Backup Plan Onestep: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• BACKUP PLAN ONESTEP provides 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.

What is BACKUP PLAN ONESTEP used for?

• BACKUP PLAN ONESTEP is an emergency or backup contraceptive. BACKUP PLAN ONESTEP 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. The sooner it is taken, the better it works.

  BACKUP PLAN ONESTEP will not work when a woman is pregnant. BACKUP PLAN ONESTEP cannot terminate an existing pregnancy. Although, there is no scientific evidence that BACKUP PLAN ONESTEP would harm a developing embryo, women who are already pregnant should not use this product.

• BACKUP PLAN ONESTEP should not be used in place of regular contraception. It does not work as well as most other contraceptives used correctly.

How does BACKUP PLAN ONESTEP work?

BACKUP PLAN ONESTEP acts as an emergency contraceptive by preventing the release of an egg from the ovary. BACKUP PLAN ONESTEP is not effective once a pregnancy has started, that is once the fertilized egg has attached to the wall of the uterus. BACKUP PLAN ONESTEP does 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:

  • Condom rupture, slippage, or misuse
  • Diaphragm or cap dislodgment, breakage, or early removal
  • Failure to withdraw before ejaculation
  • Miscalculation of the fertile period by women practising 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)

What are the ingredients in BACKUP PLAN ONESTEP?

Medicinal ingredients: Levonorgestrel

Non-medicinal ingredients: Croscarmellose sodium, lactose monohydrate fast flo, magnesium stearate vegetable, microcrystalline cellulose PH102 and poloxamer 188.

BACKUP PLAN ONESTEP comes in the following dosage forms:

BACKUP PLAN ONESTEP tablet (1.5 mg of levonorgestrel) is available as a single tablet packaged in PVC/PVDC - aluminum foil blister.

Do not use BACKUP PLAN ONESTEP if:

• you have a confirmed or suspected pregnancy
• you are allergic to levonorgestrel or to any ingredients in the formulation (see non-medicinal ingredients above)
• you have abnormal vaginal bleeding

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

• have unusual vaginal bleeding that has not yet been diagnosed
• have known or suspected breast cancer
• have active liver disease or tumour
• have diabetes
• have hypertension (a heart condition)
• are pregnant or breast feeding

Other warnings you should know about:

BACKUP PLAN ONESTEP is for Emergency Contraceptive Use Only and should not be used on a regular basis. BACKUP PLAN ONESTEP 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.

BACKUP PLAN ONESTEP provides 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.

Tell your doctor if you have taken BACKUP PLAN ONESTEP within 3 days of a Pap test, as it may affect your results.

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 BACKUP PLAN ONESTEP:

• 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.

How to take BACKUP PLAN ONESTEP:

Usual dose:

BACKUP PLAN ONESTEP 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. BACKUP PLAN ONESTEP is more effective the sooner you start after unprotected intercourse.

BACKUP PLAN ONESTEP can be taken with a glass of water.

If you vomit within 2 hours of taking BACKUP PLAN ONESTEP, 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, BACKUP PLAN ONESTEP 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. BACKUP PLAN ONESTEP 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 BACKUP PLAN ONESTEP, 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.

If you think you, or a person you are caring for, have taken too much BACKUP PLAN ONESTEP, contact a healthcare professional, hospital emergency department, 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.

What are possible side effects from using BACKUP PLAN ONESTEP?

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

BACKUP PLAN ONESTEP 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 and what to do about them

Serious adverse drug reactions following the use of BACKUP PLAN ONESTEP are rare.

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:

Store BACKUP PLAN ONESTEP at controlled room temperature 15°C to 30°C.

Keep out of reach and sight of children.

If you want more information about BACKUP PLAN ONESTEP:

• 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: (Drug Product Database: Access the database); the manufacturer’s website (http://www.apotex.ca/products); or by calling 1-800-667-4708.

Date of Authorization: 2025-09-09