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Alliance Pharmaceuticals

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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Summary of Product Characteristics last updated on the eMC: 11/08/2011

SPC	Menadiol Diphosphate Tablets 10mg

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. DOSIMETRY
12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

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1. NAME OF THE MEDICINAL PRODUCT

Menadiol Diphosphate Tablets 10mg

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 10mg of Menadiol Diphosphate (as Menadiol Sodium Diphosphate USP).

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3. PHARMACEUTICAL FORM

The tablets are round, white to pale pink with CL 1L3 imprinted on one face and a single break bar on the other.

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4. CLINICAL PARTICULARS

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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).

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4.2 Posology and method of administration

Menadiol Diphosphate Tablets 10mg 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.

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4.3 Contraindications

Administration to neonates, infants or to mothers in the pre- and post-natal periods.

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4.4 Special warnings and precautions for use

None.

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4.5 Interaction with other medicinal products and other forms of interaction

Large doses of menadiol sodium diphosphate may decrease patient sensitivity to anticoagulants.

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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.

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4.7 Effects on ability to drive and use machines

None known.

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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.

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4.9 Overdose

No information is available.

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5. PHARMACOLOGICAL PROPERTIES

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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.

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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.

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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.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Lactose

Maize starch

Talc

Magnesium stearate

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