Prescription drugs info

Your health care professional may begin your dose on the first day of your menstrual period (called Day-1 start) or on Sunday (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even when you miss a dose . Do not change your schedule on your own . If the schedule that you have been put on is not convenient, check with your health care professional about changing schedules.

* For oral dosage forms (monophasic, biphasic, or triphasic tablets):

o For contraception:

+ Adults and teenagers:

# For the twenty-one-day cycle: Take 1 tablet a day for twenty-one days. Skip seven days. Then repeat the cycle.

# For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eight days. Then repeat the cycle.

* For oral dosage forms (norethindrone acetate and ethinyl estradiol triphasic tablets and norgestimate and ethinyl estradiol triphasic tablets :

o To treat acne:

+ Adults and teenagers 15 years of age and over:

# For the twenty-one-day cycle: Take 1 tablet a day for twenty-one days. Skip seven days. Then repeat the cycle.

# For the twenty-eight-day cycle: Take 1 tablet a day for twenty-eight days. Then repeat the cycle.

+ Teenagers up to 15 years of age—Use and dose must be determined by your doctor.

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To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of oral contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

Take this medicine with food to help prevent nausea that might occur during the first few weeks. Nausea usually disappears with continued use or if the medicine is taken at bedtime.

When you begin to use oral contraceptives , your body will require at least 7 days to adjust before a pregnancy will be prevented. You will need to use an additional birth control method for at least 7 days. Some doctors recommend using an additional method of birth control for the first cycle (or 3 weeks) to ensure full protection. Follow the advice of your doctor or other health care professional.

Try to take the doses no more than 24 hours apart to reduce the possibility of side effects and to prevent pregnancy . Since one of the most important factors in the proper use of oral contraceptives is taking every dose exactly on schedule, you should never let your tablet supply run out. When possible, try to keep an extra month’s supply of tablets on hand and replace it monthly.

It is very important that you keep the tablets in their original container and take the tablets in the same order that they appear in the container. The containers help you keep track of which tablets to take next. Different colored tablets in the same package contain different amounts of hormones or are placebos (tablets that do not contain hormones). The effectiveness of the medicine is reduced if the tablets are taken out of order .

* Monophasic (one-phase) cycle dosing schedule: Most available dosing schedules are monophasic. If you are taking tablets of one strength (color) for 21 days, you are using a monophasic schedule. For the 28-day monophasic cycle you will also take an additional 7 inactive tablets, which are another color. If you are taking the brand name Mircette , the last seven tablets of the 28-day cycle contains two inactive tablets (for Days 22 and 23) and five tablets (for Days 24 through 28) that contain a low dose of estrogen. Taking the last 7 tablets is not required for full protection against pregnancy but they do help to replace estrogen.

* Biphasic (two-phase) cycle dosing schedule: If you are using a biphasic twenty-one-day schedule, you are taking tablets of one strength (color) for either seven or ten days, depending on the medication prescribed (the first phase). You then take tablets of a second strength (color) for the next eleven or fourteen days, depending on the medication prescribed (the second phase). At this point, you will have taken a total of twenty-one tablets. For the twenty-eight-day biphasic cycle you will also take an additional seven inactive tablets, which are a third color.

* Triphasic (three-phase) cycle dosing schedule: If you are using a triphasic twenty-one-day schedule, you are taking tablets of one strength (color) for five, six or seven days, depending on the medicine prescribed (the first phase). You then take tablets of a second strength (color) for the next five, seven, or nine days, depending on the medicine prescribed (the second phase). After that, you take tablets of a third strength (color) for the next five, seven, nine, or ten days, depending on the medicine prescribed (the third phase). At this point, you will have taken a total of twenty-one tablets. For the twenty-eight-day triphasic cycle you will also take an additional seven inactive tablets, which are a fourth color.

If you are taking one of the brand name products Estrostep Fe or Loestrin Fe each of the last seven tablets that you will take on Days 21 through 28 of your cycle contains iron. These tablets are also a different color from the other tablets in your package. They help to replace some of the iron you lose when you have a menstrual period.

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In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. If you are using oral contraceptives for contraception you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For oral contraceptives, the following should be considered:

Alesse and Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Alesse and Diet

Make certain your health care professional knows if you are on any special diet, such as a low-sodium or low-sugar diet.

Alesse and Pregnancy

Oral contraceptives are not recommended for use during pregnancy and should be discontinued if you become pregnant or think you are pregnant. When oral contraceptives were accidently taken early in pregnancy, problems in the fetus did not occur. Women who are not breast-feeding may begin to take oral contraceptives two weeks after having a baby.

Alesse and Breast-feeding

Oral contraceptives pass into the breast milk and can change the content or lower the amount of breast milk. Also, they may shorten a woman’s ability to breast-feed by about 1 month, especially when the mother is only partially breast-feeding. Because the amount of hormones is so small in low-dose contraceptives, your doctor may allow you to begin using an oral contraceptive after you have been breast-feeding for a while. However, it may be necessary for you to use another method of birth control or to stop breast-feeding while taking oral contraceptives.

Alesse and Adolescents

This medicine is frequently used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking this medication exactly as prescribed.

Alesse and Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking oral contraceptives, it is especially important that your health care professional know if you are taking any of the following:

* Amiodarone (e.g., Cordarone) or

* Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or

* Androgens (male hormones) or

* Anti-infectives by mouth or by injection (medicine for infection) or

* Barbiturates or

* Carbamazepine (e.g., Tegretol) or

* Carmustine (e.g., BiCNU) or

* Dantrolene (e.g., Dantrium) or

* Daunorubicin (e.g., Cerubidine) or

* Disulfiram (e.g., Antabuse) or

* Divalproex (e.g., Depakote) or

* Estrogens (female hormones) or

* Etretinate (e.g., Tegison) or

* Gold salts (medicine for arthritis) or

* Griseofulvin (e.g., Fulvicin) or

* Hydroxychloroquine (e.g., Plaquenil) or

* Mercaptopurine (e.g., Purinethol) or

* Methotrexate (e.g., Mexate) or

* Methyldopa (e.g., Aldomet) or

* Naltrexone (e.g., Trexan) (with long-term, high-dose use) or

* Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or

* Phenylbutazone (e.g., Butazolidin) or

* Phenytoin (e.g., Dilantin) or

* Plicamycin (e.g., Mithracin) or

* Primidone (e.g., Mysoline) or

* Rifabutin (e.g., Mycobutin) or

* Rifampin (e.g., Rifadin) or

* Troleandomycin (e.g., TAO)—These medicines may increase the chance of liver problems if taken with oral contraceptives; also, these medicines may decrease the effect of oral contraceptives and increase your chance of pregnancy. Use of an additional form of birth control is recommended unless directed otherwise by your health care professional

* Corticosteroids (cortisone-like medicine) or

* Theophylline—Oral contraceptives may increase the effects of these medicines and increase the chance of problems occurring

* Cyclosporine—Oral contraceptives increase the effect of cyclosporine and increase the chance of problems occurring

* Ritonavir (e.g., Norvir) or

* Troglitazone (e.g., Rezulin)—These medicines may decrease the effect of oral contraceptives and increase your chance of pregnancy. Use of an additional form of birth control is recommended unless directed otherwise by your health care professional

* Smoking, tobacco—Smoking may decrease the effect of oral contraceptives and increase the chance of causing serious blood clot, vein, or heart problems

Alesse and Other medical problems

The presence of other medical problems may affect the use of oral contraceptives. Make sure you tell your doctor if you have any other medical problems, especially:

* Abnormal changes in menstrual or uterine bleeding or

* Endometriosis or

* Fibroid tumors of the uterus—Oral contraceptives usually improve these female conditions but sometimes they can make them worse or make the diagnosis of these problems more difficult

* Blood clots (or history of) or

* Heart or circulation disease or

* Stroke (or history of)—If these conditions are already present, oral contraceptives may have a greater chance of causing blood clots or circulation problems, especially in women who smoke tobacco. Otherwise, oral contraceptives may help prevent circulation and heart disease if you are healthy and do not smoke

* Breast disease (not involving cancer)—Oral contraceptives usually protect against certain breast diseases, such as breast cysts or breast lumps; however, your doctor may want to follow your condition more closely

* Cancer, including breast cancer (or history of or family history of)—Oral contraceptives may worsen some cancers, especially when breast, cervical, or uterine cancers already exist. Use of oral contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, oral contraceptives may still be a good choice but you may need to be tested more often

* Chorea gravidarum or

* Gallbladder disease or gallstones (or history of) or

* High blood cholesterol or

* Liver disease (or history of, including jaundice during pregnancy or oral contraceptive use) or

* Mental depression (or history of)—Oral contraceptives may make these conditions worse or, rarely, cause them to occur again. Oral contraceptives may still be a good choice but you may need to be tested more often

* Diabetes mellitus (sugar diabetes)—Use of oral contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take. You or your doctor will want to test for any changes in your blood sugar for 12 to 24 months after starting to take oral contraceptives in case the dose of your diabetes medicine needs to be changed

* Epilepsy (seizures) (or history of) or

* Heart or circulation problems or

* High blood pressure (hypertension) or

* Migraine headaches—Oral contraceptives may cause fluid build-up and may cause these conditions to become worse; however, some people have fewer migraine headaches when they use oral contraceptives.

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* If you have any questions about Alesse , please talk with your doctor, pharmacist, or other health care provider.

* Alesse 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 Alesse. 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.

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include nausea; vaginal bleeding; vomiting.

Proper storage of Alesse :

Store Alesse 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 Alesse out of the reach of children and away from pets.

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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:

Acne; breast tenderness or enlargement; changes in appetite; changes in sexual interest; changes in weight; dizziness; hair loss; headache; nausea; stomach cramps or bloating; unusual spotting or bleeding; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in amount of urine produced; change in vaginal secretions; changes in vision or speech; confusion; coughing of blood; crushing chest pain or heaviness in the chest; dark-colored urine; depression; difficulty sleeping; difficulty wearing contact lenses; fainting; fluid retention (swelling of the fingers and ankles); lack of energy; light-colored bowel movements; mental or mood changes; missed menstrual period; numbness of an arm or leg; one-sided weakness; persistent headache or migraines; persistent or recurrent abnormal vaginal bleeding; persistent or severe dizziness; severe pain or tenderness in the stomach; shortness of breath; sudden partial or complete loss of vision; sudden severe headache or vomiting; tiredness; vaginal irritation or discharge; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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* Alesse may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Alesse with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

* Follow your doctor’s instructions for examining your own breasts, and report any lumps immediately.

* If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Alesse.

* You should usually not take Alesse within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.

* Alesse may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.

* Use of Alesse will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).

* Bleeding or spotting may occur while taking Alesse . Do not stop taking Alesse if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.

* Smoking while using Alesse may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.

* Alesse may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Alesse.

* Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Alesse may decrease the effectiveness of Alesse . To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.

* If you wear contact lenses and you develop problems with them, contact your doctor.

* If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.

* Alesse may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Alesse. Discuss any concerns with your doctor or pharmacist.

* Lab tests, such as PAP tests, may be performed while you use Alesse. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

* Alesse should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.

* PREGNANCY AND BREAST-FEEDING: Do not use Alesse if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Alesse is found in breast milk. Do not breast-feed while taking Alesse.

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Use Alesse as directed by your doctor. Check the label on the medicine for exact dosing instructions.

* An extra patient leaflet is available with Alesse . Talk to your pharmacist if you have questions about this information.

* Take Alesse by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

* Begin taking Alesse 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 Alesse on that day. Try to take Alesse 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 Alesse to be effective it must be taken every day. Do not skip doses.

* If you miss a dose of Alesse and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of Alesse , see the additional patient information leaflet that comes with Alesse or contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of Alesse , 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 Alesse.

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Some medical conditions may interact with Alesse . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

* if you are pregnant, 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 endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer

* if you are overweight, you have not yet had your first menstrual period, or you use tobacco

* if you have given birth or otherwise ended a pregnancy within the past 4 weeks

Some MEDICINES MAY INTERACT with Alesse . Tell your health care provider if you are taking any other medicines, especially any of the following:

* Atorvastatin, indinavir, or troleandomycin because they may increase the risk of Alesse ’s side effects

* Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, primidone, rifabutin, rifampin, St. John’s wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Alesse ’s effectiveness, resulting in breakthrough bleeding or pregnancy

* Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by Alesse

* Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by Alesse

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alesse 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.

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* you are allergic to any ingredient in Alesse

* you are pregnant or think you may be pregnant

* you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer

* you are at risk for developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)

* you have chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding; or diabetes that affects circulation

* you have liver disease, liver tumors or cancer, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use

* you have had surgery and are or will be confined to a bed or a chair for an extended period of time

* you are older than 35 years old and you smoke 15 or more cigarettes per day

Contact your doctor or health care provider right away if any of these apply to you.

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