Mifegymiso

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.

It is important to take Mifegymiso 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.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, such as the following: Heavier bleeding, stronger cramps and pain than during your usual menstrual period Nausea, vomiting and diarrhea Headaches Fever and chills Fatigue and dizziness - use caution if driving However, some signs and symptoms may indicate complications and require a medical consultation or a visit to the emergency department, such as: Very heavy bleeding (e.g. full use of two maxi pads per hour for two consecutive hours) Loss of consciousness Dizziness or lightheadedness Increased heart rate Fever (38°C or over) for more than 6 hours, especially if it continues or occurs more than 24 hours after taking the second medication, misoprostol; Severe pain unrelieved by an appropriate treatment Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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 Mifegymiso 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
• have chronic adrenal failure
• are taking long-term corticosteroids
• have a bleeding disorder
• are taking medications to prevent Blood Clots
• have inherited porphyria
• have uncontrolled Asthma.

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

• Abiraterone
• acetylsalicylic acid (Asa)
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• amantadine
• Amiodarone
• androgens (e.g., methyltestosterone, nandrolone, testosterone)
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel; Doxorubicin; Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• Apomorphine
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• bexarotene
• birth control pills
• Bisoprolol
• Bosentan
• Bromocriptine
• Buprenorphine
• Bupropion
• Buspirone
• Busulfan
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Celecoxib
• chloral hydrate
• chloroquine
• cilostazol
• cisapride
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Dantrolene
• Dapsone
• Deferasirox
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Nateglinide, Rosiglitazone)
• Digoxin
• Disopyramide
• Domperidone
• Dronedarone
• drospirenone
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Ethosuximide
• Everolimus
• Famotidine
• felbamate
• Fentanyl
• Flecainide
• Flutamide
• formoterol
• fosphenytoin
• fosaprepitant
• Galantamine
• GnRH analogs (e.g., Leuprolide, Goserelin)
• Granisetron
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Hydrocodone
• Indapamide
• kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib)
• lidocaine
• lithium
• Lomitapide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• maraviroc
• Mefloquine
• mestranol
• Methadone
• Metronidazole
• Mirtazapine
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Montelukast
• nateglinide
• nefazodone
• nilotinib
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• Octreotide
• Oxycodone
• pentamidine
• Perampanel
• Phenobarbital
• Phenytoin
• Pimozide
• praziquantel
• Primaquine
• primidone
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• Propafenone
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Rivaroxaban
• Romidepsin
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• rivaroxaban
• romidepsin
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
• Sildenafil
• simprevir
• Sirolimus
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfamethoxazole
• Tacrolimus
• Tamoxifen
• telaprevir
• Temsirolimus
• Teniposide
• Tetrabenazine
• Tetracycline
• Theophylline
• Ticagrelor
• Ticlopidine
• Tizanidine
• Tolterodine
• Tolvaptan
• trabectedin
• Tramadol
• Trazodone
• Trimethoprim
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Vardenafil
• Venlafaxine
• Warfarin
• Zafirlukast
• 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 Mifegymiso. 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.

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 Mifegymiso.

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 Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

Diabetes: The safety and effectiveness of Mifegymiso have not been studied for women with diabetes. Mifegymiso is not recommended for women with diabetes.

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 Mifegymiso have not been established for women with heart disease. Mifegymiso is not recommended for women with heart disease. If you have risk factors for developing heart disease, discuss with your doctor how Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

High blood pressure: The safety and effectiveness of Mifegymiso have not been studied for women with high blood pressure. Mifegymiso is not recommended for women with high blood pressure.

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 Mifegymiso have not been determined for women with renal failure. Mifegymiso is not recommended for women with renal failure.

Liver function: The safety and effectiveness of using Mifegymiso have not been determined for women with liver failure. Mifegymiso 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 Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

Treatment failure: Although Mifegymiso 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 Mifegymiso, and Mifegymiso 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 Mifegymiso have not been established for children less than 15 years of age.

Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This information handout only provides an overview of your treatment. Given the complex nature of your treatment, you will receive information that is much more comprehensive and that deals specifically with your needs. Make sure that you have all the relevant information regarding your medication. If you vomit within one hour after taking the medication, contact your health care professional, an additional dose may be prescribed. If you forget a dose, contact your pharmacist. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.