This medication contains two different medications that are taken at different times: mifepristone and misoprostol. Mifepristone belongs to the class of medications called progesterone receptor modulators. It works by disrupting the way the hormone progesterone works in the body. Misoprostol belongs to the class of medications called prostaglandins. It works by causing muscle contractions in uterus, relaxation of the opening of the cervix, and shedding of the endometrium.

Mifepristone - misoprostol is used to terminate a developing pregnancy up to 63 days from the start of the last menstrual period.

Every month, progesterone is produced by the body to prepare the endometrium (the lining of the uterus) for a fertilized egg to implant. When no egg attaches to the wall of the uterus, the body stops producing progesterone and a menstrual bleed occurs. When a fertilized egg attaches to the wall of the uterus, progesterone continues to be produced, to support the growing embryo. When mifepristone is taken, it blocks the effect of the progesterone, causing the endometrium to break down and bleeding to begin.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

It is very important that these medications be taken in a specific order and at the times described by your doctor's instructions.

The usual dose of mifepristone is a single 200 mg tablet, taken by mouth. After 24 to 48 hours, 4 tablets of misoprostol 200 µg should be taken in a single dose. The misoprostol tablets should be placed between the cheek and gum for 30 minutes and allowed to dissolve. After 30 minutes, any remaining fragments can be swallowed with water. Plan to rest for 3 hours after taking the misoprostol tablets.

It is important to take this medication exactly as prescribed by your doctor. If you forget to take the misoprostol tablets and it is more than 48 hours after you took the mifepristone tablet, contact your doctor immediately.

Store this medication in its original package, protected from light, at room temperature. Keep it out of the reach of children.

Mifepristone 200 mg

Each white-to-off-white, round, biconvex tablet with "MF" embossed on one side contains 200 mg of mifepristone. Nonmedicinal ingredients: colloidal silica anhydrous, magnesium stearate, maize starch, microcrystalline cellulose, and povidone K30.

Mifepristone is packaged in a PVC/PVDC/Aluminum blister of 1 tablet presented in a green box of one tablet.

Misoprostol 200 µg

Each white, round, flat tablet with "ML" debossed on one side and "200" on the other side contains 200 µg of misoprostol. Nonmedicinal ingredients: hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.

Misoprostol tablets are packaged in dual-faced aluminum blisters and presented in an orange box of 4 tablets.

The two products are provided in two different boxes, which are packed together.

Do not take this medication if you:

• are allergic to mifepristone, misoprostol, or any ingredients of the medication
• have an ectopic pregnancy (a pregnancy developing outside of the uterus)
• have an intrauterine device (IUD) in place
• do not know exactly how far you are into your pregnancy
• do not have access to emergency medical care in the 14 days after starting this medication
• have chronic adrenal failure
• are taking long-term corticosteroids
• have a bleeding disorder
• are taking a blood thinner (anticoagulant)
• have inherited porphyria
• have uncontrolled asthma

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

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

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if one of the following side effects occurs:

• fever
• low blood pressure (e.g., dizziness, fainting)
• skin rash

Stop taking the medication and seek immediate medical attention if any of the following occur:

• hemorrhagic shock (shock from blood loss: dizziness; confusion; rapid breathing and heartbeat; low blood pressure; cool, clammy skin; thirst; dry mouth)
• prolonged heavy vaginal bleeding
• signs of a severe allergic reaction (e.g., itching, rash, hives; swelling of the face, lips, tongue or throat; difficulty breathing or swallowing)
• signs of a severe skin reaction (e.g., skin peeling, especially around mouth and eyes; red spots which burn, itch, or sting; tender red lumps)
• signs of an infection of the uterus lining (e.g., pain in the lower abdomen, fever, and abnormal vaginal discharge)
• signs of infection more than 24 hours after taking misoprostol (e.g., nausea, vomiting, diarrhea or unusual weakness)
• signs of toxic shock syndrome (e.g., fever, diarrhea, nausea, vomiting, muscle aches, low blood pressure, confusion, seizures, red spots or rash that looks like a sunburn)
• worsening asthma symptoms or bronchospasms (e.g., difficulty breathing, coughing, whistling sounds when you breathe, chest tightness).

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Asthma: People with breathing problems may experience increased difficulty breathing when taking misoprostol. It may decrease the effectiveness of corticosteroids or cause tightening of the airways. If you have asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness:Mifepristone - misoprostol may cause drowsiness, dizziness, or headaches, affecting the mental or physical abilities needed to drive and operate machinery. These effects slow down after day 3 and are usually gone by day 14. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

Heavy bleeding: Treatment with mifepristone - misoprostol usually results in vaginal bleeding. This is not proof that the pregnancy has been terminated. Complete termination of pregnancy is confirmed at your follow-up appointment with your doctor.

Heavy vaginal bleeding is described as bleeding heavily enough to soak through 2 full-size sanitary pads an hour for 2 hours in a row. This may be a sign that the medication has not worked completely. Contact your doctor immediately if you have heavy vaginal bleeding that lasts more than several hours.

Heart disease: The safety and effectiveness of this medication have not been established for women with heart disease or risk factors for heart disease (e.g., diabetes, high blood pressure, smokers over the age of 35 years). This medication is not recommended for women with heart disease. Infection: Rarely, serious and possibly fatal bacterial infections have occurred after taking mifepristone - misoprostol. If you experience abdominal pain or a general feeling of illness more than 24 hours after taking misoprostol, contact your doctor immediately.

Kidney function: The safety and effectiveness of using this medication have not been determined for women with renal failure. This medication is not recommended for women with renal failure.

Liver function: The safety and effectiveness of using this medication have not been determined for women with liver failure. This medication is not recommended for women with liver failure.

Medical monitoring: It is important to have an appointment with your doctor 7 to 14 days after taking the mifepristone in the doctor's office. This will let your doctor confirm that your pregnancy has safely been terminated.

Seizures: Seizures have been reported with other medications that are similar to misoprostol. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin reactions:Rarely, people taking mifepristone - misoprostol may experience a severe skin reaction that can be life-threatening. These reactions may start as target-like reddish patches on the chest and stomach with blisters and mouth, throat, or nose ulcers. It can cause peeling skin and may appear with fever and flu-like symptoms. If you experience any of these symptoms, or any other unusual skin reaction of the skin, contact your doctor immediately.

Treatment failure: Although this medication is generally effective, there is a possibility it will not work. Babies that are born after failed use of these medications are at an increased risk of birth defects.

Pregnancy: You can become pregnant immediately after using this medication, and this medication may cause harm to a developing baby. To decrease the chance of birth defects, avoid becoming pregnant before your next menstrual period.

To avoid becoming pregnant, start using birth control right away.

Breast-feeding: Mifepristone may pass into breast milk. Misoprostol does pass into breast milk. If you are a breast-feeding mother and take mifepristone - misoprostol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding

Children: The safety and effectiveness of using this medication have not been established for children less than 15 years of age. Adolescents between 15 and 18 years of age appear to be more likely to experience vomiting and abdominal pain with the use of mifepristone - misoprostol than older women.

There may be an interaction between mifepristone - misoprostol and any of the following:

• acetylsalicylic acid (ASA)
• alitretinoin
• alpha blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
• amiodarone
• androgens (e.g., methyltestosterone, nandrolone, testosterone)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• anti-cancer medications (e.g., busulfan, cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, trabectedin, vincristine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apixaban
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• benzodiazepines (e.g., chlordiazepoxide, clonazepam, diazepam, lorazepam)
• birth control pills
• bosentan
• bromocriptine
• buprenorphine
• bupropion
• buspirone
• calcitriol
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• cannabis
• celecoxib
• cisapride
• clindamycin
• cobicistat
• colchicine
• conivaptan
• corticosteroids (e.g., dexamethasone, fluticasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• dapsone
• darifenacin
• deferasirox
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• diclofenac
• digoxin
• disopyramide
• domperidone
• dronedarone
• drospirenone
• edoxaban
• elagolix
• eliglustat
• eplerenone
• ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• esketamine
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• everolimus
• fesoterodine
• fludrocortisone
• galantamine
• grapefruit juice
• guanfacine
• heparin
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., doravirine, efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• ivabradine
• lemborexant
• letermovir
• lidocaine
• lithium
• lomitapide
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• macitentan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• magnesium-containing antacids
• maraviroc
• mefloquine
• methadone
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• narcotic pain relievers (e.g., codeine, fentanyl, hydrocodone, oxycodone, tramadol)
• naloxegol
• octreotide
• ospemifene
• pegvisomant
• pentamidine
• pimecrolimus
• praziquantel
• procainamide
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• propafenone
• protein kinase inhibitors (e.g., bosutinib, crizotinib, dabrafenib, dasatinib, imatinib, nilotinib)
• riociguat
• rivaroxaban
• romidepsin
• quinidine
• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin)
• rifabutin
• rifampin
• rivaroxaban
• romidepsin
• rupatadine
• St. John's wort
• salmeterol
• seizure medications (e.g., clobazam, levetiracetam, phenobarbital, phenytoin, primidone, rufinamide, topiramate, valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
• sirolimus
• solifenacin
• solriamfetol
• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)
• sotalol
• sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
• "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
• sulfamethoxazole
• tacrolimus
• theophylline
• ticagrelor
• tizanidine
• tolterodine
• tolvaptan
• trazodone
• tretinoin
• "triptan" migraine medications (e.g., almotriptan, eletriptan, rizatriptan, sumatriptan)
• triazolam
• vilanterol
• warfarin
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.