Summary of Product Characteristics (SmPC) - Cyanocobalamin 1 mg film-coated tablets

1 NAME OF THE MEDICINAL PRODUCT

Cyanocobalamin 1 mg film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 1 mg cyanocobalamin (Vitamin B12). Cyanocobalamin contains cobalt.

Excipient(s) with known effect

Each 1 mg film-coated tablet contains 64.00 mg mannitol. For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet.

Light pink to pink, round, biconvex, film coated tablets, 8 mm diameter, debossed with “C” on one side and plain on other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Cyanocobalamin is indicated for adults.

Acute and long-term maintenance treatment of Vitamin B12 deficiency due to malnutrition, medications or malabsorption, in the absence of neurological symptoms.
Maintenance treatment of pernicious anaemia, following initial parenteral treatment.

In cases where patients require rapid normalisation of associated Vitamin B12 biomarkers, acute treatment with parenteral administration of Vitamin B12 should be performed.

4.2 Posology and method of administration

Posology

Adults:

1 film-coated tablet daily.

Where rapid normalisation of vitamin B₁₂associated biomarkers is required, vitamin B₁₂should initially be given parenterally. In case of hematological and neurological symptoms, parenteral therapy should be administered until blood values return to normal.

Paediatric population

Cyanocobalamin is not suitable for use in children and adolescents under 18 years of age.

Elderly patients

For elderly patients, the normal dosing schedule is recommended.

Patients with renal dysfunction

Cyanocobalamin 1000 micrograms film-coated tablets can be used at the normal dosage in patients with renal dysfunction. In cases of severe renal impairment it should be used under supervision of a doctor. Serum vitamin B12 values should be checked regularly and the dosage reduced if necessary.

Patients with hepatic dysfunction

No pharmacokinetic data and no clinical experience are available for patients with hepatic dysfunction. Safety and efficacy in patients with hepatic dysfunction have not been investigated.

Duration of treatment

If tolerability is good, there are no restrictions on the duration of use. Orally administered vitamin B12 is usually given on a life-long basis, provided that adequate vitamin absorption from the intestine has been demonstrated or for as long as vitamin B12 deficiency persists. In case of pernicious anaemia a life-long substitution is required. The response to treatment must be regularly monitored.

Method of administration

Oral use.

The tablets need to be taken with water, preferably between meals or in the morning on an empty stomach.

4.3 Contraindications

Hypersensitivity to cyanocobalamin (Vitamin B12) or any of the excipients.
Leber's hereditary optic atrophy.
Tobacco and alcohol amblyopia.
Tropical ataxic neuropathy.

4.4 Special warnings and precautions for use

Clinical response to treatment should be monitored, including rechecking appropriate plasma levels as needed. If vitamin b12 deficiency fails to respond to oral treatment, adherence to treatment should be checked and the dose or route of cyanocobalamin should be adjusted.

4.5 Interaction with other medicinal products and other forms of interaction

The absorption of Vitamin B12 from the gastrointestinal tract can be reduced by oral contraceptives, aminoglycosides, aminosalicylic acid, anticonvulsants, biguanides, chloramphenicol, cholestyramine, potassium salts, methyldopa and gastric-acid-inhibiting agents (e.g. omeprazole and cimetidine). The clinical relevance of many of these interactions is likely to be small.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no known risks with use during pregnancy.

Breast-feeding

Cyanocobalamin is excreted into human milk, but at therapeutic doses of Cyanocobalamin no effects on the breastfed newborns/infants are anticipated.

4.7 Effects on ability to drive and use machines

Cyanocobalamin has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Rare (≥1/10,000 to <1/1,000)

Immune system disorders: Anaphylaxis. Fever.

Skin and subcutaneous tissue disorders: Urticaria Exanthema. Exanthematous rash. Allergic reactions, including skin reactions and angioedema.

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. By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Toxicity:

Low acute toxicity.

Symptoms:

None expected, even after very high doses.

Treatment:

Should not be required.

Symptomatic treatment might be necessary, in exceptional cases.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antianemic Preparations, Vitamin B12 (cyanocobalamin and analogues), ATC code: B03BA01

Vitamin B12 is essential in humans and is primarily active in two important enzyme reactions. The adenosylising form is the co-factor to the mitochondrial enzyme methyl malonate mutase. This reaction is significant for normal lipometabolism. The methylated form of Vitamin B12 is the co-factor for methionine synthetase and therefore essential for normal cell division. Lack of methylcobalamin is also considered to underlie demyelination as seen in Vitamin B12 deficiency. A disturbance of this system leads to abnormal DNA metabolism with symptoms primarily from organs with rapid cell division, such as bone marrow and mucosa. It has been shown experimentally that a lack of the methylating form is accompanied by neurological damage.

5.2 Pharmacokinetic properties

Orally administered cyanocobalamin is absorbed passively in the duodenum and small intestines even without the presence of intrinsic factor. The degree of absorption is dose-dependent and is about 1% of a dose of 1 mg or 10–12 μg after one Cyanocobalamin tablet. This dose is sufficient for the maintenance treatment of patients with pernicious anaemia and other forms of malabsorption of Vitamin B12. Oral therapy with higher doses can be given initially, but in cases of manifest B12 deficiency, parenteral therapy should be preferred for faster remission and liver repletion.

5.3 Preclinical safety data

There is no relevant preclinical data for evaluation of safety beyond that already stated in the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core

Mannitol

Microcrystalline cellulose

Pregelatinised starch

Potato starch

Stearic acid

Magnesium stearate

Film-coating

Hypromellose 6 mPas

Hypromellose 15 mPas

Rice starch

Isomalt

Medium chain triglycerides

Iron oxide yellow

Black iron oxide

Carmine

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

PVC/PVDC-Alu blisters pack.

Pack sizes: 28 film-coated tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Biovantic Pharma Limited

Kemp House, 160 City Road,

London, EC1V 2NX

8 MARKETING AUTHORISATION NUMBER(S)

PL 53475/0034

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

08/10/2026

10 DATE OF REVISION OF THE TEXT