Estradiol, Norethindrone Acetate Transdermal patch - biweekly

What is this medicine?

ESTRADIOL; NORETHINDRONE (es tra DYE ole; nor eth IN drone) contains a mixture of female hormones. This medicine helps to relieve the symptoms of menopause like hot flashes, night sweats, mood changes, and vaginal dryness and irritation. It is also used to treat women with low estrogen levels or those who have had their ovaries removed.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease or blood clots
• breast, cervical, endometrial, or uterine cancer
• diabetes
• endometriosis
• fibroids
• gallbladder disease
• heart disease or recent heart attack
• high blood cholesterol
• high blood pressure
• high level of calcium in the blood
• hysterectomy
• kidney disease
• liver disease
• mental depression
• migraine headaches
• porphyria
• stroke
• systemic lupus erythematosus (SLE)
• tobacco smoker
• vaginal bleeding
• an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the directions on the prescription label. Use exactly as directed. Tear open the pouch, do not use scissors. Remove the stiff protective liner covering the adhesive. Try not to touch the adhesive. Apply the patch, sticky side to the skin, to an area of the lower abdomen that is clean, dry and hairless. Avoid injured, irritated, calloused, or scarred areas. Do not apply the skin patches to your breasts or around the waist area. Use a different site each time to prevent skin irritation. You should change your patch on the same days each week. Do not cut or trim the patch. Do not stop using except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

A patient information sheet will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you forget to change your patch as scheduled, apply it as soon as possible. Remember to remove the old patch. If it is almost time to apply the next patch, skip the missed patch and get back on your normal schedule. Do not wear more than one patch at a time unless you are told to do so by your doctor or health care professional.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medicine may also interact with the following medications:

• barbiturates, such as phenobarbital
• benzodiazepines
• bosentan
• bromocriptine
• carbamazepine
• cimetidine
• cyclosporine
• dantrolene
• grapefruit juice
• griseofulvin
• hydrocortisone, cortisone, or prednisolone
• isoniazid (INH)
• medications for diabetes
• methotrexate
• mineral oil
• phenytoin
• raloxifene
• rifabutin, rifampin, or rifapentine
• tamoxifen
• thyroid hormones
• topiramate
• tricyclic antidepressants
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines.

This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.

If you have any reason to think you are pregnant; stop taking this medicine at once and contact your doctor or health care professional.

Tobacco smoking increases the risk of getting a blood clot or having a stroke, especially if you are more than 35 years old. You are strongly advised not to smoke.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

If you are going to have elective surgery, you may need to stop taking this medicine beforehand. Consult your health care professional for advice prior to scheduling the surgery.

If you are going to have a MRI procedure, let your MRI technician know about the use of these patches. Some drug patches contain an aluminized backing that can become heated when exposed to MRI and may cause burns. You may need to temporarily remove the patch during the MRI procedure.

You may bathe or participate in other activities while wearing your patch. If the patch pulls loose or falls off, you may reapply it if the patch is sticky enough to stay on the skin. You should reapply the patch in a different area. Otherwise use a fresh patch.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast tissue changes or discharge
• changes in vision
• chest pain
• confusion, trouble speaking or understanding
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• nausea, vomiting
• pain, swelling, warmth in the leg
• right upper belly pain
• severe headaches
• shortness of breath
• sudden numbness or weakness of the face, arm or leg
• trouble walking, dizziness, loss of balance or coordination
• unusual vaginal bleeding
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• brown spots on the face
• change in appetite
• change in sexual desire
• depressed mood or mood swings
• fluid retention and swelling
• stomach cramps or bloating
• unusually weak or tired
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in the sealed foil pouch. Throw away any unused medicine after 6 months or the expiration date on the package, whichever is sooner.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.