CombiPatch is a transdermal patch containing estradiol and norethindrone acetate as active ingredients. Estradiol is a form of estrogen, and norethindrone acetate is a progestational agent. This adhesive-based patch is designed to deliver these hormones continuously through the skin. Key inactive ingredients include acrylic adhesive, silicone adhesive, oleic acid, povidone, and dipropylene glycol.

How should I use this medication?

This medication 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 care team.

Talk to your care team about the use of this medication in children. Special care may be needed.

A patient package insert for the product 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 care team.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in the refrigerator. Do not freeze. Avoid exposure to extreme heat. Keep this medication in the original packaging until you are ready to use it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Unusual vaginal discharge, itching, or odor
• Vaginal bleeding after menopause, pelvic pain

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

• Bloating
• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Hair loss
• Irregular menstrual cycles or spotting
• Nausea
• Stomach pain
• Swelling of the ankles, hands, or feet

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.

What should I tell my care team before I take this medication?

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

• Blood vessel disease or blood clots
• Breast, cervical, endometrial, or uterine cancer
• Depression
• 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
• Migraine headaches
• Porphyria
• Stroke
• Systemic lupus erythematosus (SLE)
• Tobacco use
• Vaginal bleeding
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

This medication may also interact with the following:

• 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 medication?

Visit your care team 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 care team, and follow their guidelines.

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

If you have any reason to think you are pregnant, stop taking this medication at once and contact your care team.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are over the age of 35.

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

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

If you are going to have an MRI procedure, let your MRI technician know about the use of these patches. Some medication 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 your patch falls off, reapply it. If you cannot reapply the patch, apply a new patch to another area and continue to follow your usual dose schedule.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, or blood clots.

Estrogens with progestins may increase your chances of getting breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps.

Estrogens with or without progestins may increase your chance of getting dementia based on a study of women 65 years of age or older.

If you have a uterus, using estrogens alone (without progestins) may increase your chance of uterine cancer (cancer of the womb).