Consumer Information

LoSeasonique

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Treatment & Uses
Side Effects
Treating Overdose
Safety Information
Before Using

Generic Name: ethinyl estradiol and levonorgestrel (extended-cycle) (ETH in ill ess tra DYE ol and lee voe nor JESS trel)
Brand Names: Jolessa, LoSeasonique, Quasense, Seasonale, Seasonique

What is LoSeasonique?

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LoSeasonique contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). It also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

LoSeasonique is used as contraception to prevent pregnancy.

LoSeasonique may also be used for other purposes.

Important information about LoSeasonique

Do not use LoSeasonique if you are pregnant or recently had a baby. Do not use LoSeasonique if you have: a history of stroke or blood clot, circulation problems, breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control when you first start using LoSeasonique.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make LoSeasonique less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use.

Before taking LoSeasonique

LoSeasonique can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use LoSeasonique if you have:

a history of a stroke or blood clot;
circulation problems (especially if caused by diabetes);
a hormone-related cancer such as breast or uterine cancer;
abnormal vaginal bleeding;
liver disease or liver cancer;
severe high blood pressure;
severe migraine headaches;
a heart valve disorder; or
a history of jaundice caused by birth control pills.

Before using LoSeasonique, tell your doctor if you have any of the following conditions.

high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
high cholesterol or if you are overweight;
a history of depression;
gallbladder disease;
diabetes;
seizures or epilepsy;
a history of irregular menstrual cycles; or
a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take LoSeasonique?

Take LoSeasonique exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
Many women have spotting or light bleeding, or may feel sick to their stomach during the first few months of taking LoSeasonique. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
If you have trouble remembering to take LoSeasonique, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking LoSeasonique

Decide what time of day you want to take your pill. It is important to take it at about the same time every day.
Look at your Extended-Cycle Tablet Dispenser. Your Tablet Dispenser consists of 3 trays with cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 orange and 7 yellow pills. Trays 1 and 2 each contain 28 orange pills (4 rows of 7 pills). Tray 3 contains 35 pills consisting of 28 orange pills (4 rows of 7 pills) and 7 yellow pills (1 row of 7 pills).
Also find:
- Where on the first tray in the pack to start taking pills (upper left corner at the start arrow) and
- In what order to take the pills (follow the weeks and arrow).
Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills.

When to Start LoSeasonique

Take the first orange pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first orange pill that same day.
Use another method of birth control (such as condoms or spermicides) as a back-up method if you have sex anytime from the Sunday you start your first orange pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the "patch," or the "vaginal ring"), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken LoSeasonique for 7 days.

How to Take LoSeasonique

Take one pill at the same time every day until you have taken the last pill in the tablet dispenser.
- Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).
- Do not skip pills even if you do not have sex very often.
When you finish a tablet dispenser
- After taking the last yellow pill, start taking the first orange pill from a new Extended-Cycle Tablet Dispenser the very next day (this should be on a Sunday) regardless of when your period started.
If you miss your scheduled period when you are taking the yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking LoSeasonique.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking LoSeasonique?

Do not smoke while using LoSeasonique, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

LoSeasonique will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

LoSeasonique side effects

Get emergency medical help if you have any of these signs of an allergic reaction to LoSeasonique: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
a change in the pattern or severity of migraine headaches;
nausea, stomach pain, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
swelling in your hands, ankles, or feet; or
symptoms of depression (sleep problems, weakness, mood changes).

Less serious LoSeasonique side effects may include:

mild nausea, vomiting, bloating, stomach cramps;
breast pain, tenderness, or swelling;
freckles or darkening of facial skin;
increased hair growth, loss of scalp hair;
changes in weight or appetite;
problems with contact lenses;
vaginal itching or discharge;
changes in your menstrual periods, decreased sex drive; or
headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect LoSeasonique?

The following drugs can make birth control pills less effective, which may result in pregnancy:

acetaminophen (Tylenol) or ascorbic acid (vitamin C);
phenylbutazone (Azolid, Butazolidin);
prednisolone (Orapred);
theophylline (Respbid, Theo-Dur);
cyclosporine (Neoral, Sandimmune, Gengraf);
St. John's wort;
antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin, Fulvicin), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline, and others;
seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);
a barbiturate such as butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept), and others.

This list is not complete and there may be other drugs that can interact with LoSeasonique. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about LoSeasonique.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.