ALYSENA 21 TB

Generic Name: levonorgestrel - ethinyl estradiol
Brand Name: Alysena
Drug class: Contraceptives

WHAT IS THE DOSAGE OF THIS MEDICATION?

Alysena and its generic ethinyl estradiol/levonorgestrel is available as a three month supply of 21 day and 28 day tablets.

WHAT IS THIS MEDICATION USED FOR?

Levonorgestrel - ethinyl estradiol is a progestin (levonorgestrel) and estrogen (ethinyl estradiol) combination birth control pill used to prevent pregnancy. The ingredients of this medication primarily work by preventing ovulation (the release of an egg from an ovary). This medication 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 this medication 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.

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 this medication 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 this medication 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.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not use levonorgestrel - ethinyl estradiol 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

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POTENTIAL INTERACTION WITH OTHER MEDICATION

The following medications could potentially interact with levonorgestrel - ethinyl estradiol:

• 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

WHAT ARE THE SIDE EFFECTS OF THIS MEDICATION?

Possible side effects include:

• 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

• 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

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