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MEDABON: COMBIPACK OF MIFEPRISTONE is a brand name for Misoprostol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Medabon is indicated for medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea.
Verbatim from this product's MHRA label. Tap a section to expand.
e. 2mg each) vaginally in a single dose. If the patient vomits shortly after administration of mifepristone, she should inform the doctor. Medabon has only been studied in women over age 18. Paediatric population The product is not evaluated for use in children and adolescents.
Method of administration Misoprostol vaginal tablets can be administered by a health care provider (place two tablets on each side of the cervix in vaginal vault) or by the woman herself. The woman should be instructed to clean her hands thoroughly before inserting the misoprostol vaginal tablets as high as possible into the vagina, and remain recumbent for at least 30 minutes.
Undesirable effects are ranked under headings of frequency. Within each frequency grouping, the effects are presented in order of decreasing seriousness. Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, ≤1/100) Rare (≥1/10,000 ≤1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data).
Vascular Disorders Rare:
Hypotension.
Cardiac Disorders Not known:
Arteriospasm coronary** Myocardial infarction** Cardiac arrest** Gastrointestinal System Common: Cramping, light or moderate. Nausea, vomiting, diarrhoea (these gastrointestinal effects are related to misoprostol use).
Skin and subcutaneous tissue disorders Uncommon:
Hypersensitivity: skin rashes.
Rare:
Urticaria, erythroderma, erythema nodosum, epidermal necrolysis. Not known Acute generalised exanthematous pustulosis Reproductive system and breast disorders Very common: Uterine contractions or cramping (up to 70 to 80%) in the hours following misoprostol intake.
8% of the cases.
Uncommon:
Infection following abortion: Suspected or confirmed infections (endometritis, pelvic inflammatory disease) have been reported in less than 1% of women.
General disorders and administration site conditions Rare:
Headaches, malaise, vagal symptoms (hot flushes, dizziness, chills have been reported) and fever.
Injury, poisoning and procedural complications Rare:
Warnings In the absence of specific studies, caution is advised when Medabon use is considered in patients with: - renal failure - hepatic failure - malnutrition. Patients with prosthetic heart valves or who have had one previous episode of infective endocarditis should receive appropriate prophylactic antibiotic treatment.
e. to first take mifepristone and then follow with misoprostol to be administered 36-48 hours later, - the need for a follow-up visit within 14-21 days after intake of mifepristone in order to check that abortion is complete, - the possibility of failure of the method which may require pregnancy termination by a surgical method.
In the case of a pregnancy occurring with an intra-uterine device in situ, this device must be removed before administration of mifepristone. The expulsion of the product of conception may take place before misoprostol administration (in 1 to 2% of cases).
This does not preclude the follow-up visit in order to check that abortion is complete. Before Medabon is given to a woman who has undergone genital mutilation (FGM) a physical examination must be performed by a qualified trained medical professional to exclude any anatomical obstacles to medical abortion.
6). A second termination of pregnancy procedure shall be considered. In case of continuation of the pregnancy close monitoring by ultrasound scan must be performed in specialised centres. 8). In patients who experience severe cutaneous adverse reactions, retreatment with mifepristone is not recommended.
Because it is important to have access to appropriate medical care if an emergency develops, the treatment procedure should only be performed where the patient has access to medical facilities equipped to provide surgical treatment for incomplete abortion, or emergency blood transfusion or resuscitation during the period from the first visit until discharged by the administering qualified medical professional.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Misoprostol in United Kingdom.
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Uterine rupture * * Uterine rupture has been uncommonly reported after prostaglandin intake for induction of termination of second trimester pregnancy or labour induction for foetal death in utero in the third trimester. Uterine ruptures occurred particularly in multiparous women or in women with a caesarean section scar.
4 Special warnings and precautions for use). Very rare cases of fatal toxic shock caused by Clostridium sordellii endometritis, presenting without fever or other obvious symptoms of infection, have been reported. 4. Special warnings and precautions for use).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.
8% of the cases, makes the follow-up visit mandatory in order to check that abortion is complete. The patient should be informed that surgical treatment may be required to achieve complete abortion. - Bleeding The patient must be informed of the occurrence of prolonged vaginal bleeding (an average of about 13 days after mifepristone intake, up to three weeks in some women).
In a few cases, heavy bleeding may require surgical evacuation of the uterus. Bleeding is not in any way a proof of termination of pregnancy as it occurs also in most cases of failure. The patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been confirmed.
She should receive precise instructions as to whom she should contact and where to go, in the event of any problems or emergency, particularly in the case of very heavy vaginal bleeding. A follow-up visit must take place within a period of 14-21 days after administration of mifepristone to verify by the appropriate means (clinical examination, ultrasound scan, or beta-hCG measurement) that expulsion the abortion has been completed and that vaginal bleeding has stopped or substantially reduced.
In case of persistent bleeding (even light) beyond the follow-up visit, its disappearance should be checked a few weeks later. If an ongoing pregnancy is suspected, a further ultrasound scan may be required to evaluate its viability.
Persistence of vaginal bleeding at this point could signify incomplete abortion, or an unnoticed extra-uterine pregnancy, and appropriate investigation/treatment should be considered. In the event of an ongoing pregnancy diagnosed at the follow-up visit, termination by another method should be proposed to the woman.
8% of the cases during the medical method of pregnancy termination, special care should be given to patients with haemostatic disorders with hypocoagulability, or with anaemia. The decision to use the medical or the surgical method should be decided with specialised consultants according to the type of haemostatic disorder and the level of anaemia.
- Infection The genital tract is more susceptible to ascending infection when the cervix is dilated after abortion or childbirth. There are few data on the incidence of clinically significant pelvic infection after medical abortion, but it seems to be rare and probably occurs less often than after vacuum aspiration.
Many of the symptoms of pelvic infection, such as pain, are often non-specific and hence precise diagnosis is difficult. In women with clinical signs such as pelvic pain, abdominal or adnexal tenderness, vaginal discharge and fever, a pelvic infection should be suspected and appropriate treatment should be given.
Very rare cases of fatal or serious toxic shock caused by pathogens like Clostridium sordellii endometritis, Escherichia coli presenting with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200mg mifepristone followed by non authorised vaginal administration of misoprostol tablets for oral use.
It cannot be excluded that this infection may occur also with vaginal misoprostol as in Medabon. Clinicians should be aware of this potentially fatal complication. • Other risks Pregnancy-related symptoms such as nausea and vomiting may […]