likely have more bleeding or spotting between your scheduled periods than if you were using a birth control pill on a 28-day dosing cycle. This bleeding or spotting decreases with each successive cycle. Do not stop using RIVELSA because of this bleeding or spotting. If the spotting continues for more than seven days in a row or the bleeding is heavy, call your doctor.

What happens if I miss my scheduled period while taking RIVELSA?

You should consider the possibility of being pregnant if you miss your planned period (no bleeding on the days you take the yellow pills). Since taking RIVELSA reduces the chance of a planned period, tell your doctor that you have missed your period and you are taking RIVELSA. Also, tell your doctor if you experience pregnancy symptoms such as morning sickness or unusual breast tenderness. It is important that your doctor examines you to determine if you are pregnant. Stop taking RIVELSA if you have been diagnosed with pregnancy.

What ingredients does RIVELSA contain?

Active ingredients:

Pale pink tablets, pink tablets, purple tablets: levonorgestrel acetate and ethinyl estradiol

Yellow tablets: ethinyl estradiol

Inactive Ingredients:

Pale pink tablets: Anhydrous Lactose, D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol/Macrogol, Titanium Dioxide and Triacetin.

Pink Tablets: Lactose Anhydrous, D&C Red #27/Phloxin Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol/Macrogol, Titanium Dioxide, and Triacetin.

Purple Tablets: Lactose Anhydrous, D&C Red #27/Phloxin Aluminum Lake, FD&C Blue #1/FCF Brilliant Blue Aluminum Lake, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol/Macrogol, Titanium Dioxide and Triacetin.

Yellow Tablets: Anhydrous Lactose, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polacriline Potassium, Polyethylene Glycol/Macrogol, Polysorbate 80, and Titanium Dioxide.