Details for: BACKUP PLAN ONESTEP
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02433532 | BACKUP PLAN ONESTEP | LEVONORGESTREL | 1.5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
BACKUP PLAN ONESTEP® (levonorgestrel tablets) is an
emergency or backup contraceptive.
Levonorgestrel tablets can prevent pregnancy after a
contraceptive accident (such as a broken condom) or when no
form of birth control was used. Treatment is most effective if
used in the first 72 hours (3 days) following unprotected sex.
Levonorgestrel tablets cannot terminate an existing
pregnancy. Although there is no scientific evidence that
levonorgestrel tablets would harm a developing embryo,
women who are already pregnant should not use this product.
Levonorgestrel tablets should not be used in place of
regular contraception. It does not work as well as most other
contraceptives used correctly.
What it does
Levonorgestrel tablets act as an emergency contraceptive by
preventing the release of an egg from the ovary, or preventing
sperm and egg from uniting. In addition, levonorgestrel tablets
may prevent the fertilized egg from attaching to the wall of the
uterus. Levonorgestrel tablets is not effective once a
pregnancy has started, that is once the fertilized egg has
attached to the wall of the uterus. Levonorgestrel tablets do
not cause an abortion.
Levonorgestrel tablets can be used following any unprotected
act of sexual intercourse, including:
- When no contraceptive has been used
- When a contraceptive method may have failed, including:
- Miscalculation of the fertile period by women practicing periodic abstinence
- IUD expulsion
- Missed oral contraceptives
- A delay in starting a new packet of oral contraceptives
- A delay in getting a scheduled contraceptive injection
- In cases of sexual assault (rape)
When it should not be used
Do not use levonorgestrel tablets if:
- you have a confirmed or suspected pregnancy
- you are allergic to levonorgestrel, or to any ingredient in the formulation (see nonmedicinal ingredients below)
- you have abnormal vaginal bleeding
What the medicinal ingredient is
Levonorgestrel
What the non-medicinal ingredients are
Croscarmellose Sodium, Lactose Monohydrate fast flo, Magnesium Stearate vegetable, Microcrystalline cellulose PH102, Poloxamer 188.
What dosage form it comes in
BACKUP PLAN ONESTEP® tablet (1.5 mg of levonorgestrel) is available as a single tablet packaged in PVC/PVDC - aluminum foil blister.
Warnings and precautions
Serious Warnings and Precautions
- Levonorgestrel tablets provide no protection against HIV/AIDS and other sexually transmitted diseases (STDs), such as syphilis, gonorrhoea, chlamydia, and herpes. If you are worried about whether you may have been infected with HIV/AIDS, or other sexually transmitted diseases, talk to your health professional about your concerns and ask how you can protect yourself in the future.
- If your period is delayed more than 1 week, you should contact your doctor and have a pregnancy test done.
Levonorgestrel tablets are for Emergency
Contraceptive Use Only and should not be used on a
regular basis. Levonorgestrel tablets are not as
effective in preventing pregnancy as most other birth
control methods (e.g. oral contraceptive pills, IUDs,
implants or condoms, etc.). It should not be relied on
for routine birth control by sexually active women.
Levonorgestrel tablets provide only short-term protection
against pregnancy. Sexual activity that takes place later
can still result in pregnancy if no contraceptive is used.
You must abstain from sex or use another barrier method
of birth control until your next normal period to make
sure you do not get pregnant.
In all women, emergency contraception should be taken
as soon as possible after unprotected intercourse. There is
some data that levonorgestrel may be less effective with
increasing body weight or body mass index (BMI), but
these data were limited and inconclusive. If you have any
questions regarding this, please consult with a health care
professional.
BEFORE you use levonorgestrel tablets, talk to your
doctor or pharmacist if you have now or have previously
had any of the following conditions:
- Unusual vaginal bleeding that has not yet been diagnosed
- Known or suspected breast cancer
- Active liver disease or tumour
- You have diabetes
- You have hypertension (a heart condition)
- You are pregnant or breast feeding
Interactions with this medication
Before you use levonorgestrel tablets, talk to your doctor
or pharmacist if you are taking any of the following
drugs:
Drugs that may decrease the efficacy of levonorgestrel
tablets include:
- anti-HIV drugs (efavirenz, ritonavir)
- anticonvulsant drugs (phenytoin, carbamazepine, primidone, phenobarbital)
- antibiotics (ampicillin, cotrimoxazole, tetracycline, temafloxacin, clarithromycin)
- rifampicin
- rifabutin
- griseofulvin
- Hypericum perforatum (St. John’s wort)
- ulipristal acetate
If your period is delayed more than 1 week and you were
taking any of these medications, you should contact your
doctor or pharmacist and have a pregnancy test done.
Tell your doctor if you have taken levonorgestrel tablet
within 3 days of a Pap test, as it may affect your results.
Proper use of this medication
Usual Dose
Levonorgestrel tablet can prevent pregnancy if the
tablet is taken within 72 hours (3 days) and preferably
within 12 hours, after a contraceptive accident or
unprotected sex (sex without birth control). Do not
delay starting treatment. Levonorgestrel tablet is more
effective the sooner you take the tablet after unprotected
intercourse.
Levonorgestrel tablet can be taken with a glass of water.
If you vomit within 2 hours of taking levonorgestrel
tablet, call your doctor or pharmacist as you might need
another dose.
Important: If more than 72 hours (3 days) have passed
since unprotected sex occurred, levonorgestrel tablet may
not be effective. See your health professional as soon as
possible to discuss other options.
Although the risk of pregnancy is highest in the middle of
the menstrual cycle (possibly as early as day 10 after the
beginning of your last period), pregnancy can occur at
other times during the menstrual cycle. Levonorgestrel
tablet can be administered anytime during your monthly
cycle if you are worried about an unwanted pregnancy.
The treatment does not bring on menstruation. You may
experience spotting a few days after taking levonorgestrel
tablet, but this is not a period. Your next menstrual period
should come on time (or a few days early or late). If your
period is delayed more than a week or if you have any
other cause for concern, talk to a health professional.
More than occasional use (more than once in a menstrual
cycle or more than once a month) may upset your
menstrual cycle (period).
If you are sexually active and do not wish to become
pregnant, you should use a reliable method of
contraception on a regular basis. If you want more
information about regular contraceptives or if you are
having trouble using a method, ask your health
professional for help in choosing a method that works for
you
Overdose
Symptoms of overdose may include nausea, vomiting, vaginal bleeding, and may lead to menstrual cycle disturbances.
Side effects and what to do about them
BACKUP PLAN ONESTEP® (levonorgestrel tablets) can cause temporary side effects in some women. These side effects generally do not last more than 24 hours. Common side effects include:
- Nausea: This occurs in about 14 to 23% of women taking levonorgestrel tablets.
- Abdominal pain: This occurs in about 18% of women taking levonorgestrel tablets.
- Fatigue: This occurs in about 17% of women taking levonorgestrel tablets.
- Headache: This occurs in about 17% of women taking levonorgestrel tablets.
- Dizziness: This occurs in about 11% of women taking levonorgestrel tablets.
- Breast tenderness: This occurs in about 11% of women taking levonorgestrel tablets.
- Vomiting: This occurs in about 6% of women taking levonorgestrel tablets.
- Diarrhea: This occurs in about 5% of women taking levonorgestrel tablets.
- Irregular menstrual bleeding: Some women may experience spotting after taking levonorgestrel tablets. The majority of women will have their next menstrual period at the expected time or early. When levonorgestrel tablets are used repeatedly (more than once in a menstrual cycle, or more than occasional once a month use), menstrual changes may occur, including a shorter or longer cycle and a heavier or lighter period than normal.
Less common side effects: Migraine or severe headache,
lower abdominal pain, painful menstruation and vaginal
discharge. If the symptoms continue for more than 48
hours or are severe, see your health professional.
Delayed menstrual period: If your period is delayed
more than 1 week, you should contact your doctor or
pharmacist and have a pregnancy test done.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Call your doctor immediately if the following symptoms and signs of serious adverse effects occur:
- 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
- Vaginal hemorrhage
How to store
Store BACKUP PLAN ONESTEP® at controlled room
temperature 15°C to 30°C.
Keep out of reach of children.
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.
More information
If you want more information about BACKUP PLAN ONESTEP®:
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website. Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800- 667-4708.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario, M9L 1T9.
Last revised: January 24, 2020