Seasonale

The dose of this birth control pill is one tablet daily at the same time each day. Each pack contains 84 active tablets and 7 inactive tablets. Take 1 active tablet daily for 84 days, then take 1 inactive tablet daily for 7 days, and then begin the next pack to start the 91-day cycle again.

Talk with your doctor about the best time to start Seasonale. The first day of your menstrual period (bleeding) is known as Day 1. You should start taking your active tablets on the first Sunday after your period starts. If your period starts on a Sunday, take the first active tablet that day. Continue taking the active tablets for 84 consecutive days, then take 7 days of the white inactive tablets. You should have menstrual bleeding during the first 7 days after you have finished the active tablets.

The pills should be taken approximately the same time every day. You should use a second method of birth control (e.g., latex condoms or spermicides) for the first 7 days of the first cycle of pill use.

Many women have spotting or light bleeding during the first few months of taking the pill. Do not stop taking the pill even if you are having irregular bleeding. If the bleeding lasts for more than a few days, check with your doctor. Many women may also feel sick to their stomach during the first few weeks of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor.

If you experience vomiting or Diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex condoms or spermicides, until you can check with your doctor or pharmacist.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Seasonale be taken exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases. If you miss one pink "active" pill, take it as soon as you remember, and then take the next pill at the usual time. This may mean that you might have to take 2 pills in one day. You do not need a backup method of birth control.

If you miss 2 pink "active" pills in a row, take 2 pills on the day you remember and 2 pills the next day. Then take one pill once a day until you finish the pack. Use a second method of birth control (e.g., latex condoms or spermicides) if you have sex in the 7 days after you missed the pills.

If you miss 3 or more active pills in a row, do not take the missed pills and leave them in the pack. Keep taking one pill every day until you finish taking the rest of the pills in the pack (except for the pills that were missed). For example, if you restart taking the pill on Thursday, take the pill under "Thursday" and do not take the previous missed pills. You may experience some bleeding during the week following the missed pills. Use a second method of birth control (e.g., latex condoms or spermicides) during the first 7 days after you restart your pills. If you miss your period when you are taking the inactive pills, call your doctor as you may be pregnant.

If you miss any of the white "inactive" pills, throw away the missed pills and keep taking the scheduled pills once a day until the pack is finished. A backup method of birth control is not needed unless you missed 2 or more pink "active" pills in a row within 7 days prior to starting the white "inactive" pills.

If you are not sure what to do about the pills you have missed, use a backup method of birth control any time you have sex and keep taking one pill each day until you can consult your doctor or pharmacist.

Store Seasonale at room temperature, and keep it out of the reach of children and pets.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause nausea or, rarely, vomiting; it could cause water retention and swelling; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; it may cause your breasts to feel swollen and tender; it may affect your appetite. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Active tablets
Each pink, round, film-coated, biconvex, unscored tablet, debossed with "S" on one side and "62" on the other side, contains 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. Nonmedicinal ingredients: anhydrous lactose, FD&C Blue No. 1, FD&C Red No. 40, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

Inactive tablets
Each white, round, biconvex, unscored tablet, debossed with "S" on one side and "197" on the other side, contains no active ingredients. Nonmedicinal ingredients: anhydrous lactose, hydroxypropyl methylcellulose, magnesium stearate, and microcrystalline cellulose.

Levonorgestrel - ethinyl estradiol (extended cycle) should not be taken by anyone who:

• is allergic to levonorgestrel, ethinyl estradiol, or to any of the ingredients of the medication
• is or may be pregnant
• has active liver disease
• has any eye lesion resulting from blood vessel disease of the eye, such as partial or complete loss of vision or defects in visual fields
• has, has had, or may have Breast Cancer
• has heart valve disease with complications
• has or has had a Heart Attack or heart disease (e.g., Angina pectoris)
• has or has had benign or malignant liver tumours
• has or has had cerebrovascular disorders (e.g., Stroke or "mini-stroke" [transient ischemic attacks, or TIAs])
• has or has had jaundice (yellowing of skin or whites of the eyes) during pregnancy or while on hormonal medications (e.g., birth control pills)
• has or has had migraine Headaches
• has or has had Thrombophlebitis or thromboembolic (blood clotting) disorders
• has or may have an endometrium (lining of the uterus) tumour, or other suspected or diagnosed estrogen-dependent tumours
• has risk factors for developing Blood Clots, including:
  • Diabetes with complications
  • heavy smoking (more than 15 cigarettes per day) and over the age of 35
  • high blood cholesterol or triglyceride levels
  • known abnormalities of the blood clotting system that increases the risk for developing blood clots
  • prolonged bed rest
  • recent or scheduled major surgery
  • severe high blood pressure
• has undiagnosed abnormal vaginal bleeding
• have or have had pancreatitis with high triglycerides

There may be an interaction between levonorgestrel - ethinyl estradiol (extended cycle) and any of the following:

• Acetaminophen
• acetylsalicylic acid (Asa)
• acitretin
• Adapalene
• alcohol
• Amiodarone
• Anastrozole
• antacids
• antibiotics (e.g., ampicillin, chloramphenicol, cotrimoxazole, Metronidazole, neomycin, Nitrofurantoin, penicillin, rifampin, sulfonamides, tetracyclines)
• Apixaban
• Aprepitant
• Aripiprazole
• Atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital, Phenobarbital)
• benzodiazepines (e.g., Diazepam, Lorazepam, Oxazepam)
• boceprevir
• Bosentan
• caffeine
• Celecoxib
• chloral hydrate
• cholesterol-lowering medications (e.g., Cholestyramine, Colestipol, clofibrate)
• Clomipramine
• Clonidine
• Clozapine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Prednisone, Hydrocortisone)
• Cyclosporine
• Cyclobenzaprine
• dabigatran
• Dabrafenib
• Dacarbazine
• Deferasirox
• dofetilide
• dehydroepiandrosterone
• other estrogens (estradiol, conjugated/equine, esterified, Estropipate
• Exenatide
• Flunarizine
• Flutamide
• Heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• Hydrocodone
• Isotretinoin
• lidocaine
• Lomitapide
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• medications for diabetes
• medications that are used to treat high blood pressure
• Mexiletine
• mifepristone
• Mirtazapine
• Mitotane
• Modafinil
• mycophenolate
• nefazodone
• Olanzapine
• penicillin
• Perampanel
• Pimozide
• phenothiazines (e.g., Chlorpromazine)
• Prucalopride
• Rasagiline
• rifabutin
• rifampin
• Rivaroxaban
• Rufinamide
• Ropinirole
• St. John's wort
• seizure medications (e.g., Clobazam, Ethosuximide, felbamate, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• Selegiline
• siltuximab
• sulfonamides (e.g., co-trimoxazole, sulfisoxazole, sulfamethoxazole)
• tetracyclines
• thalidomide
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Thyroid replacements (e.g., dessicated thyroid, Levothyroxine)
• Tizanidine
• Tocilizumab
• Tranexamic acid
• tretinoin
• Ulipristal
• vitamin C
• Venlafaxine
• Warfarin
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Seasonale. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Seasonale.

Blood clots: Blood clots are the most common serious side effects of birth control pills. Developing blood clots is especially high during the first year a woman ever uses a hormonal contraceptive. Clots can occur in many parts of the body (brain, eyes, heart, legs, or lungs). If you notice any of the following signs or symptoms that may suggest a potential clot, notify your doctor immediately.

• crushing chest pain or heaviness may indicate a possible heart attack
• pain or swelling in the calf may suggest a possible blood clot in the leg
• sharp pain in the chest, coughing blood, or sudden shortness of breath may indicate a possible blood clot in the lung
• sudden partial or complete loss of vision may indicate a blood clot in the eye
• sudden severe or worsening headache, vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg may suggest a stroke

People with a blood clot or history of blood clot should not use Seasonale (See "Who should NOT take Seasonale?").

Blood pressure: People with high blood pressure should discuss with their doctor how Seasonale may affect their medical condition, and whether any special monitoring is needed. The use of Seasonale is not recommended in people with severe or uncontrolled high blood pressure.

Breast cancer: The chance of having breast cancer diagnosed may be slightly higher in women who use birth control pills, especially if you started using them at a younger age. You should have regular breast examinations by your doctor and examine your own breasts regularly. Women who currently have or have had breast cancer should not use birth control pills because the hormones in the pills may stimulate the cancer to grow. People who have or have had breast cancer should not use Seasonale (See "Who should NOT take Seasonale?").

Cervical cancer: Some studies have found an increase of cancer of the cervix in women who use birth control pills. This finding may be related to other factors other than the use of birth control pills. However, there is insufficient evidence to rule out the possibility that birth control pills may cause such cancers.

Cholesterol: Blood cholesterol or triglyceride levels may increase while taking Seasonale. People with cholesterol problems should discuss with their doctor how Seasonale may affect their medical condition, and whether any special monitoring is needed.

Cigarette smoking: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills increase this risk, especially with increasing age (over 35 years of age). All women are urged not to smoke while taking Seasonale.

Diabetes: Birth control pills can affect blood sugar. People with diabetes or those with a family history of diabetes should discuss with their doctor how Seasonale may affect their medical condition, and whether any special monitoring is needed.

Emotional problems: Women with a history of emotional problems, especially depression, may be more likely to have a recurrence of their condition while taking birth control pills. If you notice your condition worsen while on Seasonale, consult your doctor.

Eye problems: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye, which can lead to visual disturbances and changes in tolerance to contact lenses, especially the rigid type. Disturbances usually do not occur with soft contact lenses. If you experience visual changes or difficulty wearing your contact lenses, consult your doctor.

Fibroids: Seasonale may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gallbladder disease: Women who use birth control pills have a greater risk of developing gallbladder disease. If you notice severe pain in the abdomen (stomach area), Fever, or yellowing of skin or eyes (jaundice), contact your doctor immediately.

Heart diseases: Women at high risk for heart disease such as those with diabetes, high blood pressure, abnormal cholesterol levels, or a family history of these conditions should discuss with their doctor how Seasonale may affect their medical condition, and whether any special monitoring is needed.

Liver disease: Though rare, birth control pills can cause liver problems. If you develop yellowing of the eyes or skin, fever, fatigue, loss of appetite, dark urine, or light-coloured stools, stop taking the medication and contact your doctor.

Liver tumours: The short- and long-term use of birth control pills has been linked to the growth of liver tumours. Contact your doctor immediately if you notice yellowing of your skin or whites of your eyes, fever, fatigue, loss of appetite, dark urine, or pale stools. Stop taking the medication and talk to your doctor. People who have or have had liver tumours should not use birth control pills (See "Who should NOT take Seasonale?").

Migraine and headaches: The onset or worsening of a migraine or the development of new types of recurrent, persistent, or severe headaches should be reported to your doctor.

Regular checkups: Physical examinations and follow-up visits with your doctor should be done 3 months after starting Seasonale and then yearly thereafter.

Return to fertility: After stopping birth control therapy, you should delay getting pregnant until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Sexually transmitted infections (STIs): Birth control pills do not protect against STIs, including HIV/AIDS. For protection against these diseases, use latex condoms in combination with birth control pills.

Pregnancy: Do not take birth control pills if you are pregnant. If you become pregnant while taking birth control pills, contact your doctor immediately.

Breast-feeding: The hormonal components of Seasonale passes into breast milk and may reduce the quantity and quality of breast milk. The use of Seasonale is not recommended for breast-feeding women.

Children and adolescents: The safety and effectiveness of using Seasonale have not been established for children and adolescents under 18 years of age. The use of Seasonale is not recommended before menarche (first menstrual period).

Seniors: The use of birth control pills is not recommended for postmenopausal women.

To ensure effectiveness, this medication should be taken at the same time each day. It may be taken with or without food.<br/><br/>Birth control pills are dispensed in specific packaging. It is important to follow the sequence of tablets. Always start a new pack at the set date.<br/><br/>If you forget a pill, take it as soon as you remember and then continue to take one pill every day as usual. If you are more than 24 hours late in taking your pill, contact your pharmacist. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects.