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MIFEPRISTONE is a brand name for Mifepristone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1- Medical termination of developing intra-uterine pregnancy. In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea (see section 4.2). 2- Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester. 3- Preparation for the action of…
Verbatim from this product's MHRA label. Tap a section to expand.
3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 μg orally, or gemeprost 1 mg per vaginam. e. 1. pharmacodynamic properties). 5 Interaction with other medicinal products and other forms of interactions).
e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam. e. 1. pharmacodynamic properties). 5 Interaction with other medicinal products and other forms of interactions).
Information on the posology of misoprostol or gemeprost can be found in the respective product information. 2- Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester. Mifepristone is taken as a single 200 mg (1 tablet) oral dose, followed 36 to 48 hours later (but not beyond) by surgical termination of pregnancy.
e. 3 tablets of 200 mg each) oral dose, 36 to 48 hours prior to scheduled prostaglandin administration which will be repeated as often as indicated. g. 3 tablets of 200 mg each) oral daily dose, for two consecutive days. Labour should be induced by the usual methods if it has not started within 72 hours following the first administration of mifepristone.
g. 3 tablets of 200 mg each) is recommended in this case. Paediatric population Only limited data are available on the use of mifepristone in adolescents. Method of administration Mifepristone tablets are for oral use only and should not be taken by any other route of administration.
The frequencies of occurrence of side effects are classified as follows:
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Infections and infestations Common: - Infection following abortion.
Suspected or confirmed infections (endometritis, pelvic inflammatory disease) have been reported in less than 5% of women. Very rare: - Very rare cases of serious or fatal toxic and septic shock (caused by Clostridium sordellii or Escherichia coli), which can be with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of unauthorised vaginal or buccal administration of misoprostol tablets for oral use.
4. – special warnings and special precautions for use). 25%) Gastrointestinal disorders Very common: - Nausea, vomiting, diarrhoea (these gastro intestinal effects related to prostaglandin use are frequently reported). Common: - Cramping, light or moderate.
2%). Rare - Single cases of urticaria, erythroderma, erythema nodosum, toxic epidermal necrolysis have also been reported. Very rare - Angioedema Not known - Acute generalised exanthematous pustulosis Reproductive system and breast disorders Very common: - Very common uterine contractions or cramping (10 to 45%) in the hours following prostaglandin intake.
4% of the cases. Rare: - During induction of second trimester termination of pregnancy or labour induction for foetal death in utero within the third trimester, uterine rupture has been uncommonly reported after prostaglandin intake.
The reports occurred particularly in multiparous women or in women with a caesarean section scar. General disorders and administration site conditions Rare: - Malaise, vagal symptoms (hot flushes, dizziness, chills), fever. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Warnings Because of its abortifacient properties, mifepristone should never be used in a woman with an ongoing pregnancy who wants to complete it. The age of the pregnancy must be determined from the questioning and the clinical examination of the patient.
Uterine ultrasound is recommended. 8). In patients who experience severe cutaneous adverse reactions, treatment with mifepristone should be immediately discontinued. Re- treatment with mifepristone is not recommended. The pharmacokinetics, safety and tolerability of mifepristone 200 mg were investigated in women with moderate hepatic impairment versus healthy women participants with normal hepatic function.
Statistical analyses of total AUC∞ and Cmax for the mifepristone, N-demethylated metabolite, hydroxylated metabolite and di-demethylated metabolite showed a decrease in both overall peak and exposure in patients with moderate hepatic impairment compared to healthy-matched participants.
This decrease in exposure could be caused by a decrease in absorption and/or protein binding. However, the possible consequences of moderate hepatic impairment on the unbound fraction could not be determined. In conclusion, the clinical consequences of 200 mg mifepristone administration in patient with moderate hepatic impairment are unknown.
In the absence of specific studies, mifepristone is not recommended in patients with: - Malnutrition - Hepatic failure - Renal failure 1- Medical termination of developing intra-uterine pregnancy This method requires an active involvement of the woman who should be informed of the method's requirements: - the necessity to combine treatment with a prostaglandin analogue to be administered at a second visit 36 – 48 hours after administration of this medicine, - the need for a follow-up visit (3rd visit) within 14 to 21 days after intake of mifepristone in order to check for complete expulsion, - the possible failure of the method, leading to a pregnancy termination by another method.
This product SHOULD NEVER be prescribed in the following situations. 1, - severe asthma uncontrolled by therapy, - inherited porphyria. In the indication: medical termination of developing pregnancy - pregnancy not confirmed by ultrasound scan or biological tests, - pregnancy beyond 63 days of amenorrhea, - suspected extra-uterine pregnancy, - contra-indication to the prostaglandin analogue selected.
In the indication: softening and dilatation of the cervix uteri prior to surgical termination of pregnancy: - pregnancy not confirmed by ultrasound scan or biological test, - pregnancy of 84 days of amenorrhea and beyond - suspected extra-uterine pregnancy.
In the indication: preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester) - contra-indications to the prostaglandin analogue selected
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In the case of a pregnancy occurring with an intra-uterine device in situ, this device must be removed before administration of mifepristone. 5 % of the cases, makes the control visit mandatory in order to check that the expulsion is completed.
In rare case of non complete expulsion, a surgical revision may be necessary. The efficacy of method decreases with parity, and consequently increasing age of the woman. - Bleeding The patient must be informed of the occurrence of prolonged vaginal bleeding (an average of about 12 days or more after mifepristone intake) which may be heavy.
Bleeding occurs in almost all cases and is not in anyway a proof of complete expulsion. The bleeding can occur very quickly after misoprostol intake, and sometimes later: - In 60%, expulsion occurs within 4 hours following misoprostol intake - In the remaining 40% of the cases, expulsion occurs within 24 to 72 hours following misoprostol intake.
Rarely the expulsion may occur before administration of the prostaglandin analogue (around 3% of the cases). This does not preclude the control visit in order to check for the complete expulsion and the uterine vacuity. The patient should be informed not to travel far away from the prescribing centre as long as complete expulsion has not been recorded.
She will receive precise instructions as to whom she should contact and where to go, in the event of any problems emerging, particularly in the case of very heavy vaginal bleeding. This is bleeding that lasts longer than 12 days and/or that is heavier than the normal menstrual bleeding.
A follow-up visit must take place within a period of 14 to 21 days after the intake of mifepristone to verify by the appropriate means (clinical examination, together with beta-hCG measurement or ultrasound scan) that expulsion has been completed and that vaginal bleeding has stopped.
In case of persistent bleeding (even light) beyond the control visit, its disappearance should be checked within a few days. If an ongoing pregnancy is suspected, a further ultrasound scan may be required. Persistence of vaginal bleeding at this point could signify incomplete abortion, or an undiagnosed ectopic pregnancy, and appropriate treatment should be considered.
4% 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.
In the event of an ongoing pregnancy diagnosed after the follow-up visit, termination by another method will be proposed to the woman. - Infection Serious cases (including fatal cases) of toxic shock and septic shock following infection with atypical pathogens (Clostridium sordellii or Escherichia coli) have been reported after medical abortion with the use of mifepristone 200 mg followed by unauthorised vaginal or buccal administration of misoprostol tablets.
Clinicians should be aware of this potentially fatal complication. 2- Softening and dilatation of the cervix uteri prior to surgical pregnancy termination For the full efficacy of therapy, the use of Mifepristone 200 mg tablets must be followed, 36 to 48 hours later and not beyond, by surgical termination.
• Risks related to the method - Bleeding The woman will be informed of the risk of vaginal bleeding which may be heavy, following intake of Mifepristone 200 mg tablets . She should be informed of the risk of abortion prior to surgery (although minimal).
She will be informed on where to […]