Summary of product characteristics

Deltavit B12 1000 mcg Sublingual Tablets

1.Name Of The Medicinal Product

Deltavit B12 1000 mcg Sublingual Tablets.

2.Qualitative And Quantitative Composition

1 tablet contains 1000 mcg of cyanocobalamine For a full list of excipients, see section 6.1.

3.Pharmaceutical Form

Sublingual Tablets

4.Clinical Data

4.1 Therapeutic Indications

Hematological, neurological and other symptoms as a result of vitamin B12 deficiency. Malabsorption of vitamin B 12, for example due to lack of Intrinsic Factor (pernicious anemia), ventricular resection or small intestine disease. In the case of aminosalyl therapy, which may cause impaired B12 resorption.

4.2. Posology and method of administration

Dosage

One tablet should be placed under the tongue to dissolve once daily or as prescribed by the physician.

Method of administration

Deltavit B12 tablets 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 warning

No special.

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 aminoglycosides, aminosalicylic acid, antiepileptics, biguanides, chloramphenicol, cholestyramine, potassium, methyldopa and gastric acid inhibitors (e.g., omeprazole and cimetidine). The clinical relevance of many of these interactions is probably small.

4.6 Pregnancy And Lactation

Pregnancy

No known risks during use during pregnancy.

Breast-feeding

Cyanocobalamin passes into breast milk, but no effects on the breastfed newborns / infants are expected at therapeutic doses of Deltavit B12.

4.7 Effects On Ability To Drive And Use Machines

Deltavit B12 does not affect the ability to drive and use machines.

4.8 Side Effects

Immune system: Rare (≥ 1/10,000 <1/1.000):

Anaphylaxis. Fever.

Skin and subcutaneous tissue: Rare (≥ 1/10,000 <1/1.000):

Urticaria. Exanthema. Exemplary rash.Allergic reactions including skin reactions and angioedema.

4.9 Overdose

Toxicity: Low acute toxicity

Symptoms: Not to be expected even after very high doses.

Treatment: Should not be required. (Symtomatically in exceptional cases.)

5. Pharmacological Properties

5.1 Pharmacodynamic Properties.

Pharmacotherapeutic group: Preparations for oral B 12 therapy, ATC code: B03BA01 Vitamin B12 is essential in humans and active in mainly two important enzyme systems. The adenosylated form is the cofactor of the mitochondrial enzyme methylmalonyl CoA-mutas.

This reaction is important for normal fatty acid metabolism. The methylated form of vitamin B12 cofactor of methionine synthetase and thus essential for normal cell division.

Lack of methylcobalamin is also considered to be behind the demyelination seen in vitamin B12 deficiency. A disorder in this system leads to abnormal DNA metabolism with symptoms of primary organs with rapid cell division like bone marrow and mucosa. Experimentally, it has been shown that a lack of the methylating form is accompanied by neurological damage.

5.2 Pharmacokinetic Properties

After absorption from the sublingual mucosa:

Vitamin B12 is extensively bound to specific plasma proteins called transcobalamin, transcobalamin 2 appears to be involved in the rapid transport of the cobalamin to tissue.

Vitamin B12 is stored in the liver, excreted in the bile, and undergoes extensive enterohepatic recycling: part of the dose excreted in the urine, most of it in the first 8 hours; urinary excretion, however, accounts for only a small fraction in the reduction of total body stores acquired by dietary means. Vitamin B12 across the placenta and also appears in breast milk.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Data

6.1 List Of Excipients

Inactive ingredients: Microcrystalline cellulose, Aspartame, Magnesium stearate, Crosscarmellose sodium Talc, Citric acid, Sodium bicarbonate, Colloidal silicon dioxide, Povidone K30.

6.2 Incompatibilities