Elfy: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Cigarette smoking increases the risk of serious effects on the heart and blood vessels. This risk increases as you get older, particularly once you are over 35 years of age. The risk also increases with the number of cigarettes smoked. For this reason, women who smoke and are over 35 years of age should not use ELFY.
• Birth control pills do not protect against sexually transmitted infections (STIs), including HIV and AIDS. To protect yourself against STIs, use latex or polyurethane condoms when you have sex and take your birth control pills.

What is ELFY used for?

• ELFY is used to prevent pregnancy.
• ELFY is a birth control pill. It is considered to be a combination oral contraceptive. This is because it contains two female sex hormones: norethindrone acetate and ethinyl estradiol. ELFY has been shown to be effective in preventing pregnancy when taken as prescribed by your healthcare professional.

How does ELFY work?

Combination hormonal contraceptives, like ELFY work in two ways:

• to stop the monthly release of an egg by the ovaries.
• to change the mucus produced by your cervix. This slows the movement of the sperm through the mucus and through the uterus.

Effectiveness of ELFY

The results of one clinical trial show that, about 3 out of 100 women may get pregnant during the first year they use ELFY. The chance of becoming pregnant increases if ELFY is not used correctly.

Women who were overweight (with a Body Mass Index (BMI) above 35 kg/m²) were not studied in the clinical trial. It is not known how well ELFY will prevent pregnancy in these women. If you are overweight (obese), you and your healthcare professional will decide if ELFY is the best choice for you.

Other Ways to Prevent Pregnancy

There are other methods of birth control available. These are usually less effective than birth control pills. If used properly, the other methods of birth control are effective enough for many women.

The following table lists pregnancy rates for different types of birth control. A pregnancy rate is the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies per 100 Women per Year:

There are differences in these pregnancy rates. This is because not all people use birth control as carefully or as regularly as they should. This does not apply to IUDs since these are implanted in the uterus. If you are careful and use your birth control regularly, pregnancy rates should be lower. Some types of birth control will require more effort than taking a single pill every day.

What are the ingredients in ELFY?

Medicinal ingredients: ethinyl estradiol and norethindrone acetate

Non-medicinal ingredients for the blue tablets and white tablets: Lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate and vitamin E. The blue tablets also contain FD&C Blue No. 1 Aluminum Lake.

Ingredients for the lilac tablets: FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 3 Aluminum Lake and FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

ELFY comes in the following dosage forms:

• White tablets: 10 mcg ethinyl estradiol
• Blue tablets: 1 mg norethindrone acetate and 10 mcg ethinyl estradiol
• Lilac tablets: no active ingredient (placebo)

Do not use ELFY if:

• you have or had a blood clot in the legs (deep vein thrombosis), lung (pulmonary embolism), eyes or somewhere else in your body;
• you have or had inflammation of a vein. This is called thrombophlebitis;
• you had a stroke or heart attack;
• you have coronary artery disease (including angina) or a condition that may be a first sign of stroke (such as ministroke or small reversible stroke);
• you have or had a disease of the heart valves with complications;
• you have liver disease (including hepatitis C) or have a history of liver tumours (cancerous or non- cancerous);
• you have or had jaundice. This is when the skin or whites of the eyes turn yellow. This may have been related to other medicines you were taking or may have happened during pregnancy;
• you have or you think you have breast cancer, cancer of the endometrium (lining of the uterus) or a cancer that is sensitive to hormones;
• you have unusual vaginal bleeding without a known reason;
• you have blood vessel disease of the eye that has caused loss of vision;
• you are pregnant or think you may be pregnant;
• you have or had migraine headaches;
• you have or had inflammation of the pancreas (pancreatitis) and high levels of fat in your blood (triglycerides);
• you have severe high blood pressure or high blood pressure that is not under control;

• you have a blood clotting disorder such as:

  • Factor V Leiden mutation,
  • Activated protein C (APC) resistance,
  • Protein C deficiency,
  • Protein S deficiency,
  • Hyperhomocysteinemia,
  • Prothrombin mutation G20210A,
  • Antiphospholipid-antibodies.
• you have diabetes with complications;
• you have an unusual amount of lipoproteins in your blood;
• you are over age 35 and you smoke;
• you are scheduled for major surgery;
• you have or will have long periods where you are not mobile including prolonged bed rest;
• you are taking medicines to treat hepatitis C called ombitasvir, paritaprevir, ritonavir, with or without dasabuvir. Using these drugs at the same time as ELFY can cause problems with your liver, such as an increase in the alanine transaminase (ALT) liver enzyme. You must finish your hepatitis C treatment first before starting ELFY. Your healthcare professional will tell you when to start, stop or restart ELFY if you need to take these hepatitis C drugs;
• you are allergic to ethinyl estradiol, norethindrone acetate or to any of the other ingredients in ELFY.

Tell your doctor if you have ever had any of the above conditions. Your healthcare professional can recommend another method of birth control.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ELFY. Talk about any health conditions or problems you may have, including if you:

• are overweight;
• have a history of breast disease (such as breast lumps) or family history of breast cancer;
• have high blood pressure;
• have high cholesterol;
• have diabetes;
• have heart or kidney disease;
• have a history of seizures or have epilepsy;
• have a history of depression;
• have cholestasis. This is a condition where the bile flow from the liver is decreased.
• wear contact lenses;
• have uterine fibroids. These are benign tumours of the uterus.
• are under 18 years of age;
• are in menopause;
• have porphyria. This is a disease of blood pigment that is passed down in families (inherited).
• have systemic lupus erythematosus. This is a disease of the immune system that affects many organs of the body.
• have inflammatory bowel disease including Crohn’s disease or ulcerative colitis;
• have haemolytic uremic syndrome. This is when there is an abnormal breakdown of blood cells, which clogs the kidney.
• have sickle cell disease. This is a disease that affects hemoglobin, a molecule in red blood cells that delivers oxygen throughout the body.
• have problems with the valves in your heart and/or have an irregular heart beat;
• have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, eyes or airway passages.

Other warnings you should know about:

Blood clot in legs, lungs, heart, eyes or brain

Women who use birth control that contains hormones are more likely to develop blood clots. Blood clots are the most common serious side effects of birth control pills. The risk for clots is highest during the first year a woman uses a hormonal birth control. Clots can occur in many areas of the body and can lead to blindness or impaired vision as well as damage to or loss of a limb and death.

While you are taking ELFY, if you have any of the below symptoms, contact your healthcare professional right away. These are signs of blood clots:

• sharp pain in your chest,
• coughing up blood,
• sudden shortness of breath,
• pain and / or swelling in your calf,
• crushing chest pain or chest heaviness,
• sudden severe or worsening headache,
• vomiting,
• dizziness,
• fainting,
• changes in vision,
• changes in speech,
• weakness or numbness in an arm or leg,
• sudden pain, swelling and slight blue discoloration of an arm or leg.

Cancer

Using birth control pills may increases the risk of certain cancers including cancer of the breast, cervix and liver.

Breast cancer:

The risk of breast cancer in women increases as you get older. It also increases if there is family history of breast cancer, meaning if your mother or sister have or had breast cancer. Other factors that increase your risk for breast cancer are being obese, never having children, or having your first full-term pregnancy at a late age.

If you have breast cancer now, or had it in the past, do not use birth control pills. The hormones in these pills can affect some cancers.

Some women who use birth control pills may have a higher risk of developing breast cancer before menopause. These women may have used birth control pills for a long time (more than eight years), or may have started using birth control pills at an early age.

In a few women, using of birth control pills can speed up the growth of a breast cancer that has not yet been found. Finding breast cancer early can reduce the effect of the cancer on a woman’s life expectancy. The risks for breast cancer related to using birth control pills seem to be small. You should, however, have a healthcare professional check your breasts at least once per year.

While you are taking ELFY, check your breasts often. See your healthcare professional if you notice any changes, such as:

• dimpling or sinking of the skin,
• changes in the nipple, or
• any lumps you can see or feel.

Cervical cancer:

Women who use birth control pills may have a higher chance of getting cervical cancer. However, this may be due to other reasons including infection with the Human Papilloma Virus (HPV). HPV is an important risk factor for cervical cancer. However, it is possible that oral birth control pills may also cause such cancers.

Liver cancer:

Liver cancer (hepatocellular carcinoma) and liver tumours may be linked to oral birth control pills. The risk for liver cancer increases the longer these pills are used. However liver tumours are extremely rare. If you feel severe abdominal pain or find a lump in your abdomen, contact your healthcare professional right away.

Gallbladder disease

The risk for gallbladder disease that needs surgery is higher in women using birth control pills. The risk is highest in the first year of use and increases the longer these pills are used.

Vaginal bleeding

Breakthrough bleeding or spotting sometimes happens in women using birth control pills including ELFY. This is blood coming from the vagina between periods. It is most likely to happen in the first three months of starting a birth control pill. If the bleeding is heavy or does not stop, contact your healthcare professional.

While you are taking ELFY you may not get your period each month. If you were not taking ELFY as directed by your healthcare professional, you should have a pregnancy test. This will rule out if the missed period is because you are pregnant.

If you go more than 6 months without a period contact your healthcare professional. This will be especially important if you also notice secretions from your breasts.

Use after pregnancy, miscarriage or an abortion

Your healthcare professional will tell you when to start using ELFY after childbirth, miscarriage or an abortion.

Pregnancy after stopping ELFY

You will have a menstrual period when you stop using ELFY. Wait until after your next period before getting pregnant. This will help to better date the pregnancy. Speak to your healthcare professional about other forms of birth control you can use during this time.

Breast feeding

If you are breastfeeding, talk to your healthcare professional before starting the birth control pill. Other types of birth control, instead of a birth control pill, are recommended until your baby has stopped breastfeeding. The hormones in the pill may lower the amount and quality of your breast milk. This may not happen, however, if you wait until after nursing is established.

Skin conditions

Chloasma may develop while you are using ELFY. This appears as yellowish-brown patches on the skin, particularly of the face. It is more likely to happen if you have previously had chloasma gravidarum. This is when these patches appear on the skin of the face during pregnancy. This is commonly known as “the mask of pregnancy”.

If you have or had chloasma, avoid too much exposure to the sun while using ELFY. Sunlight contains invisible rays (ultraviolet light) that can burn the skin.

Surgery or medical treatment

Be sure to tell your healthcare professional if you are scheduled for surgery or other medical treatment. You may need to stop using ELFY four weeks before surgery. You may need to wait until after your first period following surgery before restarting ELFY.

Check-ups and tests

Before starting ELFY, you will need to have examinations and tests. Your healthcare professional will conduct a physical exam. He or she will examine your breasts, liver, arms and legs and will conduct a pelvic exam. Your healthcare professional will also ask you some questions about your personal health history and that of your close relatives. He or she will also measure your blood pressure and do blood tests.

While you are taking ELFY, you will need to have regular check-ups with your healthcare professional. Your first check up should be about three months after starting ELFY. Afterward, you will see your healthcare professional about once per year. At these visits, your healthcare professional will conduct physical and internal exams. He or she will also measure your blood pressure and do blood tests.

If you are scheduled for any laboratory tests, be sure to tell your healthcare professional that you are taking ELFY. This is because birth control pills can affect some blood tests.

ELFY may not work as well as it should to prevent pregnancy if you:

• miss pills,
• don’t take your pills as directed by your healthcare professional,
• have gastrointestinal problems
• are taking certain medicines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Some medicines can affect how birth control pills work. In fact, some medicines may make birth control pills less effective. This means that you may not be fully protected from getting pregnant. As well, you may develop unexpected vaginal bleeding. You may need to use an additional (back-up) method of birth control while you are taking other medicines. Your healthcare professional will talk to you about this and tell you for how long this will be needed.

If you see a different healthcare professional or a dentist who prescribes another medicine to you, be sure to tell him or her that you are using ELFY. They can tell you if you need to use additional birth control and, if so, for how long.

The following may interact with ELFY:

• medicines to treat epilepsy including ethosuximide, felbamate, lamotrigine,

  • oxcarbazepine, phenobarbital, phenytoin, primidone, barbiturates, carbamazepine, topiramate;
• medicines to treat tuberculosis including rifampin, rifabutin;
• medicines to treat HIV infections including ritonavir, nevirapine;
• alpha-II adrenoreceptor agents including clonidine;
• medicines for hepatitis C virus including ombitasvir, paritaprevir/ritonavir, with or without dasabuvir, telaprevir;
• medicines to treat bacterial infections including ampicillin, cotrimoxazole, penicillins, chloramphenicol, neomycin, nitrofurantoin, sulfonamides, tetracyclines, troleandomycin, metronidazole;
• medicines to treat fungal infections including griseofulvin;
• medicines to lower cholesterol levels including clofibrate;
• medicines to prevent blood clots;
• St. John’s wort, an herbal product used to treat depression and other conditions;
• medicines to treat high blood pressure including guanethidine, methyldopa, beta blockers, reserpine;
• medicines to treat diabetes including insulin and oral drugs that lower blood sugar;
• medicines to help you relax or sleep including benzodiazepines, chlordiazepoxide, lorazepam, oxazepam, diazepam, phenothiazines, reserpine, barbiturates, chloral hydrate, glutethimide, meprobamate;
• medicines to treat depression including clomipramine;
• medicines to treat fever, pain or inflammation including acetaminophen, acetylsalicylic acid (ASA), antipyrine, meperidine, prednisone, phenylbutazone;
• medicines to treat allergies;
• medicines to treat migraine headaches;
• folic acid and vitamins E and B12;
• a medicine to help prevent organ rejection called cyclosporine;
• a medicine to help treat bleeding called aminocaproic acid;
• medicines to treat lung diseases such as asthma and Chronic obstructive pulmonary disease (bronchitis, emphysema) including theophylline;
• medicines to slow the heart rate including isoproterenol;
• medicine to treat high blood pressure in the blood vessels between the heart and the lungs (pulmonary hypertension) including bosentan.

Antacids may affect how ELFY is absorbed in your body. If you need to use antacids, like TUMS, take them 2 hours before or 2 hours after taking ELFY.

The effects of caffeine and alcohol may also be increased. This is because birth control pills affect how these are metabolized.

How to take ELFY:

• Be sure to read these directions:

  • before you start taking your pills, and
  • anytime you are not sure what to do.
• For Day 1 Starters, pick the Day Label strip that corresponds with the first day of your period. This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins. If you are a Sunday Starter (your healthcare professional has told you to start ELFY on the Sunday after your period begins), pick the day label strip that starts with Sunday.

• Place the Day Label strip on the top edge of the blister card. This sticker will go over the words: “Place Day Label Here”. Labelling the card with the days of the week will help remind you to take your pill everyday.

  • Look at your pill pack:

    • Each ELFY pack contains:

      • 24 blue pills. These contain progestin and estrogen hormones.
      • 2 white pills. These contain only estrogen.
      • 2 lilac pills. These do not contain any hormones and are considered placebos.

    • Check the pill pack for:

      • where to start taking pills; and

      • the order to take the pills. Follow the arrows in the diagram. Take pills from left to

        • right in the pack each week.

          Start here for both Sunday Starters and Day 1 Starters

Week 1

Week 2

Week 3

Week 4

Take pills in this direction from left to right each week

• Taking ELFY:

  • Take ELFY exactly as directed by your healthcare professional.

    For Day 1 Starters, pick the Day label strip that corresponds with the first day of your period. This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins. If you are a Sunday Starter (your healthcare professional has told you to start ELFY on the Sunday after your period begins), pick the day label strip that starts with Sunday.

  • Take 1 pill each day at about the same time.

  • Take ELFY with or without food.

  • Start taking ELFY on either:

    • Day 1 of your period. This is called “Day 1 Start”; or
    • The first Sunday after your period starts. This is called “Sunday Start”.

  • Take ELFY according to this schedule:

    • Take 1 blue tablet each day for 24 days in a row.
    • Then, take 1 white tablet each day for 2 days in row.
    • Then, take 1 lilac tablet each day for 2 days in a row.
    • Start a new pack of ELFY on the next day. Follow the above schedule with each pack of ELFY.
  • Be sure to use all the pills in each pack.
  • Do not skip any days. There is no need to stop taking ELFY for a rest period.
  • Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach.
  • Do not skip pills even if you do not have sex very often.

If you have trouble remembering to take the pill, talk to your healthcare professional. He or she can advise on how to make pill-taking easier or about using another method of birth control.

For Day 1 Starters: ELFY will start working right away.

For Sunday Starters: Use a second method of birth control (e.g. latex or polyurethane condoms and spermicidal foam or gel) for the first 7 days of your first cycle of ELFY use. This will provide a back-up while you are getting used to taking ELFY.

You may miss your period while you are taking ELFY. If you have been having regular periods and then do not have a period for two or more cycles, you may be pregnant. Contact your healthcare professional if this happens.

If you vomit or have diarrhea within 3 or 4 hours of taking a white or blue ELFY tablet, ELFY may not work as well. If this happens, use a back-up method of birth control until you check with your healthcare professional.

You may have spotting or light bleeding or you may feel sick to your stomach while you are taking your first 1 to 3 packs of ELFY. This is normal. If this happens, do not stop taking ELFY. These symptoms will usually go away. If they remain for a long time, check with your healthcare professional.

Switching to ELFY from a different type of birth control:

• If you are switching from another birth control pill, talk to your healthcare professional about when to start taking ELFY. You may need to wait about 1 week between the different pills.
• If you are switching from a vaginal ring or skin patch, wait 7 days after removing the ring or patch before starting ELFY.
• If you are switching from a type of birth control that is implanted under your skin, start taking ELFY on the day the implant is taken out.
• If you switch from a type of birth control that is injected into your body, start taking ELFY on the day the next injection would happen.
• If you are switching from an IUD, talk to your healthcare professional about when to start ELFY. You may need to use a back-up method of birth control during the switch.

Usual dose:

Females 18 years and older: 1 tablet per day

Overdose:

If young children swallow large doses of birth control pills, serious side effects are not expected. If too many birth control pills are taken at one time, nausea, vomiting and vaginal bleeding in women are possible.

If you think you, or a person you are caring for, have taken too much ELFY, contact your healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

If you miss blue or white pills, you could get pregnant. The more pills you miss, the more likely you are to get pregnant. This is especially true if you miss taking the first few or the last few blue pills in a pack.

Missing pills can cause you to have some spotting or light bleeding, even if you take the missed pills.

The following chart tells you what to do if you miss taking one or more birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack. If you miss one or more blue or white pills and do not have a period that month, you may be pregnant. If this happens, contact your healthcare professional.

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 forget either of the 2 lilac pills in Week 4, follow these steps:

• Throw away the pills you missed.
• Keep taking 1 pill each day until the pack is empty.
• You do not need to use a back-up method of birth control.

If you are not sure what to do about the pills you have missed:

• Use a back-up method of birth control anytime you have sex.
• Keep taking 1 blue or white pill each day until you can reach your healthcare provider.

Always be sure you have on hand:

• an extra, full pack of pills; and
• back-up methods of birth control. These are types of birth control that do not include hormones such as latex or polyurethane condoms and spermicidal foam or gel. You will need back-up birth control if you miss pills and in some other situations. Always talk to your healthcare professional if you are not sure whether you need to use back-up birth control.

What are possible side effects from using ELFY?

These are not all the possible side effects you may have when taking ELFY. If you experience any side effects not listed here, tell your healthcare professional.

• abdominal pain
• nausea
• vomiting
• weight change
• abnormal cervical (PAP) smear
• painful period cramps
• vaginal infection
• Human Papilloma Virus
• fungal infection
• urinary tract infection
• upper respiratory tract infections including bronchitis, runny nose, stuffy nose, sore throat
• influenza
• acne
• breast tenderness
• anxiety
• depression
• mood swings
• headache

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at 15°C – 30°C. Keep the tablets in their original package.

Do not keep medicine that is out of date or that you no longer need. Keep out of reach and sight of children.

If you want more information about ELFY:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: APR 20, 2026