SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cytacon 50micrograms Tablets Cyanocobalamin 50micrograms Tablets

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 micrograms Cyancobalamin BP.

3.    PHARMACEUTICAL FORM

Tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic Indications

Recommended Clinical Indications:

Treatment of nutritional Vitamin B12 deficiency.

Treatment of vitamin B 12 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

Dosage:    Adults: - One to three tablets (50 to 150 micrograms) or more daily 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.

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

Children: - One tablet (50 micrograms) daily at the discretion of the physician.

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

Method of administration: Oral.

4.3 Contra-indications

Hypersensitivity to the product or any of the excipients.

4.4 Special Warnings and Special Precautions For Use

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

Indiscriminate administration of this medicine may mask precise diagnosis.

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 this medicine may be lowered by oral contraceptives. These interactions are unlikely to have clinical significance.

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

4.6 Pregnancy and Lactation

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

4.7 Effects on Ability to Drive and Use Machines

4.8    Undesirable Effects

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

Acneform and bullous eruptions have been reported rarely.

Patients who have become sensitised to this medicine by injection are often able to tolerate 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.

4.9    Overdose

Overdosage is unlikely to require treatment.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

This medicine contain cyanocobalamin vitamin B 12, which is used for the treatment of pernicious anaemia, and nutritional deficiencies of vitamin B 12 which results in macrocytic anaemia.

5.2    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.

5.3 Preclinical safety data

No further relevant data.

6 PHARMACEUTICAL PARTICULARS

List of excipients

Lactose BP Maize Starch BP Magnesium Stearate BP Purified Water BP

Film coat

Hydroxypropyl Methylcellulose 2910 Ph.Eur Ethylcellulose Ph Eur Acetylated Monoglyceride

Speedcolour White 27120 Ansteads HSE (Titanium dioxide, talc and polysorbate)

Isopropyl Alcohol BP Dichloromethane BP

6.2 Incompatibilities

None stated.

6.3 Shelf Life

24 months in securitainers. 24 months in blisters

6.4 Special Precautions for Storage

Securitainer Protect from light.

Store in well closed containers.

Blisters

Store below 25°C, protected from light.

6.5    Nature and Contents of Container

Polyproylene container with a tamper evident low density polyethylene lid, containing 50 or 100 Cyanocobalamin Tablets.

Tampertainer staysafe made from high density polyethylene containing 50 or 100 tablets.

PVC/PVdC /Aluminium blister packs with 28, 56 or 112 tablets.

6.6    Instructions for Use, Handling and Disposal

7 MARKETING AUTHORISATION HOLDER

Mercury Pharma Group Ltd Capital House, 85 King William Street,

London EC4N 7BL, UK

8.    MARKETING AUTHORISATION NUMBER

PL 10972/0028

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/11/2003

10 DATE OF REVISION OF THE TEXT

09/05/2014