YASMIN

Important information about Yasmin
This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Do not use Yasmin if you have any of the following conditions: a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a heart valve disorder, breast or uterine cancer, abnormal vaginal bleeding, kidney or liver disease, an adrenal gland disorder, severe high blood pressure, migraine headaches, or a history of jaundice caused by birth control pills.

Before taking Yasmin
Do not take Yasmin if you are allergic to drospirenone or ethinyl estradiol, or if you have:

• uncontrolled high blood pressure, migraine headaches, or a heart valve disorder;
• a history of stroke, blood clot, or circulation problems of diabetes;
• kidney or liver disease;
• adrenal gland disorder;
• unusual vaginal bleeding;
• any type of breast, uterine, or hormone-dependent cancer; or
• a history of jaundice caused by birth control pills.

Before using Yasmin, tell your doctor if you have any of the following conditions.

• high blood pressure or heart disease;
• high cholesterol or if you are overweight;
• liver cancer;
• gallbladder disease;
• diabetes;
• seizures or epilepsy; or
• a history of depression, irregular menstrual cycles, or history of breast or uterine cancer.

FDA pregnancy category X. Yasmin can cause birth defects. Do not use Yasmin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. The hormones in this medication can pass into breast milk and may harm a nursing baby. Yasmin may also slow breast milk production. Do not use if you are breast-feeding a baby. Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels, including liver disease, kidney disease, and adrenal gland disorders. Before using Yasmin, tell your doctor if you have any of these conditions.

Studies have shown that the hormones in Yasmin do pass through breast milk in low amounts. These tiny amounts are probably too low to cause significant problems in breastfeeding infants, although this has not been confirmed by any studies. However, there is some concern that Yasmin could cause problems in male infants, because drospirenone (one of the hormones in Yasmin) counteracts the effects of testosterone and other male hormones. Also, there have been reports of problems, such as breast enlargement and jaundice, in babies whose mothers took other combined oral contraceptives while breastfeeding.

Perhaps more importantly, combined oral contraceptives may decrease the production and quality of breast milk. For this reason, healthcare providers almost always recommend progestin-only oral contraceptives (also known as "mini-pills") instead of combined contraceptives for women who are breastfeeding. However, progestin-only contraceptive pills are usually less effective than combined contraceptives. As soon as you stop breastfeeding, it may be a good idea to ask your healthcare provider about switching to a combined contraceptive product such as Yasmin.

WARNING: Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Yasmin and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes);
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin, increased hair growth, or loss of scalp hair;
• changes in weight or appetite, swelling of your hands or feet;
• problems with contact lenses;
• vaginal itching or discharge; or
• 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.