What is the most important information I should know about LoJaimiess?
Do not use LoJaimiess 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 LoJaimiess?
LoJaimiess 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. LoJaimiess does not protect against HIV infection (AIDS) and other sexually transmitted infections.
How does LoJaimiess 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 LoJaimiess.
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.
Who should not take LoJaimiess?
Do not take LoJaimiess if you:
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smoke and are over 35 years of age
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have or had blood clots in your arms, legs, eyes or lungs
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had a stroke
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had a heart attack
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have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
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have an inherited problem with your blood that makes it clot more than normal
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have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems
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have diabetes and are over the age of 35; have diabetes with high blood pressure; kidney, eye, nerve, or blood vessel damage; or for more than 20 years
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have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over the age of 35
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have or had breast cancer
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have liver disease, including liver tumors
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have unexplained vaginal bleeding
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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 to you while you are taking LoJaimiess, stop taking LoJaimiess right away and talk to your healthcare provider. Use non-hormonal contraception (such as condoms and spermicide) when you stop taking LoJaimiess.
What should I tell my healthcare provider before taking LoJaimiess?
Tell your healthcare provider if you:
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are pregnant or think you may be pregnant
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are scheduled for surgery. LoJaimiess may increase your risk of blood clots after surgery. You should stop taking LoJaimiess at least 4 weeks before you have surgery and not restart LoJaimiess until at least 2 weeks after your surgery.
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are depressed now or have been depressed in the past
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had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
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are breastfeeding or plan to breastfeed. LoJaimiess may decrease the amount of breast milk you make. A small amount of the hormones in LoJaimiess 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 if you have ever had any of the conditions listed in, “Who should not take LoJaimiess” 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.
LoJaimiess may affect the way other medicines work, and other medicines may affect how well LoJaimiess works.
Some medicines and herbal products may make birth control pills less effective, including:
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barbiturates
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bosentan
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carbamazepine
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felbamate
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griseofulvin
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oxcarbazepine
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phenytoin
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rifampin
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St. John’s wort
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topiramate
Use a back-up or alternative 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 physician may need to adjust the dose of lamotrigine.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
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 LoJaimiess?
Read the Instructions for Use at the end of this Patient Information.
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 over 35 years old. 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:
A few 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:
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Persistent leg pain
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Sudden shortness of breath
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Sudden blindness, partial or complete
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Severe pain in your chest
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Sudden, severe headache unlike your usual headaches
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Weakness or numbness in an arm or leg, or trouble speaking
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Yellowing of the skin or eyes
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:
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Acne
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Less sexual desire
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Bloating or fluid retention
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Blotchy darkening of the skin, especially on the face
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High blood sugar, especially in women who already have diabetes
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High fat levels in the blood.
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Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
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Problems tolerating contact lenses
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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.
What else should I know about taking LoJaimiess?
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If you are scheduled for any lab tests, tell your healthcare provider you are taking LoJaimiess. Certain blood tests may be affected by LoJaimiess.
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Do not skip any pills, even if you do not have sex often.
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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.
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You should stop LoJaimiess 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.
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If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like LoJaimiess, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants.
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If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider.
How should I store LoJaimiess?
General information about the safe and effective use of LoJaimiess
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LoJaimiess for a condition for which it was not prescribed. Do not give LoJaimiess to anyone else.
This Patient Information summarizes the most important information about LoJaimiess. If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare providers 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 LoJaimiess?
When you take LoJaimiess, 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 light peach pills). Each period is likely to last about 2 to 3 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 time. Do not stop taking LoJaimiess 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 LoJaimiess?
You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking light peach tablets). Since scheduled periods are less frequent when you are taking LoJaimiess, notify your healthcare provider that you have missed your period and that you are taking LoJaimiess. 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 LoJaimiess if it is determined that you are pregnant.
What are the ingredients in LoJaimiess?
Active ingredients:
white to off-white tablets: levonorgestrel and ethinyl estradiol
light peach tablets: ethinyl estradiol
Inactive ingredients:
White to off-white tablets: lactose monohydrate, magnesium stearate and polacrilin potassium.
Light peach tablets: anhydrous lactose, dl-α-tocopherol, FD&C Yellow No. 6 (Sunset Yellow) Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone k-25 and polacrilin potassium.
INSTRUCTIONS FOR USE
LoJaimiess®
How do I take LoJaimiess?
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Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
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Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking LoJaimiess. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
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Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
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If you have trouble remembering to take LoJaimiess, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
Before you start taking LoJaimiess
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Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
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Look at your Extended-Cycle Tablet Blister Pack. Your Tablet Blister Pack consists of 3 blisters with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 white to off-white and 7 light peach pills. Blisters 1 and 2 each contain 28 white to off-white pills (4 rows of 7 pills). Blister 3 contains 35 pills consisting of 28 white to off-white pills (4 rows of 7 pills) and 7 light peach pills (1 row of 7 pills).
3. Also find:
4. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills.
When to start LoJaimiess
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Take the first white to off-white pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first white to off-white pill that same day.
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Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first white to off-white pill until the next Sunday (first 7 days).
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”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken LoJaimiess 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 LoJaimiess for 7 days.
How to take LoJaimiess
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Take one pill at the same time every day until you have taken the last pill in the tablet blister pack.
2. When you finish a tablet blister pack
3. If you miss your scheduled period when you are taking the light peach pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking LoJaimiess.
What To Do If You Miss Pills
If you MISS 1 white to off-white pill:
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Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
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You do not need to use a back-up birth control method if you have sex.
If you MISS 2 white to off-white pills in a row:
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Take 2 pills on the day you remember, and 2 pills the next day.
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Then take 1 pill a day until you finish the pack.
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You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back up for the 7 days after you restart your pills.
If you MISS 3 OR MORE white to off-white pills in a row:
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Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may experience bleeding during the week following the missed pills.
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You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.
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You MUST use a non-hormonal birth control method (such as condoms or spermicide) as a back-up when you miss pills and for the first 7 days after you restart your pills. If you do not have your period when you are taking the light peach pills, call your healthcare provider because you may be pregnant.
If you MISS ANY of the 7 light peach pills:
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Throw away the missed pills.
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Keep taking the scheduled pills until the pack is finished.
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You do not need a back-up method of birth control.
Finally, if you are still not sure what to do about the pills you have missed
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Use a back-up method anytime you have sex.
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Keep taking one pill each day until you contact your healthcare provider.
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.
Manufactured for:
Xiromed, LLC
Florham Park, NJ 07932
Made in India
Code No.: GUJ-DRUGS/G/28/1297
PI-207-00
Revised: 11/2024