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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
What else should I know about TWIRLA? TWIRLA is a birth control patch for women with a BMI less than 30 kg/m2 who can become pregnant. It contains two female hormones, a progestin called levonorgestrel, and an estrogen called ethinyl estradiol. TWIRLA may not be as effective in women with a BMI of 25 kg/m2 or more. If you have a BMI of 30 kg/m2 or more, please talk with your health care provider about which method of birth control is right for you.
Do not use TWIRLA if you have or have had blood clots; history of heart attack or stroke, high blood pressure that medicine cannot control, any condition that makes your blood clot more than normal, certain heart valve problems; smoke and are over 35 years old; BMI = 30 kg/m2. TWIRLA is also not for women who have diabetes and are over 35 years old, diabetes with high blood pressure or kidney, eye, nerve, or blood vessel damage, diabetes for longer than 20 years; have had breast cancer or any cancer that is sensitive to female hormones; certain kinds of severe migraine headaches; have liver problems or liver tumors; unexplained bleeding from the vagina, who are or may be pregnant; or take hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood. TWIRLA may not be a good choice for you if you have ever had depression; jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy) or related to previous use of hormonal birth control.
What are the most serious side effects of TWIRLA? TWIRLA increases the risks of serious side effects, including blood clots, stroke, or heart attack especially in women who have other risk factors. These can be life-threatening or lead to permanent disability. This increased risk is highest when you first start using hormonal birth control and when you restart the same or different hormonal birth control after not using it for a month or more. Treatment with TWIRLA should be stopped at least 4 weeks before and through 2 weeks after major surgery. What are the most common side effects of TWIRLA? The most common side effects reported by women using TWIRLA in a study were skin reactions at the patch site, nausea, headache, menstrual cramps, and weight gain. These are not all the possible side effects of TWIRLA. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
