Use the medicine exactly as directed.Take your first pill on the first day of your period or on the first Sunday after your period begins. The first 2-3 months I had really bad headaches and bad mood swings that would come after taking the pill at night and I was about to call my doctor to switch off of it. Use of this product before menarche is not indicated.Balcoltra has not been studied in postmenopausal women and is not indicated in this population.The pharmacokinetics of Balcoltra has not been studied in women with hepatic impairment. The better you follow the directions, the less chance you have of getting pregnant.Based on the results of one clinical study of a 28-day regimen of levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets, about 1 out of 100 women may get pregnant within the first year they use Balcoltra.The following chart shows the chance of getting pregnant for women who use different methods of birth control. See Remove the orange pill by pressing the pill through the foil in the bottom of the pill pack. The incidence of hypertension increases with increasing concentrations of progestin.Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Not all brands are listed on this leaflet.Balcoltra may also be used for purposes not listed in this medication guide.Taking Balcoltra can increase your risk of blood clots, stroke, or heart attack. Take 1 pill every day at the same time. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTSCigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. Although the overall incidence of FD&C Yellow No. You can ask your pharmacist or healthcare provider for information about Balcoltra that is written for health professionals.Birth control pills do not seem to cause breast cancer. Among the women in the trial, 5.3% had never used COCs.A total of 5 pregnancies were reported. Other adverse events occurring in < 1% of those who discontinued included amenorrhea, depression, emotional lability, hypertension, acne, menorrhagia, nausea, hypercholesterolemia, weight gain, dysmenorrhea, and flatulence. Take the pills in the order directed on your blister pack. Balcoltra is a birth control pill that includes levonorgestrel, a widely studied hormone commonly used in oral contraceptives and intrauterine devices (IUDs). The average weight was 66.4 kg with a range of 38.0-154.2 kg. Look at your Balcoltra pill pack. It may harm them. If you notice other effects not listed above, contact your doctor or pharmacist.Call your doctor for medical advice about side effects. If you are a Sunday starter, keep taking a pill every day until Sunday. The most frequent were due to headache and metrorrhagia (1% each). See Figure A. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy.Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. All other reasons for discontinuation were reported by 3 or fewer subjects.The following additional adverse drug reactions have been reported from worldwide postmarketing experience with levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg tablets. Use of COCs may worsen existing gallbladder disease. Look at your Balcoltra pill pack. Version: 13.02.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.No specific pharmacodynamics studies were conducted with Balcoltra.No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets USP) in humans has been conducted. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]).Combined oral contraceptives containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations.