Summary of Product Characteristics (SmPC) - Cyanocobalamin 50 micrograms film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Cyanocobalamin 50 microgram Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 microgram Cyanocobalamin.
Excipient(s) with known effect:
Each film-coated tablet contains 62.130 mg of lactose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to pale pink colour, round shape film coated tablet “D” debossed on one side and “C5” debossed on other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cyanocobalamin is indicated for:
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
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.
Paediatric population:
One tablet (50 micrograms) daily at the discretion of the physician.
Method of administration: Oral.
When possible, This medicine should be taken between meals.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 three months for 18 months until stabilised, and then annually.
Indiscriminate administration of this medicine may mask precise diagnosis.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction 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 Fertility, pregnancy and lactation
Pregnancy
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
None
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 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
Pharmacotherapeutic group: Antianemic preparations, Vitamin B12 (cyanocobalamin).
ATC code: B03BA01
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
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
Tablet Core
Lactose monohydrate
Pregelatinized Starch (E1422) Magnesium Stearate (E 572) Isopropyl Alcohol
Purified Water
Film coating
Opadry complete film coating 03H58880 white composed of: Hypromellose (E464)
Titanium dioxide (E171) Polyethylene glycol (E1520) Talc (E553b)
6.2 Incompatibilities
None stated.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container in order to protect from light.
6.5 Nature and contents of container
Polypropylene container with tamper evident PE cap containing 50 tablets. Each container contains one 1gm silica gel desiccant pouch, which must be kept in the container to help protect your tablets, and it should not be swallowed.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Farmak Pharmaceuticals UK Ltd
First Floor, 47 Queen Street,
Hull, HU1 1UU,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 59209/0158
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/07/2026
10 DATE OF REVISION OF THE TEXT
15/09/2026