Seasonale

Generic Name: Ethinyl Estradiol and Levonorgestrel
Typical Brand Name(s): Alesse, Aviane, Enpresse, Lessina-28, Levlen, Levlite, Levora, Nordette, Portia, Seasonale, Tri-Levlen, Triphasil, Trivora-28

What Is It Used For?
Seasonale (ETHINYL ESTRADIOL/LEVONORGESTREL) products are effective as oral contraceptives (birth control pills or "the pill"). These products combine natural or synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman's body. Ethinyl estradiol is an estrogen and levonorgestrel is a progestin. These products can prevent ovulation and pregnancy. In general, a combination of estrogen and progestin works better than a single-ingredient product. After consultation with a health care professional, this combination of products can be used under specific circumstances for emergency contraception after unprotected sex, contact your health care prescriber for information. Ethinyl estradiol/levonorgestrel tablets can also help regulate menstrual flow, treat acne, or may be used for other hormone related problems in females. The type and amount of estrogen and/or progestin may be different from one product to another.

How Is It Used?

a) For routine prevention of pregnancy:
Take ethinyl estradiol/levonorgestrel pills by mouth. Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day and in the order directed. Swallow the pills with a drink of water. Take with food to reduce stomach upset. Do not take more often than directed.

Most products contain a 21-day supply of pills containing the active ingredients. Some products contain an additional 7 pills containing iron or inactive ingredients to be taken during the week of menstruation; this reduces the chance of missing the first day of the next cycle.

One product (Seasonale) contains a 91-day supply of pills. This product has 84 pills with active ingredients and 7 inactive pills to be taken during the week of menstruation. This product allows you to only have 4 menstrual cycles per year.

Most products are to be started on the first Sunday after you start your period or on the first day of your period. You may need to ask your health care provider which day you should start your packet.

b) For emergency prevention of pregnancy:
Take ethinyl estradiol/levonorgestrel pills by mouth. You will need to follow the instructions provided by your health care provider exactly. You will be told what product and how many pills of that product you should take for each dose. Take the first dose as soon as you can after having unprotected sex, preferably in the first 24 hours, but no later than 72 hours (3 days) after the event. You MUST take the second dose 12 hours after you take the first dose. Do not take any extra pills. Extra pills will not decrease your risk of pregnancy, but may increase your risk of side effects.

c) For all uses of this medicine:
Before starting this medication, read the paper on your prescription provided by your pharmacist. This paper will tell you about the specific product you are taking. Make certain you understand the instructions.

Keep an extra month's supply of your pills available to ensure that you will not miss the first day of the next cycle.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What should my health care professional know before I take ethinyl estradiol; levonorgestrel?
They need to know if you have any of these conditions:

• Blood clots
• Blood sugar problems, like Diabetes
• Cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional
• Depression
• Fibroids
• Gallbladder disease
• Heart or Circulation problems
• High Blood Pressure
• Jaundice
• Liver disease
• Menstrual problems
• Migraine headaches
• Tobacco smoker
• Stroke
• An unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

Are There Possible Side Effects?
Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking oral contraceptives. On average, more women have problems due to complications from getting pregnant than have problems with oral contraceptives. Many of the minor side effects may go away as your body adjusts to the medicine. However, the potential for severe side effects does exist and you may want to discuss these with your health care provider.

The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help:

• Chest pain
• Coughing up blood
• Dizziness or fainting spells
• Leg, arm or groin pain
• Severe or sudden headaches
• Stomach pain (severe)
• Sudden shortness of breath
• Sudden loss of coordination, especially on one side of the body
• Swelling of the hands, feet or ankles, or rapid weight gain
• Vision or speech problems
• Weakness or numbness in the arms or legs, especially on one side of the body

Other serious side effects are rare. Contact your health care provider as soon as you can if the following side effects occur:

• Breast tissue changes or discharge
• Changes in vaginal bleeding during your period or between your periods
• Headaches or migraines
• Increases in blood sugar, especially if you have diabetes
• Increases in blood pressure, especially if you are known to have high blood pressure
• Symptoms of vaginal infection (itching, irritation or unusual discharge)
• Tenderness in the upper abdomen
• Vomiting
• Yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your health care provider if they continue or are bothersome):

• Breakthrough bleeding and spotting that continues beyond the 3 initial cycles of pills
• Breast Tenderness
• Mild stomach upset
• Mood changes, anxiety, depression, frustration, anger, or emotional outbursts
• Increased or decreased appetite
• Increased sensitivity to sun or ultraviolet light
• Nausea
• Skin rash, acne, or brown spots on the skin
• Tiredness
• Weight gain

If you are taking this medicine for emergency prevention of pregnancy, it is common to have nausea, headache, abdominal pain or cramping, breast tenderness and dizziness. You may vomit. If you throw-up within 1 hour of taking your dose, you will need to contact your health care professional for instructions. If any of the other side effects are severe or continue, contact your health care professional. After you finish your prescription, it is common for you to have changes in your next period, or to have spotting. If you do not get a period within 21 days of taking your prescription, you should see your health care professional and get a pregnancy test.

What drug(s) may interact with ethinyl estradiol; levonorgestrel?

• Antibiotics or medicines for infections, especially rifampin
• Aprepitant
• Barbiturate medicines for producing sleep or treating seizures (convulsions)
• Bosentan
• Sarbamazepine
• Caffeine
• Clofibrate
• Cyclosporine
• Dantrolene
• Grapefruit juice
• Hydrocortisone
• Medicines for anxiety or sleeping problems, such as diazepam or temazepam
• Medicines for mental depression
• Medicines for diabetes, including troglitazone and pioglitazone
• Mineral oil
• Modafinil
• Mycophenolate
• Nefazodone
• Oxcarbazepine
• Phenytoin
• Prednisolone
• Ritonavir or other medicines for the treatment of the HIV virus or AIDS
• Selegiline
• Soy isoflavones supplements
• St. John's wort
• Tamoxifen or raloxifene
• Theophylline
• Topiramate
• Warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medicines.

What should I watch for while taking ethinyl estradiol; levonorgestrel?
Visit your prescriber or health care provider for regular checks on your progress. You should have a complete check-up every 6 to 12 months. If you have any unusual vaginal bleeding contact your doctor or health care provider for advice. If you miss a period, the possibility of pregnancy must be considered. See your prescriber or health care professional as soon as you can.

Use an additional method of contraception during the first 7 days that you take these tablets.

If you stop taking these tablets and want to get pregnant, a return to normal ovulation can take some time. You may not return to normal ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with your health care provider.

If you are taking oral contraceptives for the treatment of acne, hirsutism (male-like hair growth), endometriosis or other hormone related problems, it may take several months of continued treatment to notice improvement in your symptoms or condition.

Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking oral contraceptives, especially if you are more than 35 years old. You are strongly advised not to smoke.

Oral contraceptives can increase your sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing during long periods outdoors. Tanning booths should be used with caution.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist.

In some women, tenderness, swelling, or minor bleeding of the gums may occur. Notify your dentist if this happens. Brushing and flossing your teeth regularly may help limit this. See your dentist regularly and inform your dentist of the medicines you are taking.

You may get a vaginal yeast infection. If you have never had a yeast infection before, see your prescriber or other health care provider to confirm the problem. If you have had yeast infections in the past and are comfortable with self-medicating the problem, get and use a nonprescription medication to treat the yeast infection.

If you are going to have elective surgery, you may need to stop taking your contraceptive pills one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

Taking contraceptive pills does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What If I Miss A Dose?
If you miss a dose of an emergency contraceptive prescription, or vomit the dose within an hour of taking it, you MUST contact your health care professional for instructions.

Try not to miss a dose of your regular birth control prescription. If you do, it may be necessary to consult your prescriber or health care professional. The following information describes only some of the ways that missed doses can be handled.

For all cycles:
21-day schedule:
If you miss one dose, take it as soon as you remember and then take the next pill at the regular time as usual. You may take 2 tablets in one day. If you miss two doses (days) in a row, take 2 tablets the day you remember and 2 tablets the next day, then, continue with your regular schedule. Whenever 1 or 2 doses are missed, you should use a second method of contraception for the next 7 days in addition to taking the pills. If you miss three doses in a row, you should notify your physician or other health care professional for instructions. You will probably need to throw away the rest of the tablets in that cycle pack and start over. Another method of contraception should be used until at least 7 doses have been taken in the new cycle. Missing a pill can cause spotting or light bleeding. Make sure that no more than 7 days pass at the end of the 21 day cycle, before you start your next pack of pills.

28-day schedule:
Follow the same directions as above for the first 21 days of the schedule. If you miss 1 of the last 7 pills, you can either double the dose or skip it, but it is important to start the next month's cycle on the scheduled day.

91-day schedule:
If you miss one dose for the first 84 days of the schedule, take it as soon as you remember. Take the next pill at your regular time as usual, which means you may take 2 tablets in one day. If you miss 2 doses (days) in a row, take 2 tablets on the day you remember and 2 tablets the next day. Then, continue with your regular schedule. You could become pregnant if you have sex in the 7 days after you miss 2 doses in a row. You should use another method of birth control during the 7 days after you restart your pills. If you miss 3 doses (days) in a row, you will not take any of the 3 pills that you missed. Restart taking your pills for the actual day you restart. For example, if you resume taking the pill on Thursday, take the pill under 'Thursday' and do not take the missed pills. Keep taking 1 pill every day until you have completed all of the remaining pills in the pack. You may experience bleeding during the week following the missed pills. You could become pregnant if you have sex in the 7 days after you miss 3 doses in a row. You should use another method of birth control during the 7 days after you restart your pills. If you miss any of the last 7 pills, throw away the missed pills. You will not need a back-up method of birth control. Keep taking the scheduled pills until the pack is finished.

How Should It Be Stored?
Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE: The above 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 the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.