Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: EXELGYN, 216, Boulevard Saint-Germain, 75007 Paris, France
Medical termination of developing intra-uterine pregnancy, in sequential use with mifepristone, up to 49 days of amenorrhea (see section 4.2).
Misoprostol is indicated in adults.
Misoprostol is taken as a single 400 microgram oral dose 36 to 48 hours after taking a single 600 mg oral dose of mifepristone. Information on the posology of mifepristone can be found in the product information of mifepristone.
Vomiting within 30 minutes after the intake could lead to a decrease in misoprostol efficacy: oral intake of a new misoprostol 400 microgram tablet is recommended in this case.
Only limited data is available on the use of misoprostol in adolescents.
Misoprostol tablets are for oral use only and should not be administered by any other route of administration.
In the event of overdosage, symptomatic treatment and appropriate medical care should be done. Gastrointestinal haemorrhage, renal failure, acute rhabdomyolysis, uterine haemorrhage and death have been reported after a massive dose of 12 mg misoprostol.
Symptoms related to an overdose of misoprostol: sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, haemorrhage, spasm of coronary arteries, hypotension, and bradycardia.
PVC-PCTFE/Alu blister: 1 year.
OPA-Alu-PVC/Alu blister: 24 months.
Store below 25°C.
Any tablet stored outside the blister or not used immediately has to be discarded.
1, 4, 16 or 40 tablet per carton box.
Tablets are packed in perforated unit-dose PVC-PCTFE/Alu or OPA-Alu-PVC/Alu blister.
Not all pack sizes may be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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