Ocella®

What is Ocella®?

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and drospirenone (a progestin) are used to prevent pregnancy, treat certain types of acne, and to relieve the symptoms of premenstrual dysphoric disorder (symptoms that occur before the menstrual period each month). Your doctor will select the best medication for your needs. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives treat acne by decreasing the amounts of certain natural substances in the body that can cause acne.

Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

How should this medicine be used?

Ethinyl estradiol and drospirenone oral contraceptives come as tablets to take by mouth. Take once a day on the days specified by your doctor. Take your oral contraceptive at the same time on those days.

Take ethinyl estradiol and drospirenone oral contraceptives exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Oral contraceptives come in many different brands. Different brands of oral contraceptives contain different doses and may also contain inactive tablets or ones containing iron. Oral contraceptives are taken on specific schedules. Be sure that you know which brand of oral contraceptives you are using and exactly how you should use it. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.

Your doctor will tell you when you should start taking your oral contraceptive. It is usually started on the first day of your menstrual period or on the first Sunday after bleeding begins. You will probably be told to use another method of birth control during the first 7 days that you take your oral contraceptive. Talk to your doctor or pharmacist about what method is best for you. Follow these directions carefully to prevent pregnancy.

You will probably experience withdrawal bleeding similar to a menstrual period while you are taking the inactive tablets or during the time that you do not take your oral contraceptive. If you are taking the type of packet that only contains active tablets, you will not experience any scheduled bleeding, but you may experience unexpected bleeding and spotting, especially at the beginning of your treatment. Be sure to start taking your new packet on schedule even if you are still bleeding.

If you vomit or have diarrhea while you are taking ethinyl estradiol and drospirenone oral contraceptive, it may not work as well. If this happens, contact your doctor about what to do. You may be told to use a back-up method for 7 days. Talk to your doctor about an appropriate backup method of birth control in case it is needed at any point during therapy.

Ethinyl estradiol and drospirenone oral contraceptives will work only as long as they are taken regularly. Continue to take them as directed even if you are spotting or bleeding, have an upset stomach, or do not think that you are likely to become pregnant. Do not stop taking oral contraceptives without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking ethinyl estradiol and drospirenone oral contraceptives,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with ethinyl estradiol and drospirenone oral contraceptives. Make sure you have discussed any medications you are currently taking or plan to take before starting ethinyl estradiol and drospirenone oral contraceptives with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ethinyl estradiol and drospirenone oral contraceptives, please get the advice of your doctor or pharmacist.you should also know that some medications may decrease the effectiveness of oral contraceptives (birth control pills). You will need to use another method of contraception to prevent pregnancy while taking these drugs. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.
• the following nonprescription or herbal product may interact with ethinyl estradiol and drospirenone oral contraceptives: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medications before you start taking ethinyl estradiol and drospirenone oral contraceptives. Do not start this medication while taking ethinyl estradiol and drospirenone oral contraceptives without discussing with your healthcare provider.
• tell your doctor if you have or have ever had problems with your adrenal glands (glands near your kidneys that produce hormones), diabetes that has affected your circulation; migraines or headaches that come along with other symptoms such as vision changes, weakness, and dizziness; high blood pressure that medication cannot control; unexplained vaginal bleeding; breast cancer; liver cancer, liver tumors, or other types of liver disease; or kidney disease. Your doctor will probably tell you that you should not take ethinyl estradiol and drospirenone oral contraceptives.
• tell your doctor if you are overweight, and if you have or have ever had high blood cholesterol or fats; diabetes; depression; gallbladder disease; swelling in a part of your body.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.If you miss periods while you are taking ethinyl estradiol and drospirenone oral contraceptives, you may be pregnant. Ask your doctor what you should do if you miss a period. Call your doctor and have a pregnancy test if you experience symptoms of pregnancy such as nausea, vomiting, and breast tenderness, or if you suspect you may be pregnant.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ethinyl estradiol and drospirenone oral contraceptives.
• you should know that oral contraceptives may cause dark skin patches, especially on the face. If you have experienced changes in your skin color during pregnancy or while you were taking oral contraceptives in the past, you should avoid exposure to real or artificial sunlight while you are taking oral contraceptives. Wear protective clothing, sunglasses, and sunscreen.
• tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking oral contraceptives, see an eye doctor.

What side effects can this medication cause?

Ethinyl estradiol and drospirenone oral contraceptives may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea, vomiting
• weight gain
• spotting or irregular bleeding between periods
• swelling, redness, irritation, burning, or itching of the vagina
• breast tenderness or enlargement
• swelling of the hands, arms, feet, and legs
• difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking ethinyl estradiol and drospirenone oral contraceptives and call your doctor immediately or get emergency medical treatment:

• yellowing of skin or eyes
• pain or tenderness of your abdomen
• a lump in your breast
• unusual bleeding, including menstrual bleeding that is unusually heavy or that lasts for longer than 7 days in a row

Oral contraceptives may increase the chance that you will develop liver tumors. These tumors are not a form of cancer, but they can break and cause serious bleeding inside the body. Oral contraceptives may also increase the chance that you will develop breast or liver cancer. Talk to your doctor about the risks of using oral contraceptives.

Ethinyl estradiol and drospirenone oral contraceptives may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vaginal bleeding

🔗 Reference: https://medlineplus.gov/druginfo/meds/a625047.html