IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.
COMMON BRAND NAME(S): Lunelle
WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).
USES: This combination medication is used to prevent pregnancy. Using this medication does not protect you or your partner against HIV or other sexually transmitted diseases.
HOW TO USE: Learn all preparation and usage instructions in the product package. If any of the information is unclear, consult your doctor or pharmacist. Shake the vial well before each dose. Inject this medication into a muscle (IM) once monthly within the first 5 days of your menstrual period; or as directed by your doctor. Additional doses may be given between day 28 and day 30 (from the start of your menstrual cycle); do not use bleeding episodes to determine the injection schedule for this drug. If it has been 33 days or longer since your last dose, inform your doctor promptly before receiving your next dose. A pregnancy test should be done and an alternate form of birth control (e.g., diaphragm, condoms) should be used until the results of the pregnancy test are obtained. Do not use this medication if it is within 4 weeks following childbirth (if not breast-feeding) or 6 weeks following childbirth if you are breast-feeding. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.
SIDE EFFECTS: Irregular vaginal bleeding (e.g., decreased, breakthrough, prolonged bleeding), weight gain, headache, nausea, acne, or breast tenderness may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: stomach pain, swelling, mental/mood disorders, dizziness. Tell your doctor immediately if any of these unlikely, but serious side effects occur: vision problems, increased urination, weight loss, vaginal changes (e.g., infection, cervical changes). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: leg pain, chest pain, trouble breathing, severe headache, one-sided weakness, yellowing of the eyes and skin. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially of: tobacco (smoking) use, blood circulation problems (e.g., blood clots in the legs), stroke, heart disease, abnormal vaginal bleeding not diagnosed by your doctor, liver disease, cancer, high blood pressure, diabetes, headache problems (e.g., migraines), gallbladder disease, high cholesterol or triglyceride levels in your blood (e.g., blood lipids), eye problems or if you wear contact lenses, epilepsy, depression, any allergies. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: aminoglutethimide, anti-seizure medication (e.g., carbamazepine, phenobarbital, phenytoin), other hormones (e.g., estrogen, progesterone), antibiotics, rifampin, ascorbic acid (vitamin C), acetaminophen, St John's Wort, cyclosporine, prednisolone, theophylline, aspirin, anti-anxiety drugs (e.g., diazepam), morphine, clofibric acid. This drug may interfere with certain laboratory tests (e.g., folic acid, proteins, thyroid hormones). Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe nausea or vomiting.
NOTES: Do not share this medication with others. Laboratory and/or medical tests may be performed to monitor your progress. Make sure laboratory personnel and your doctors know you use this drug.
MISSED DOSE: If you miss a dose, consult your doctor or pharmacist to establish a new dosing schedule.
STORAGE: Store at room temperature 77 degrees F (25 degrees C) away from light and moisture. Brief storage in temperatures 59 to 86 degrees F (15 and 30 degrees C) is permitted.
Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.