Loryna is an oral contraceptive containing the active ingredients drospirenone and ethinyl estradiol. It consists of light pink to pink active tablets with each tablet containing 3 mg of drospirenone and 0.02 mg of ethinyl estradiol, and 4 green inert tablets. The inactive ingredients in the active tablets include corn starch, FD&C Red No. 40, lactose monohydrate, magnesium stearate, povidone, talc, and vitamin-E. Loryna is intended to be used as a birth control method.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often. Talk to your care team about the use of this medication in children. Special care may be needed.

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 miss a dose, refer to the patient information sheet you received with your medication for direction. If you miss more than one pill, this medication may not be as effective, and you may need to use a back-up contraceptive.

Where should I keep my medication?

Keep out of the reach of children and pets. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

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—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 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

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 or ever had any of these conditions: -Abnormal vaginal bleeding -Adrenal gland disease -Blood vessel disease or blood clots -Breast, cervical, endometrial, ovarian, liver, or uterine cancer -Diabetes -Gallbladder disease -Heart disease or recent heart attack -High blood pressure -High cholesterol -High potassium level -Kidney disease -Liver disease -Migraine headaches -Stroke -Systemic lupus erythematosus (SLE) -Tobacco use -An unusual or allergic reaction to estrogens, progestins, or 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: -Aminoglutethimide -Amprenavir, fosamprenavir -Atazanavir; cobicistat -Anastrozole -Bosentan -Exemestane -Letrozole -Metyrapone -Testolactone This medication may also interact with the following: -Acetaminophen -Antiviral medications for HIV or AIDS -Aprepitant -Barbiturates -Certain antibiotics like rifampin, rifabutin, rifapentine, and possibly penicillins or tetracyclines -Certain diuretics like amiloride, spironolactone, triamterene -Certain medications for fungal infections like griseofulvin, ketoconazole, itraconazole -Certain medications for high blood pressure or heart conditions like ACE-inhibitors, Angiotensin-II receptor blockers, eplerenone -Certain medications for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin -Cholestyramine -Cobicistat -Corticosteroid like hydrocortisone and prednisolone -Cyclosporine -Dantrolene -Felbamate -Grapefruit juice -Heparin -Lamotrigine -Medications for diabetes, including pioglitazone -Modafinil -NSAIDs -Potassium supplements -Pyrimethamine -Raloxifene -St. John's wort -Sulfasalazine -Tamoxifen -Topiramate -Thyroid hormones -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 will need a regular breast and pelvic exam and Pap smear while on this medication. You may need to use another form of contraception, such as a condom, during the first cycle of this medication. 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 in 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 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. 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. This medication can cause tooth and gum problems. Tenderness, swelling, or minor bleeding of the gums may occur. 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).

What are the most serious risks of this medication?

This medication can increase the risk of serious blood clots, which can cause a heart attack or stroke. This risk increases if you are older than 35 years of age or use tobacco. You are strongly advised not to use tobacco.