IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION o Missed oral contraceptives

PLAN B® o A delay in starting a new packet of oral
Levonorgestrel Tablets 0.75 mg contraceptives
o A delay in getting a scheduled contraceptive
injection
This leaflet is part III of a three-part "Product • In cases of sexual assault (rape)
Monograph" published when Plan B® was approved
for sale in Canada and is designed specifically for When it should not be used:
Consumers. This leaflet is a summary and will not tell
you everything about Plan B®. Contact your doctor Do not use Plan B® if:
or pharmacist if you have any questions about the • you have a confirmed or suspected pregnancy
drug. • you are allergic to Levonorgestrel, or to any
ingredient in the formulation (see non-medicinal
ABOUT THIS MEDICATION ingredients below)
• you have abnormal vaginal bleeding
What the medication is used for:
What the medicinal ingredient is:
®
Plan B is an emergency or backup contraceptive.
Levonorgestrel
®
Plan B can prevent pregnancy after a contraceptive
accident (such as a broken condom) or when no form of What the non-medicinal ingredients are:
birth control was used. Treatment is most effective if
used in the first 72 hours (3 days) following unprotected Lactose monohydrate, corn starch, talc, magnesium
sex . stearate, potato starch, colloidal silicon dioxide.

Plan B® cannot terminate an existing pregnancy. What dosage forms it comes in:
Although there is no scientific evidence that Plan B®
would harm a developing embryo, women who are The package contains two tablets, each containing 0.75
already pregnant should not use this product. mg of levonorgestrel. Each tablet is white, round, and
marked INOR.
Plan B® should not be used in place of regular
contraception. It does not work as well as most other WARNINGS AND PRECAUTIONS
contraceptives used correctly.
Serious Warnings and Precautions
What it does:

Plan B® acts as an emergency contraceptive by • Plan B® provides no protection against

preventing the release of an egg from the ovary, or HIV/AIDS and other sexually transmitted
preventing sperm and egg from uniting. In addition, Plan diseases (STDs), such as syphilis,
B® may prevent the fertilized egg from attaching to the gonorrhoea, chlamydia, and herpes. If you
wall of the uterus. Plan B® is not effective once a are worried about whether you may have been
pregnancy has started, that is once the fertilized egg has infected with HIV/AIDS, or other sexually
attached to the wall of the uterus. Plan B® does not cause transmitted diseases, talk to your health
an abortion. professional about your concerns and ask how
you can protect yourself in the future.

Plan B® can be used following any unprotected act of • If your period is delayed more than 1 week,
sexual intercourse, including: you should contact your doctor and have a
• When no contraceptive has been used pregnancy test done.
• When a contraceptive method may have
failed, including:
o Condom rupture, slippage, or misuse
o Diaphragm or cap dislodgment,
®
breakage or early removal Plan B is for Emergency Contraceptive Use Only
o Failure to withdraw before ejaculation ®
and should not be used on a regular basis. Plan B is
o Miscalculation of the fertile period by not as effective in preventing pregnancy as most other
women practising periodic abstinence birth control methods (e.g. oral contraceptive pills,
o IUD expulsion

Plan B - Product Monograph Page 31 of 33

 IMPORTANT: PLEASE READ

IUDs, implants or condoms, etc.). It should not be

relied on for routine birth control by sexually active
PROPER USE OF THIS MEDICATION
women.

Plan B® provides only short-term protection against Usual dose:

pregnancy. Sexual activity that takes place later can
still result in pregnancy if no contraceptive is used. Plan B® can prevent pregnancy if the 2 tablets are
You must abstain from sex or use another barrier taken together within 72 hours (3 days) and
method of birth control until your next normal period preferably within 12 hours, after a contraceptive
to make sure you do not get pregnant. accident or unprotected sex (sex without birth
control). Do not delay starting treatment. Plan B is more
In all women, emergency contraception should be effective the sooner you start after unprotected
taken as soon as possible after unprotected intercourse. intercourse.
There is some data that levonorgestrel may be less
effective with increasing body weight or body mass Plan B® can be taken with a glass of water.
index (BMI), but these data were limited and
inconclusive. If you have any questions regarding this, If you vomit within 2 hours of taking Plan B®, call your
please consult with a health care professional. doctor or pharmacist as you might need another dose.

BEFORE you use Plan B®, talk to your doctor or Important: If more than 72 hours (3 days) have passed
pharmacist if you have now or have previously had any since unprotected sex occurred, Plan B® may not be
of the following conditions: effective. See your health professional as soon as
• Unusual vaginal bleeding that has not yet been possible to discuss other options.
diagnosed
Although the risk of pregnancy is highest in the middle
• Known or suspected breast cancer
of the menstrual cycle (possibly as early as day 10 after
• Active liver disease or tumour
the beginning of your last period), pregnancy can occur
• You have diabetes at other times during the menstrual cycle. Plan B® can
• You have hypertension (a heart condition) be administered anytime during your monthly cycle if
• You are pregnant or breast feeding you are worried about an unwanted pregnancy.

INTERACTIONS WITH THIS MEDICATION The treatment does not bring on menstruation. You may
experience spotting a few days after taking Plan B®, but
this is not a period. Your next menstrual period should
Before you use Plan B®, talk to your doctor or come on time (or a few days early or late). If your
pharmacist if you are taking any of the following period is delayed more than a week or if you have any
drugs: other cause for concern, talk to a health professional.
More than occasional use (more than once in a
Drugs that may decrease the efficacy of Plan B® menstrual cycle or more than once a month) may upset
include: your menstrual cycle (period).
 anti-HIV drugs (efavirenz, ritonavir) If you are sexually active and do not wish to become
 anticonvulsant drugs (phenytoin, pregnant, you should use a reliable method of
carbamazepine, primidone, phenobarbital) contraception on a regular basis. If you want more
 antibiotics (ampicillin, cotrimoxazole, information about regular contraceptives or if you are
tetracycline, temafloxacin, clarithromycin) having trouble using a method, ask your health
 rifampicin professional for help in choosing a method that works
 rifabutin for you.
 griseofulvin
 Hypericum perforatum (St. John’s wort)
Overdose:
 ulipristal acetate
In case of drug overdose, contact a health care
If your period is delayed more than 1 week and you
professional, hospital emergency department or
were taking any of these medications, you should
regional Poison Control Centre immediately, even if
contact your doctor or pharmacist and have a
there are no symptoms.
pregnancy test done.
Symptoms of overdose may include nausea, vomiting,
Tell your doctor if you have taken Plan B® within 3 days
vaginal bleeding, and may lead to menstrual cycle
of a Pap test, as it may affect your results.
disturbances.

Plan B - Product Monograph Page 32 of 33

 IMPORTANT: PLEASE READ

• Vaginal hemorrhage
SIDE EFFECTS AND WHAT TO DO ABOUT
THEM HOW TO STORE IT

Plan B® can cause temporary side effects in some Store Plan B® tablets between 15°C and 30°C (59-86 °F).
women. These side effects generally do not last more Protect from high humidity (such as damp storage
than 24 hours. conditions).

Common side effects include: Keep out of reach of children.

• Nausea: This occurs in about 14 to 23% of
women taking Plan B® Reporting Side Effects
• Abdominal pain: This occurs in about 18% You can help improve the safe use of health products for
of women taking Plan B® Canadian by reporting serious and unexpected side effects to
• Fatigue: This occurs in about 17% of women Health Canada. Your report may help to identify new side
taking Plan B® effects and change the product safety information.
• Headache: This occurs in about 17% of
women taking Plan B® 3 ways to report:
• Dizziness: This occurs in about 11% of
women taking Plan B® • Online at MedEffect;
• Breast tenderness: This occurs in about 11% • By calling 1-866-234-2345 (toll-free);
of women taking Plan B® • By completing a Consumer Side Effect Reporting
• Vomiting: This occurs in about 6% of women Form and sending it by:
Taking Plan B®.
• Diarrhea: This occurs in about 5% of women o Fax to 1-866-678-6789 (toll-free), or
taking Plan B® o Mail to: Canada Vigilance Program
• Irregular menstrual bleeding: Some women Health Canada, Postal Locator 0701E
may experience spotting after taking Plan B®. Ottawa, ON
The majority of women will have their next K1A 0K9
menstrual period at the expected time or early.
When Plan B® is used repeatedly (more than Postage paid labels and the Consumer Side Effect Reporting
once in a menstrual cycle, or more than Form are available at MedEffect.
occasional once a month use), menstrual
Note: Contact your health professional if you need
changes may occur, including a shorter or
information about how to manage your side effects. The
longer cycle and a heavier or lighter period
Canada Vigilance Program does not provide medical advice.
than normal.
Less common side effects: Migraine or severe MORE INFORMATION
headache, lower abdominal pain, painful menstruation
and vaginal discharge. If the symptoms continue for
This document plus the full product monograph,
more than 48 hours or are severe, see your health
prepared for health professionals can be found by
professional.
contacting the distributor, Paladin Labs Inc., at:
1-888-867-7426 or at www.paladinlabs.com
Delayed menstrual period: If your period is delayed
more than 1 week, you should contact your doctor or
This leaflet was prepared by:
pharmacist and have a pregnancy test done.
Paladin Labs Inc.
Saint-Laurent, Canada H4M 2P2
SERIOUS SIDE EFFECTS, HOW OFTEN THEY Last revised: October 20, 2017
HAPPEN AND WHAT TO DO ABOUT THEM
Owned by:
Call your doctor immediately if the following Teva Branded Pharmaceutical Products R&D, Inc.
symptoms and signs of serious adverse effects occur: 41 Moores Road, Frazer, PA 19355 USA
• Itching and rash
• Cramping or severe pain in your stomach or belly
prior to your next normal period, since this can be
a warning sign of tubal (ectopic) pregnancy – a
serious medical problem
• Uterine hemorrhage

Plan B - Product Monograph Page 33 of 33