MEDABON CO Tablet, Vaginal tablet Ref.[50466] Active ingredients: Mifepristone Misoprostol

MEDABON CO should never be prescribed in the following situations:

• Hypersensitivity to mifepristone, misoprostol or a previous known allergy to prostaglandins, or any of the inactive ingredients of MEDABON CO (see section 6.1).
• Pregnancy not confirmed by gynaecological examination, ultrasound scan or biological tests.
• Pregnancy beyond 63 days of amenorrhoea.
• Confirmed or suspected extra-uterine pregnancy.
• Severe asthma uncontrolled by therapy.
• Inherited porphyria.
• Adrenal failure, acute or chronic.

Signs and symptoms

No cases of mifepristone overdose has been reported.

The signs and symptoms are expected to be aggravation of the adverse events listed in section 4.8.

The toxic dose of misoprostol in humans have not been determined. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia.

Treatment

In the event of accidental overdose ingestion of mifepristone, signs of adrenal failure might occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone. Treatment should be symptomatic and supportive.

Because misoprostol is metabolised like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage. In cases of overdose, standard supportive measures should be adopted as required.

36 months.

Store at or below 25°C.

Keep the blister strip in the outer carton until required for use.

Silver aluminium blister strip with a peelable paper backed aluminium lid, containing 1 oral tablet of mifepristone 200 mg and 4 vaginal tablets of misoprostol 0,2 mg. Each blister strip is packed together with a silica gel sachet in a sealed aluminium pouch and placed in an outer carton.

Pack sizes:

1 combipack (containing 1 blister strip with 1 mifepristone tablet and 4 misoprostol vaginal tablets),

or

30 × 1 combipacks.

Not all pack sizes may be marketed.

The treatment procedure should be fully explained and completely understood by the patient.