Angeliq

What is Angeliq?

Angeliq is a medicine that contains 2 kinds of hormones, estrogen and progestin.

• Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) and Angeliq 0.5 mg DRSP/1 mg E2 are both used after menopause to reduce moderate to severe hot flashes.
• Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."
• When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq.
• Angeliq 0.5 mg drospirenone (DRSP)/1 mg estradiol (E2) is used after menopause to treat moderate to severe dryness, itching, and burning in or around the vagina. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq to control these problems. If you use Angeliq only to treat dryness, itching, and burning in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you.

What is the most important information I should know about Angeliq?

• Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function)
• Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
• Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
• Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia
• Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)
• Using estrogen-alone may increase your chances of getting strokes or blood clots
• Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
• You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq

Who should not take Angeliq?

Do not start taking Angeliq if you:

• have had your uterus removed (hysterectomy).
• Angeliq contains a progestin to decrease the chances of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use Angeliq.
• have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or had cancer, talk with your healthcare provider about whether you should take Angeliq.
• had a stroke or heart attack in the past year.
• currently have or have had blood clots.
• have kidney disease, liver disease, or disease of your adrenal glands. Angeliq contains drospirenone which may increase the potassium level in your blood. Liver, kidney, or adrenal gland disease may also increase the potassium level in your blood.
• have been diagnosed with a bleeding disorder.
• are allergic to Angeliq or any of its ingredients. See the end of this leaflet for a list of ingredients in Angeliq.
• are pregnant or plan to become pregnant.

What should I tell my healthcare provider before taking Angeliq?

Before you take Angeliq, tell your healthcare provider if you:

• have or have had problems with your adrenal glands.
• have high levels of fat in your blood (triglycerides)
• have any other medical conditions. Your healthcare provider may need to check you more carefully if you have certain conditions, such as:
  • asthma (wheezing)
  • epilepsy (seizures)
  • migraine
  • endometriosis
  • lupus
  • hypertension (high blood pressure)
  • problems with your heart, liver, thyroid or kidneys
  • benign breast disease
  • have high calcium in your blood
  • have high potassium levels in your blood
  • have low sodium levels in your blood
• are pregnant or plan to become pregnant. Angeliq is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results before you start taking Angeliq.
• are breastfeeding or planning to breastfeed. You should not breastfeed while taking Angeliq. The hormone in Angeliq can decrease the amount of breast milk you make. Also, the hormone in Angeliq can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take Angeliq.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Angeliq works. Some other medicines and food products may increase or decrease the concentrations of the hormones in Angeliq in the blood. Angeliq may also affect how your other medicines work. Angeliq may increase the potassium level in your blood and some medicines may also increase potassium level. In some situations, your healthcare provider may recommend testing your blood for potassium level.

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

If you are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop taking Angeliq.

How should I take Angeliq?

• Take one Angeliq tablet at the same time each day.
• Take Angeliq tablets whole. Do not break, crush, dissolve, or chew Angeliq tablets before swallowing. If you cannot swallow Angeliq tablets whole, tell your healthcare provider. You may need a different medicine.
• If you miss a dose of Angeliq, take it as soon as possible.
• If more than 24 hours have passed since you missed a dose of Angeliq, you should not take the missed dose.
• Estrogens should be used at the lowest dose possible for your treatment only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Angeliq.

What are the possible side effects of Angeliq?

Angeliq may cause serious side effects.

Serious but less common side effects include:

• Heart attack
• Stroke
• Blood clots
• Dementia
• Breast cancer
• Cancer of the lining of the uterus (womb)
• Cancer of the ovary
• High blood pressure
• High blood sugar
• Gallbladder disease
• Liver problems
• Enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare provider right away if you have any of the following warning signs or any other unusual symptoms that concern you:

• New breast lumps
• Changes in vision or speech
• Sudden new severe headaches
• Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Less serious, but common side effects include:

• Headache
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal pain
• Nausea
• Diarrhea
• Vaginal yeast infection
• Fluid Retention
• Moodiness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Angeliq. For more information, ask your healthcare provider or pharmacist about side effects.

You may report side effects to Bayer HealthCare Pharmaceuticals at 1-888-842-2937 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of a serious side effect with Angeliq?

• Talk with your healthcare provider regularly about whether you should continue taking Angeliq.
• See your healthcare provider right away if you get vaginal bleeding while taking Angeliq.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about the safe and effective use of Angeliq

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Angeliq for conditions for which it was not prescribed. Do not give Angeliq to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Angeliq. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Angeliq that is written for health professionals.

For more information, go to www.angeliq-us.com by or calling our toll free number (1-888-842-2937).

How should I store Angeliq?

Store Angeliq at room temperature between 59˚F to 86˚F (15˚C to 30˚C).

Keep Angeliq and all medicines out of the reach of children.

What are the ingredients in Angeliq?

Active ingredients: drospirenone (a progestin) and estradiol.

Inactive ingredients 0.5 mg DRSP/1 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

Inactive ingredients in 0.25 mg DRSP/0.5 mg E2 tablets: lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol 6000 NF, talc USP, titanium dioxide USP, and yellow ferric oxide pigment NF.