Cyanocobalamin (vitamin b12)

Overdose

Overdosage is unlikely to require treatment.

Shelf life

24 months

Contraindications

Hypersensitivity to the product.

Incompatibilities

None stated.

List of excipients

Sodium carboxymethylcellulose

Syrup BP or Sucrose EP

Saccharin sodium BP

Methyl hydroxybenzoate BP

Ariavit amaranth (E123)

Citric acid monohydrate powder BP

Blackcurrant essence bush 36

Purified water

Pharmaceutical form

Syrup

Undesirable effects

Sensitisation to cyancobalamin is rare, but may present as an itching exanthema, and exceptionally as anaphylactic shock.

Acneform and bullous emptions have been reported rarely.

Patients who have become sensitised to cyanocobalamin by injection are often able to tolerate cyancobalamin by the oral route without trouble.

Reporting of side effects

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.

Preclinical safety data

No further relevant data.

Therapeutic indications

Treatment of nutritional Vitamin B12 deficiency.

Treatment of vitamin B12 deficiency following partial gastrectomy.

Treatment of tropical sprue, alone or with folic acid.

Treatment of pernicious anaemia when parenteral administration is not possible or not advised.

Pharmacodynamic properties

This medicine contains cyancobalamin vitamin B12, which is used for the treatment of pernicious anaemia, and nutritional deficiencies of vitamin B12 which results in macrocytic anaemia.

Pharmacokinetic properties

The absorption of cobalamins from the gut is dependent upon the glycoprotein intrinsic factor. Cobalamins are transported rapidly into the blood bound to protein, known as transcobalamins. Cobalamins are stored in the liver and excreted in the bile. They are known to cross the placenta.

Date of revision of the text

09/05/2014

Name of the medicinal product

Cytacon 35micrograms/5ml Syrup

Cyanocobalamin 35mcg/5ml Syrup

Marketing authorisation holder

Mercury Pharma Group Ltd

Capital House, 85 King William Street,

London EC4N 7BL, UK

Special precautions for storage

Protect from light.

Store in well closed containers.

Nature and contents of container

200ml - Amber glass bottles with plastic child resistant closure or a polypropylene screwcap or a ropp aluminium closure with either a PVDC faced EPE wad of a LDPE faced PVDC/EPE wad.

2000ml - Amber glass bottles with screw-on polypropylene closure with natural expanded polyethylene wad, polyethylene faced.

Marketing authorisation number(s)

PL 10972/0029

Cyanocobalamin (Vitamin B12) price

We have no data on the cost of the drug.
However, we will provide data for each active ingredient

Qualitative and quantitative composition

One 5ml spoonful contains 35 micrograms of cyanocobalamin

Special warnings and precautions for use

For pernicious anaemia, an adequate dose must be used and the blood picture must be examined regularly at least every 3 months for 18 months until stabilised, and then annually.

Indiscriminate administration of this medicine may mask the precise diagnosis.

Long term treatment with this medicine may increase the risk of dental carnes. It is important that adequate dental hygiene is maintained.

Medicines containing sugar should be administered with care to patients with Diabetes Mellitus.

Effects on ability to drive and use machines

None.

Dosage (Posology) and method of administration

Dosage:

Adults: - One or two 5ml spoonfuls of this medicine two or three times daily, or more at the discretion of the physician.

Elderly: - The normal adult dose is appropriate for the elderly.

Children: - One 5 ml spoonful of this medicine two or three times daily, or more at the disacretion of the physician.

In pernicious anaemia intramuscular therapy is preferable for initial correction of vitamin B12 deficiency. However, if necessary, the oral route may be used to follow this, in which case at least 300 micrograms should be given daily.

When possible, this medicine doses should be taken between meals.

Method of administration: Oral.

Special precautions for disposal and other handling

None

Date of first authorisation/renewal of the authorisation

14th February 1994