Minestrin 1/20: Uses, Side Effects and Dosage

What is MINESTRIN^® 1/20 used for?

MINESTRIN^® 1/20 is used to prevent pregnancy.

MINESTRIN^® 1/20 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. It has been shown to be highly effective in preventing pregnancy when taken as prescribed by your healthcare professional.

How does MINESTRIN^® 1/20 work?

Combination birth control pills work in a few ways:

1. 1. They stop the monthly release of an egg by the ovaries.
2. 2. They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).
3. 3. Uterine changes that prevent pregnancy
4. 4. Changes in the function of the corpus luteum (a hormone-producing structure in the ovaries)

Serious Warnings and Precautions

Smoking

Cigarette smoking increases the risk of serious heart and blood vessel problems. 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 MINESTRIN® 1/20.

Sexually Transmitted Infections

Birth control pills, including MINESTRIN^® 1/20, 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.

Other ways to prevent pregnancy

There are other methods of birth control are available. They 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 they 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 MINESTRIN^® 1/20?

Medicinal ingredients: norethindrone acetate and ethinyl estradiol

Non-medicinal ingredients: acacia, lactose monohydrate, magnesium stearate, modified corn starch, sugar and talc. In addition, for lilac tablets: FD Blue No. 1, FD&C Red No. 3, & FD&C Red No. 40

MINESTRIN^® 1/20 comes in the following dosage forms:

MINESTRIN^® 1/20 is available in compact dispensers of 21 tablets (white) and 28 tablets (21 white tablets and 7 lilac “reminder” tablets). Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol.

Do not use MINESTRIN^® 1/20 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 MINESTRIN^® 1/20 can cause problems with your liver, such as an increase in the ALT liver enzyme. You must finish your hepatitis C treatment first before starting MINESTRIN^® 1/20. Your healthcare professional will tell you when to start, stop or restart MINESTRIN^® 1/20 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 MINESTRIN^® 1/20.

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 MINESTRIN^® 1/20 Talk about any health conditions or problems you may have, including if you:

• 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:

If you and your healthcare professional decide that, for you the benefits of MINESTRIN^®

1/20 outweigh the risks, you should be aware of the following:

The Risks of Using Combination Birth Control Pills

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 MINESTRIN^® 1/20, 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

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 MINESTRIN^® 1/20, 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.

Use after pregnancy, miscarriage or an abortion

You will be at increased risk for blood clots. Your healthcare professional will advise you of the appropriate time to start the use of MINESTRIN^® 1/20 after childbirth, miscarriage or therapeutic abortion.

Pregnancy after stopping MINESTRIN^® 1/20

You will have a menstrual period when you stop using MINESTRIN^® 1/20. 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.

Use while breastfeeding

If you are breastfeeding, talk to your healthcare professional before starting MINESTRIN^® 1/20.

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 MINESTRIN^® 1/20. 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 MINESTRIN^® 1/20. 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 MINESTRIN^® 1/20 four weeks before surgery. You may need to wait until after your first period following surgery before restarting MINESTRIN^® 1/20.

Check-ups and tests

Before starting MINESTRIN^® 1/20, 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 MINESTRIN^® 1/20, you will need to have regular check-ups with your healthcare professional. Your first check up should be about three months after starting MINESTRIN^® 1/20.

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 MINESTRIN^® 1/20. This is because birth control pills can affect some blood tests.

Certain medicines may interact with combination birth control pills and prevent them from working properly. This makes them less effective in preventing pregnancy or causing unexpected bleeding (spotting or breakthrough bleeding).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Also tell any doctor or dentist (or the dispensing pharmacist) who prescribes another medicine that you use MINESTRIN^® 1/20. They can tell you if you need to use a back-up method of birth control and if so, for how long.

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 MINESTRIN^® 1/20:

• medicines to treat epilepsy (including primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• medicines to treat tuberculosis (including rifampicin, rifabutin)
• medicines used to treat HIV infections (including ritonavir)
• medicines for Hepatitis C virus (HCV) (including ombitasvir, paritaprevir/ritonavir, with or without dasabuvir, telaprevir)
• medicines to treat bacterial infections (including penicillins, tetracyclines, metronidazole)
• medicines to treat fungal infections (including griseofulvin)
• medicines to lower cholesterol (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 lower the immune system including prednisone and cyclosporine
• medicines to help you relax or sleep including benzodiazepines, chlordiazepoxide, lorazepam, oxazepam, diazepam, phenothiazines, reserpine, barbiturates, chloral hydrate, glutethimide, meprobamate
• medicines to help with pain medication (including meperidine)
• medicines to treat depression (including clomipramine)
• other medicines such as phenylbutazone, antihistamines and medicines used to treat migraines
• some nutritional supplements (including Vitamin E and Vitamin B12)
• antacids (use 2 hours before or after taking MINESTRIN^® 1/20)
• a medicine to help treat bleeding called aminocaproic acid;

• medicines to treat lung diseases such as asthma and COPD (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;

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

This is not a complete list of possible drug interactions with MINESTRIN^® 1/20. Talk to your healthcare professional for more information about interactions with other medicines.

How to take MINESTRIN^® 1/20:

1. 1.

   Read these Instructions:

   • Before you start taking your pills, and
   • Any time you are not sure what to do
2. 2.

   Look at your pill pack to see if it has 21 or 28 pills:

   • 21-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then no pills for one week.

     or

   • 28-Pill Pack: 21 active pills (with hormones) taken daily for three weeks, and then seven

     “reminder” pills (no hormones) taken daily for one week.

3. 3. You can use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will help as a back up in case you forgot to take your pills.
4. 4. When you get any medical treatment, tell your healthcare professional that you are using birth control pills.
5. 5. Many women have spotting or light bleeding, or may feel sick to their stomach during the first three months taking birth control pills. If you do feel sick, do not stop taking MINESTRIN^® 1/20. The problem will usually go away. If it does not go away, check with your healthcare professional or clinic.
6. 6. Missing pills can also 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 two pills to make up for missed pills.
7. 7. Do not stop taking MINESTRIN^® 1/20 or skip any pills even if you are sick to your stomach, have bleeding between your periods or do not have a lot of sex.
8. 8.

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

   • When you start a pack late.
   • When you miss pills at the beginning or at the very end of the pack.
9. 9.

   Always be sure you have ready:

   • Another kind of birth control (such as latex condoms and spermicidal foam or gel) to use as a back-up in case you miss pills, and
   • An extra full pack of pills.
10. 10.

    If you have vomiting or diarrhea, or if you take certain medicines, such as antibiotics, MINESTRIN^® 1/20 may not work as well. Use a back-up method, such as latex condoms and spermicidal foam or gel, until you can check with your healthcare professional or clinic.

    1. 11. If you forget more than one pill two months in a row, talk to your healthcare professional or clinic about how to make pill-taking easier or about using another method of birth control.
    2. 12. If your questions are not answered here, call your healthcare professional or clinic.

Usual dose:

Decide with your healthcare professional or clinic what is the best day for you to start taking your first pack of pills. Your pills may be either a 21-Day or a 28-Day type.

Label the pill pack by selecting the correct day label strip: Day 1 or Sunday start (see below for explanation). Place the day label strip in the space where you see the words “Place Day Label Here”. Labelling the dispenser with the days of the week will help remind you to take your pill every day.

A. MINESTRIN^® 1/20 21-Day Pill Pack

With this type of birth control pill, you are on pills for 21 days and off pills for seven days. You must not be off the pills for more than seven days in a row.

1. 1.

   The first day of your menstrual period (bleeding) is Day 1 of your cycle. Your healthcare professional may tell you to start taking MINESTRIN^® 1/20 on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day. MINESTRIN^® 1/20 is recommended for a Day 1 start.

   • On the day you have been told to start taking MINESTRIN^® 1/20, take the first pill in the top row (where you see the word “start”). The day on the day label on top of the first pill should match the day of the week you are starting on. To remove the pill, push it through the back of the compact dispenser.
   • On the following day, take the next pill in the row, always from left to right. Each new row will always begin on the same day of the week.
2. 2.

   Take one pill at around the same time every day for 21 days. Try to link taking

   MINESTRIN^® 1/20 with a regular activity such as eating a meal or going to bed.

3. 3. Then, do not take any pills for seven days. You will probably have a period during the seven days you do not take MINESTRIN^® 1/20. This bleeding may be lighter and shorter than your usual period.
4. 4. Start a new pack on the eighth day.

B. MINESTRIN^® 1/20 28-Day Pill Pack

With this type of birth control pill, you take 21 pills, which contain hormones, and seven “reminder” pills, which contain no hormones.

1. 1.

   The first day of your menstrual bleeding (period) is Day 1 of your cycle.

   Your healthcare professional may advise you to start taking MINESTRIN^® 1/20 on Day 1, on Day 5, or on the first Sunday after your period begins. If your period starts on Sunday, start that same day. MINESTRIN^® 1/20 is recommended for a Day 1 start.

   • On the day you have been told to start taking MINESTRIN^® 1/20, take the first pill in the top row (where you see the word “start”). The day on the day label on top of the first pill should match the day of the week you are starting on. To remove the pill, push it through the back of the compact dispenser.
   • On the following day, take the next pill in the row, always from left to right. Each new row will always begin on the same day of the week.
2. 2.

   Take one pill at around the same time every day for 28 days. Try to link taking

   MINESTRIN^® 1/20 with a regular activity such as eating a meal or going to bed. Your period should occur during the last seven days of using that pill pack (i.e. while you are taking the lilac “reminder” pills).

3. 3. Begin a new pack the next day. Do not miss any days.

Overdose:

If you think you have taken too much MINESTRIN^® 1/20, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

The following chart explains what you should do if you miss one or more of your birth control pills on a Day 1 start. If you are not using a Day 1 start, check with your healthcare professional or clinic.

Day 1 Start

Miss 1 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.

Miss 2 Pills in a Row

First 2 Weeks:

1. 1. Take 2 pills the day you remember and 2 pills the next day.
2. 2. Then take 1 pill a day until you finish the pack.
3. 3. Use a backup (barrier) method of birth control if you have sex in the 7 days after you miss the pills.

Third Week:

1. 1. Throw away the pills you missed and start a new pack that same day.
2. 2. Use a backup method of birth control if you have sex in the 7 days after you miss the pills.
3. 3. You may not have a period this month.

If you miss 2 periods in a row, call your healthcare professional.

Miss 3 or More Pills in a Row

Anytime in the cycle:

1. 1. Throw away the pills you missed and start a new pack that same day.
2. 2. Use a backup method of birth control if you have sex in the 7 days after you miss the pills.
3. 3. You may not have a period this month.

If you miss 2 periods in a row, call your healthcare professional.

28-Day Pill Pack: If you forget any of the seven lilac “reminder” pills (without hormones) in Week 4, just throw away the pills you missed. Then keep taking one pill each day until the pack is empty. You do not need to use a backup method.

What are possible side effects from using MINESTRIN^® 1/20?

These are not all the possible side effects you may feel when taking MINESTRIN^® 1/20 If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• breast tenderness
• change in appetite
• changes in sex drive (libido)
• difficulty wearing contact lenses
• dizziness

•

•

•

•

• increase or decrease in hair growth
• irregular bleeding

•

•

• nervousness
• uncontrolled movement of the arms or legs (also called chorea)
• painful menstrual cramps
• change in menstrual flow
• skin pigmentation changes
• stomach cramps/pain
• urinary tract (bladder) infections or inflammation
• vaginal irritation or infections
• vaginal pain or discharge
• temporary change in the ability to get pregnant after stopping the pills
• changes in the size of benign tumours (also called fibroids) on the uterus
• vomiting
• bloating
• not able to have as much carbohydrates
• weight gain

Serious side effects and what to do about them

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, talk to 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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 room temperature (15°C-25°C).

Keep out of reach and sight of children.

If you want more information about MINESTRIN^® 1/20:

• 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.allergan.ca, or by calling 1-800-668-6424

Last Revised July 23, 2020

MINESTRIN^® is a registered trademark of Allergan Pharmaceuticals International Limited, used under license by Allergan Inc.

Allergan^® and its design are trademarks of Allergan Inc.

© 2019 Allergan. All rights reserved.