Your Period on Balcoltra®
If you do not become pregnant during your monthly cycle, then blood and tissue from the lining of the uterus are discharged through the vagina. This is known as menstruation—or your period. When taking birth control pills like Balcoltra, you may experience light periods (known as withdrawal bleeding when you are on birth control).
In a study of a birth control pill containing the same formulation as Balcoltra:
The mean intensity of periods was light1,*
The mean length of periods was <5 days1,*
*Outpatient multicenter, open-label trial with a single treatment group. A total of 1708 healthy women aged 17 to 49 years were enrolled in the study, providing 27,011 cycles of exposure. Study subjects participated for approximately 36 cycles, until they withdrew or were withdrawn, or until the study was terminated.1
What If I Miss My Period?
Some women miss periods on hormonal birth control, even if they are not pregnant. The medical term for this is amenorrhea, and in some cases, it does not indicate a problem.2
However, if you miss a period after a month in which you did not take all your pills correctly, or if you go 2 or more months in a row without a period, you should call your doctor. This could be a sign of pregnancy.2
You should also call your doctor if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking Balcoltra if you are pregnant.2
Not an actual patient.
What is Balcoltra?
Balcoltra is a prescription birth control pill used for the prevention of pregnancy.
IMPORTANT RISK INFORMATION for Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets)
WARNING TO WOMEN WHO SMOKE
Do not use Balcoltra 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.
Who should not take Balcoltra?
Do not use Balcoltra if you have or have had blood clots, history of heart attack or stroke, high blood pressure that medicine cannot control, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, hypersensitivity to any of the components, if you are or may be pregnant, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.
What else should I know about taking Balcoltra?
Treatment with Balcoltra should be stopped if you have a blood clot, and at least 4 weeks before and through 2 weeks after major surgery. You should not take Balcoltra any earlier than 4 weeks after having a baby. If you are breastfeeding, talk to your doctor before taking Balcoltra. If you experience yellowing of the skin or eyes due to problems with your liver, you should stop taking Balcoltra. If you are prediabetic or diabetic, your doctor should monitor you while using Balcoltra. Your doctor should evaluate you if you have any significant change in headaches or irregular menstrual bleeding. Balcoltra contains FD&C Yellow No. 5 and may cause an allergic reaction, including in those with an allergy to aspirin.
What are the most serious risks of taking Balcoltra?
Balcoltra increases the risk of serious conditions, including blood clots, stroke, and heart attack. These can be life-threatening and require immediate medical care.
What are the possible side effects of Balcoltra?
The most common side effects of Balcoltra are headache, spotting or bleeding between periods or no menstrual bleeding, nausea, breast tenderness or pain, stomach pain, pain during periods, depression, acne, and vaginal infections.
Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‐800‐FDA‐1088.
References: 1. Archer DF, Maheux R, DelConte A, O’Brien FB; North American Levonorgestrel Study Group. Efficacy and safety of a low-dose monophasic combination oral contraceptive containing 100 μg levonorgestrel and 20 μg ethinyl estradiol (Alesse®). Am J Obstet Gynecol. 1999;181(5)(suppl):S39-S44. doi:10.1016/S0002-9378(99)70362-5. 2. Balcoltra [package insert]. Alpharetta, GA: Avion Pharmaceuticals LLC; 2018.