MIFEGYMISO Q&A

MIFEGYMISO (Mifepristone / Misoprostol) Q&A

 

Please read this information carefully. We encourage you to ask your health professional questions about the information provided. You may also wish to discuss the information in this Q & A with a friend or family member.

Further information about MIFEGYMISO and a printed copy of the Patient Information Brochure is available from your health professional. We suggest you review this information and keep a copy of the Patient Information Brochure for future reference.

Do NOT use MIFEGYMISO as birth control. To prevent a pregnancy please see your health professional for contraception options.

What is MIFEGYMISO used for:

MIFEGYMISO is used for ending your pregnancy. This is called an abortion. MIFEGYMISO is only used if your last period started 63 days ago or less.

How does MIFEGYMISO work?

Step 1 (Green Box)

Mifepristone is taken first to block a hormone that is needed for your pregnancy to continue.

Step 2 (Orange Box)

Misoprostol is the second drug. It is taken 24-48 hours later. It causes the uterus to contract and relaxes the opening of the cervix.

Vaginal bleeding usually starts a few hours after taking the Misoprostol tablets.

 

How is MIFEGYMISO used?

MIFEGYMISO must be used within the first 63 days of pregnancy (based on a 28-day cycle) and is only available through prescription.

The process for achieving medical termination of pregnancy involves the combination of two drugs (green box and orange box). You must take both to terminate your pregnancy.

Take MIFEGYMISO as directed by your health professional.

Step 1:

(Green box)

Take the Mifepristone tablet

  • Swallow tablet with a glass of water

24 to 48 hours after taking the Mifepristone tablet, you must do Step 2.

 

Step 2:

(Orange box)

  • Place the 4 Misoprostol tablets (as a single 800 mcg buccal dose) in your mouth, at the same time.
  • Keep the 4 tablets between your cheeks and gums for 30 minutes
  • Then, swallow any fragments that are left with water

Plan to rest for 3 hours after taking the Misoprostol tablets.

Cramping and vaginal bleeding are normal with this treatment. Usually, this indicates that the treatment is working. Bleeding lasts for an average of 11 days. It is usual for bleeding to be heavier than a normal period for 2 to 3 days.

If you experience problems or are at all concerned about side effects you should contact your health professional, clinic, or the Info-Health telephone line.

While you are bleeding, plan to stay near a health professional or a clinic. That way you can call or visit them if necessary.

Where can I get MIFEGYMISO?

You will need to discuss this with your health professional.

For a list of Abortion Providers please refer to: Action Canada for Sexual Health & Rights, http://www.sexualhealthandrights.ca/, NAF Canada, http://www.nafcanada.org/, and Abortion Rights Coalition of Canada PDF http://www.arcc-cdac.ca/list-abortion-clinics-canada.pdf to view a partial list of abortion clinics in Canada.

Can I become pregnant after MIFEGYMISO use?

Yes, you can become pregnant again soon after your pregnancy ends. If you do not want to become pregnant, please see your health professional for contraception that may best suit your needs.

Once you start MIFEGYMISO, you should complete both steps. Both Mifepristone and Misoprostol can cause birth defects if your pregnancy is continued.

You can get pregnant right after the abortion. To decrease the chance of birth defects, avoid getting pregnant again before your next period. This will protect the baby from any exposure to MIFEGYMISO. Use birth control during this one month waiting period.

What are the typical signs and symptoms of the termination?

  • The onset of vaginal bleeding is usually within 4 hours of taking the misoprostol tablets and most women will experience the onset within 48 hours.
  • Bleeding can range from light to heavy. Bleeding is usually more than a typical menstrual period. This bleeding should diminish once the pregnancy is expelled.
  • Vaginal bleeding does not mean that the pregnancy has been expelled but it is normal to see blood clots and tissues. A follow-up assessment is very important, to confirm termination of pregnancy.
  • Sometimes bleeding can occur after taking the mifepristone but before taking the misoprostol.
  • The bleeding lasts on average 11 days. Light bleeding can continue for 30 days or more but does not normally go beyond the first menstrual period following your treatment.

What are some of the effects of treatment and when is prompt medical attention required?

Cramping and vaginal bleeding are normal with this treatment. Usually, this indicates that the treatment is working, but as with every medication there is a possibility of unwanted side effects.

Side effect may include:

  • breast tenderness
  • hot flushes, chills
  • diarrhea
  • dizziness, headache, fainting
  • fatigue
  • nausea
  • vomiting

PROMPT MEDICAL ATTENTION IS NEEDED IN THE FOLLOWING CIRCUMSTANCES. YOU SHOULD CONTACT YOUR HEALTH PROFESSIONAL FOR IMMEDIATE MEDICAL ATTENTION IF YOU EXPERIENCE:

  • heavy vaginal bleeding (soaking two or more thick sanitary pads per hour for 2 consecutive hours or have large fist-sized clots). This could be “problem bleeding”.
  • prolonged heavy bleeding or severe cramping. It is expected that, on average, bleeding will occur for 11 days after MIFEGYMISO administration and may initially be heavy. You should return to the clinic if any bleeding occurs after this time.
  • cramping which is not improved by pain relief medication
  • fever, chills or malaise lasting six hours or more
  • any abnormal vaginal discharge
  • severe abdominal pain
  • feeling sick (including weakness, nausea, vomiting, diarrhea, abdominal discomfort, cramps, fatigue, chills) with or without a fever more than 24 hour after taking misoprostol tablets.

Call your health professional if you have any serious side effect, such as:

  • general ill feeling and fast heart rate;
  • a fever higher than 100.4 °F (38 °C);
  • severe pelvic pain or tenderness;
  • severe or ongoing nausea, vomiting, diarrhea, weakness;
  • you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours; or
  • no vaginal bleeding at all after taking MIFEGYMISO (Mifepristone/Misoprostol)

This is not a complete list of unwanted side effects and others may occur. Additional information can be obtained in the product monograph available on this site, from the Health Canada site or from your health professional.

If you have serious symptoms or side effects, get immediate medical help. Contact your health professional, clinic, or go to the nearest medical emergency centre.

YOU SHOULD ALSO CONTACT YOUR HEALTH PROFESSIONAL IF YOU ARE WORRIED ABOUT THE FOLLOWING:

  • headache
  • breast tenderness
  • fainting
  • hot flushes; skin rashes or itching

It is possible that other side effects may occur in some people which have not been discovered yet. Other side effects not listed in this website may also occur in some people. You should discuss possible side effects that you may experience with your health professional.

Other Warnings you should know about:

This treatment does carry a small risk of the pregnancy continuing despite the attempt to terminate.

MIFEGYMISO does not work 3 to 5 cases out of 100. As pregnancy progresses the risk of this goes up. If this happens to you, you will need a surgical abortion.

What can I expect after taking MIFEGYMISO?

Cramping and vaginal bleeding are normal with this treatment. Usually, this indicates that the treatment is working. Bleeding lasts for an average of 11 days. It is usual for bleeding to be heavier than a normal period for 2 to 3 days.

You may see blood clots and tissue. This is an expected part of ending the pregnancy.

CRAMPING:

  • Cramping can start within 4 hours of taking the misoprostol tablets.
  • Cramping can range from mild to severe and is usually more than a typical menstrual period.
  • Significant cramping should diminish once the pregnancy is expelled and does not usually last longer than 24 hours.

PAIN MANAGEMENT:

TO HELP MANAGE YOUR PAIN, ENSURE THAT YOU:

  • rest
  • use hot packs on your abdomen or back
  • massage the lower abdomen frequently
  • take pain relief medications, always as directed by your health professional.

OTHER POSSIBLE SIDE EFFECTS:

  • headache
  • breast tenderness
  • fainting
  • hot flushes, skin rashes or itching

MISOPROSTOL TABLETS CAN CAUSE:

  • nausea
  • vomiting
  • diarrhea
  • dizziness

These side effects are usually short term and do not last more than 24 hours.

What are the Provincial/Territorial Telehealth/Telemedicine lines to contact if I require?

Alberta
Capital Health 8-1-1
Within Edmonton – 780-408-LINK (5465)
Toll-free elsewhere in Alberta – 1-866-408-LINK (5465) Within Calgary – 403-943-LINK (5465)

British Columbia
BC HealthGuide NurseLine
Throughout BC – 8-1-1

Manitoba
HealthLinks www.wrha.mb.ca/healthinfo/healthlinks/
Within Winnipeg – 204-788-8200
Toll-free throughout Manitoba 1-888-315-9257

New Brunswick
TeleCare www.gnb.ca/0217/tele-care-e.asp
Throughout NB – 8-1-1

PEI Telehealth 8-1-1

Newfoundland & Labrador www.nlchi.nl.ca/index.php/ehealth-systems/telehealth

Northwest Territories
www.hss.gov.nt.ca

Nova Scotia
Health Links For non-emergency health information and services – 8-1-1 Hearing impaired – 7-1-1

Ontario
Telehealth Ontario
1-866-797-0000
TTY 1-866-797-0007

Québec – Info-Santé
Throughout Québec – 8-1-1
To find your local CLSC, please visit the following website http://www.msss.gouv.qc.ca/reseau/info-sante.html.

Saskatchewan
HealthLine 8-1-1
TTY 1-888-425-4444

Yukon
Yukon Health Guide www.ykhealthguide.org 1-800-661-0408 Local 3673

What if I have worrying symptoms after taking MIFEGYMISO?

If you experience problems or are at all concerned about side effects you should contact your health professional, clinic, or the Info-Health telephone line.

When can tampons be used for post-abortion bleeding?

Always use sanitary pads for post-abortion bleeding until your health professional says otherwise.

MIFEGYMISO Pre-and- Post Care

The health professional will counsel and advise you on effects and adverse events relating to MIFEGYMISO. A copy of the Patient Information Brochure describing these facts can be obtained through this website or from your health professional.

It is very important to have a follow up appointment with the health professional 7 to 14 days after taking MIFEGYMISO.

A Patient Information Card should be provided to you by your health professional and will have emergency information and your scheduled follow up information written on the card for reference. Keep this card with you always while taking MIFEGYMISO until your health professional tells you that your abortion is complete.

If emergency care is required, Show the Patient Information Card to the emergency health professional.

Post care includes confirmation of abortion completion as well as discussing contraception options. If the pregnancy continues, there is a possibility of birth defects. Your health professional will talk with you about your options.

DISCLAIMER

The information provided on this website is for general information only.

Linepharma International Inc. and its affiliates make every effort to ensure the accuracy and reliability of the information that appears on this website but cannot guarantee that it is error free or complete.

Formerly Celopharma Inc., Linepharma International Inc. is the Canadian sales and distribution arm of Linepharma International.