Each co-package of mifepristone tablet and misoprostol tablets (hereinafter called as Co-package) contains 1 tablet of mifepristone 200mg and 4 tablets of misoprostol 200mcg. These two types of medications that are used together to induce abortion

Mifepristone is given first to blocks the effects of the hormone progesterone and to helps soften the cervix (the opening to the womb). Once mifepristone has acted, misoprostol is given to soften and open the cervix and triggers contractions of the womb, expelling its contents.

Medical termination of pregnancy at less than 12 weeks of gestation

1. • One Mifepristone 200 mg tablet should be swallowed with some water

   • After 24 to 48 hours, you will need to take 4 tablets of Misoprostol 200mcg (total of 800 mcg) together The tablets should be taken together and can be given in different ways, by inserting them in your vagina, or placing them under your tongue or at the side of your mouth to dissolve.

Medical termination of pregnancy at or beyond 12 weeks of gestation

2. • One Mifepristone 200 mg tablet should be swallowed with some water

   • After 24 to 48 hours, you will need to take 2 tablets of Misoprostol 200 mcg (total of 400 mcg). The tablets should be taken together and can be given in different ways, by inserting them in your vagina, or placing them under your tongue or at the side of your mouth to dissolve

   • Three hours later, you should repeat this dose by taking 2 more tablets of Misoprostol 200 mcg (total of 400 mcg) in the same way.

   • Your health care provider may provide additional tablets of Misoprostol 200 mcg to be taken every three hours

Remark: To ensure the full dose of Co-package is taken, the tablets must not be crushed, broken or chewed.

Do not take Co-package if you:

3. • are allergic to mifepristone or misoprostol or any of the other ingredients of the tablets

   • have had a previous allergic reaction to prostaglandins

   • have adrenal failure

   • have severe asthma that cannot be adequately treated with medication

   • have hereditary porphyria (a rare metabolic disorder)

   • have severe liver disease

   • have an ectopic pregnancy, where the embryo is known or suspected to be growing outside of your womb

4. • you have heart disease or have risk factors for heart disease, such as high blood pressure or high cholesterol levels

   • you suffer from asthma

   • you have a bleeding disorder or severe anaemia

   • you have liver or kidney disease

   • you have been using corticosteroid medication

   • you have had genital cutting or circumcision

   • you are taking or have recently taken any other medicines,

Do not drink grapefruit juice when you are treated with Mifepristone 200mg tablets.

Birth defects have been seen in babies born to mothers where mifepristone and misoprostol did not work to terminate pregnancy. If Co-package does not terminate your pregnancy successfully, your baby may be at risk of birth defects. It is not known how big the risk may be.

If the pregnancy continues and you decide to keep it, discuss this with your health care provider who may arrange careful prenatal monitoring.

If you are breastfeeding, talk to your health care provider before using Co-package. Do not breastfeed while taking mifepristone and misoprostol as these medicines are passed into breast milk.

Co-package does not affect fertility. You can become pregnant again as soon as your termination is completed. You should start contraception immediately after the termination of the pregnancy is confirmed.

If you take more Mifepristone 200 mg tablets than you should:

As you will be supervised during administration of the treatment it is unlikely that you will take more Mifepristone 200 mg tablets than you should.

If you take more Misoprostol 200 mcg Tablets than you should:

The symptoms that may indicate an overdose of misoprostol are the following: fever, blood pressure disorders, feeling sick (nausea), stomachache (abdominal pain) and shaking (tremors).  If you have accidentally taken too many tablets, contact your healthcare provider as soon as you can.