Norgestimate; Ethinyl Estradiol Tablets

NORGESTIMATE; ETHINYL ESTRADIOL (nor JES ti mate; ETH in il es tra DYE ole) prevents ovulation and pregnancy. It may also be used to treat acne. It belongs to a group of medications called oral contraceptives. It is a combination of the hormones estrogen and progestin.

Take this medication by mouth. To reduce nausea, it can be taken with food. Follow the directions on the prescription label. Take this medication at the same time each day and in the order directed on the package. Do not take your medication more often than directed.

Contact your care team about the use of this medication in children. Special care may be needed. This medication has been used in children who have started having menstrual periods.

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.

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

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• 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, fatigue
• New or worsening migraines or headaches
• 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
• Unusual vaginal discharge, itching, or odor
• Worsening mood, feelings of depression

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

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Irregular menstrual cycles or spotting
• Nausea
• Weight gain

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). 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, empty 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.

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

• Abnormal vaginal bleeding
• Blood vessel disease
• Cancer, such as breast, cervical, endometrial, ovarian, liver, or uterine cancer
• Diabetes
• Gallbladder disease
• Having surgery
• Heart disease or recent heart attack
• High blood pressure
• High cholesterol or triglycerides
• History of blood clots
• History of irregular heartbeat or heart valve problems
• History of a stroke
• Kidney disease
• Liver disease
• Lupus
• Migraine headaches
• Protein C deficiency
• Protein S deficiency
• Recently had a baby, miscarriage, or abortion
• Tobacco use
• An unusual or allergic reaction to estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

Do not take this medication with the following:

• Dasabuvir; ombitasvir; paritaprevir; ritonavir
• Ombitasvir; paritaprevir; ritonavir

This medication may also interact with the following:

• Acetaminophen
• Antibiotics or medications for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
• Aprepitant
• Ascorbic acid (vitamin C)
• Atorvastatin
• Barbiturate medications, such as phenobarbital
• Bosentan
• Carbamazepine
• Caffeine
• Clofibrate
• Cyclosporine
• Dantrolene
• Doxercalciferol
• Felbamate
• Grapefruit juice
• Hydrocortisone
• Medications for anxiety or sleeping problems, such as diazepam or temazepam
• Medications for diabetes, including pioglitazone
• Mineral oil
• Modafinil
• Mycophenolate
• Nefazodone
• Oxcarbazepine
• Phenytoin
• Prednisolone
• Raloxifene
• Ritonavir or other medications for HIV infection or AIDS
• Rosuvastatin
• Selegiline
• Soy isoflavones supplements
• St. John's wort
• Tamoxifen
• Theophylline
• Thyroid hormones
• Topiramate
• Warfarin

If you miss a dose, refer to the patient information sheet you received with your medication for directions on what to do. If you miss more than one pill, this medication may not work as well, and you may need to use a back-up contraceptive.

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medication. You should also discuss the need for regular mammograms with your care team, and follow his or her guidelines for these tests.

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.

Use an additional method of contraception during the first cycle that you take these tablets.

If you may be pregnant, stop taking this medication right away and contact your care team.

If you are taking this medication for hormone related problems, it may take several cycles to see improvement in your condition.

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 35 years or older.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

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

Tenderness, swelling, or minor bleeding of the gums may occur. Talk to your dentist if this happens. Brushing and flossing your teeth regularly may reduce the risk of side effects. Visit your dentist on a regular basis. Tell your dentist about any medications you are taking.

If you are going to have elective surgery, tell your care team you are taking this medication. You may need to stop taking this medication before the surgery.

Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs).