Summary of product characteristic
MIFE 200
Mifepristone Tablets 200 mg
Prescription drug.
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.
INGREDIENTS AND CONTENT
Each tablet contain:
Active ingredientst:
Mifepristone (micronised).....................200 mg
Excipients just enough: Silica K200, Microcrystalline cellulose 102, lactose monohydrate, copovidon, crospovidon XL, magesium stearate, talc.
DESCRIPTION ABOUT PRODUCT
Tablets are light yellow, rounded, beveled, 2 flat surfaces, one surface with “HERA” words, the other with grooves, intact edge and walls.
PACKAGING:
Box of 1 blister x 1 Tablet.
PHARMACODYNAMIC
Mife 200 is an anti-hormonal drug that inhibits the action of progesteron, a hormone needed to maintain pregnancy. Mife 200 may cause the termination of pregnancy in the uterus. This drug can also be used for soften and dilate the cervix and uterus.
Mife 200 is recommended in the following cases:
- Termination of pregnancy up to 22 weeks.
- Promoting labor in case of intrauterine fetal death and can not used for other medical treatment (prostaglandin or oxytocin).
ADMINISTRATION AND DOSAGE
The drug is taken orally in the presence of doctors or medical staff.
Termination of pregnancy development in the uterus until the end of 9 weeks and from the week 9th to the end of 12 weeks:
Pregnancy to the end of 63 days:
- Use 200 mg mifepristone.
- After use mifepristone from 24 to 48 hours, sublingually or on the cheeks 800 mcg mifsoprostol at a health facility or at home depending on your gesational age and your expectation. From the 8th week of gestation to the end of 9 weeks should use misoprotol and follow-up miscarrage at the medical facilities.
- Doctors will choose the right time to use misoprotol.
Pregnancy from 64 to the end of 84 days:
- Use 200 mg mifepristone.
- After taken mifepristone from 24 to 48 hours:
+ Place the 800 mcg misoprostol vaginal delivery bag at the facility
+ After every 3 hours, take 400 mcg misoprostol sublingually, maximum of 4 dose until complete the miscarrage.
+ If after 3 hours of 5th misoprostol dose is not miscarrage, continue taking 200 mg mifeprostone, you need to rest for 9 – 11 hours, repeat the dose of misoprostol as above until miscarrge.
+ If after 2 regiments are still not miscarrage, doctor will switch to anther method.
Termination of pregnancy development in the uterus from the 13th week to the end of 22 weeks:
Gestation age from 13 to the end of 18 weeks:
- Use 200 mg mifepristone.
- After 24 – 48 hours, place the 800 mcg misoprostol vaginal delivery bag. After every 3 hours, take 400 mcg misoprotol sublingually or on the cheeks until miscarrage. If after taking 5 dose of misoprostol without miscarrage, in the next day, take 5 dose of 400 mcg misoprostol every 3 hours sublingually or on the cheeks until miscarrage. If no miscarrage, follow misoprestol on the 3th day according to above regiment. After 3 days no absorption, using another method.
Gestation age from 19 to 22 weeks:
- Use 200 mg mifepristone.
- After 24 – 48 hours, place the 800 mcg misoprostol vaginal delivery bag. After every 3 hours, take 400 mcg misoprotol sublingually or on the cheeks until miscarrage. If after taking 5 dose of misoprostol without miscarrage, in the next day, take 5 dose of 400 mcg misoprostol every 3 hours sublingually or on the cheeks until miscarrage. If no miscarrage, switch to another method.
Promote labor in case of stillbirth:
Take the dose with 600 mg mifepristone daily for 2 days.
In all cases, the using of mifepristone requires measures to prevent the sensitive Rh factor (if negative Rh) and general measures during termination of pregnancy. You can get pregnant again after the termination of pregnancy is complete. Because some effects of mifepristone may still occur, therefore it is recommended to avoid re-pregnancy before the the next menstrual period after using Mife 200.
CONTRAINDICATIONS
Do not taking Mife 200 when:
- If you are allergic to mifepristone or any other ingredients, misoprostol.
- If you have adrenal insufficiency.
- If you have severe asthma and are not adequated treated.
- If you have inherited porphyria.
- Miral valve stenosis, embolism and history of embolism.
- Hemophilia, using anticoagulant.
- Anemia (severe or moderate)
With prescribed to terminate the pregnancy development in the uterus in the end of 9 weeks and from 10th week to the end of 12 weeks, definitely no use when:
- Confirmation or suspicion of ectopic pregnancy.
- Pregnancy at the previous scar in the uterus.
With prescribed to terminate the prenancy development in the uterus from 13th week to the end of 22 weeks, definitely no use when:
- There is a old scar at the body of uterus.
- Placenta accreta.
UNDESIRABLE EFFECTS
Like other medications, Mife 200 may cause side effects, although not all of people may experience it.
Very common (may affect more than 1 in 10 patients)
Uterine contraction or scramps after several hour of using prostaglandin, the effects associated with the use of prostaglandin such as nausea, vomiting or diarrhea.
Common (may affect 1 in 10 patients)
Severe bleeding, infection after absorption, mild to moderate gastrointestial tract.
Uncommon (may affect 1 in 100 patients)
Exanthema, hypotension.
Rare (may affect 1 in 1000 patients)
Headache, irritability, vasovagal (hot flushes, dizziness, chills), fever, exanthema and sometimes the severe skin disorder (exfoliative dermatilis, epidermal necrolysis or and etythema).
Very rare (may affect 1 in 10000 patients)
Swelling of the face and/or larynx may be with urticaria.
Death or septic shock from infection cause by pathogens such as Clostridium sordellii cause endometritis, Escherichia with or without fever and another symtpoms.
In very few women, especially people who had surgery in the uterus or were born with surgery, there is risk of the torm uterus.
With pregnancy, if you are still presnant or to keep going, talk to doctor to monitor and check for you regularly.
DRUG INTERACTION
Medicines containing active ingredients below interact with mifepristone:
- Corticosteroids (used to treat asthma or inflamentary treatment).
- Ketoconazole, itraconazole (used for antifungal treatment).
- St John’s Wort (herbal medicine used to treat mild depression).
- Phenytoin, phenobarbital, carbamazepine (used to treat epilepsy).
Please inform your doctor if you are taking or have recently taken other medicines, including prescription and non-precription drugs.
NSAIDs (nonsteroidial anti-inflammatory drugs) and aspirin (acetyl salicylic acid) may reduce the effects of aborption method.
Should not use grapefruit juice when treating with Mife 200.
FORGET ONE DOSE
If you forget to take a dose of Mife 200, this treatment may be ineffective.
Notify to your doctor if you forgot taking drug.
STORAGE
Store in a cool, dry place, temperature below 300C.
OVERDOSE
No serious side effects have been reported in studies in healthy and non-pregnant women when mifepristone is used with a single dose that more 3 times than the recommended dose for termination of pregnancy. Overdose may lead to more severe indesirable effects.
TREATMENT FOR OVERDOSE
Because you use drugs under the supervision of doctor and medical staff so you are unlikely to overdose. In case of overdose, please inform your doctor immediately.
CONTRAINDICATION
In some case, the treatment may not suitable for you, notify to your doctor if:
- Heart diseases.
- There are risk factors of heart diseases such as hypertension or high blood cholesterol (hyperlipidemia).
- Asthma
- Disease that affecting to the blood clotting.
- Liver or kidney disease.
- Anemia or malnutrition.
Doctor will discuss with you if you can be treated.
Your colporrhagia may be prolonger or more severe (an average of 12 days after taking Mife 200). Bleeding is not related to the success of the treatment.
Pregnant and breastfeeding:
In the clinical reality, lower limb defomity have been rarely reported after used Mife 200 alone or in combination with prostaglandins.
In cases of failure in termination of pregnancy, the risk to the fetus in unknown:
- If the failure was diagnosed in the periodic inspection times, and if you are agree, another method is used to terminate pregnancy.
- If you want to continue to be pregnant, you have to know there is an unspecified risk to your baby. In that case, checking by medical ultrasound before birth and gie especially attention to the limb.
You should not be pregnant before the next menstrual period after used Mife 200.
Because Mife 200 can be pass through breast milk, so breastfeeding should be stopped when treated with Mife 200.
Ability to drive and operate machines:
The drug is not affect the ability to drive and operate machinery. If you have headache, be careful when driving and operating machinery.
CONSULTATION WITH DOCTOR AND PHARMACIST
When you have any undesirable effects, no treatment response or the symptoms became worse. Consult to your doctor or pharmcist for more information.
SHELF LIFE
24 months from manufacturing day
Manufactured by:
HERA BIOPHARMACRUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam.
© 2016 Hera Biopharm. All Rights Reserved. Designed By Herabiopharm
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