Instructions B12 Ankerman film-coated tablets 1 mg blister No. 50
Composition
active ingredient: cyanocobalamin;
1 tablet contains cyanocobalamin 1 mg (1000 mcg);
Excipients: lactose, monohydrate, povidone K 30, stearic acid, croscarmellose sodium, gum arabic, calcium carbonate, polyethylene glycol (macrogol) glyceryl monostearate, macrogol 6000, sucrose, talc, titanium dioxide (E171), kaolin, sodium lauryl sulfate, aquapolish P white, montan glycol wax.
Dosage form
Film-coated tablets.
Main physicochemical properties: round, biconvex tablets from white to slightly pink in color.
Pharmacotherapeutic group
Antianemic agents. Cyanocobalamin. ATX code B03B A01.
Pharmacological properties
Pharmacodynamics.
Vitamin B12 is necessary for the conversion of propionic acid to succinic acid. In addition, like folic acid, vitamin B12 is involved in the formation of labile methyl groups, which are transferred to other methyl acceptors through transmethylation processes. Vitamin B12 also affects the synthesis of nucleic acids, in particular during hematopoiesis and other processes of cell maturation. Vitamin B12 (cyanocobalamin) is necessary for cellular metabolic processes. It affects the function of hematopoiesis.
In the body (mainly in the liver) it is converted into a coenzyme form – adenosylcobalamin, or cobamamide, which is the active form of vitamin B12. Cobamamide is a component of numerous enzymes, in particular, a component of reductase, which reduces folic acid to tetrahydrofolic acid.
Signs of Vitamin B12 Deficiency. Impaired or absent absorption of vitamin B12 will eventually lead to clinical symptoms if plasma levels fall below 200 pg/mL. The consequences are megaloblastic anemia and neurological deficits in the peripheral and central nervous systems. Early signs of deficiency may include fatigue and pallor, tingling in the hands and feet, unsteady gait, and decreased physical strength.
Symptoms caused by vitamin B12 deficiency can only be resolved by taking vitamin B12.
Pharmacokinetics.
Vitamin B12 is absorbed in two different ways. Active absorption in the small intestine involving intrinsic factor. Transport of vitamin B12 into tissues involves attachment to transcobalamin.
Independently of intrinsic factor, vitamin B12 can also enter the bloodstream by passive diffusion through the gastrointestinal tract or mucous membranes. Approximately 1–3% is absorbed into the blood when taken orally, depending on the dose. Thus, at high oral doses (1000 μg/day), absorption is ensured even in patients with intrinsic factor deficiency.
Up to 90% of the body's vitamin B12 stores are in the liver, where the vitamin is stored as an active coenzyme at a loss rate of 0.5 to 0.8 mcg per day. In healthy adults, the total body vitamin B12 content is 3 to 5 mg. It usually takes 3–5 years for clinical signs of vitamin B12 deficiency to appear.
Vitamin B12 is excreted mainly via the gallbladder and up to 1 μg is reabsorbed via enterohepatic circulation. If the storage volume in the body is exceeded due to high doses, particularly after parenteral administration, some is excreted in the urine.
Indication
Vitamin B12 deficiency, which may manifest as impaired erythrocyte maturation (hemopoietic disorders such as hyperchromic macrocytic megaloblastic anemia, pernicious anemia, and other macrocytic anemias) and/or neurological disorders such as funicular myelosis (a disease of the spinal cord).
Vitamin B12 deficiency, which can occur due to:
long-term nutritional deficiency (for example, a strict vegetarian diet);
impaired absorption of food (malabsorption due to insufficient production of intrinsic factor), ileal diseases (e.g. celiac disease);
hereditary vitamin B12 transport disorder.
Contraindication
Hypersensitivity to the components of the drug. Erythremia, erythrocytosis. Neoplasms, except for cases accompanied by megaloblastic anemia and vitamin B12 deficiency. Acute thromboembolic diseases. Angina, exertion of high functional class.
Increased susceptibility to tobacco amblyopia or retrobulbar neuritis in pernicious anemia or any other condition requiring cyanide detoxification.
Interaction with other medicinal products and other types of interactions
Aminoglycosides, salicylates, antiepileptic drugs, colchicine, potassium preparations reduce the absorption of the drug and affect its kinetics.
When used simultaneously with kanamycin, neomycin, polymyxins, tetracyclines, proton pump inhibitors, and H2-histamine receptor blockers, cyanocobalamin absorption is reduced.
Nitric oxide causes functional vitamin B12 deficiency.
Metformin can reduce vitamin B12 levels in the blood.
Oral contraceptives reduce the concentration of cyanocobalamin in the blood.
Steroid medications, such as prednisone, increase the absorption of vitamin B12 in patients with pernicious anemia.
Chloramphenicol reduces the hematopoietic response to the drug.
Application features
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Contains 0.259 g of lactose per tablet. Use with caution in patients with diabetes.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Contains 0.059 g of sucrose per tablet. Use with caution in diabetics.
This medicinal product contains approximately 2 mmol (or approximately 273.0 mg) sodium/tablet. Caution should be exercised when administering this medicinal product to patients on a controlled sodium diet.
In case of haematopoietic and/or neurological disorders, treatment should be monitored. Seven days after the start of treatment, it is recommended to check the reticulocyte count, complete blood count (including haemoglobin [Hb] and haematocrit [Hk]), and mean corpuscular volume (MCV). Subsequently, monitoring should be carried out every 4 weeks for the first three months of treatment, and then every six months/yearly.
If you have a folic acid deficiency, treatment may not be effective. In this case, the use of cyanocobalamin is not indicated.
Patients with moderate renal insufficiency can take vitamin B12 in normal doses. In case of severe renal insufficiency, it is advisable to reduce the dose and monitor the level of vitamin B12 in the blood serum.
In case of tobacco and alcoholic amblyopia or retrobulbar neuritis, in case of pernicious anemia or any other condition of patients requiring cyanide detoxification, as well as in case of predisposition to the development of Leber's optic nerve atrophy, other cobalamin derivatives should be used.
Patients with hepatic impairment. There are no pharmacokinetic data and clinical experience in patients with hepatic impairment. Safety and efficacy in patients with hepatic impairment have not been established.
The medicine does not contain gluten.
Use during pregnancy or breastfeeding
Use during pregnancy is not recommended.
Use during breastfeeding is not recommended. Vitamin B12 passes into breast milk.
B12 Ankerman is not used during pregnancy to treat megaloblastic anemia caused by folate deficiency.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reservations regarding the use of the drug for drivers of vehicles and persons working with other mechanisms.
Method of administration and doses
The dosage depends on the patient's condition.
| Patients with vitamin B12 deficiency | Initial therapy | Supportive therapy |
| Patients with hematological and additional severe neurological disorders | Parenteral | 1–2 tablets per day |
| Patients with certain severe neurological disorders | parenterally | 1–2 tablets per day |
| Patients with hematological and/or neurological disorders | 2 x 2 tablets per day | 1–2 tablets per day |
| Patients without hematological and neurological disorders | 2 x 1–2 tablets per day | 1–2 tablets per day |
| Patients after post-gastrectomy or other resorptions | 1–2 tablets per day | 1–2 tablets per day |
| Patients on a diet (e.g. vegetarianism) | 1–2 tablets per day | 1–2 tablets per day |
The tablets should be swallowed whole, without chewing, with sufficient water; it is advisable to take them in the morning on an empty stomach.
For patients with pernicious anemia, the doctor makes the decision independently regarding the duration and method of treatment.
The duration of the treatment course depends on the nature and course of the disease and is determined individually.
Children. The use of the drug is contraindicated in children (under 18 years of age).
Overdose
Symptoms: nausea, vomiting, dizziness, agitation, tachycardia.
Treatment: symptomatic and supportive therapy.
Side effects
When assessing undesirable effects, the following classification of frequency of occurrence is established: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1/10,000 to <1/1000), very rare (<1/10,000), unknown (cannot be estimated from the available data).
Immune system disorders: uncommon: allergic reactions including skin manifestations and angioedema; anaphylactic shock, anaphylactoid reactions, fever.
Skin and subcutaneous tissue disorders: hyperemia, urticaria, exanthema, exanthematous rash, pruritus, dermatitis; not known: acne, bullous eruptions; edema.
On the part of the blood: hypercoagulation.
General disorders: nausea, sweating, purine metabolism disorders; unknown: malaise, fever.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicinal product has been authorised is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
25 film-coated tablets in a blister; 2 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Artezan Pharma GmbH and Co. KG/Artesan Pharma GmbH & Co. KG.
Location of the manufacturer and its business address.
29439, Luechow, Wendlandstrasse 1, Germany/29439, Luechow, Wendlandstrasse 1, Germany
