Drospirenone

What it is used for

SLYND is a birth control pill (oral contraceptive) also called a POP (progestin only pill) that is used by females who can become pregnant to prevent pregnancy.

The progestin drospirenone may increase potassium levels in your blood. You should not take SLYND if you have kidney, liver or adrenal disease because this could cause serious heart problems as well as other health problems. Other medicines may also increase potassium levels in your blood. If you are currently on daily, long-term treatment for a chronic health condition with any of the medicines listed below, talk to your healthcare provider about whether SLYND is right for you. If you take any of the medicines listed below for a chronic health condition you should have a blood test to check the potassium level in your blood before you start taking SLYND and during the first month that you take SLYND.

• medicines to treat fungal infections, such as ketoconazole, itraconazole, or voriconazole
• medicines to treat Human Immunodeficiency Virus (HIV) infection or Hepatitis C infection, such as indinavir or boceprevir
• clarithromycin

How to take it

Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take SLYND.

While you are taking it

Some females miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your SLYND correctly, call you healthcare provider because you may be pregnant. Also call your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. Stop taking SLYND if you are pregnant.

Side effects, and when to stop

SLYND may cause serious side effects, including:

• High potassium levels in your blood (hyperkalemia). Certain medicines and conditions can also increase the potassium levels in your blood. Your healthcare provider may check the potassium levels in your blood before and during treatment with SLYND. Call you healthcare provider or go to a hospital emergency room right away if you have signs or symptoms of high potassium levels in your blood including:
  • weakness or numbness in an arm or leg
• palpitations (feel like your heart is racing or fluttering) or irregular heartbeat
• nausea
• vomiting
• severe pain in your chest
• shortness of breath
• Blood clot forming in blood vessels (thromboembolism problems). Tell your healthcare provider if you have had a blood clot. Tell your healthcare provider if you plan to have surgery or are not able to be active due to illness or injury. Call your healthcare provider or go to a hospital emergency room right away if you have:
  • leg pain that will not go away
  • a sudden, severe headache unlike your usual headaches
  • sudden, severe shortness of breath
  • sudden change in vision or blindness
  • chest pain
  • weakness or numbness in your arm or leg
  • trouble speaking
• Bone loss. It is not known if the decrease in a sex hormone that happens with SLYND can result in decreased bone density (bone loss).
• Cervical cancer. See " Do birth control pills cause cancer? "
• Liver problems, including rare liver tumors. Call your healthcare provider right away if you have yellowing of your skin or eyes.
• Ectopic pregnancy (pregnancy in your tubes). If you get pregnant while using SLYND, you might have an ectopic pregnancy. That means that the pregnancy is not in the uterus. Ectopic pregnancy is a medical emergency that often requires surgery. If you have severe abdominal (belly) pain, call your healthcare provider or go to a hospital emergency room right away.
• Risk of high blood sugar levels in people with diabetes. If you have diabetes, you may need to monitor your blood sugar level more often or adjust your diabetes medicine.
• Changes in menstrual bleeding. Irregular vaginal bleeding, especially between menstrual periods, and irregular periods or the absence of menstrual periods are common side effects of SLYND, but can sometimes be serious. Tell your healthcare provider if you have any of these changes in menstrual bleeding.
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.

The most common side effects of SLYND include:

These are not all the possible side effects of SLYND.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you are pregnant or breastfeeding

You may stop taking SLYND whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking SLYND.

Storing it

• Store SLYND at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep SLYND and all medicines out of the reach of children.

General information about the safe and effective use of SLYND.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SLYND for a condition for which it was not prescribed. Do not give SLYND to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SLYND that is written for health professionals.

Do birth control pills cause cancer?

Hormonal contraceptives do not appear to cause breast cancer. However if you have breast cancer now, have had it in the past, or you have (or have had) another cancer that may be sensitive to hormones, do not use hormonal contraceptives.

Women who use hormonal contraceptives may have a higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners and exposure to the human papilloma virus (HPV).

How does SLYND work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. 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 SLYND about 4 out of 100 females may get pregnant within the first year they use SLYND.

The following chart shows the chance of getting pregnant for females who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for females who do not use birth control and are trying to get pregnant.

Do not take SLYND if you:

• have kidney disease or kidney failure.
• have reduced adrenal gland function (adrenal insufficiency).
• have or have had cervical cancer or any cancer that is sensitive to female hormones.
• have liver disease, including liver tumors.
• have unexplained vaginal bleeding.

Tell your healthcare provider if you have or have had any of these conditions. Your healthcare provider can suggest a different method of birth control.

If any of these conditions happen while you are taking SLYND, stop taking SLYND right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking SLYND.

Before you take SLYND, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or think you may be pregnant.
• have ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism) or a stroke or heart attack (myocardial infarction).
• have or have had depression

Tell your healthcare provider about all the medicine you take including prescription and over-the-counter medicines, vitamins and herbal supplements, such as St. John's Wort.

SLYND may affect the way other medicines work, and other medicines may affect how well SLYND works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What else should I know about taking SLYND?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking SLYND. Certain blood tests may be affected by SLYND.

What should I know about my period when taking SLYND?

Some females may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking SLYND, especially during the first few months of use. If the irregular vaginal bleeding or spotting continues or happens again after you have had regular menstrual cycles call your healthcare provider. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.