This information is intended for use by health professionals

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).

4.2 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 Fertility, 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. Pharmaceutical particulars
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 and other handling

None.

7. Marketing authorisation holder

Alliance Pharmaceuticals Ltd

Avonbridge House

2 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