Option 2: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Option 2^® is an emergency or backup contraceptive.

Option 2^® 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.

Option 2^® cannot terminate an existing pregnancy. Although there is no scientific evidence that levonorgestrel would harm a developing embryo, women who are already pregnant should not use this product.

Option 2^® should not be used in place of regular contraception. It does not work as well as most other contraceptives used correctly.

What it does:

Option 2^® acts as an emergency contraceptive by preventing the release of an egg from the ovary, or preventing sperm and egg from uniting. In addition, Option 2^® may prevent the fertilized egg from attaching to the wall of the uterus. Option 2^® is not effective once a pregnancy has started, that is once the fertilized egg has attached to the wall of the uterus. Option 2^® does not cause an abortion.

Option 2^® 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:

  o Condom rupture, slippage, or misuse

  o Diaphragm or cap dislodgment, breakage or early removal

  o Failure to withdraw before ejaculation

  o Miscalculation of the fertile period by women practising periodic abstinence

  o IUD expulsion

  o Missed oral contraceptives

  o A delay in starting a new packet of oral contraceptives

  o A delay in getting a scheduled contraceptive injection

  • In cases of sexual assault (rape)

When it should not be used:

Do not use Option 2^® if:

• you have a confirmed or suspected pregnancy
• you are allergic to Levonorgestrel, or to any ingredient in the formulation (see list of non-medicinal ingredients below).
• you have abnormal vaginal bleeding

What the medicinal ingredient is:

Levonorgestrel

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, magnesium stearate, corn starch, lactose monohydrate and povidone.

What dosage forms it comes in:

The package contains two tablets, each containing 0.75mg of levonorgestrel. The tablet is White to off-white, circular, flat beveled, uncoated tablet debossed with ‘L840’ on one side and plain on other side.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE you use Option 2® talk to your doctor or pharmacist if

You weigh 75kg (165 lbs) or more.

Option 2^® is for Emergency Contraceptive Use Only and should not be used on a regular basis. Option 2^® is 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.

Option 2^® 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.

BEFORE you use Option 2^®, 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 tumor
• You have diabetes
• You have hypertension (a heart condition)
• You are pregnant or breast feeding You weigh 75 kg (165 lbs) or more

INTERACTIONS WITH THIS MEDICATION

Before you use Option 2^®, talk to your doctor or pharmacist if you are taking any of the following drugs:

Drugs that may decrease the efficacy of Option 2^® include:

• 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 Option 2^® within 3 days of a Pap test, as it may affect your results.

PROPER USE OF THIS MEDICATION

Usual dose:

Option 2^® can prevent pregnancy if the 2 tablets are taken together 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. Option 2^® is more effective the sooner you start after unprotected intercourse.

Option 2^® can be taken with a glass of water.

If you vomit within 2 hours of taking Option 2^®, 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, Option 2^® 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. Option 2^® 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 Option 2^®, 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.

Option 2® is less effective in women weighing 75 kg (165 lbs) or more and not effective in women weighing more than 80 kg (176 lbs) If your weight is 75 kg or more, ask your health professional for advice on alternative methods of emergency contraception.

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

Option 2^® 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 Option 2^®.
• Abdominal Pain: This occurs in about 18% of women taking Option 2^®.
• Fatigue: This occurs in about 17% of women taking Option 2^®.
• Headache: This occurs in about 17% of women taking Option 2^®.
• Dizziness: This occurs in about 11% of women taking Option 2^®.

• Breast tenderness: This occurs in about 11% of women taking Option 2^®.

  • Vomiting: This occurs in about 6% of women taking Option 2^®.
  • Diarrhea: This occurs in about 5% of women taking Option 2^®. .
  • Irregular menstrual bleeding: Some women may experience spotting after taking Option 2^®. The majority of women will have their next menstrual period at the expected time or early. When Option 2^® is 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 IT

Store Option 2^® tablets between 15°C and 30°C (59-86 °F).

Keep out of reach of children.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the distributor, Teva Canada Limited at:

1-800-268-4127 ext. 1255005 (English)

or druginfo@tevacanada.com

Perrigo^® International

Allegan Michigan, 49010 USA

Last revised: September 3, 2014

Manufactured by: Perrigo^® International

Allegan Michigan 49010 USA

Imported by: Teva Canada Limited

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.health.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, ON 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.health.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.