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Indications and Usage for Camrese Lo
Camrese Lo® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.
Camrese Lo Description
Camrese Lo (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets provide an oral contraceptive regimen of 84 orange tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 yellow tablets each containing 0.01 mg ethinyl estradiol.
The structural formulas for the active components are:
Levonorgestrel
C21H28O2 MW: 312.4
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.
Ethinyl Estradiol
C20H24O2 MW: 296.4
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.
Inactive ingredients for the orange tablets include FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin.
Inactive ingredients for the yellow tablets include anhydrous lactose, FD&C Yellow # 10 aluminum lake, FD&C Yellow # 6 (Sunset Yellow) aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide.
Patient Counseling Information
See FDA-APPROVED PATIENT LABELING (17.2)
Information for Patients
• Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs. • Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases. • Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. • Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established. • Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days.FDA Approved Patient Labeling
Guide for Using Camrese Lo®
WARNING TO WOMEN WHO SMOKE
Do not use Camrese Lo 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.
Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.
WHAT IS Camrese Lo?
Camrese Lo is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.
HOW WELL DOES Camrese Lo 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 a single clinical study lasting 12 months, 2 to 4 women, out of 100 women, may get pregnant during the first year they use Camrese Lo.
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.
HOW DO I TAKE Camrese Lo?
1. 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. 2. Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking Camrese Lo. 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. 3. 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. 4. If you have trouble remembering to take Camrese Lo, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.Before you start taking Camrese Lo
1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day. 2. Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 orange and 7 yellow pills. Trays 1 and 2 each contain 28 orange pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills). 3. Also find: • Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and • In what order to take the pills (follow the weeks and arrow). 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 Camrese Lo
1. Take the first orange pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first orange pill that same day. 2. 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 orange pill until the next Sunday (first 7 days). 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 Camrese Lo for 7 days.How to Take Camrese Lo
1. Take one pill at the same time every day until you have taken the last pill in the tablet dispenser. • Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea). • Do not skip pills even if you do not have sex very often. 2. When you finish a tablet dispenser • After taking the last yellow pill, start taking the first orange pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started. 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 Camrese Lo.WHAT TO DO IF YOU MISS PILLS
If you MISS 1 orange pill:
1. 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. 2. You do not need to use a back-up birth control method if you have sex.If you MISS 2 orange pills in a row:
1. Take 2 pills on the day you remember, and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. 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 orange pills in a row:
1. 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. 2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills. 3. 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 yellow pills, call your healthcare provider because you may be pregnant.If you MISS ANY of the 7 yellow pills:
1. Throw away the missed pills. 2. Keep taking the scheduled pills until the pack is finished. 3. 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
1. Use a back-up method anytime you have sex. 2. Keep taking one pill each day until you contact your healthcare provider.WHO SHOULD NOT TAKE Camrese Lo?
Your healthcare provider will not give you Camrese Lo if you have:
• Ever had breast cancer or any cancer that is sensitive to female hormones • Liver disease, including liver tumors • Been prescribed 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 visionAlso, do not take birth control pills if you:
• Smoke and are over 35 years old • Are pregnantBirth 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.
WHAT ELSE SHOULD I KNOW ABOUT TAKING Camrese Lo?
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.
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.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Camrese Lo, 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.
Tell your health care 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 • topiramateConsider 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 physician 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 condoms or a spermicide, until you check with your health care provider.
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 >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 tumorsAll of these events are uncommon in healthy women.
Call your health care 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 eyeballsWHAT 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 • Breast tenderness • HeadacheThese 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 health care provider immediately if you have any thoughts of harming yourself. • Problems tolerating contact lenses • Weight changesThis is not a complete list of possible side effects. Talk to your health care provider if you develop any side effects that concern you.
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 appear 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 Camrese Lo?
When you take Camrese Lo, 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 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 Camrese Lo 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 Camrese Lo?
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 tablets). Since scheduled periods are less frequent when you are taking Camrese Lo, notify your healthcare provider that you have missed your period and that you are taking Camrese Lo. 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 Camrese Lo if it is determined that you are pregnant.
WHAT IF I WANT TO BECOME PREGNANT?
You may stop taking the pill whenever you wish. Consider a visit with your health care provider for a pre-pregnancy checkup before you stop taking the pill.
Rx only
TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. 9/2017
Package/Label Display Panel, Part 2 of 2
Camrese Lo® (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets. 2 Extended-Cycle Dispensers 91 Tablets Each Carton Text
2 Extended-Cycle Tablet Dispensers
91 Tablets Each / NDC 0093-6148-82
Camrese Lo®
levonorgestrel/ethinyl estradiol 0.1 mg/0.02 mg tablets
ethinyl estradiol 0.01 mg tablets
Rx only
Contains 2 Extended-Cycle Tablet Dispensers, each containing
91 tablets: 84 orange tablets, each containing 0.1 mg levonorgestrel
with 0.02 mg ethinyl estradiol, and 7 yellow tablets, each
containing 0.01 mg ethinyl estradiol.
TEVA
TEVA WOMEN’S HEALTH
TEVA WOMEN’S HEALTH, INC.
Subsidiary of TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
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| Labeler - Teva Pharmaceuticals USA, Inc. (001627975) |