Vitaprompt film-coated tablets 1000 mcg 50 pcs.

The drug Vitaprompt, tablets, is used for:

• treatment of vitamin B12 deficiency due to malnutrition;
• long-term treatment of vitamin B12 deficiency syndrome, for example, due to malabsorption;
• Oral treatment of pernicious anemia and vitamin B12 deficiency with neurological symptoms after rapid normalization of vitamin B12 blood levels with vitamin B12 injections.

Note: Initial treatment for patients who need to quickly achieve normal vitamin B12 blood levels should be with vitamin B12 injections until remission is achieved.

active ingredient: cyanocobalamin;

• 1 tablet contains 1000 mcg of cyanocobalamin (vitamin B12);
• excipients: mannitol, microcrystalline cellulose (grade: PH 102), sodium starch glycolate (type A), magnesium stearate, white film-coating mixture consisting of: hypromellose 6 mPas type 2910, hydroxypropylcellulose 100 mPas, talc, medium chain triglycerides, titanium dioxide (E 171).

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Vitaprompt should not be used to treat megaloblastic anemia caused solely by folic acid deficiency.

Acute thromboembolic diseases. Angina pectoris, exertion of high functional class.

Vitaprompt should not be used in patients requiring cyanide detoxification (e.g. patients with retrobulbar neuritis in pernicious anemia). In such cases, other cobalamin derivatives should be used.

Patients with vitamin B12 deficiency at risk of developing Leber’s optic atrophy should not use cyanocobalamin to treat vitamin B12 deficiency.

Vitaprompt should not be used in patients with tobacco or alcohol-induced amblyopia.

On the part of the immune system – allergic reactions, including skin manifestations and angioedema; anaphylactic shock.

On the part of the skin and subcutaneous tissue – severe hypersensitivity reactions, which may manifest as urticaria, rash or itching over large areas of the body, acne-like skin reactions and blisters.

On the blood side – hypercoagulation.

General disorders – anaphylactic reactions, fever, nausea, sweating, purine metabolism disorders; unknown: malaise, fever.

Adults

1 tablet per day.

If rapid normalization of vitamin B12-related biomarkers is required, it should be administered parenterally first.

Duration of treatment

Provided that it is well tolerated, there is no limit to the duration of use. Oral vitamin B12 is usually prescribed for life, provided that adequate absorption of the vitamin from the intestine has been demonstrated, or as long as vitamin B12 deficiency persists. In the case of pernicious anemia, replacement therapy is mandatory for life. The response to treatment should be monitored regularly.

Vitaprompt tablets are taken orally, preferably on an empty stomach, with water.

Use during pregnancy or breastfeeding

The use of Vitaprompt tablets is not recommended during pregnancy and breastfeeding.

Children

Vitaprompt should not be used in children (under 18 years of age) as there is insufficient clinical data and the dose is inappropriate for use in children at a dose of 1 mg.

Ability to influence reaction speed when driving vehicles or other mechanisms

Unknown. No relevant data available.

The likelihood of acute toxicity is low.

Overdose usually does not cause any symptoms, and symptomatic treatment of overdose is only required in exceptional cases.

Vitamin B12 absorption may be impaired by concomitant use with proton pump inhibitors (e.g. omeprazole), H2-histamine receptor blockers (e.g. cimetidine), kanamycin, neomycin, polymyxins, tetracyclines, aminosalicylic acid, colchicine, antiepileptic drugs, potassium preparations, aminoglycosides (e.g. neomycin) and cholestyramine.

Serum vitamin B12 levels may decrease in patients taking metformin.

Chloramphenicol may reduce the effect of vitamin B12 in anemia.

Prolonged exposure to nitrous oxide (laughing gas; N2O) can cause functional vitamin B12 deficiency and potentially serious neurological adverse reactions.

Second-generation antipsychotics (such as olanzapine and risperidone) are also substances with a known potential to decrease serum vitamin B12 levels.

Glucocorticoids, such as prednisone, increase vitamin B12 absorption in patients with pernicious anemia.

Store in the original packaging at a temperature not exceeding 30 ºC. Keep out of the reach of children.