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Generic Name: Levonorgestrel/Ethinyl Estradiol Tablets 91-Day Pack (LEE-voe-nor-JES-trel/ETH-i-nil ES-tra-DYE-ol)
Brand Name: Examples include Jolessa and Seasonale
Smoking cigarettes while using Jolessa increases your chance of having serious heart problems. Do not smoke while using Jolessa . The risk of heart problems increases with age and with frequent smoking. Women older than 35 years of age and women who smoke 15 or more cigarettes per day are at a greater risk for heart problems.
Jolessa is used for:
Preventing pregnancy. It may be used for other conditions as determined by your doctor.
Jolessa is a progesterone and estrogen combination birth control pill. It works by preventing
ovulation, thickening the mucus in the cervix, and changing the lining of the uterus.
Do NOT use Jolessa if:
- you are allergic to any ingredient in Jolessa
- you have a history of blood clots (eg, in the lungs, legs, eyes); certain heart problems (eg, heart valve problems, irregular heartbeat); chest pain caused by angina; certain blood problems (eg, porphyria); blood vessel problems
(eg, bleeding in the brain, heart attack, or stroke); certain types of headaches or migraines with aura; uncontrolled high blood pressure; diabetes that affects circulation; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; undiagnosed vaginal bleeding; or breast cancer
- you have active liver disease or liver tumors, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use
are pregnant or think you may be pregnant
- you have had surgery and are or will be confined to a bed or a chair for an extended period of time
Contact your doctor or health care provider right away if any of these apply to you.
Before using Jolessa :
Some medical conditions may interact with Jolessa . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are planning to become pregnant or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, fibrocystic breast
disease, or if a family member has had breast cancer
- if you have a history of diabetes or high blood sugar, gallbladder problems, migraines or severe or persistent headaches, heart problems, high blood pressure, high blood cholesterol or lipid levels, kidney or liver problems, blood or bleeding problems, blood in the urine, mental or mood problems (eg, depression), lupus, high blood calcium levels, chorea (jerky, involuntary movements of the face, arms, or legs), varicose veins, yellowing of the eyes or skin, pancreas problems, or seizures
- if you are overweight, have swelling problems,you have not yet had your first menstrual period, or you smoke or use tobacco
- if you are more than 40 years old
Some MEDICINES MAY INTERACT with Jolessa . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Troleandomycin because the risk of serious liver problems may be increased
- Acetaminophen, ascorbic acid (vitamin C), or atorvastatin because they may increase the risk of Jolessa "s side effects
- Azole antifungals (eg, ketoconazole) because they may decrease Jolessa "s effectiveness or increase the risk of Jolessa "s side effects
- Aprepitant, barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins
(eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, ampicillin), rifampin, phenylbutazone, primidone, tetracyclines (eg, doxycycline), topiramate, troglitazone, or St. John"s wort because they may decrease Jolessa "s effectiveness, resulting in breakthrough bleeding or pregnancy
- Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone),
cyclosporine, theophylline, or tizanidine because the risk of their side effects may be increased by Jolessa
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Jolessa
- Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by Jolessa
This may not be a complete list of all interactions that may occur. Ask your health care provider if Jolessa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Jolessa :
Use Jolessa as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Jolessa . Talk to your pharmacist if you have questions about this information.
- Take Jolessa by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do not remove the tablet from the blister packaging until you are ready to take Jolessa .
- Begin taking Jolessa on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Jolessa on that day.
- If you are switching from another form of hormonal birth control to Jolessa , be sure you know when you should start taking Jolessa . Talk with your doctor if you have any questions about how to switch from another form of hormonal birth control to Jolessa .
- Try to take Jolessa at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.
- For Jolessa to be effective it must be taken every day. Do not skip doses, even if you are spotting, bleeding, or nauseous. Do not skip pills even if you do not have sex very often.
- If you miss 1 dose of Jolessa , take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day. You do not need to use a backup method of birth control if you only miss 1 pill. If you miss more than 1 dose of Jolessa , read the additional patient information leaflet that comes with Jolessa or contact your doctor for instructions. You must use a backup method of birth control if you miss more than 1 dose of Jolessa . If you are not sure about how to handle missed doses of Jolessa , use an extra form of birth control
(eg, condoms) until you talk with your doctor.
Ask your health care provider any questions you may
have about how to use Jolessa .
Important safety information:
- Jolessa may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Jolessa with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Jolessa may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke. Do not smoke or use other tobacco products while taking Jolessa .
- During the first 7 days of the first cycle of Jolessa , you may not be protected from getting pregnant. Use an extra form of birth control (eg, condoms) until you have taken Jolessa for longer than 7 days.
- You could become pregnant if you miss 2 or more doses of Jolessa . You could also become pregnant if you start the
pack later than the proper day. If you have sex, you must use another form of birth control as a backup (eg, condoms) during the days that you miss doses and for the first 7 days after you begin to take it again. Talk with you doctor for more information or if you have trouble remembering to take Jolessa .
- If your period does not occur when expected, or if you experience unusual breast tenderness or symptoms of morning sickness, call your doctor right away. These symptoms may indicate that you are pregnant.
- Bleeding or spotting may occur while taking Jolessa . Do not stop taking Jolessa if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.
- The effectiveness of Jolessa may be decreased by certain medicines
(eg, antibiotics, medicines for seizures, St. John"s
wort) or conditions (eg, vomiting or diarrhea). This could cause breakthrough bleeding or increase the risk of an unplanned pregnancy if you have sex. To prevent pregnancy, use an extra form of birth control (eg, condoms). Talk with your doctor or pharmacist for more information.
- Tell your doctor or dentist that you take Jolessa before you receive any medical or dental care, emergency care, or surgery. If possible, Jolessa should be stopped at least 4 weeks before and for 2 weeks after surgery or any time you might be confined to a bed or chair for a long period of time
(such as a long plane flight, bedrest, or lengthy illness).
- You should usually not start taking Jolessa within 4 weeks after giving birth. Discuss any questions or concerns with your doctor.
- If you wear contact lenses and you develop problems with them or with
your vision, contact your doctor as soon as possible.
- Jolessa may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to Jolessa . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- You may experience a delay in being able to become pregnant after stopping Jolessa . This effect may be greater in patients who had irregular periods before starting Jolessa . Discuss any concerns with your doctor or pharmacist.
- Jolessa does not stop the spread of HIV and other sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
- Diabetes patients - Jolessa may affect
your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including breast exams, Pap tests, physicals, and blood pressure, may be performed while you take Jolessa . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Examine your breasts monthly as directed by your doctor. Report any lumps right away.
- Jolessa may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Jolessa .
- Jolessa should not be used in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take Jolessa
if you are pregnant. If you think you may be pregnant, contact your doctor right away. Jolessa is found in breast milk. Do not breast-feed while taking Jolessa .
Possible side effects of Jolessa :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Acne; breast tenderness or enlargement; changes in appetite; changes in weight; dizziness; headache; loss of scalp hair; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing;
tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or
tenderness; change in amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines;
numbness of an arm or leg; one-sided weakness; pale stools; persistent vaginal spotting; persistent, severe, or recurring headache or dizziness; severe pain or tenderness in the stomach; shortness of breath;
slurred speech; sudden severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes
(eg, sudden vision loss, double vision); yellowing of the skin or eyes (with or without fever).
This is not a complete list of all side effects that may occur. If you have questions or
need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea;
Proper storage of Jolessa :
Store Jolessa at room temperature, between 68 and 77 degrees F
(20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Jolessa out of the reach of children and away from pets.
- If you have any questions about Jolessa , please talk with your doctor, pharmacist, or other health care
- Jolessa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Jolessa . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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