Summary of product characteristic
HERAPROSTOL
Misoprostol 200 mcg tablet
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:
Heraprostol (Misoprostol 200 mcg tablet):
Active ingredientst:
Misoprostol HPMC 1% Dispresion equivalent Misoprostol ………. 200 mcg
Excipients just enough: Microcrystalline cellulose 102, sodium starch glycolate type A, hydrogenated vegetable oil type 1.
DESCRIPTION ABOUT PRODUCT
Heraprostol (Misoprostol 200 mcg tablet):
Tablets are white, rounded, beveled, 2 flat surfaces, smooth, one surface with “HERA” words, the other with grooves, intact edge and walls.
PACKAGING:
Heraprostol (Misoprostol 200 mcg tablet): Box of 03 blister x 10 Tablets.
PHARMACODYNAMIC
Heraprostol tablet contains misoprostol that analogous to a chemical compound called “prostaglandin” that is naturally produced in the body.The prostaglandins are produced in stomach and intestines, helping to protect the lining.
Heraprostol tablet may help prevent stomach and duodenal ulcers. The ulcers may be caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac and naproxen. NSAIDs reduce the amount of prostaglandin in stomach and intestines. This can cause the indigestion and lead to ulcers. Heraprostol tablet will replace prostaglandin and protect your stomach and intestines, so you can continue to take NSAID. Heraprostol aldo reduce acid and increase bicarbonate in gastric secretions. Heraprostol can also be used to heal existing ulcers.
Heraprostol may be assisted by mifepristone to stop the development of pregnancy in uterine within the first 49 days of pregnancy.
Take the Heraprostol before using abortion tips trong the first trimester (make the cervix “ripe”).
Induction of labor for termination of pregnancy in the middle and the last trimester of pregnancy when fetal malformation or death in uterus.
Treatment of severe postpartum haemorrhage due to uterine dysfunction when oxytocine, ergometrine and carboprost are neither available nor appropriate.
DOSAGE AND ADMINISTRATION
Administration:
Alsway use Heraprostol as the doctor prescibed it. You should check with your doctor or pharmacist if you are unsure.
Misoprostol should be taken several times a day, taken at meal or immediately after meal and at bedtime.
Dosage:
Benign gastric – doudenum ulcers:
Adults: 100 -200 micrograms for one time, 4 times a day or 400 micrograms for one time, 2 times a day. Treatment lasts for at least 4 weeks, even if the symptoms reduce earlier and may continued up to 8 weeks if necessary. The following batch may be used if the disease recurs.
Prevention of stomach ulcer cause by NSAID:
Adults: 200 micrograms for one time, 4 times a day. If this dose is not tolerance, the dose may be reduced to 100 micrograms, 4 times/day, or 200 micrograms, 2 -3 times/day but less effective. It is unclear about the optimal time to use drug, the controlled studies for safety and effectiveness has only be evaluated for up to 3 months. However, misoprostol is recommended for the duration of NSAID treament.
Supporting mifepristone for miscarrage within 49 days in gestation:
Take a dose of 400 micrograms in 36 - 48 hours after taking mifepristone.
Cervical ripening before the procedure termination of pregnancy in the first trimester:
Take one dose of 400 micrograms 3 -4 hours bofore surgery.
Causing the labor in the second and the last trimester of pregnancy when the fetal maformation or death in the uterus:
placed in vagina is more effective than oral. The dosage regimens are various, include the cumulative dose from 400 – 3200 micrograms in 24 hours, the time between doses is 3 – 12 hours. Misoprostol can also be used with mifeprostone in the case of stillbirth in uterus.
Treatment of postpartum haemorrhage (final solution):
Take 200 – 800 micrograms.
No dose adjustment is necessary for kidney failure or elderly patients, but if the patients can not tolerate the usual dose, the dose may be reduced.
CONTRAINDICATIONS
Contraindicated use of Heraprostol in the following cases:
- Pregnant or planning to become prenant because this durg can cause miscarrage.
- Breastfeeding women.
- Have ever been allergic to misoprostol or any other ingredients, or other prostaglandins.
UNDESIRABLE EFFECTS
Like all other medications, this drug can cause side effects, although not everyone is affected. The majority of undesirable effects occured infrequently, not serious and often appear after a period of use. If you are worried about side effects, talk to your doctor.
The following side effects have been reported with misoprostol:
- Effects on stomach and intestines: indigestion, stomach ache, constipation, nausea and vomiting. Diarrhea is the common and sometimes serious problem. You will experiance less diarhea if you taked Heraprostol with foods. If you taked the antacids, you should avoid using magnesium – containing drug because they can cause more severe diarrhea. Doctor or pharmcist will help you to choose the approriate antacids.
- Effects on reproductive system: some women may have problems such as scramps, prolonged severe bleeding, bleeding between menstrual period, irregular menstruation and severe uterine pain. Some elderly women may have vaginal bleeding, although they have had menopause.
- Other side effects: chills, high temperature, skin rash and dizziness may occur.
- In addition, when Heraprostol is used for other purposes than medical indication and ulcers prevention, reported side effects include:
+ Abnormal uterine contractions.
+ Bleeding from uterine.
+ the tissues in the uterus is torn.
+ Omit the placenta in the womb after birth, termination of pregnancy and miscarrage.
+ Amniotics fluid in the mother’s blood causes the allergic reactions.
+ Miscarrage and premature birth.
+ Fetal death and congenital defects.
DRUG INTERACTION
You can take Heraprostol with most medicine without any problem. If you are taking antacids (occasionally reduce acids in your stomach), you should avoid using magnesium – containing antacids because they can cause more severe diarrhae.
If you are taking any medicine of cardiac diseases, consult your doctor.
Notify to doctor or pharmacist if you are taking or have recently taken any drug, including prescription or nonprescription medications.
You should take Heraprostol with food.
FORGET ONE DOSE
If you forget to take your medication, taking it as soon as you remember. But if it near the next dose, ignore the missed dose and continue to take the medicantion on schedule.
STORAGE
Store in a cool, dry place, temperature below 30oC.
OVERDOSE
When taking over the recommended dose may be experiancing the symptoms: sedation, tremors, convultion, dyspnea, abdominal pain, diarrhea, fever, palptation, hypotension, bradycardia.
TREATMENT FOR OVERDOSE
If you take the overdose, immediately notify to your doctor or go to the nearest medication canter.
CAUTIONS AND RECOMMENDED WHEN TAKING MEDICINE
Notify to doctor if you have the following signs that your doctor may decide to take Heraprostol for you:
- Cardiac diseases
- Hypertension or hypotension, or any blood vessels diseases.
- Imflammatory bowel diseases.
If you are a young woman who has not undergone the menopause, doctor will prescribe Heraprostol when you are at the high risk of ulcers development by NSAID. Doctor will let you know about the risk of pregnant.
Pregnant:
Heraprostol may cause miscarrage or affect your uterus, so using the reliable contraception while taking this drug is necessary. The risk of harm to the uterus is higher than the later stage of pregnancy, and if you have had caesarean or many previous pregnancy. If you are planning to become pregnant, notify to your doctor, you can stop using Heraprostol or use other treatments.
Heraprostol should not be used for pregnant women or planning to become pregnant.
Breastfeeding women:
Do not breastfeed when using Heraprostol.
Driving and operating machines:
Dizziness has been reported after taking Heraprostol. Be careful when driving and operating machinery until you know how drug affect you.
CONSULTATION WITH DOCTOR AND PHARMACIST
When you have indesirable effects of the drug, no treatment respone or symptons became worse. Consult to doctor and pharmacist 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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