It is very important that your doctor check your progress at regular visits to make sure ALESSE 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 ALESSE before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue taking ALESSE.

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 ALESSE, 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 ALESSE 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.

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.

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 ALESSE 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 ALESSE for hirsutism:

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

For patients taking ALESSE 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 ALESSE, 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.