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The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral-contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

Increased menstrual cycle regularity

Decreased blood loss and decreased incidence of iron-deficiency anemia

Decreased incidence of dysmenorrhea

Effects related to inhibition of ovulation:

Decreased incidence of functional ovarian cysts

Decreased incidence of ectopic pregnancies

Effects from long-term use:

Decreased incidence of fibroadenomas and fibrocystic disease of the breast

Decreased incidence of acute pelvic inflammatory disease

Decreased incidence of endometrial cancer

Decreased incidence of ovarian cancer

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Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, and drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

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An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives:

Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

Acne

Amenorrhea

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

Breast changes: tenderness, pain, enlargement, secretion

Budd-Chiari syndrome

Cervical erosion and secretion, change in

Cholestatic jaundice

Chorea, exacerbation of

Colitis

Contact lenses, intolerance to

Corneal curvature (steepening), change in

Dizziness

Edema/fluid retention

Erythema multiforme

Erythema nodosum

Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)

Hirsutism

Infertility after discontinuation of treatment, temporary

Lactation, diminution in, when given immediately postpartum

Libido, change in

Melasma/chloasma which may persist

Menstrual flow, change in

Mood changes, including depression

Nausea

Nervousness

Pancreatitis

Porphyria, exacerbation of

Rash (allergic)

Scalp hair, loss of

Serum folate levels, decrease in

Spotting

Systemic lupus erythematosus, exacerbation of

Unscheduled bleeding

Vaginitis, including candidiasis

Varicose veins, aggravation of

Vomiting

Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

Cataracts

Cystitis-like syndrome

Dysmenorrhea

Hemolytic uremic syndrome

Hemorrhagic eruption

Optic neuritis, which may lead to partial or complete loss of vision

Premenstrual syndrome

Renal function, impaired

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Combination oral contraceptives should not be used in women with any of the following conditions:

Thrombophlebitis or thromboembolic disorders

A history of deep-vein thrombophlebitis or thromboembolic disorders

Cerebrovascular or coronary artery disease (current or past history)

Valvular heart disease with thrombogenic complications

Thrombogenic rhythm disorders

Hereditary or acquired thrombophilias

Major surgery with prolonged immobilization

Diabetes with vascular involvement

Headaches with focal neurological symptoms

Uncontrolled hypertension

Known or suspected carcinoma of the breast or personal history of breast cancer

Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

Undiagnosed abnormal genital bleeding

Cholestatic jaundice of pregnancy or jaundice with prior pill use

Hepatic adenomas or carcinomas, or active liver disease

Known or suspected pregnancy

Hypersensitivity to any of the components of Alesse

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21 pink active tablets each containing 0.10 mg of levonorgestrel, d(-)-13β-ethyl-17α-ethinyl-17β‑hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17α‑ethinyl-1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present are cellulose, hypromellose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and montanic ester wax.

7 light-green inert tablets, each containing cellulose, FD&C blue no. 1, hypromellose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and montanic ester wax.

Generic Name: levonorgestrel and ethinyl estradiol

Dosage Form: tablets

Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

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Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, oral contraceptives are used in certain patients with the following medical conditions:

* Amenorrhea (stopping of menses for several consecutive months)

* Dysfunctional uterine bleeding (abnormal uterine bleeding)

* Dysmenorrhea (painful menstrual bleeding)

* Hypermenorrhea (excessive menstrual bleeding)

* Emergency contraception within 72 hours of unprotected intercourse

* Endometriosis (painful bleeding from uterine-like tissue that can grow in different parts of the female body)

* Hirsutism in females (male-like hair growth)

* Hyperandrogenism, ovarian (excessive production of male hormones)

* Polycystic ovary syndrome (many problems that include amenorrhea, hirsutism, infertility, and many tiny cysts or sacs usually in both ovaries)

For patients taking this medicine for emergency contraception :

* Must be taken with food within 72 hours of unprotected sexual intercourse. One single course (2 doses 12 hours apart) is a one-time emergency protection. Using more than one course in a month will reduce the effectiveness.

* Because the hormones are strong, watch for danger signs. Call your doctor if you experience any severe pains in your leg, stomach, or chest; any vision or breathing changes; yellowing of skin; headaches; numbness; or trouble in speaking.

* You may experience nausea so take it with food and call your doctor if you vomit the medicine.

* Your menstrual period may start earlier than usual. If it doesn’t start, call your doctor.

For patients taking this medicine for hirsutism :

* You may need to use oral contraceptives for 6 to 12 months before you see less new hair growth.

For patients taking this medicine for endometriosis :

* Sometimes instead of following the directions on the oral contraceptive’s package, your doctor may ask you to follow different directions, such as taking the active tablets in the package each day without stopping for 6 to 9 months. This means that after 21 days you will start a new package of pills. If you are not sure about how to take this medicine, discuss any questions with your health care professional.

* Also, your symptoms of endometriosis may worsen at first but with continued use of the oral contraceptives your symptoms should lessen and your condition improve.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

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Healthy women who do not smoke cigarettes have almost no chance of having a severe side effect from taking oral contraceptives. For most women, more problems occur because of pregnancy than will occur from taking oral contraceptives. But for some women who have special health problems, oral contraceptives can cause some unwanted effects. Some of these unwanted effects include benign (not cancerous) liver tumors, liver cancer, or blood clots or related problems, such as a stroke. Although these effects are very rare, they can be serious enough to cause death. You may want to discuss these effects with your doctor.

Smoking cigarettes during the use of oral contraceptives has been found to greatly increase the chances of these serious side effects occurring. To reduce the risk of serious side effects, do not smoke cigarettes while you are taking oral contraceptives . Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. The risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.

The following side effects may be caused by blood clots. Get emergency help immediately if any of the following side effects occur:

Rare

Abdominal or stomach pain (sudden, severe, or continuing); coughing up blood; headache (severe or sudden); loss of coordination (sudden); loss of vision or change in vision (sudden); pains in chest, groin, or leg (especially in calf of leg); shortness of breath (sudden or unexplained); slurring of speech (sudden); weakness, numbness, or pain in arm or leg (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur:

More common—usually less common after the first 3 months of oral contraceptive use

Changes in the uterine bleeding pattern at menses or between menses, such as decreased bleeding at menses, breakthrough bleeding or spotting between periods, prolonged bleeding at menses, complete stopping of menstrual bleeding that occurs over several months in a row, or stopping of menstrual bleeding that only occurs sometimes

Less common

Headaches or migraines (although headaches may lessen in many users, in others, they may increase in number or become worse); increased blood pressure; vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

For women with diabetes mellitus

Mild increase of blood sugar—Faintness, nausea, pale skin, or sweating

Rare

Mental depression; swelling, pain, or tenderness in upper abdominal area

For women who smoke tobacco

Pains in stomach, side, or abdomen; yellow eyes or skin

For women with a history of breast disease

Lumps in breast

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Abdominal cramping or bloating; acne (usually less common after first 3 months and may improve if acne already exists); breast pain, tenderness, or swelling; dizziness; nausea; swelling of ankles and feet; unusual tiredness or weakness; vomiting

Less common

Brown, blotchy spots on exposed skin; gain or loss of body or facial hair; increased or decreased interest in sexual intercourse; increased sensitivity of skin to sunlight; weight gain or loss

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Tell the medical doctor or dentist in charge that you are taking this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking this medicine.

The following medicines may reduce the effectiveness of oral contraceptives. You should use an additional method of birth control during each cycle in which any of the following medicines are used :

* Ampicillin

* Barbiturates

* Carbamazepine (e.g., Tegretol)

* Griseofulvin (e.g., Fulvicin)

* Penicillin V

* Phenytoin (e.g., Dilantin)

* Primidone (e.g., Mysoline)

* Rifampin (e.g., Rifadin)

* Ritonavir (e.g., Norvir)

* Tetracyclines (medicine for infection)

* Troglitazone (e.g., Rezulin)

Check with your doctor if you have any questions about this.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier. If this should occur:

* Continue on your regular dosing schedule.

* The bleeding usually stops within 1 week.

* Check with your doctor if the bleeding continues for more than 1 week.

* After you have been taking oral contraceptives on schedule and for more than 3 months and bleeding continues, check with your doctor.

Missed menstrual periods may occur:

* If you have not taken the medicine exactly as scheduled. Pregnancy must be considered as a possibility.

* If the medicine is not the right strength or type for your needs.

* If you stop taking oral contraceptives, especially if you have taken oral contraceptives for 2 or more years.

Check with your doctor if you miss any menstrual periods so that the cause may be determined.

In some patients using estrogen-containing oral contraceptives, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums. Also, it has been shown that estrogen-containing oral contraceptives may cause a healing problem called dry socket after a tooth has been removed. If you are going to have a tooth removed, tell your dentist or oral surgeon that you are taking oral contraceptives.

Some people who take oral contraceptives may become more sensitive to sunlight than they are normally. When you begin taking this medicine, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. If you have a severe reaction, check with your doctor. Some people may develop brown, blotchy spots on exposed areas. These spots usually disappear gradually when the medicine is stopped.

If you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

If you are scheduled for any laboratory tests, tell your doctor that you are taking birth control pills.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

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To store this medicine:

* Keep out of the reach of children.
* Store away from heat and direct light.
* Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat and moisture may cause the medicine to break down.
* Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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Follow your doctor’s orders or the directions on the label if you miss a dose of this medicine. The following information includes only some of the ways to handle missed doses. Your health care professional may want you to stop taking the medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your health care professional can tell you how to begin taking your medicine again.

For monophasic, biphasic, or triphasic cycles :

* If you miss the first tablet of a new cycle—Take the missed tablet as soon as you remember and take the next tablet at the usual time. You may take 2 tablets in one day. Then continue your regular dosing schedule. Also, use another birth control method until you have taken seven days of your tablets after the last missed dose.

* If you miss 1 tablet during the cycle—Take the missed tablet as soon as you remember. Take the next tablet at the usual time. You may take 2 tablets in one day. Then continue your regular dosing schedule.

* If you miss 2 tablets in a row in the first or second week—Take 2 tablets on the day that you remember and 2 tablets the next day. Then continue taking 1 tablet a day. Also use another birth control method until you begin a new cycle.

* If you miss 2 tablets in a row in the third week; or

* If you miss 3 or more tablets in a row at any time during the cycle—

o Using a Day-1 start: Throw out your current cycle and begin taking a new cycle. Also, use another birth control method until you have taken seven days of your tablets after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.

o Using a Sunday start: Keep taking one tablet a day from your current pack until Sunday. Then, on Sunday, throw out your old pack and begin a new pack. Also use another birth control method until you have taken seven days of your tablets after the last missed dose. You may not have a menstrual period this month. But if you miss two menstrual periods in a row, call your health care professional.

If you miss any of the last seven (inactive) tablets of a twenty-eight-day cycle, there is no danger of pregnancy. However, the first tablet (active) of the next month’s cycle must be taken on the regularly scheduled day, in spite of any missed doses, if pregnancy is to be avoided. The active and inactive tablets are colored differently for your convenience.

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