DROSPIRENONE AND ESTRADIOL

(droe SPYE re none and ES tra Paint ole) Brand: Angeliq

What is the most significant information I must know about drospirenone and estradiol?

• Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant.

• You must not take this medication if you have any of the next conditions: a bleeding or blood-clotting mess, circulation problems, unusual vaginal bleeding, kidney malady, liver malady, an adrenal gland mess, if you have had a hysterectomy, if you have had a heart onslaught a stroke, or if you have ever had breast or uterine cancer, or a blood clot (especially in your lung or your lower body).

• Smoking can magnify your risk of blood clots, stroke, or heart onslaught caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to reason blood clots than another types of female hormone medication.

• Stop using drospirenone and estradiol and call your doctor at once if you have chest pain, sudden numbness or weakness, a sudden severe headache, confusion, problems with vision or speech, or if you have pain, swelling, warmth, or redness in one or both legs.

• Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes).

• Drospirenone and estradiol must not be used to prevent heart malady, stroke, or dementia, because this medication may actually magnify your risk of developing these conditions.

What is drospirenone and estradiol?

• Drospirenone is a female hormone that helps regulate ovulation and menstruation.

• Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

• The combination of drospirenone and estradiol is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medicine is for use only if you have a uterus (if you have not had a hysterectomy).

• Drospirenone and estradiol must not be used to prevent heart malady, strokes, or dementia, because this medication may actually magnify your risk of developing these conditions.

• Drospirenone and estradiol may also be used for purposes not listed in this medicine guide.

What must I discuss with my doctor till taking drospirenone and estradiol?

• You must not take this medication if you are allergic to drospirenone or estradiol, or if you have:

· a bleeding or blood-clotting mess, or circulation problems;

· unusual vaginal bleeding that has not been checked by a doctor;

· kidney disease;

· liver disease;

· an adrenal gland disorder;

· a history of hormone-related cancer such as breast or uterine cancer;

· if you have had your uterus removed (hysterectomy);

· if you are pregnant or plan to become pregnant;

· if you have had a heart onslaught or stroke; or

· if you have ever had a blood clot (especially in your lung or your lower body).

• To create certain you can safely take drospirenone and estradiol, speak your doctor if you have any of these another conditions:

· heart malady, tall blood pressure;

· risk factors for coronary artery malady (such as smoking, being overweight, or a family history of coronary artery disease);

· tall cholesterol or triglycerides;

· diabetes;

· a thyroid disorder;

· tall levels of calcium, sodium, or potassium in your blood;

· endometriosis;

· gallbladder disease;

· asthma;

· severe migraines (with aura, numbness, weakness, or vision changes), especially if you are older than 35;

· a history of jaundice caused by pregnancy or birth control pills;

· epilepsy or another seizure disorder;

· hereditary angioedema (an immune system disorder);

· a history of fibrocystic breast malady, lumps, nodules, or an emergency mammogram;

· systemic lupus erythematosus (SLE); or

· porphyria (a genetic enzyme mess that causes symptoms affecting the skin or nervous system).

• Estradiol may magnify your risk of developing a condition that may lead to uterine cancer. Taking the combination of drospirenone and estradiol may reduce this risk. Conversation with your doctor about your individual risk, and message any unusual vaginal bleeding right away.

• FDA pregnancy category X. Do not use drospirenone and estradiol if you are pregnant or plan to become pregnant. Speak your doctor right away if you become pregnant during treatment.

• The hormones in drospirenone and estradiol can pass into breast milk and may harm a nursing child. This medicine may also slow breast milk manufacture. Do not use if you are breast feeding a baby.

How must I take drospirenone and estradiol?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Do not crush, chew, or interrupt a drospirenone and estradiol tablet. Swallow it intact.

• Try to take drospirenone and estradiol at the same time every day.

• If you need surgery or medical trials or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you must know that you are taking drospirenone and estradiol.

• Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while taking drospirenone and estradiol.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• If you are smaller than 24 hours late in taking your medication, take the missed doze as soon as you remember. Skip the missed doze if it is time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe nausea or vaginal bleeding.

What must I avoid while taking drospirenone and estradiol?

• Smoking can magnify your risk of blood clots, stroke, or heart onslaught caused by birth control pills, especially if you are older than 35. Drospirenone may be more likely to reason blood clots than another types of female hormone medication.

• Avoid drinking alcohol while you are taking this medication.

• Grapefruit and grapefruit juice may interact with drospirenone and estradiol and lead to unwanted side effects. Discuss the use of grapefruit commodity with your doctor.

What are the possible side effects of drospirenone and estradiol?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using drospirenone and estradiol and call your doctor at once if you have a serious side effect such as:

· chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common ill feeling;

· sudden numbness or weakness, especially on one side of the body;

· sudden severe headache, problems with vision, speech, or balance;

· sudden cough, wheezing, rapid breathing, coughing up blood;

· pain, swelling, warmth, or redness in one or both legs;

· confusion, unusual thoughts or behavior;

· emergency vaginal bleeding;

· tall blood sugar (increased thirst, heighten urination, famine, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

· severe pain in your upper stomach spreading to your back, vomiting;

· itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

· a breast lump.

• Smaller serious side effects may include:

· mild nausea or stomach pain, diarrhea;

· mild headache;

· irregular vaginal bleeding, spotting;

· breast pain or tenderness;

· weight gain, swelling in your hands or feet;

· mood changes; or

· vaginal itching or discharge.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect drospirenone and estradiol?

• Speak your doctor about all another medicines you use, especially:

· eplerenone (Inspra);

· heparin;

· ritonavir (Norvir, Kaletra);

· St. John's wort;

· an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifater, Rifadin, Rifamate);

· an antifungal medicine such as ketoconazole (Nizoral) or itraconazole (Sporanox);

· aspirin or another NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

· a blood thinner such as warfarin (Coumadin, Jantoven);

· a diuretic ("water pill") such as spironolactone (Aldactone), triamterene (Dyrenium, Dyazide, Maxzide), amiloride (Midamor), or eplerenone (Inspra);

· heart or blood pressure medications such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), fosinopril (Monopril), irbesartan (Avapro, Avalide), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar), ramipril (Altace), valsartan (Diovan), telmisartan (Micardis);

· a potassium supplement such as Klor-Con, K-Dur, K-Tab; or

· seizure medications such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).

• This list is not complete and another drugs may interact with drospirenone and estradiol. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about drospirenone and estradiol.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

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