Mya: Uses, Side Effects and Dosage

Serious warnings and precautions box

• Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age particularly in women older than 35 years of age, who use hormonal birth control. 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 MYA.
• Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms AND take your birth control pills.

What MYA is used for:

• To prevent pregnancy
• To treat moderate acne in women 14 years of age and older who are able to use birth control pills and have had their first menstrual period

How MYA works:

Preventing Pregnancy

MYA is a birth control pill (oral contraceptive). It is considered to be a combination oral contraceptive. This is because it contains two female sex hormones; progestin drospirenone and estrogen ethinyl estradiol. Both hormones are synthetic and similar to those that occur naturally in your body. MYA works in two ways:

1. 1. Stopping the monthly release of an egg by the ovaries.
2. 2. Changing the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).

Acne Treatment

MYA lowers androgen levels in the body. Androgens can cause glands in the skin to over-produce oil.

This results in acne. MYA works by blocking the effects of androgens at the gland.

Effectiveness of Combination Birth Control Pills

Combination birth control pills are more than 99 percent effective in preventing pregnancy when:

• the pill is TAKEN AS DIRECTED, and
• the amount of estrogen is 20 micrograms or more.

A 99 percent effectiveness rate means that if 100 women used birth control pills for one year, one woman in the group would get pregnant.

The chance of becoming pregnant increases with incorrect use.

Other Ways to Prevent Pregnancy

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

The following table lists pregnancy rates for different types of birth control, including no 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:

Combination pill

less than 1 to 2

Intrauterine device (IUD)

less than 1 to 6

Condom with spermicidal foam or

gel

1 to 6

Mini-pill

3 to 6

Condom

2 to 12

Diaphragm with spermicidal foam or

gel

3 to 18

Spermicide

3 to 21

Sponge with spermicide

3 to 28

Cervical cap with spermicide

5 to 18

Periodic abstinence (rhythm), all

types

2 to 20

No birth control

60 to 85

Pregnancy rates vary widely because people differ in how carefully and regularly they use each method. This does not apply to IUDs since they are implanted in the uterus.

The ingredients in MYA are:

Medicinal ingredients: drospirenone and ethinyl estradiol

Non-medicinal ingredients:

• Pink (hormone-containing) tablets: croscarmellose sodium, iron oxide black, iron oxide red, lactose monohydrate, macrogol (polyethylene glycol), magnesium stearate, polysorbate, polyvinyl alcohol-partial hydrolyzed, povidone, pregelatinized starch, talc and titanium dioxide.

• White (hormone-free) tablets: lactose anhydrous, macrogol (polyethylene glycol), magnesium stearate, polyvinyl alcohol- partial hydrolyzed, povidone, talc and titanium dioxide.

MYA comes in the following dosage forms:

• Pink tablets: 3 mg drospirenone and 0.02 mg ethinyl estradiol
• White (hormone-free) tablets: no medicinal ingredient

MYA tablets are available in a 28-day regimen. Each blister pack contains 24 hormone-containing pink film- coated, round tablets with MY and 15 debossed on opposite sides, and 4 hormone-free white, film-coated, plain round tablets.

Do not use MYA if you:

• have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body
• have or have had inflammation or swelling in the veins
• have or have had a stroke or heart attack
• have or have had conditions that affect blood flow to your brain
• have or have had coronary artery disease (for example, chest pain) or a condition that may be a first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
• have or have had disease of the heart valves with complications

• have severe or multiple health conditions that put you at greater risk of developing blood clots in your veins or arteries, such as if you:

  • have or have had severe high blood pressure
  • have inherited or developed issues with your blood clotting system. For example, Factor V Leiden mutation
  • have or have had diabetes with complications
  • have or have had very high blood cholesterol or triglyceride levels
  • smoke and are over age 35
  • have or have had migraine headaches
  • are scheduled for major surgery
  • are or were on prolonged bed rest
• are taking ombitasvir, paritaprevir, ritonavir, with or without dasabuvir for the treatment of Hepatitis C. Using these drugs at the same time as MYA has the potential to cause liver problems
• have or have had jaundice (yellowing of the eyes or skin)
• have liver disease or liver tumor
• have or have had known or suspected cancer of the breast, uterus (womb) or other estrogen-dependent cancer
• have or have had unusual vaginal bleeding without a known reason
• have or have had loss of vision due to blood vessel disease of the eye
• are or think you might be pregnant
• have or have had inflammation of the pancreas and high levels of fat in your blood
• have kidney disease
• have adrenal disease
• are allergic to ethinyl estradiol, drospirenone, or to any of the other ingredients in MYA or its container

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

• smoke
• are overweight
• have a history of breast disease (for example, breast lumps) or a family history of breast cancer
• have a family history of blood clots, heart attacks or strokes
• have diabetes
• have heart disease
• have a history of seizures / epilepsy
• have a history of depression
• wear contact lenses
• have uterine fibroids (benign tumors of the uterus)
• are breastfeeding
• have systemic lupus erythematosus
• have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• have hemolytic uremic syndrome
• have sickle cell disease
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages

Other warnings you should know about:

• Check-ups and testing:

  • You will have regular visits with your healthcare professional while taking MYA. They may:

    • Do blood tests to check your potassium level. This should be done during the first month that you take MYA.
    • Check your blood pressure.
    • Do a breast, liver, abdominal and a pelvic exam, including a Pap smear.
  • You should visit your healthcare professional three months or sooner after the initial examination. Afterward, visit your healthcare professional at least once a year.
  • Tell your healthcare professional if you are scheduled for any laboratory tests since certain blood tests may be affected by MYA.

  • Surgery:

    • Tell your healthcare professional if you are scheduled for major surgery. You should talk your healthcare professional about stopping the use of MYA for one month before surgery and not using MYA for a time period after surgery or during bed rest.
    • If you see a different healthcare professional, inform them that you are using MYA.

  • High potassium levels in the blood:

    • MYA is a birth control pill containing estrogen and progestin. The progestin in MYA is

      • known as drospirenone and it may increase levels of potassium in your blood.
    • You should not take MYA if you have conditions that can alter the body’s fluid and mineral balance (such as kidney, liver, or adrenal disease). This can cause serious heart and health problems.
    • Other medicines may also increase potassium. See The following may interact with MYA, below, for a list of medicines that can affect your potassium levels.

  • Skin problems:

    • MYA can cause chloasma gravidarum (gray-brown patches on face). It is more likely to happen if you have previously had chloasma gravidarum.
    • Avoid exposure to the sun or ultraviolet light while taking MYA if you have a history of developing this skin condition.

  • Pregnancy and breastfeeding

    • Use in pregnancy

      • Do not take MYA if you are pregnant.
      • Talk to your healthcare professional right away if you become or think you might be pregnant while using MYA. There are specific risks you should discuss with your healthcare professional.

    • Use while breastfeeding

      • You should avoid MYA if you are breastfeeding.
      • The hormones in MYA are known to appear in breast milk. This may cause yellowing of the skin and enlarged breast to develop in your child. These hormones also may decrease the flow of your breast milk.
      • Talk to your healthcare professional about other methods of birth control that may be right for you.

      • Use after pregnancy, miscarriage, or an abortion

        • Your healthcare professional will decide when you can start taking MYA after childbirth, miscarriage, or abortion.

        • Pregnancy after stopping MYA

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

MYA can cause serious side effects including:

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

  • Drospirenone, the progestin in MYA may carry a higher risk of blood clots than some other progestins (including levonorgestrel). You should talk to your healthcare professional about the available options.
  • The risk of clotting seems to increase with higher doses of estrogen. Your healthcare professional will make sure you use the lowest dosage of estrogen as possible.
  • Women who use hormonal birth control are more likely to develop blood clots. Blood clots are the most common serious side effects of birth control pills. These blood clots can cause death or disability. The risk of developing blood clots is especially high during the first year a woman ever uses a hormonal birth control or restarts the same or a different hormonal birth control.
  • Clots can occur in many parts of the body. When they occur in blood vessel of eye, it can result in blindness or impaired vision. When they occur in blood vessel leading to an arm or leg, it can cause damage to or loss of a limb.
  • You should be alert for symptoms and signs of serious adverse effects (see Serious side effects and what to do about them). Call your healthcare professional immediately if they occur.

• Breast cancer, cervical cancer or liver tumors

  • MYA may increase the risk of developing breast cancer, cervical cancer or liver tumors. This can be life-threatening or may cause death.

    • Breast cancer

      • Your risk for breast cancer increases as you get older and if there is a strong history of breast cancer in the family (mother or sister).

      • Some women who use MYA may be at a higher risk of breast cancer. Other factors that may increase your risk of breast cancer includes:

        • Being overweight
        • Never having children
        • Having your full-term pregnancy at a late age
        • Using birth control for a long time (more than 8 years)
        • Starting birth control at an early age
      • It is recommended that you have a yearly breast examination by a healthcare professional. Ask your healthcare professional for advice and instruction on regular self-examination of your breasts.

    • Cervical cancer

      • You are at a higher risk of developing cervical cancer if you have persistent human papillomavirus infection (HPV).

    • Liver tumors

      • The risk of developing liver tumors increases with duration of hormonal birth control use.
      • These tumors are extremely rare.

• Gallbladder disease

  • Women who use birth control pills have a higher chance of developing gallbladder disease requiring surgery within the first year of use.
  • The risk for developing gallbladder disease may double after 4 or 5 years of use.

• Vaginal bleeding

  • You may experience spotting or light bleeding during the first three months on MYA. This is when you have bleeding from the vagina between periods. This problem will usually go away. If it does not go away, check with your healthcare professional or clinic.

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

The following may interact with MYA:

• medicines used for the treatment of epilepsy including primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate
• medicines used to treat tuberculosis including rifampin, rifabutin
• medicines used to treat HIV infections including ritonavir, nevirapine
• medicines used to treat bacterial infections including penicillins, tetracyclines, clarithromycin, erythromycin
• a medicine used to prevent organ rejection called cyclosporine

• medicines used to treat Hepatitis C including:

  • ombitasvir, paritaprevir, ritonavir, with or without dasabuvir
  • boceprevir and telaprevir
• medicines used to treat fungal infections including griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole
• medicines used to lower cholesterol levels including clofibrate
• medicines used for the treatment of certain heart diseases or high blood pressure including diltiazem, verapamil
• medicines used to treat diabetes including insulin
• prednisone, a medicine used to treat many different conditions like asthma, allergic reactions and arthritis
• sedatives and hypnotics, medicines used to induce or maintain sleep, including benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate
• a pain medicine called meperidine
• medicines used to treat depression including clomipramine
• a medicine used to treat multiple sclerosis called tizanidine
• a medicine used to treat asthma called theophylline

• medicines that may increase your potassium levels

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (for example, ibuprofen, naproxen or others)
  • Potassium-sparing diuretics (spironolactone and others) used to treat high blood pressure and fluid retention
  • Potassium supplements
  • ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (for example, captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others)
  • Heparin, used to thin blood and prevent blood clots
• some nutritional supplements including vitamin B₁₂, folic acid
• antacids, used to treat heartburn. You should use it 2 hours before or after taking MYA
• St. John’s wort, a herbal product primarily used to treat depressive moods
• grapefruit juice

Certain medicines may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. MYA may also interfere with the working of other medicines.

You should tell any other healthcare professional who prescribes another medicine that you use MYA. They can tell you if you need to use an additional method of birth control and if so, for how long.

How to take MYA:

1. 1.

   Read these directions

   • before you start taking your pills, and
   • any time you are not sure what to do.
2. 2. Take exactly as directed by your healthcare professional. Check with your healthcare professional if you are not sure. Otherwise, you may become pregnant.
3. 3. Decide with your healthcare professional or clinic what is the best day for you to start taking your first pack of pills.
4. 4. You should use a second method of birth control (e.g., latex or polyurethane condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while you are getting used to taking them.
5. 5. If you experience vomiting or diarrhea, or if you take certain medicines, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your healthcare professional or clinic.
6. 6. Visit your healthcare professional three months or sooner after the initial examination. Afterward, visit your healthcare professional at least once a year.
7. 7. When receiving any medical treatment, be sure to tell your healthcare professional that you are using birth control pills.
8. 8. Your healthcare professional will tell you the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.
9. 9. There is no need to stop taking birth control pills for a rest period.
10. 10.

    If your questions are not answered here, call your healthcare professional or clinic.

    INSTRUCTIONS FOR USE

Before you start:

• Look at your pill pack. The MYA pill pack has 28 pills.
• Also check the pill pack for: 1) where to start taking pills and 2) the order to take pills in (follow the arrows).

MYA (28-Pill Pack): 24 hormone-containing pink “active” pills to be taken for 24 days, followed by 4 hormone-free white pills to be taken for four days.

DIRECTIONS FOR USE OF THIS STICKER:

(Your package includes this sticker card)

Peel the sticker off for the day of the week you plan to start your pills. Place the sticker over the space provided for the days of the week and make sure it lines up with the pills. This sticker will help to remind you to take your pill every day.

Taking MYA

1. 1. The first day of your menstrual period (bleeding) is day 1 of your cycle. Your healthcare professional may advise you on when to start taking MYA. You will need to start taking the pills on Day 1 (first day of your period) or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
2. 2.

   Take one pill at approximately the same time every day for 28 days.

   • Try to associate taking your pill with some regular activity, such as eating a meal or going to bed.
   • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
   • Do not skip pills even if you do not have sex very often.
3. 3. The pack of pills should be finished after 28 days. Your period should occur during the last four days of using that pill pack.
4. 4. When you have taken all 28 pills in this pack, begin a new pack the next day, not missing any days. Take 1 pill every day. Do not wait any days between packs.

Switching to MYA from a different type of birth control

• If you are switching from another type of birth control, talk to your healthcare professional about when to start taking MYA.

Usual dose:

Take 1 pill per day, starting with the pink pill. Then, when all the 24 pink pills are done, take 1 white pill per day for 4 days.

Overdose:

Symptoms of overdose may include nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstrual period but have accidentally taken this medicine may experience such bleeding.

If you think you, or a person you are caring for, have taken too much MYA, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

Missing pills can cause some spotting or light bleeding, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take 2 pills to make up for missed pills.

If you miss pills at any time, you could get pregnant. The greatest risks for pregnancy are:

• when you start a pack late, or
• when you miss pills at the beginning or at the very end of the pack.

What to do if you miss pills

The following chart tells you what to do if you miss one or more of your birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack.

NOTE: If you forget any of the 4 hormone-free white pills in Week 4, just safely discard the pills you missed. Then keep taking 1 pill each day until the pack is empty. You do not need to use a back-up method.

Always be sure you have on hand:

• a backup method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) in case you miss pills, and
• an extra, full pack of pills.

If you forget more than 1 pill two months in a row, talk to your healthcare professional or clinic about ways to make pill-taking easier or about using another method of birth control.

Possible side effects from using MYA:

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

• nausea
• vomiting
• breast pain, tenderness, enlargement, discharge
• acne
• itching
• migraine
• dizziness
• emotional lability (sudden changes in emotional state without a reason)
• painful menstrual cramps
• headache
• vaginal yeast infection
• back pain
• nervousness
• rash
• gastrointestinal symptoms (abdominal cramps and bloating)
• darkening of the skin (particularly on the face)
• change in appetite
• change in libido (sex drive)
• hair loss
• change in weight (increase or decrease)
• temporary infertility after discontinuation of treatment
• difficulty wearing contact lenses
• vaginal irritation or infections
• urinary tract infections or inflammation
• upper respiratory tract infections including colds, bronchitis, runny or stuffy nose, sore throat
• insomnia
• flu-like symptoms
• allergy
• fatigue
• fever
• diarrhea
• flatulence
• excess hair on face, chest, abdomen or legs
• high blood pressure

Serious side effects and what to do about them

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

• Keep tablets in blister until ready to use. Store at controlled room temperature 15°C to 30°C. Carton includes blister of 28 tablets and storage sleeve.
• Keep out of reach and sight of children and pets.
• Do not throw away any medicines via wastewater or household waste. Ask your healthcare professional how to throw away any medicines you no longer use. These measures will help to protect the environment.

If you want more information about MYA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database 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.

Date of Authorization: 2025-12-16