This information is intended for use by health professionals
Menadiol Diphosphate 10mg Tablets
Each tablet contains 10mg of Menadiol Diphosphate (as Menadiol Sodium Diphosphate).
Excipient(s) with known effect: Lactose monohydrate 180.26 mg per tablets
For the full list of excipients, see section 6.1
The tablets are 9.0 mm, round, white to pale pink with CL 1L3 debossed on one face and a single break bar on the other.
The tablet can be divided into equal doses
For the treatment of haemorrhage or threatened haemorrhage associated with a low blood level of prothrombin or factor vii. The main indication is obstructive jaundice (before and after surgery).
Menadiol Diphosphate 10mg Tablets are for oral administration.
Usual therapeutic dose: 10-40mg daily
If, on the recommendation of a physician, a children's dosage is required, it is suggested that 5-20mg daily be given.
Recommendations for use in the elderly do not differ from those for other adults.
Administration to neonates, infants or to mothers in the pre- and post-natal periods. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Large doses of menadiol sodium diphosphate may decrease patient sensitivity to anticoagulants.
There is evidence of hazard if menadiol sodium diphosphate is used in human pregnancy. It is known to be associated with a small risk of haemolytic anaemia, hyperbilirubinaemia and kernicterus in the infant if administered to the mother in late pregnancy or during labour. Menadiol sodium diphosphate is therefore contra-indicated during late pregnancy.
Menadiol sodium diphosphate may induce haemolysis (especially in the newborn infant) in the presence of erythrocyte glucose-6-phosphate dehydrogenase deficiency or low concentrations of alpha-tocopherol in the blood.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
No information is available.
Menadiol sodium diphosphate is a water-soluble vitamin K analogue. The presence of vitamin K is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X. Lack of vitamin K leads to increased tendency to haemorrhage.
Menadione is absorbed from the gastro-intestinal tract without being dependent upon the presence of bile salts. Vitamin K is rapidly metabolised and excreted by the body.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
No information is available.
Do not store above 30°C and keep the tablets in their original container to protect from light.
White HDPE bottles containing 100 tablets.
Alliance Pharmaceuticals Ltd
2 Bath Road
30 April 1992