GENERIC NAME: NORGESTREL (CONTRACEPTIVE) - ORAL (nor-JESS-trel)
BRAND NAME(S): Ovrette
USES: This medication is used to prevent pregnancy. It is often referred to as the "mini-pill" because it does not contain any estrogen. Norgestrel (a form of progestin) is a hormone that prevents pregnancy by changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or for the fertilized egg to attach to the wall of the womb (implantation). Regular use of the "mini-pill" prevents the release of an egg (ovulation) in about half of the women who use it.While the "mini-pill" is more effective than certain other methods of birth control (e.g., condoms, cervical cap, diaphragm), it is less effective than estrogen/progestin birth control because it does not consistently prevent ovulation. It is usually used by women who cannot take estrogen. For the most effective results, it is very important to take this medication exactly as prescribed.Using this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.Norgestrel may also be used to help decrease pain and blood loss from a certain menstrual condition (heavy/painful periods due to endometriosis) and to help make your periods more regular.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information on when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food, usually once daily or as directed by your doctor. For this medication to be effective, you must take it at the same time each day. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Missing a pill, taking it more than 3 hours late, or starting a new pack late will increase your risk of becoming pregnant. If you miss a pill or take this medication 3 or more hours later than usual, use a backup method of birth control (e.g., condom, spermicide) every time you have sex for the next 2 days.Taking this medication after your evening meal or at bedtime may help if you have any stomach upset or nausea with the medication. You may choose to take this medication at another time of day that is easier for you to remember. No matter what dosing schedule you use, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.Continue taking one tablet every day. After taking the last tablet in your old pack, start a new pack the next day. There is no break between packs, and you do not take any "reminder" tablets (tablets without medication). Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods. Do not stop taking your pills if this happens.If you vomit within 4 hours after taking this medication or have diarrhea, use a back-up method of birth control (e.g., condoms, spermicide) every time you have sex for the next 2 days.If you continue to have regular menstrual periods while on this medication, you may be ovulating. This medication might still prevent pregnancy even if you are ovulating. Consult your doctor for more information, and ask about your risk of pregnancy and the possible use of other forms of birth control.If this is the first time you are using this medication and you are not switching from another form of hormonal birth control (e.g., patch, other birth control pills), take the first pill in the pack on the first day of your period. Use an additional form of birth control for the first 2 days if you are instructed to start this medication on any other day.Ask your doctor or pharmacist for information about how to switch from other forms of hormonal birth control (e.g., patch, other birth control pills) to this product. If any of this information is unclear, consult the Patient Information Leaflet or your doctor or pharmacist.
SIDE EFFECTS: Nausea, vomiting, stomach cramping/bloating, dizziness, headache, tiredness, breast tenderness, decrease in breast size, acne, oily scalp, hair loss, weight gain, and vaginal infections may occur. If any of these effects persist or worsen, notify your doctor promptly. Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row (or 1 period if the pill has not been used properly), contact your doctor for a pregnancy test.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these infrequent but serious side effects occur: depression, unwanted facial/body hair, swelling of the ankles/feet.This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal/pelvic pain, lumps in the breast, unusual tiredness, dark urine, yellowing eyes/skin.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to norgestrel; or to other progestins (e.g., norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: abnormal breast exam, breast cancer, liver problems (e.g., liver tumor, active liver disease), current or suspected pregnancy, unexplained vaginal bleeding.Before you take this medication, tell your doctor your entire medical history, including family medical history, especially of: certain breathing problem (asthma), stroke or other blood clots (e.g., in the legs, eyes, lungs), high blood pressure, low levels of "good" cholesterol (HDL), diabetes, heart disease (e.g., heart attack, chest pain), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, migraine headaches, obesity, long period of sitting or lying down (e.g., immobility such as being bedridden).Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).Before having surgery, including dental surgery, tell your doctor or dentist that you are using this medication.Norgestrel should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.This drug passes into breast milk and may have undesirable effect on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because very serious interactions may occur: sodium tetradecyl sulfate.If you are currently using the medication listed above, tell your doctor or pharmacist before starting this medication.Before taking this medication, tell your doctor of all prescription and nonprescription medications you may use, especially of acitretin, drugs that speed up the movement of the gut (e.g., metoclopramide), isotretinoin, troleandomycin.Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.This medication can affect the results of certain lab tests (e.g., sex-hormone-binding globulin, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe nausea, vomiting. Females may experience sudden/unusual vaginal bleeding.
NOTES: Do not share this medication with others.Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
MISSED DOSE: Read the package information for advice on missed/late doses. You may need to use back-up birth control (e.g., condoms or spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.If you often forget to take the pill as directed, contact your doctor to discuss switching to another form of birth control.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from moisture and light. Do not store in the bathroom. Keep all medication away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.