Angeliq (Page 7 of 7)

1. Genitourinary system

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

2. Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

3. Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

4. Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.

5. Skin

Chloasma or melasma, which may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash.

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.

8. Miscellaneous

Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, anaphylactoid/anaphylactic reactions including urticaria and angioedema, hypocalcemia, exacerbation of asthma, increased triglycerides.

OVERDOSAGE

In cases of ANGELIQ overdose, monitor serum concentrations of potassium and sodium since drospirenone has antimineralocorticoid properties.

Serious ill effects have not been reported following acute ingestion of large doses of progestin/estrogen-containing oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding may occur in females.

Dosage and Administration

The dosage of ANGELIQ is one tablet daily. Women who are already using a product containing estrogen should stop taking that product before starting ANGELIQ.

Use of estrogen, alone or in combination with a progestin, should be limited to the lowest effective dose available and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary (see Boxed Warnings and Warnings sections). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

The lowest effective dose of ANGELIQ has not been determined.

How Supplied

ANGELIQ TABLETS (drospirenone and estradiol) 0.5 mg/1 mg are available as round, biconvex pink film-coated tablets embossed with “CK” inside a hexagon, and supplied in the following packaging:

1 blisters of 28 tablets NDC 54868-6184-0

Storage Conditions

Store at 25° C (77° F); excursions permitted to 1530° C (5986° F) [See USP Controlled Room Temperature].

REFERENCES FURNISHED UPON REQUEST

PATIENT INFORMATION

September 2005

ANGELIQ® TABLETS

(drospirenone and estradiol)

(an”ju le k’)

Read this PATIENT INFORMATION before you start taking ANGELIQ and read what you get each time you refill ANGELIQ. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ANGELIQ (a combination of estrogen and a progestin)?

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.

Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots. Using estrogens with or without progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with ANGELIQ.

What is ANGELIQ?

ANGELIQ is a medicine that contains two kinds of hormones, estrogen and progestin.

What is ANGELIQ used for?

ANGELIQ is 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 health care provider should talk regularly about whether you still need treatment with ANGELIQ.

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.

Who should not use ANGELIQ?

Do not use 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.

Do not start taking ANGELIQ if you:

  • have unusual vaginal bleeding.
  • 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 health care 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.
  • are allergic to ANGELIQ or any of its ingredients. See the end of this leaflet for a list of ingredients in ANGELIQ.
  • think you may be pregnant.

Tell your health care provider:

  • if you are breastfeeding. The hormone in ANGELIQ can pass into your milk.
  • about all of your medical problems. Your health care 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) or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
  • about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how ANGELIQ works. ANGELIQ may also affect how your other medicines work.
  • if you are going to have surgery or will be on bed rest. You may need to stop taking estrogens.

How should I take ANGELIQ?

  1. Take one tablet every day.
  2. Estrogens should be used only as long as needed. The lowest effective dose of ANGELIQ has not been determined. 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 is different from other hormonal medicines for menopausal symptoms because it contains drospirenone, and drospirenone may increase the potassium or lower the sodium in your blood.

You should not take ANGELIQ if you have kidney, liver or adrenal disease because these conditions may also increase the potassium in your blood. Some other medicines also increase potassium. If you regularly take another medicine that increases potassium levels, talk with your healthcare provider about whether ANGELIQ is right for you. In some situations, your healthcare provider may recommend testing your blood for potassium.

Less common but serious side effects include the following and should be discussed with your healthcare provider to assess your personal risks:

  • Breast cancer
  • Cancer of the uterus
  • Stroke
  • Heart attack
  • Blood clots
  • Dementia
  • Gallbladder disease
  • Ovarian cancer

These are some of the warning signs of serious side effects:

  • Breast lumps
  • Unusual vaginal bleeding
  • Dizziness and faintness
  • Changes in speech
  • Severe headaches
  • Chest pain
  • Shortness of breath
  • Pains in your legs
  • Changes in vision
  • Vomiting

Call your health care provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.

Common side effects include:

  • Headache
  • Breast pain
  • Irregular vaginal bleeding or spotting
  • Stomach/abdominal cramps, bloating
  • Nausea and vomiting
  • Hair loss

Other side effects include:

  • High blood pressure
  • Liver problems
  • High blood sugar
  • Fluid retention
  • Enlargement of benign tumors of the uterus (“fibroids”)
  • Vaginal yeast infection

These are not all the possible side effects of ANGELIQ. For more information, ask your health care provider or pharmacist.

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

Talk with your health care provider regularly about whether you should continue taking ANGELIQ.

See your health care provider right away if you get vaginal bleeding while taking ANGELIQ.

Have a breast exam and mammogram (breast X-ray) every year unless your health care 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 health care provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of ANGELIQ.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use 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.

Keep ANGELIQ out of the reach of children

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. You can get more information by calling our toll free number (1-888-237-5394) or visit www.angeliq-us.com

What are the ingredients in ANGELIQ?

The active ingredients in ANGELIQ are drospirenone (a progestin) and estradiol. ANGELIQ also contains lactose monohydrate NF, corn starch NF, modified starch NF, povidone USP, magnesium stearate NF, hydroxylpropylmethyl cellulose USP, macrogol NF, talc USP, titanium dioxide USP, and ferric oxide pigment NF.

Do not store above 86°F (30°C).

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc.
Wayne, NJ 07470

©2008 Bayer HealthCare Pharmaceuticals Inc.
All rights reserved.

6702400 US 80621990

March 2008

Relabeling of “Additional Barcode Label” by:
Physicians Total Care, Inc.
Tulsa, OK 74146

Rx Only

Angeliq® Tablets

(Drospirenone and Estradiol)

0.5 mg/1 mg

— 0.5 mg/1 mg

— 28 tablets

— oral

Angeliq package label
(click image for full-size original)
ANGELIQ
drospirenone and estradiol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6184(NDC:50419-0483-01)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL (ESTRADIOL) ESTRADIOL 1 mg
DROSPIRENONE (DROSPIRENONE) DROSPIRENONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
MAGNESIUM STEARATE
POVIDONE K25
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code CK
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6184-0 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 28 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (54868-6184-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021355 09/29/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 05/2009 Physicians Total Care, Inc.

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