Levonorgestrel - ethinyl Estradiol is a progestin (levonorgestrel) and estrogen (ethinyl estradiol) combination birth control pill used to prevent pregnancy. The ingredients of Alysena primarily work by preventing ovulation (the release of an egg from an ovary). Alysena also causes changes in the mucus of the cervix, which make it difficult for sperm to penetrate and for an egg to implant.

Most brands of Alysena may also be used to treat Acne in women 14 years of age and older who are able to use birth control pills and have had a period.

Alysena may be available under multiple brand names and/or in several different forms. Any specific brand name of Alysena may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Alysena may not be used for all of the conditions discussed here.

Your doctor may have suggested Alysena for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Alysena, speak to your doctor. Do not stop taking Alysena without consulting your doctor.

Do not give Alysena to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Alysena if their doctor has not prescribed it.

21-day pack: Take 1 tablet daily for 21 days, then take no pills for 7 days, and then begin the next pack.

28-day pack: Take 1 tablet daily for 21 days, then take 1 "reminder" pill daily for 7 days, and then begin the next pack.

Many things can affect the dose of 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.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 or Day 5 of your period. The pills should be taken approximately the same time every day, preferably after the evening meal or at bedtime. These pills can be taken with or without food.

You should use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use. Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months 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 or clinic.

If you have vomiting or Diarrhea, or if you take certain medications such as antibiotics, your pills may not work as well. If you vomit a dose of the medication within 4 hours of taking it, the absorption of the medication may not be complete. Treat this as a missed dose and follow the instructions for a missed dose. Reducing the number of doses taken during the month may reduce the effectiveness of the medication.

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 and spermicidal foam or gel, until you can check with your doctor or pharmacist.

It is important to take Alysena exactly as prescribed by your doctor.

If you miss pills at any time, the risk of becoming pregnant increases. If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills on the day you remember and 2 pills the next day. Then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you missed the pills.

If you start your pills on Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. Use a second method of birth control if you have sex in the 7 days after you missed the pills.

If you start your pills on a day other than Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills at any time during your cycle, safely dispose of the rest of the pill pack and start a new pack that same day. Use another method of birth control if you have sex in the 7 days after you missed the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

See the package insert for more information on what to do should you forget to take a pill. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Alysena at room temperature, protect it from light and moisture, and keep it out of the reach of children.

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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Alysena. If you are concerned about side effects, discuss the risks and benefits of Alysena with your doctor.

The following side effects have been reported by at least 1% of people taking Alysena. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal cramping or bloating
• acne
• breast pain, tenderness, or swelling
• contact lens discomfort
• gain or loss of body or facial hair
• headache
• increase or decrease in appetite
• increased or decreased interest in sexual activity
• nausea
• skin rash
• swelling of the ankles and feet
• vomiting
• weight changes

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

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

• breast lump(s)
• brown, blotchy spots on exposed skin
• changes in bleeding pattern during periods or between periods (e.g., breakthrough bleeding or spotting, lack of period, prolonged bleeding during periods)
• increased blood pressure
• migraines (although headaches may lessen in many people, in others, they may increase in number or become worse)
• severe headaches
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling, pain, or tenderness in upper abdominal area
• symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• Varicose Veins

Stop taking Alysena and seek medical attention immediately if any of the following side effects occur:

• signs of a blood clot in blood vessels (e.g., sudden loss of vision or change in vision, pain in the chest, groin, or leg [especially with swelling in the calf of the leg], sudden or unexplained shortness of breath)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a stroke (e.g., headache, loss of coordination, slurred speech, weakness, numbness, or unexplained pain in the arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Alysena.

Alysena 21

Each pink, round, flat-faced, bevelled-edged tablet, engraved "100" on one side and "20" on the other side, contains 100 µg of levonorgestrel and 20 µg of ethinyl estradiol. Non-medicinal ingredients: corn starch, crospovidone (Polyplasdone XL), crospovidone (Polyplasdone XL 10), FD&C Red No. 40 Lake, lactose monohydrate, magnesium stearate (vegetal), and povidone K30.

Alysena 28

Each pink, round, flat-faced, bevelled-edged tablet, engraved "100" on one side and "20" on the other side, contains 100 µg of levonorgestrel and 20 µg of ethinyl estradiol. Each pink active tablet contains corn starch, crospovidone (Polyplasdone XL), crospovidone (Polyplasdone XL 10), FD&C Red No. 40 Lake, lactose monohydrate, magnesium stearate (vegetal), and povidone K30.

Each inactive, round, white tablet, plain on both sides, contains corn starch, crospovidone (Polyplasdone XL), lactose anhydrous, magnesium stearate (vegetal), and povidone K30.

Do not take Alysena if you:

• are allergic to levonorgestrel, ethinyl estradiol, or any ingredients of the medication
• are or may be pregnant
• have or have had migraine Headaches with auras
• have Blood Clots or have a history of developing blood clots in the blood vessels
• have active liver disease or decreased liver function
• have any eye lesion resulting from blood vessel disease of the eye, such as partial or complete loss of vision or defect in visual fields
• have Diabetes with blood vessel complications (e.g., heart disease, eye disease, Kidney Disease, foot infections)
• have had a Heart Attack
• have, have had, or may have an estrogen-dependent tumour
• have, have had, or may have Breast Cancer
• have heart rhythm disorders that may produce blood clots
• have or have had benign or cancerous liver tumours
• have or have had cerebrovascular disorders (blood vessel problems in the brain such as Stroke)
• have or have had Coronary Artery Disease
• have or have had disease involving the heart valves
• have or have had Thrombophlebitis (inflammation of blood vessels) or thromboembolic (blood clotting) disorders
• have uncontrolled high blood pressure
• have undiagnosed abnormal vaginal bleeding
• have or have had pancreatitis with high triglycerides
• are taking Hepatitis C antiviral drug combinations of ombitasvir, paritaprevir, and ritonavir, with or without dasubivir

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

• Acetaminophen
• acitretin
• Adapalene
• alcohol
• ampicillin
• Amiodarone
• Anastrozole
• antacids
• Apixaban
• Aprepitant
• Aripiprazole
• Asa (acetylsalicylic acid)
• Atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• benzodiazepines (e.g., Diazepam, Lorazepam, Oxazepam)
• Bosentan
• caffeine
• Celecoxib
• chloral hydrate
• Cholestyramine
• clofibrate
• Clomipramine
• Clonidine
• Clozapine
• Colesevelam
• Colestipol
• conivaptan
• corticosteroids (e.g., Dexamethasone, Prednisone, Hydrocortisone)
• Cyclosporine
• Cyclobenzaprine
• dabigatran
• Dabrafenib
• Dacarbazine
• Deferasirox
• dofetilide
• dehydroepiandrosterone
• Edoxaban
• other estrogens (estradiol, conjugated/equine, esterified, Estropipate
• Exenatide
• Flunarizine
• Flutamide
• Heparin
• hepatitis C antivirals (e.g., asunaprevir, ombitasvir,  paritaprevir, ritonavir, dasabuvir, ritonavir)
• 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
• Pimozide
• phenothiazines (e.g., Chlorpromazine)
• Prucalopride
• Rasagiline
• rifabutin
• rifampin
• Rivaroxaban
• Rufinamide
• Ropinirole
• St. John's wort
• seizure medications (e.g., Clobazam, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Selegiline
• siltuximab
• simeprevir
• 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
• Ursodiol
• vitamin C
• Warfarin

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 Alysena. 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 taking 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 take Alysena.

Blood clots: Alysena may increase the chance of developing blood clots. If you have a history of developing blood clots or of blood clotting problems, you should not take Alysena. If you experience symptoms of a blood clot such as sharp pain and swelling in the calf or upper leg, sudden shortness of breath, crushing chest pain, blurred vision, or difficulty speaking, get immediate medical attention.

If you are immobilized (e.g., confined to bed for a long-term illness or accident), you will be at an increased risk of experiencing a blood clot and your doctor may recommend that you stop taking Alysena for a certain period of time.

Blood pressure: If you have high blood pressure, discuss with your doctor how Alysena may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alysena, and whether any special monitoring is needed.

You may need to visit your doctor more frequently to have your blood pressure checked while using Alysena. Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping Alysena.

Breast cancer: Increasing age and a strong family history of breast cancer are the most significant risk factors in developing breast cancer. Other risk factors include Obesity, not having children, and a late age at the first full-term pregnancy.

The identified groups of women that may be at increased risk of developing breast cancer before Menopause are long-term users of birth control pills (more than 8 years) and those who start taking it at an early age. In a few women, the use of birth control pills may speed up the growth of an existing but undiagnosed breast cancer.

If you are taking birth control pills, you should learn breast self-examination. Notify your doctor any time you detect a lump. A yearly clinical breast examination is also recommended because, if a breast cancer should develop, medications that contain estrogen may cause the cancer to grow more quickly.

Cigarette smoking and heart disease: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills increase this risk, especially with increasing age. Research data support an upper age limit of 35 years for birth control pill use by women who smoke. All women are urged not to smoke while taking Alysena.

Other women who are at high risk for heart disease include those with diabetes, high blood pressure, abnormal cholesterol levels, or a family history of these conditions. It is unclear whether taking birth control pills increases this risk.

For low-risk, non-smoking women of any age, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease. Consequently, birth control pills may be used by these women up to the age of menopause.

Depression: Hormones, such as estrogen, have been known to cause changes in mood and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Alysena may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alysena, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Alysena contact your doctor as soon as possible.

Diabetes: Current low-dose birth control pills do not have a large effect on blood glucose control. If you have diabetes or are at risk for developing diabetes, discuss with your doctor whether any special monitoring is needed.

Eye disorders: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye that may cause visual disturbances and changes in tolerance to rigid (i.e., hard) contact lenses. Soft contact lenses usually do not cause disturbances. If visual changes or alterations in tolerance to contact lenses occur, you may need to stop wearing them.

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

Gall bladder disease: Alysena can cause gall bladder disease to become worse. If you have gall bladder disease, discuss with your doctor how Alysena may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alysena, and whether any special monitoring is needed.

Inflammation of the pancreas: A small number of women who take levonorgestrel - ethinyl estradiol experience an increase in triglycerides in the blood. When triglyceride (a type of fat) levels are allowed to be high for a long period of time, inflammation of the pancreas (pancreatitis) may develop. Pancreatitis can quickly become serious and life-threatening. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen), contact your doctor as soon as possible.

Liver problems: Alysena may reduce liver function and can cause liver problems. If you have active liver disease, decreasing liver function, or liver tumours, you should not take Alysena. If you have a history of liver problems, discuss with your doctor how Alysena may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Alysena, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Migraine and headache: 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 should be done three months after starting Alysena and then yearly by your doctor.

Return to fertility: After stopping birth control therapy, you should delay pregnancy 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: Birth control pills do not protect against sexually transmitted infections, including HIV or AIDS. For protection against these infections, latex condoms should be used in addition to Alysena.

Surgery: Ideally, Alysena should be stopped at least one month before major scheduled surgery since prolonged bed rest can increase the risk of blood clots. Inform any health care professional involved in your care that you are taking birth control pills so the risk of blood clots is reduced.

Pregnancy: Levonorgestrel - ethinyl estradiol should not be taken during pregnancy. If you become pregnant while taking Alysena, contact your doctor.

Breast-feeding: It is not recommended to use birth control pills while breast-feeding. The hormonal components of the medication pass into breast milk and may reduce its quantity and quality. As well, their long-term effects on the developing child are not known.

Children: Adolescent girls who have not yet begun to menstruate and children under the age of 14 years should not take Alysena.

Seniors: Postmenopausal women should not take Alysena.