What is Cyclessa?Cyclessa is an oral contraceptive used to prevent pregnancy.
What is the most important information I should know about Cyclessa?Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk is increased if you smoke ≥15 cigarettes per day and is quite marked in women over 35 years of age.
Cyclessa (like all oral contraceptives), is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you smoke; have high blood pressure, diabetes, or high cholesterol; or have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, or malignant or benign liver tumors.
If any of the following side effects occur while you are taking oral contraceptives, call your doctor or healthcare provider immediately as they could indicate a serious medical condition: breast lumps, change in mood, coughing of blood, crushing or sharp chest pain or heaviness in the chest, dark-colored urine, difficulty sleeping, disturbances of vision or speech, dizziness or fainting, fever, jaundice or a yellowing of the skin or whites of the eyes, lack of energy, light-colored bowel movements, loss of appetite, severe pain or tenderness in the stomach area, sudden severe headache or vomiting, sudden shortness of breath, of weakness or numbness in an arm or leg.
Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. Women who are being treated for high cholesterol should be monitored closely if they choose to use oral contraceptives.
Who should not take Cyclessa?You should not use Cyclessa if you are pregnant or think you may be pregnant. You should also not use Cyclessa if you have any of the following conditions: a history of heart attack or stroke; a history of blood clots in the legs, lungs, or eyes; a history of blood clots in the deep veins of your legs; chest pain, severe high blood pressure, diabetes with complications of the kidneys, eyes, nerves, or blood vessels; headache with neurological symptoms; known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina; unexplained vaginal bleeding (until your healthcare provider reaches a diagnosis), yellowing of the whites of the eyes or skin (jaundice) during pregnancy or during previous use of hormonal birth control of any kind (the pill, patch, vaginal ring, injection, or implant); liver tumor (benign or cancerous); heart valve or heart rhythm disorders that may be associated with formation of blood clots; need for a long period of bed rest following major surgery; known or suspected pregnancy; active liver disease with abnormal liver function tests; or an allergy or hypersensitivity to any of the components of Cyclessa.
What should I tell my doctor before I take the first dose of Cyclessa?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning Cyclessa. Also, talk to your doctor about your complete medical history, especially if you have breast nodules, fibrocystic disease of the breast, or an abnormal breast x-ray or mammogram; diabetes; elevated cholesterol or triglycerides; high blood pressure; migraine or other headaches or epilepsy; depression; gallbladder, liver, heart, or kidney disease; or scanty or irregular menstrual periods. You should also talk to you doctor if you smoke; recently had a baby, miscarriage, or abortion; or are breastfeeding.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: Take 1 tablet once a day for 28 days, then repeat. Start the first Sunday after you begin menstruating or the first day of your period.
How should I take Cyclessa?To achieve maximum contraceptive effectiveness, Cyclessa tablets must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. Cyclessa may be initiated using either a Sunday start or a Day 1 start. Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach. Do not skip pills even if you do not have sex very often. When you finish the pack or switch your brand of pills, start the next pack on the day after your last pill. Do not wait any days between packs.
During the first cycle of use: Take Cyclessa either on the first Sunday after the onset of your menstrual period (Sunday start) or on the first day of your menstrual period (Day 1 start). When switching from another oral contraceptive, Cyclessa should be started on the same day that a new pack of the previous oral contraceptive would have been started.
Day 1 start: Pick the label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). Place this label strip in the cycle tablet dispenser over the area that has the days of the week (starting with Sunday) imprinted in the plastic. Take the first "active" (light yellow) pill of the first pack during the first 24 hours of your period. You will not need to use a backup method of birth control, since you are starting the pill at the beginning of your period.
Sunday start: Take the first "active" (light yellow) pill of the first pack on the first Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. Use another method of birth control as a backup method if you have sex any time from the Sunday you start your first pack until the next Sunday (7 days).
What should I avoid while taking Cyclessa?Avoid smoking while taking this medication, especially if you are older than 35.
Cyclessa does not protect you against HIV or sexually transmitted disease; using a condom is the only way to protect yourself from acquiring these diseases.
What are possible food and drug interactions associated with Cyclessa?If oral contraceptives are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining oral contraceptives with the following: acetaminophen, antibiotics, ascorbic acid (vitamin C), atorvastatin, barbiturates, carbamazepine, celecoxib, clofibric acid, cyclosporine, diclofenac, felbamate, fluconazole, glipizide, griseofulvin, HIV protease inhibitors (e.g., ritonavir), ibuprofen, irbesartan, isoniazid, itraconazole, ketoconazole, losartan, morphine, naproxen, oxcarbazepine, phenylbutazone, phenytoin, piroxicam, prednisolone, rifampin, salicylic acid, St. John's wort, sulfamethoxazole, temazepam, theophylline, tolbutamide, topiramate, torsemide, valsartan.
What are the possible side effects of Cyclessa?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: abdominal pain (including cramps or bloating), aggravation of varicose veins, allergic reactions, blood clots, breast tenderness, change in appetite, dark spotting in the skin (particularly skin of the face), difficulty wearing contact lenses, dizziness, fluid retention (swelling of the fingers or ankles), headache, high blood pressure, intolerance to contact lenses, irregular vaginal bleeding, liver tumors, loss of scalp hair, menstrual flow changes, mood changes including depression, nausea, nervousness, rash, vaginal infections, vision changes, vomiting, weight gain
Can I receive Cyclessa if I am pregnant or breastfeeding?Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. If you are breastfeeding, consult your doctor or healthcare provider before starting oral contraceptives.
What should I do if I miss a dose of Cyclessa?If you miss pills, you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
If you miss 1 pill, take it the same day, even if it means taking 2 pills on the same day and continue taking 1 pill/day until the pack is finished.
If you miss 2 pills during the first 2 weeks, use a backup form of contraception for 7 days after the missed pills. Take 2 pills immediately and 2 pills the next day. Then continue taking 1 pill/day until the pack is finished.
If you miss 2 pills during the third week, use a backup form of contraception for 7 days after the missed pills. If you normally start on Day 1, throw out the remaining pills and start a new pack on the same day. If you normally start on Sunday, keep taking 1 pill/day until Saturday and throw out the remaining pills. On Sunday, start a new pack.
If you are still not sure what to do about the pills you have missed, use a backup method of birth control and keep taking the active pills each day until you can speak with a healthcare provider.
How should I store Cyclessa?Store at room temperature.
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