Layolis Fe

What is Layolis Fe?

Layolis Fe is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol and a progestin called norethindrone.

How Well Does Layolis Fe Work?

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 one clinical study, 1 to 3 women out of 100 women may get pregnant during the first year they use Layolis Fe.

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.

Description

Layolis Fe provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:

• 24 light green, round tablets each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol
• 4 brown, round tablets each containing 75 mg ferrous fumarate

Each light green tablet also contains the following inactive ingredients: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Yellow No. 6 aluminum lake, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor, sucralose and vitamin E.

Each brown, round tablet contains ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor and sucralose. The ferrous fumarate chewable tablets do not serve any therapeutic purpose. Ferrous fumarate chewable tablets are not USP for dissolution and assay.

The empirical formula of ethinyl estradiol is C20H24O2 and the chemical structure is:

The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,(17α)-]

The empirical formula of norethindrone is C20H26O2 and the chemical structure is:

The chemical name of norethindrone is [17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one]

Mechanism of Action

COCs lower the risk of becoming pregnant primarily by suppressing ovulation.  Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

What is the most important information I should know about Layolis Fe?

Warning to women who smoke
Do not use Layolis Fe if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) 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.

Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Who should not take Layolis Fe?

Your healthcare provider will not give you Layolis Fe if you have:

• Ever had breast cancer or any cancer that is sensitive to female hormones
• Liver disease, including liver tumors
• 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.
• Ever had blood clots in your arms, legs, or lungs
• Ever had a stroke
• Ever had a heart attack
• Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• An inherited problem with your blood that makes it clot more than normal
• High blood pressure that medicine can’t control
• Diabetes with kidney, eye, or blood vessel damage
• Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

Also, do not take birth control pills if you:

• Smoke and are over 35 years old
• Are pregnant

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).

What should I tell my healthcare provider before taking Layolis Fe?

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:

• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate

Consider using another birth control method when you take medicines that may make birth control pills less effective.

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.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.

How should I take Layolis Fe?

Before you start taking Layolis Fe

• Decide what time of day to take your pill. It is important to take it at the same time every day and in the order as directed on the blister pack.

• Look at your Layolis Fe blister pack. The blister pack has four rows of 7 pills each, for a total of 28 pills.
  Find:
  • where on the pack to start taking your pill
  • in what order to take the pills

Each Layolis Fe blister pack has 28 pills

• 24 light green pills with hormones for Weeks 1, 2 and 3 and the first part of Week 4
• 4 brown pills without hormones for the remainder of Week 4
• Be sure to have ready at all times another kind of birth control (such as a condom and spermicide) to use as a back-up in case you miss pills.

When to Start Layolis Fe

If you start taking Layolis Fe and you did not use a hormonal birth control method before:

DAY-1 START:

• Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). Pick a time of day that will be easy to remember.
• Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.
• Take the first light green pill of the first pack during the first 24 hours of your period.
• You will not need to use a back-up method of birth control because you are starting the pill at the beginning of your period. However, if you start on a day other than the first day of your period or if you are starting after having been pregnant and have not yet had a period, use a back-up method of birth control such as a condom and spermicide until you have taken a light green pill for 7 days in a row.
• After taking the last brown pill (day 28) of the blister pack, start taking the first light green pill from a new blister pack the very next day whether or not you are having your period.If you start taking Layolis Fe and you are switching from a combination hormonal method such as:
  • another pill
  • vaginal ring
  • patch
• Take the first light green pill on the first day you would have started your previous birth control pack.
• If you previously used a vaginal ring or transdermal patch, finish the 21 days of use and wait 7 days after removal of the ring or transdermal patch before starting Layolis Fe.
• Use a non-hormonal back-up method such as a condom and spermicide for the first 7 days you take Layolis Fe.If you start taking Layolis Fe and you are switching from a progestin-only method such as a:
  • progestin-only pill
  • implant
  • intrauterine system
  • injection
• Take the first light green pill on the day you would have taken your next progestin-only pill or on the day of removal of your implant or intrauterine system or on the day when you would have had your next injection.
• Use a non-hormonal back-up method such as a condom and spermicide for the first 7 days you take Layolis Fe.

What Should I do if I Miss any Pills

If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception (such as a condom and spermicide) anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant.

Your birth control pills may not be as effective if you miss any light green pills, and particularly if you miss the first few or the last few light green pills in a pack.

If you MISS ONE light green pill

• Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in 1 day.
• You do not need to use a back‑up birth control method if you have sex.

If you MISS TWO light green pills in a row in WEEK 1 or WEEK 2 of your pack

• Take two pills on the day you remember and two pills the next day.
• Then take one pill a day until you finish the pack.
• You could become pregnant if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back‑up for those 7 days.

If you MISS TWO light green pills in a row in WEEK 3 or WEEK 4 of your pack

• THROW OUT the rest of the pill pack and start a new pack that same day.
• You could become pregnant if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back‑up for those 7 days after you restart your pills.

If you MISS THREE OR MORE light green pills in a row at any time

• THROW OUT the rest of the pill pack and start a new pack that same day.
• You could become pregnant if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back‑up the next time you have sex and for the first 7 days after you restart your pills.

If you forget any of the four brown “reminder” pills in WEEK 4

• THROW AWAY the pills you missed.
• Keep taking one pill each day until the pack is finished.
• You do not need to use a back‑up method of birth control.

If you are still not sure of what to do about the pills you have missed:

• Call your healthcare provider.
• Use a back-up contraception (such as a condom and spermicide) anytime you have sex and keep taking 1 pill each day.

What Else Should I Know about Taking Layolis Fe?

Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

Do not skip any pills, even if you do not have sex often.

If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant. Contact your healthcare provider for advice if you:

• Think you are pregnant
• Miss one period and have not taken your birth control pills according to directions
• Miss two periods in a row

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 Layolis Fe at least four weeks before you have major surgery and not restart it until 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 Layolis Fe, may decrease the amount of milk you make. A small amount of the pill’s hormones pass into breast milk.

What are the possible side effects of Layolis Fe?

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. 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:

• Legs (thrombophlebitis)
• Lungs (pulmonary embolus)
• Eyes (loss of eyesight)
• Heart (heart attack)
• Brain (stroke)

A few women who take birth control pills may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors

All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or complete
• Severe pain in your chest
• Sudden, severe headache unlike your usual headaches
• Weakness or numbness in an arm or leg, or trouble speaking
• Yellowing of the skin or eyeballs

What are the Common Side Effects of Birth Control Pills?

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
• Nausea
• Breast tenderness
• Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High fat levels in the blood
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
• Problems tolerating contact lenses
• Weight changes

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.

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 Should I Know about My Period when Taking Layolis Fe?

Unscheduled (irregular) vaginal bleeding or spotting may occur while you are taking Layolis Fe. Unscheduled bleeding may vary from slight staining to breakthrough bleeding, which is a flow much like a regular period, but which occurs between menstrual periods. Unscheduled bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems.

Approximately one-third of the women who use Layolis Fe have unscheduled bleeding or spotting in the first months of use. About one-quarter of users continue to have unscheduled bleeding or spotting after one year of use.

It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider.

What if I Miss My Scheduled Period when Taking Layolis Fe?

Women who use Layolis Fe may not have a period at the end of every 28-day pack of pills.

If you miss more than two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. 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 checks you to find out if you are pregnant. Stop taking Layolis Fe if you are pregnant.

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.

General information about the safe and effective use of Layolis Fe

Your healthcare provider prescribed Layolis Fe for you. Please do not share Layolis Fe with anyone else. Keep Layolis Fe out of the reach of children.

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.

For more information contact Actavis Medical Communications at 1-800-272-5525.

What are the ingredients in Layolis Fe?

Green tablets
Active ingredients: norethindrone, ethinyl estradiol

Inactive ingredients: D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate type A potato, spearmint, sucralose, alpha-tocopherol

Brown tablets
Inactive ingredients: ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate type A potato, spearmint, sucralose

Label

PRINCIPAL DISPLAY PANEL