TRICIRA LO 21 TB

Generic Name: norgestimate - ethinyl estradiol
Brand Name: Tricira Lo
Drug class: Contraceptives

WHAT IS THE DOSAGE OF THIS MEDICATION?

Tricira Lo and its generic norgestimate - ethinyl estradiol are available as 21 day and 28 day tablets.

WHAT IS THIS MEDICATION USED FOR?

Norgestimate - ethinyl estradiol belongs to the class of medications called oral contraceptives (birth control pills). It is an estrogen (ethinyl estradiol) and progestin (norgestimate) combination pill used to prevent pregnancy.

Norgestimate - ethinyl estradiol works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix which make it difficult for sperm to penetrate and for an egg to implant in the wall of the uterus. It may also be used to treat acne for women.

21-day pack: Take one tablet daily for 21 days, then take no pills for 7 days.

28-day pack: Take one tablet daily for 21 days, then one "reminder" pill daily for 7 days.

See the package insert for information on when to start and what to do if you forget to take a pill.

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 of your period. The pills should be taken approximately the same time every day.

It may be advisable to 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 experience vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If your doctor prescribes other medications, ask your doctor or pharmacist whether these medications could reduce the effectiveness of your birth control pills. Until you can check with your doctor or clinic to make certain that these things will not reduce the effectiveness of your birth control pills, use a backup method, such as latex condoms and spermicidal foam or gel.

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 very 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 two pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take two pills 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 miss the pills.

If 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 and you start your pills on Sunday, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If 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 and you start your pills on Day 1, 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 miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you are not sure what to do after missing pills, 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 norgestimate - ethinyl estradiol if you:

• are allergic to norgestimate, ethinyl estradiol, or any ingredients of the medication

• are over age 35 and smoke

• are going to be unable to move around for a lengthy period of time (e.g., after surgery)

• have or have had thrombophlebitis or thromboembolic disorders (blood clotting problems)

• have a condition that increases the risk of blood clotting

• have or have had cerebrovascular disorders (e.g., stroke)

• have had a heart attack or coronary artery disease

• have or have had pancreatitis (inflammation of the pancreas) as a result of high triglycerides

• have liver disease

• have or have had benign or malignant liver tumours

• have, have had, or may have breast cancer

• have or may have a tumour dependent on estrogen

• have undiagnosed abnormal vaginal bleeding

• have eye damage resulting from blood vessel disease of the eye, such as a partial or complete loss of vision

• are or may be pregnant

• have heart valve disease

• have severe high blood pressure (blood pressure of 160/100 or higher)

• have diabetes with blood vessel damage

• have jaundice (yellowing of the eyes or skin caused by liver problems or steroid use) or had jaundice during pregnancy

• have migraine headaches with an aura

• have had or are going to have major surgery that increases the risk of blood clotting

• are taking ombitasvir-paritaprevir-ritonavir, with or without dasabuvir, for the treatment of hepatitis C

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POTENTIAL INTERACTION WITH OTHER MEDICATION

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 this medication.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

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

• alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)

• ampicillin

• anastrozole

• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• apixaban

• aprepitant

• argatroban

• ascorbic acid

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• barbiturates (e.g., butalbital, phenobarbital)

• benzodiazepines (e.g., clobazam, diazepam, lorazepam)

• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)

• black cohosh

• bosentan

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• carbamazepine

• celecoxib

• cholestyramine

• clobazam

• clonidine

• cobicistat

• colestipol

• colesevelam

• conivaptan

• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• cyclosporine

• dabigatran

• dantrolene

• deferasirox

• dehydroepiandrosterone

• diabetes medications (e.g., chlorpropamide, glyburide, insulin, metformin, rosiglitazone)

• disopyramide

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• dronedarone

• elvitegravir

• enzalutamide

• other estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)

• exemestane

• exenatide

• flibanserin

• heparin

• hepatitis C antivirals (e.g., glecaprevir, ledipasvir, pibrentasvir, sofosbuvir)

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• isotretinoin

• lamotrigine

• lenalidomide

• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)

• lumacaftor and ivacaftor

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• melatonin

• mifepristone

• modafinil

• mycophenolate

• nitrofurantoin

• octreotide

• omeprazole

• oxcarbazepine

• penicillin

• perampanel

• phenytoin

• primidone

• other progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)

• protein kinase inhibitors (e.g., bosutinib, dabrafenib, imatinib, nilotinib)

• prucalopride

• rasagiline

• red clover

• rifabutin

• rifampin

• rivaroxaban

• ropinirole

• rufinamide

• St. John's wort

• sarilumab

• saw palmetto

• selegiline

• soybean

• "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)

• tamoxifen

• tetracyclines (e.g., minocycline, tetracycline)

• thalidomide

• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)

• thyroid replacements (e.g., desiccated thyroid, levothyroxine)

• ticagrelor

• ticlopidine

• tizanidine

• tocilizumab

• topiramate

• tranexamic acid

• ulipristal

• ursodiol

• valproate

• warfarin

WHAT ARE THE SIDE EFFECTS OF THIS MEDICATION?

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 this medication.

Inform your doctor about all prescription, over-the-counter (non-prescription), and herbal medications that 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.

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.

This is not a complete list of possible side effects. If you notice other effects not listed, please contact your doctor or pharmacist.

Possible side effects include:

• breast pain, tenderness, or swelling

• brown, blotchy spots on exposed skin

• diarrhea

• discomfort wearing contact lenses

• fatigue

• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)

• gas

• nausea

• rash

• swelling of ankles and feet

• trouble sleeping

• weight gain or loss

• vomiting

• breast lump

• changes in the uterine bleeding pattern during or between periods, such as:

  • decreased bleeding during periods

  • breakthrough bleeding or spotting between periods

  • prolonged bleeding at periods

  • complete stopping of menstrual bleeding that occurs over several months in a row

  • stopping of menstrual bleeding that only occurs sometimes

  • unexpected vaginal bleeding

• headaches or migraines

• increased blood pressure

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of upper respiratory tract infection (e.g., colds, runny or stuffy nose, sore throat)

• 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

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