CYANOCOBALAMIN 35MICROGRAMS / 5ML SYRUP, CYTACON 35 MICROGRAMS / 5ML SYRUP - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cytacon 35micrograms/5ml Syrup

Cyanocobalamin 35micrograms/5ml Syrup

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One 5ml spoonful contains 35 micrograms of cyanocobalamin

Excipient(s) with known effect

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Syrup

4 CLINICAL PARTICULARS

4.1 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.

4.2 Posology and method of administration

Posology

Elderly:

The normal adult dose is appropriate for the elderly

Adults:

One or two 5ml spoonful of this medicine two or three times daily, or more at the discretion of the physician.

Paediatric population:

One 5 ml spoonful of this medicine two or three times daily, or more at the discretion 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.

4.3 Contra-indications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity to the product.

4.4 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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interactions with other Medicinal Products and other Forms of

Interaction

Absorption may be reduced by Para-aminosalicylic acid, colchinine, biguanides, neomycin, cholestyramine, potassium chloride, methyldopa, and cimetidine.

Patients treated with chloramphenicol may respond poorly to this medicine.

Serum levels of cyancobalamin may be lowered by oral contraceptives.

These interactions are unlikely to have clinical significance.

Anti-metabolites and most antibiotics invalidate vitamins B12 assays by microbiological techniques.

4.6 Fertility, pregnancy and lactation

Pregnancy

This medicine should not be used to treat of megaloblastic anaemia of pregnancy because this is due to folate deficiency.

4.7 Effects on Ability to Drive and Use Machines

None.

4.8 Undesirable Effects

Sensitisation to cyanocobalamin 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdosage is unlikely to require treatment.

5 PHARMACOLOGICAL PROPERTIES

5.1 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.

ATC code: B03BA01

5.2 Pharmacokinetic Properties

Absorption

The absorption of cobalamins from the gut is dependent upon the glycoprotein intrinsic factor.

Distribution

Cobalamins are transported rapidly into the blood bound to protein, known as transcobalamins.

Elimination

Cobalamins are stored in the liver and excreted in the bile. They are known to cross the placenta.

5.3 Preclinical Safety Data

No further relevant data.

6 PHARMACEUTICAL PARTICULARS

6.1 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

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months

6.4 Special Precautions for Storage

Protect from light.

Store in well closed containers.

6.5 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.

6.6 Instructions for Use, Handling and Disposal

None

7 MARKETING AUTHORISATION HOLDER

Mercury Pharma Group Ltd

Capital House, 85 King William Street,

London EC4N 7BL, UK

8. MARKETING AUTHORISATION NUMBER

PL 10972/0029

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

06/11/2003