Patient Medication Information: uses, side effects, how to take - Next Choice
ABOUT THIS MEDICATION
What the medication is used for:
Next Choice™ is an emergency or backup contraceptive.
Next Choice™ 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.
Next Choice™ cannot terminate an existing pregnancy.
Although there is no scientific evidence that Next Choice™ would harm a developing embryo, women who are already pregnant should not use this product.
Next Choice™ should not be used in place of regular contraception. It does not work as well as most other contraceptives used correctly.
What it does:
Next Choice™ acts as an emergency contraceptive by preventing the release of an egg from the ovary, or preventing sperm and egg from uniting. In addition, Next Choice™ may prevent the fertilized egg from attaching to the wall of the uterus. Next Choice™ is not effective once a pregnancy has started, that is once the fertilized egg has attached to the wall of the uterus. Next Choice™ does not cause an abortion.
Next Choice™ 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
- Intrauterine device 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 Next Choice™ 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 important nonmedicinal ingredients are:
Colloidal silicon dioxide, corn starch, FD&C Yellow #6, lactose monohydrate, magnesium stearate, and povidone.
What dosage forms it comes in:
The package contains two tablets, each containing 0.75 mg of levonorgestrel. The tablet is peach, round, with “475” on one side and “WATSON” on the other side.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- Next Choice™ 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.
Next Choice™ is for Emergency Contraceptive Use Only and should not be used on a regular basis. Next Choice™ 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.
Next Choice™ 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 Next Choice™, 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 Next Choice™, talk to your doctor or pharmacist if you are taking any of the following drugs:
Drugs that may decrease the efficacy of Next Choice™ 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 Next Choice™ within 3 days of a Pap test, as it may affect your results.
PROPER USE OF THIS MEDICATION
Usual dose:
Next Choice™ 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. Next Choice™ is more effective the sooner you start after unprotected intercourse.
Next Choice™ can be taken with a glass of water.
If you vomit within 2 hours of taking Next Choice™, 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, Next Choice™ 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. Next Choice™ 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 Next Choice™, 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.
Next ChoiceTM 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
Next Choice™ 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 Next Choice™
- Abdominal pain: This occurs in about 18% of women taking Next ChoiceTM
Fatigue: This occurs in about 17% of women taking
Next ChoiceTM
- Headache: This occurs in about 17% of women taking Next ChoiceTM
- Dizziness: This occurs in about 11% of women taking Next ChoiceTM
- Breast tenderness: This occurs in about 11% of women taking Next ChoiceTM
Vomiting: This occurs in about 6% of women
Taking Next Choice™.
Diarrhea: This occurs in about 5% of women taking
Next ChoiceTM
- Irregular menstrual bleeding: Some women may experience spotting after taking Next Choice™. The majority of women will have their next menstrual period at the expected time or early. When Next 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.
Choice™ 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 Next Choice™ tablets between 20° to 25°C (68° to 77°F).
Protect from high humidity (such as damp storage conditions).
Keep out of reach of children.
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:
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- 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 by contacting the distributor, Actavis Pharma Company at: 1-866-254-6111.
Actavis Pharma Company
6733 Mississauga Road, Unit 400
Mississauga, Ontario
Canada, L5N 6J5