"April 10, 2012 -- Birth control pills that contain the hormone drospirenone must now carry a warning that they may increase the risk for potentially fatal blood clots, according to the FDA.
Drospirenone is a synthetic version of the f"...
Safyral Patient Information Including Side Effects
Brand Names: Beyaz, Safyral
Generic Name: drospirenone, ethinyl estradiol, and levomefolate (Pronunciation: droe SPYE re none, ETH in il ES tra DYE ol, and LEE voe me FOE late )
- What is drospirenone, ethinyl estradiol, and levomefolate (Safyral)?
- What are the possible side effects of this medication (Safyral)?
- What is the most important information I should know about this medication (Safyral)?
- What should I discuss with my healthcare provider before taking this medication (Safyral)?
- How should I take this medication (Safyral)?
- What happens if I miss a dose (Safyral)?
- What happens if I overdose (Safyral)?
- What should I avoid while taking this medication (Safyral)?
- What other drugs will affect this medication (Safyral)?
- Where can I get more information?
What is drospirenone, ethinyl estradiol, and levomefolate (Safyral)?
Drospirenone and ethinyl estradiol prevent ovulation (the release of an egg from an ovary) and also cause changes in your cervical and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Levomefolate is a type of B vitamin that helps prevent a rare birth defect that could occur in a baby if the pregnancy occurs while taking birth control pills or shortly after stopping them.
Drospirenone, ethinyl estradiol, and levomefolate is used as contraception to prevent pregnancy. The Beyaz brand of this medication is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.
Beyaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.
Drospirenone, ethinyl estradiol, and levomefolate may also be used for purposes not listed in this medication guide.
What are the possible side effects of this medication (Safyral)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, sudden and severe headache, confusion, problems with vision or speech;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious side effects may include:
- mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
- breast tenderness or swelling, nipple discharge;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- problems with contact lenses; or
- vaginal itching or discharge, changes in your menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Safyral (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about this medication (Safyral)?
Do not use birth control pills if you are pregnant or if you have recently had a baby.
You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.
Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to cause blood clots than other types of birth control pills.
You may need to use back up birth control, such as condoms or a spermicide, when you first start using this medication or if you miss a dose. Follow your doctor's instructions.
Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your birth control pills.
Additional Safyral Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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