Becozym 20 Gastro-Resistant Tablets Group B Vitamins

Becozym it's a medicinal in gastro-resistant tablets based on B vitamins, in pack of 20 tablets.

Each tablet associates seven water-soluble vitamins: thiamine (vitamin B1) 15 mg, riboflavin (vitamin B2) 15 mg, nicotinamide 50 mg, pyridoxine (vitamin B6) 10 mg, pantothenate calcium 25 mg, cyanocobalamin (vitamin B12) 10 micrograms e biotin 150 micrograms.

The covering gastroresistant it is the characteristic of the pharmaceutical form: the tablet passes through the stomach intact and dissolves in the intestine. The packaging is a cardboard case with them 20 tablets in blister packs thermoformed coupled with aluminum tape, and the manufacturer it is Dragenopharm Apotheker Püschl GmbH, Germany.

Becozym belongs to the category of unassociated B vitamins (ATC classification A11EA) and falls within the scope of deficiency and increased need for B vitamins.

INDICATIONS

Why is Becozym 20 Gastro-Resistant Tablets B Vitamins used? What is it for?

The administration of Becozym prophylactically is indicated in cases of increased need for B vitamins (for example pregnancy, breastfeeding), insufficient absorption (digestive disorders), nutritional imbalances (uniform diets), i.e. in all cases in which the body risks not taking in sufficient quantities of vitamin B.

Glossitis, cheilitis, anorexia (for example during febrile illnesses) with weight loss, growth retardation of the child, asthenia, in case of prolonged antibiotic therapy, intestinal absorption disorders during gastro-enteric illnesses.

As an adjuvant in liver disease and neuritis, treatment of the after-effects of chronic alcoholism attributable to a vitamin deficiency.

ACTIVE INGREDIENTS AND EXCIPIENTS

What is the composition of Becozym 20 Gastro-Resistant Tablets B Vitamins?

Active ingredients
One gastro-resistant tablet contains: thiamine nitrate (Vit. B1) 15 mg, riboflavin (Vit. B2) 15 mg, nicotinamide 50 mg, pyridoxine hydrochloride (Vit. B6) 10 mg, calcium pantothenate 25 mg, cyanocobalamin 10 µg (Vit. B12), biotin 150 µg.

Excipients with known effects
Lactose and sucrose.

Complete list of excipients
Tablet core: lactose monohydrate, povidone K90, light magnesium oxide, magnesium stearate, talc, sodium citrate, citric acid, maltodextrin.
Tablet coating: sucrose, talc, methacrylic acid-ethyl acrylate copolymer (1:1), macrogol 6000, red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172), cocoa flavouring, ethyl vanillin, rice starch, gum arabic, solid paraffin, liquid paraffin.

DOSAGE

How to take Becozym 20 Gastro-resistant Tablets B Vitamins?

Becozym is indicated in adults and children over 12 years of age.

For curative purposes: 2-3 gastro-resistant tablets per day, attack dose in case of symptoms of clear deficiency or insufficient absorption (for example following diarrhea, enteritis, steatorrhea, sprue).

In antibacterial treatments: as a prophylactic, 1 gastro-resistant tablet per day. Becozym is not recommended in children under 12 years of age as there are no efficacy and safety data available for this age group.

Oral use.

Swallow the gastro-resistant tablets without chewing them, with a little liquid.

CONTRAINDICATIONS AND SIDE EFFECTS

When should Becozym 20 Gastro-resistant Tablets B Vitamins not be used and what side effects can it cause?

Contraindications
Hypersensitivity to the active ingredient or to any of the excipients listed in the section «What is the composition of Becozym 20 Gastro-resistant Tablets Group B Vitamins?».

Side effects
The adverse reactions listed below were identified during the period following the approval of the medicine. Since these reactions derive from spontaneous reports it is not possible to estimate their frequency.

Gastrointestinal disorders
Gastrointestinal and abdominal pain, constipation, vomiting, diarrhea, nausea.

Immune system disorders
Allergic reaction, anaphylactic reaction, anaphylactic shock.
Hypersensitivity reactions with corresponding laboratory and clinical manifestations include asthma syndrome, mild to moderate reactions affecting the skin, respiratory tract, gastrointestinal tract and/or cardiovascular system.
Symptoms may include: rash, urticaria, facial edema, erythema, pruritus, wheezing, cardio-respiratory distress, and severe reactions including anaphylactic shock.
If an allergic reaction occurs, discontinue treatment and consult a doctor.

Nervous system disorders
Headache.

Renal and urinary disorders
Chromaturia.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

INTERACTIONS

Which medicines or foods can modify the effect of Becozym 20 Gastro-Resistant Tablets Group B Vitamins?

Various potential interactions relating to the individual active ingredients of Becozym are reported in the literature, therefore patients receiving any other medicine or therapy should consult a doctor before taking this medicine.

Interactions with other medicines due to the active ingredient contained in Becozym
Vitamin B6: Vitamin B6 enhances the metabolism of levodopa, reducing its anti-parkinsonian effects. This interaction, however, does not occur when carbidopa is used together with levodopa.
Vitamin B12: chloramphenicol can delay or interrupt the response of reticulocytes to vitamin B12 therefore it is necessary to monitor the blood count in case of concomitant intake.

Interactions with laboratory tests for the active ingredient contained in Becozym
Vitamin B1 and Vitamin B6: Vitamin B1 and/or Vitamin B6 can give rise to false positives in the determination of urobilinogen in the Ehrlich reagent test.

PREGNANCY AND BREASTFEEDING

Can Becozym 20 Gastro-Resistant Tablets Group B Vitamins be used during pregnancy and breastfeeding?

Since there are insufficient controlled clinical studies evaluating the risk of therapy with the medicine during pregnancy and breastfeeding, Becozym should be administered during pregnancy and breastfeeding only when clinically indicated and recommended by the doctor.

The recommended dose should not be exceeded as chronic overdose could be harmful to the fetus and newborn.

Particular attention should be paid to the concomitant intake of vitamins from all other sources.

The vitamins contained in the medicine are excreted in breast milk. This must be taken into account.

Fertility
There is no evidence to suggest that normal levels of vitamins contained in the medicinal product would have any adverse effect on reproduction in humans.

WARNINGS

What are the warnings of Becozym 20 Gastro-resistant Tablets B Vitamins?

The yellow color of the urine after administration of Becozym is due to vitamin B2 (riboflavin).

Do not exceed the recommended doses. Acute and chronic overdose increases the risk of side effects. Care should be taken to obtain the same vitamins from all other sources including fortified foods, dietary supplements and concomitant medications.

Patients receiving other mono- or multivitamin preparations, any other medicines, or who are on a limited diet or under medical supervision, should consult a doctor before taking this medicine.

Becozym should be used to treat vitamin B12 deficiency only if it is of food origin and not in patients with atrophic gastritis, ileal or pancreatic disorders and gastrointestinal malabsorption of vitamin B12 or intrinsic factor deficiency.

Patients with severe kidney failure should consult their doctor before taking this medicine because a dosage adjustment may be necessary. Particular attention should be paid to the daily dosage of Vitamin B6.

Interference with clinical laboratory tests
Biotin may interfere with laboratory diagnostic tests based on the biotin/streptavidin interaction, producing falsely decreased or falsely increased results, depending on the test used. The risk of interference is greater in children and patients with renal insufficiency and increases with increasing dose. Possible biotin interference should be considered when interpreting laboratory test results, especially if a lack of consistency with the clinical presentation is observed (e.g., thyroid test results suggesting Graves' disease in asymptomatic patients taking biotin or false-negative troponin test results in patients with myocardial infarction taking biotin).
In cases of suspected interference, alternative diagnostic tests that are not sensitive to interference with biotin should be used, if available. Laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.
Vitamin B1 and Vitamin B6 can interfere with laboratory tests leading to false readings of the results. Inform your doctor if you are taking this medicine and need laboratory tests.

Information on excipients
The medicine contains lactose. Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
The medicine contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.

Overdose
When used correctly, this product does not cause overdose.
Attention should be paid to the concomitant intake of vitamins from all sources.
Common manifestations of an overdose may include confusion and gastrointestinal disturbances such as constipation, diarrhea, nausea and vomiting.
If these symptoms occur, stop treatment and consult a doctor.
An acute or chronic overdose (for example up to 10 times the recommended dose) can cause specific toxicity phenomena associated with Vitamin B6.
The specific clinical signs, symptoms, diagnostic findings and consequences that an overdose can have are very different and depend on individual susceptibility and the circumstances of the case.
Daily intake of more than 40 mg of Vitamin B6 (pyridoxine) in children aged 4-8 years, or more than 60 mg in children aged 9-13 years, or more than 80 mg in adolescents aged 14-18 years, and more than 100 mg in adults increases the risk of sensory axonal neuropathy. Central level effects have also been described.
Symptoms of neuropathy have been reported most commonly after chronic ingestion of daily doses of 200 to 6000 mg over several months to years.
The neuropathy gradually improved in all cases after discontinuation of pyridoxine treatment.

Driving vehicles and using machinery
Becozym does not affect the ability to drive or use machines.

CONSERVATION

How is Becozym 20 Gastro-Resistant Tablets Group B Vitamins stored?

Do not store above 30°C.

The expiry date refers to the last day of the month indicated on the package.

Validity period: 3 years.

FORMAT

What is the format of Becozym 20 Gastro-Resistant Tablets B Vitamins?

20 gastro-resistant tablets.

DRUG LEGAL TEXT

Content responsibility

This sheet contains information that is not intended to replace a doctor's diagnosis or advice, as only the doctor can draw up any prescription and give therapeutic indications. All contents must be understood and are of an exclusively informative nature and aimed exclusively at bringing to the attention of customers or potential customers in the pre-purchase phase of the products sold through this site. In case of pathologies, disorders or allergies it is always best to consult your doctor first.

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