Generess: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• To prevent pregnancy

What it does:

GENERESS is a chewable birth control pill. It contains two female sex hormones, an estrogen called ethinyl estradiol and a progestin called norethindrone.

GENERESS has been shown to be highly effective in preventing pregnancy when taken as prescribed by your doctor. Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.

GENERESS lowers the risk of becoming pregnant primarily by suppressing ovulation.

Effectiveness of GENERESS

Based on the results of one clinical study, about 2 out of 100 women may get pregnant during the first year they use GENERESS. The chance of becoming pregnant increases with incorrect use.

Women with a Body Mass Index (BMI) above 35 kg/m² were not studied in the clinical trial, so it is not known how well GENERESS protects against pregnancy in such women. If you are overweight (obese) discuss with your healthcare provider whether GENERESS is the best choice for you.

Other ways to prevent pregnancy:

The following table gives reported pregnancy rates for various forms of birth control, including no birth

control. The reported rates represent the number of women out of 100 who would become pregnant in 1 year.

Reported Pregnancies per 100 Women per Year

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.) Regular users may achieve pregnancy rates in the lower ranges. Others may expect pregnancy rates more in the middle ranges.

When it should not be used:

The birth control pill is not suitable for every woman. In a small number of women, serious side effects may occur. Your doctor can advise you if you have any conditions that would pose a risk to you. If you see a different doctor, inform him/her that you are taking birth control pills. Tell the doctor that your birth control pills are GENERESS. The use of the birth control pill should always be supervised by your doctor.

You should not use GENERESS if you have or have had any of the following conditions:

• blood clot in the legs, lungs, eyes or elsewhere, or thrombophlebitis (inflammation of the veins).

• stroke, heart attack or coronary artery disease (e.g.

  angina pectoris) or a condition that may be a first sign of stroke (such as transient ischemic attack or small reversible stroke).

• disease of the heart valves with complications
• severe high blood pressure
• diabetes with complications

• known abnormalities of the blood clotting system

  that increases your risk for developing blood clots

• very high blood cholesterol or triglyceride levels
• over age 35 and smoke
• migraine headaches
• you are scheduled for major surgery
• prolonged bed rest

• jaundice (yellowing of the eyes or skin), liver

  disease or liver tumour

• known or suspected cancer of the breast or uterus

  (womb) or other estrogen-dependant cancer

• unusual vaginal bleeding without a known reason

• loss of vision due to blood vessel disease of the

  eye

• you are pregnant or suspect you may be pregnant

• pancreatitis (inflammation of the pancreas)

  associated with high levels of fatty substances in your blood

• allergy (hypersensitivity) to ethinyl estradiol,

  norethindrone or to any of the other ingredients in GENERESS (see What the medicinal ingredients are and What the non-medicinal ingredients are).

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

What the medicinal ingredients are:

norethindrone and ethinyl estradiol

What the non-medicinal ingredients are:

Active tablet: lactose monohydrate, povidone, vitamin E, mannitol, microcrystalline cellulose, FD&C yellow no. 6 aluminum lake, FD&C blue no. 1 aluminum lake, D&C yellow no. 10, spearmint flavour, sodium starch glycolate, sucralose and magnesium stearate

Hormone-free tablet: ferrous fumarate, mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sucralose, spearmint flavour

No therapeutic benefits from the ferrous fumarate in the hormone-free chewable tablets have been established.

What dosage forms it comes in:

GENERESS is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

• 24 light green, round tablets (active) imprinted

  with “WC” on one side and “483” on the other

  and each containing 0.8 mg norethindrone and 0.025 mg ethinyl estradiol.

  • 4 brown, round tablets (hormone-free) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate. No therapeutic benefits from the ferrous fumarate in the hormone-free chewable tablets have been established.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Do not use GENERESS if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
• Oral contraceptives DO NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS. For protection against STIs, it is advisable to use latex condoms in combination with oral contraceptives.

BEFORE you use GENERESS talk to your doctor or pharmacist if you:

• smoke
• are overweight
• have a history of breast disease (e.g. 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/epilepsy
• have a history of depression
• have a history of liver disease or jaundice
• wear contact lenses
• have uterine fibroid tumours (benign tumours of the uterus)
• may be pregnant or are breast feeding
• have systemic lupus erythematosus
• have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• have haemolytic uremic syndrome
• have sickle cell disease
• have 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

You should also inform your doctor about a family history of blood clots, heart attacks and strokes.

If you see a different doctor, inform him or her that you are using GENERESS.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of GENERESS four weeks before surgery and not using GENERESS for a time period after surgery or during bed rest.

GENERESS should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use GENERESS only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant.

If you and your doctor decide that, for you, the benefits of GENERESS outweigh the risks, you should be aware of the following:

THE RISKS OF USING GENERESS

The information contained in this section is principally from studies carried out in women who used combination oral contraceptives with higher doses of hormones than those in common use today. The effect of long-term use of combination hormonal contraceptives with lower doses of both estrogen and progestin administered orally remains to be determined.

1. 1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes or brain)

Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing clots is highest during the first year a woman uses a hormonal contraceptive. Clots may occur in many areas of the body.

Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:

• Sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.
• Pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
• Crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.
• Sudden severe or worsening headache or vomiting, dizziness or fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.
• Sudden partial or complete loss of vision. This symptom could indicate a possible blood clot in the eye.
• Other signs of a blood clot can include sudden pain, swelling and slight blue discolouration of an extremity.

Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.

The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.

1. 2. Breast cancer

The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include, obesity, never having children and having your first full-term pregnancy at a late age.

If you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Some women who use hormonal contraceptives may be at increased risk of developing breast cancer before menopause, which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman’s life expectancy. The potential risks related to birth control pills seem to be small, however; a yearly breast examination is recommended for all women.

ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS OF REGULAR SELF-EXAMINATION OF YOUR BREASTS.

1. 3. Cervical cancer

Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. Chronic infection with the Human Papilloma Virus (HPV) is believed to be the most important risk factor for cervical cancer. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

1. 4. Liver tumours

The short and long-term use of birth control pills also has been linked with the growth of liver tumours or liver injury (e.g., hepatitis, abnormal hepatic function). Such injury or tumours are extremely rare. Contact your doctor immediately if you experience severe pain or a lump in the abdomen.

1. 5. Gallbladder disease

Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.

1. 6. Use in pregnancy

Birth control pills should not be taken by pregnant women. They will not prevent the pregnancy from continuing. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.

1. 7. Use after pregnancy, miscarriage or an abortion

Your doctor will advise you of the appropriate time to start the use of GENERESS after childbirth, miscarriage or therapeutic abortion.

1. 8. Pregnancy after stopping GENERESS

You will have a menstrual period when you stop using GENERESS. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way, the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.

1. 9. Use while breast feeding

If you are breast-feeding, consult your doctor before starting the birth control pill. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception. The use of oral contraceptives is generally not recommended until the nursing mother has completely weaned her child.

INTERACTIONS WITH THIS MEDICATION

Certain drugs may interact with birth control pills and prevent them from working properly making them less effective in preventing pregnancy or causing unexpected bleeding (spotting or breakthrough bleeding). Please inform your doctor or pharmacist if you are taking or have recently taken any other medications or herbal products, even those without a prescription. Also tell any doctor or dentist (or the dispensing pharmacist) who prescribes another medicine that you use GENERESS. They can tell you if you need to use an additional method of contraception and if so, for how long.

Drugs that may interact with GENERESS include:

• drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• drugs used for the treatment of tuberculosis (e.g., rifampicin, rifabutin)
• drugs used for treatment of HIV infections (e.g., ritonavir)
• drugs used for Hepatitis C virus (HCV) (e.g., boceprevir, telaprevir)
• antibiotics (e.g., penicillins, tetracyclines, metronidazole) for infectious diseases
• antifungals (e.g., griseofulvin)
• cholesterol lowering agents (e.g., clofibrate)
• anti-coagulants (blood thinners)
• the herbal remedy St. John’s wort
• antihypertensive drugs (for high blood pressure)
• antidiabetic drugs and insulin (for diabetes)
• prednisone
• sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• pain medication (meperidine)
• antidepressants (e.g., clomipramine)
• other drugs such as phenylbutazone, antihistamines, analgesics, antimigraine preparations, Vitamin E and Vitamin B12
• cyclosporine
• antacids (use 2 hours before or after taking GENERESS)
• bosentan

GENERESS may also interfere with the working of other drugs.

Consider using another birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

This is not a complete list of possible drug interactions with GENERESS. Talk to your doctor for more information about drug interactions.

PROPER USE OF THIS MEDICATION

Usual dose: One pill at approximately the same time every day.

CHEW THE TABLET, AND SWALLOW WITHOUT WATER.

Before you start taking GENERESS

• Decide what time of day to take your pill. It is

important to take it at the same time every day and in the order as directed on the blister pack.

Look at your GENERESS blister pack. The blister pack has four rows of 7 pills each, for a total of 28 pills. Find:

• where on the pack to start taking your pills
• in what order to take the pills

Each GENERESS blister pack has 28 pills.

• 24 light green pills with hormones for Weeks 1, 2 and 3 and the first part of Week 4 that are to be chewed and swallowed with or without food at the same time of day

• 4 brown pills without hormones for the remainder of Week 4 that are to be chewed and swallowed preferably with food at the same time of day

  Be sure to have ready at all times another kind of birth control (such as a condom and spermicide) to use as a back-up in case you miss pills.

  When to Start GENERESS

  If you start taking GENERESS and you did not use a hormonal birth control method before:

  DAY-1 START:

  Pick the day label strip that starts 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). Pick a time of day that will be easy to remember.

  Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.

  Chew and swallow, without water, the first light green pill of the first pack during the first 24 hours of your period.

  You will not need to use a back-up method of birth control because you are starting the pill at the beginning of your period. However, if you start on a day other than the first day of your period or if you are starting after having been pregnant and have not yet had a period, use a back-up method of birth control such as a condom and spermicide until you have taken a light green pill for 7 days in a row.

  Chew and swallow, without water, the brown pill with food. After taking the last brown pill (day 28) of the blister pack, start taking the first light green pill from a new blister pack the very next day whether or not you are having your period.

  If you start taking GENERESS and you are switching from a combination hormonal method such as:

  • another pill
  • vaginal ring
  • patch

Take the first light green pill on the first day you would have started your previous birth control pack.

If you previously used a vaginal ring or transdermal patch, finish the 21 days of use and wait 7 days after removal of the ring or transdermal patch before starting GENERESS.

Use a non-hormonal back-up method such as a condom and spermicide for the first 7 days you take GENERESS.

If you start taking GENERESS and you are switching from a progestin-only method such as a:

• progestin-only pill
• implant
• intrauterine system
• injection

Take the first light green pill on the day you would

have taken your next progestin-only pill or on the day of removal of your implant or intrauterine system or on the day when you would have had your next injection.

Use a non-hormonal back-up method such as a condom and spermicide for the first 7 days you take GENERESS.

Overdose:

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

The 4 hormone-free brown tablets contain ferrous fumarate. Too much ferrous fumarate can seriously harm children. Be sure to safely store and dispose of both the non-hormonal and the active tablets.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception (such as a condom and spermicide) anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant.

Your birth control pills may not be as effective if you miss any light green pills, and particularly if you miss the first few or the last few light green pills in a pack.

If you MISS ONE light green pill

Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in 1 day.

• You do not need to use a back-up birth control

  method if you have sex.

If you MISS TWO light green pills in a row in WEEK 1 or WEEK 2 of your pack

• Take two pills on the day you remember and two pills

  the next day.

• Then take one pill a day until you finish the pack.

• You could become pregnant if you have sex

  during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up for those 7 days.

If you MISS TWO light green pills in a row in WEEK 3 or WEEK 4 of your pack

• THROW OUT the rest of the pill pack and start a new pack that same day.
• You could become pregnant if you have sex during the 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a backup for those 7 days after you restart your pills.

If you MISS THREE OR MORE light green pills in a row at any time

• THROW OUT the rest of the pill pack and start a new pack that same day.
• You could become pregnant if you have sex on the days when you missed pills or during the first 7 days after restarting your pills. You MUST use a non-hormonal birth control method (such as a condom and spermicide) as a back-up the next time you have sex and for the first 7 days after you restart your pills.

You may already be pregnant or COULD BECOME PREGNANT if you had sex on the days after the pills were missed. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy. You should call your doctor or healthcare provider if you are unsure whether you are already pregnant.

If you forget any of the four brown “hormone-free” pills in WEEK 4

• THROW AWAY the pills you missed.
• Keep taking one pill each day until the pack is finished.
• You do not need to use a back-up method of birth control.

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

• Call your healthcare provider.
• Use a back-up contraception (such as a condom and spermicide) anytime you have sex and keep taking 1 pill each day.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.

Noncontraceptive benefits of birth control pills

Several health advantages other than contraception have been reported:

1. 1. Combination oral contraceptives reduce the incidence of cancer of the endometrium and ovaries.
2. 2.

   Oral contraceptives reduce the likelihood of

   developing benign breast disease and, as a result, decrease the incidence of breast biopsies.

3. 3.

   Oral contraceptives reduce the likelihood of

   development of functional ovarian cysts.

4. 4.

   Pill users have less menstrual blood loss and have

   more regular cycles, thereby reducing the chance of developing iron-deficiency anemia.

5. 5.

   The use of oral contraceptives may decrease the

   severity of dysmenorrhea and premenstrual syndrome, and may improve acne vulgaris, hirsutism, and other androgen mediated disorders.

6. 6.

   Oral contraceptives decrease the incidence of acute

   pelvic inflammatory disease and, thereby, reduce as well the incidence of ectopic pregnancy.

7. 7.

   Oral contraceptives have potential beneficial

   effects on endometriosis.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

• Legs (thrombophlebitis)
• Lungs (pulmonary embolus)
• Eyes (loss of eyesight)
• Heart (heart attack)
• Brain (stroke)

A few women who take birth control pills may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumours All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or complete
• Severe pain in your chest

• Sudden, severe headache unlike your usual

  headaches

  • Weakness or numbness in an arm or leg, or trouble speaking
  • Yellowing of the skin or eyeballs

What are the common side effects of birth control pills?

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
• Nausea
• Breast tenderness
• Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High fat levels in the blood
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.
• Problems tolerating contact lenses
• Weight changes

What if I miss my scheduled period when taking GENERESS?

Women who use GENERESS may not have a period at the end of every 28-day pack of pills.

If you miss more than two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider checks you to find out if you are pregnant. Stop taking GENERESS if you are pregnant.

This is not a complete list of side effects. For any unexpected effects while taking GENERESS, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 20-25ºC (68-77ºF).

Keep out of reach of children.

The 4 hormone-free brown tablets contain ferrous fumarate. Too much ferrous fumarate can seriously harm a child. Be sure to safely store and dispose of both the non-hormonal and the active tablets.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: -------------------------------------------------------------------------- $ Report online at

www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™

Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at www.allergan.ca or by contacting Allergan Inc. at 1-800-668-6424.

Last revised: January 31, 2020

CANADA

Markham, Ontario L6G 0B5

Allergan Inc.