Summary of Product Characteristics (SmPC) - Menadiol Diphosphate 10 mg tablets
1 NAME OF THE MEDICINAL PRODUCT
Menadiol Diphosphate 10mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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
3. PHARMACEUTICAL FORM
Tablet
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
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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).
4.1 Posology and method of administration
Menadiol Diphosphate 10mg Tablets are for oral administration.
Adults
Usual therapeutic dose: 10-40mg daily
Children
If, on the recommendation of a physician, a children's dosage is required, it is suggested that 5-20mg daily be given.
The elderly
Recommendations for use in the elderly do not differ from those for other adults.
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
None.
4.5 Interaction with other medicinal products and other forms of interaction
Large doses of menadiol sodium diphosphate may decrease patient sensitivity to anticoagulants.
4.6 Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
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.
4.9 Overdose
No information is available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1 List of excipients
Lactose monohydrate
Pregelatinised starch
Talc
Magnesium stearate
6.2 Incompatibilities
No information is available.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 30˚C and keep the tablets in their original container to protect from light.
6.5 Nature and contents of container
White HDPE bottles containing 100 tablets.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 16853/0110
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30 April 1992
10 DATE OF REVISION OF THE TEXT
20/06/2018