Becozym 20 gastro-resistant tablets

Becozym 20 gastro-resistant tablets is a high-dose vitamin B complex , formulated to meet the needs of those with an increased need for B vitamins or at risk of vitamin B deficiency . Each tablet contains a balanced combination of thiamine (vitamin B1) , riboflavin (vitamin B2) , nicotinamide (vitamin B3) , pyridoxine (vitamin B6) , calcium pantothenate (vitamin B5) , cyanocobalamin (vitamin B12) and biotin (vitamin B8) , essential elements for the correct functioning of energy metabolism and the general well-being of the body.

Thanks to its gastro-resistant formulation , Becozym ensures optimal release of active ingredients, promoting the absorption of vitamins even in the presence of digestive disorders or conditions that can compromise the assimilation of nutrients. This vitamin supplement is particularly indicated in situations of fatigue , asthenia , periods of stress , monotonous diets or prolonged antibiotic therapies , as well as support in the case of pregnancy , breastfeeding or intestinal absorption disorders .

Becozym 20 gastro-resistant tablets is an over-the-counter medicine that helps prevent and treat vitamin deficiencies, supporting the health of the skin, mucous membranes, nervous system and energy metabolism. The presence of all the main B vitamins makes it ideal as an adjuvant in cases of liver disease, neuritis and in the after-effects of chronic alcoholism due to vitamin deficiency. Its effectiveness is guaranteed by the quality of the active ingredients and the technology of the gastro-resistant tablets, which protect the vitamins from the acidic environment of the stomach, ensuring optimal absorption at the intestinal level.

ACTIVE INGREDIENTS

Active ingredients contained in Becozym 20 gastro-resistant tablets - What is the active ingredient in Becozym 20 gastro-resistant tablets?

One gastro-resistant tablet contains: thiamine nitrate (Vit. B ₁ ) 15 mg, riboflavin (Vit. B ₂ ) 15 mg, nicotinamide 50 mg, pyridoxine hydrochloride (Vit. B ₆ ) 10 mg, calcium pantothenate 25 mg, cyanocobalamin 10 mg (Vit. B ₁₂ 0.1%), biotin 150 mg. Excipients with known effect: 49.9 mg of lactose and 224.2 mg of sucrose. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Becozym 20 gastro-resistant tablets - What does Becozym 20 gastro-resistant tablets contain?

Lactose monohydrate, light magnesium oxide, povidone K90, talc, magnesium stearate, sucrose , methacrylic acid-ethyl acrylate copolymer (1:1), macrogol 6000, red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172), cocoa flavour, ethyl vanillin, rice starch, glycolated montan wax.

DIRECTIONS

Therapeutic indications Becozym 20 gastro-resistant tablets - Why is Becozym 20 gastro-resistant tablets used? What is it used for?

The administration of Becozym as a prophylactic 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 sufficient quantities of vitamin B. Glossitis, cheilitis, anorexia (for example in the course of febrile conditions) with weight loss, retardation of growth in children, asthenia, in the case of prolonged antibiotic therapy, intestinal absorption disorders in the course of gastro-intestinal conditions. As an adjuvant in liver disease and neuritis, treatment of the after-effects of chronic alcoholism attributable to a vitamin deficiency.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Becozym 20 gastro-resistant tablets - When should Becozym 20 gastro-resistant tablets not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Becozym 20 gastro-resistant tablets - How to take Becozym 20 gastro-resistant tablets?

Becozym is indicated in adults and children over 12 years of age. Dosage: For treatment: 2-3 gastro-resistant tablets per day, starting dose in case of symptoms of clear deficiency or insufficient absorption (for example following diarrhoea, enteritis, steatorrhea, sprue). In antibacterial treatments: for prophylaxis, 1 gastro-resistant tablet per day. Becozym is not recommended for children under 12 years of age as there are no efficacy and safety data available for this age group. Method of administration: Oral use. Swallow the gastro-resistant tablets without chewing them, with a little liquid.

CONSERVATION

Storage Becozym 20 gastro-resistant tablets - How to store Becozym 20 gastro-resistant tablets?

Do not store above 30°C

WARNINGS

Warnings Becozym 20 gastro-resistant tablets - About Becozym 20 gastro-resistant tablets it is important to know that:

The yellow coloration of urine after administration of Becozym is due to vitamin B ₂ (riboflavin). Do not exceed the recommended doses. Acute and chronic overdose increases the risk of side effects. Care should be taken with the intake of the same vitamins from all other sources including fortified foods, food supplements and concomitant medications (see section 4.9). Patients receiving other mono- or multivitamin preparations, any other medications or who are on a restricted diet or are under medical supervision should consult a doctor before taking this medicine. Becozym should be used for the treatment of vitamin B12 deficiency only if this is of dietary origin and not in patients with atrophic gastritis, disorders of the ileum or pancreas and gastrointestinal malabsorption of vitamin B ₁₂ or intrinsic factor deficiency. Patients with severe renal insufficiency should consult their doctor before taking this medicine as 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 diagnostic laboratory 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 interference by biotin should be taken into account when interpreting laboratory test results, especially if there is a lack of consistency with the clinical presentation (e.g. thyroid test results suggestive of Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in myocardial infarction patients taking biotin). In cases of suspected interference, alternative diagnostic tests not susceptible to interference by biotin should be used, if available. Laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin. Vitamin B1 and Vitamin B6 may interfere with laboratory tests leading to false readings of the results (see section 4.5). Inform your doctor if you are taking this medicine and need to have laboratory tests. Information about excipients: The medicinal product contains 49.9 mg of lactose . Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The medicinal product contains 224.2 mg of sucrose . Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

INTERACTIONS

Interactions Becozym 20 gastro-resistant tablets - Which medicines or foods can modify the effect of Becozym 20 gastro-resistant tablets?

Several potential interactions with the individual active ingredients of Becozym have been reported in the literature, therefore patients receiving any other medicinal product or therapy should consult a doctor before taking this medicine. Interactions with other medicinal products for the active ingredient contained in Becozym: - Vitamin B6 : Vitamin B6 enhances the metabolism of levodopa , reducing its anti-parkinsonian effects. However, this interaction does not occur when carbidopa is used together with levodopa. - Vitamin B12 : Chloramphenicol may 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 may give rise to false positives in the determination of urobilinogen in the test with the Ehrilch reagent.

SIDE EFFECTS

Like all medicines, Becozym 20 gastro-resistant tablets can cause side effects - What are the side effects of Becozym 20 gastro-resistant tablets?

The adverse reactions listed below have been identified during the post-approval period of the medicinal product. As these reactions are derived from spontaneous reporting it is not possible to estimate their frequency. Gastrointestinal disorders : Gastrointestinal and abdominal pain, constipation, vomiting, diarrhoea, 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 involving the skin, respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms may include: rash, urticaria, facial oedema, erythema, pruritus, wheezing, cardio-respiratory distress and serious 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 of suspected adverse reactions that occur 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 national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Becozym 20 gastro-resistant tablets - What are the risks of Becozym 20 gastro-resistant tablets in case of overdose?

When used correctly, this product does not cause overdose. Caution should be exercised when taking concomitant vitamins from all sources. Common manifestations of an overdose may include confusion and gastrointestinal disturbances such as constipation, diarrhoea, nausea and vomiting. If these symptoms occur, discontinue treatment and consult a doctor. An acute or chronic overdose (e.g. up to 10 times the recommended dose) may cause specific toxicity phenomena associated with Vitamin B6. The specific clinical signs, symptoms, diagnostic findings and consequences of an overdose are very diverse 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 effects have also been described. Symptoms of neuropathy have been reported most commonly after chronic ingestion of daily doses of 200 to 6000 mg for several months or years. Neuropathy gradually improved in all cases after discontinuation of pyridoxine treatment.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Becozym 20 gastro-resistant tablets.

Fertility : There is no evidence to suggest that the normal levels of vitamins contained in the medicinal product may have any adverse effect on reproduction in humans. Pregnancy and lactation : Since there are insufficient controlled clinical studies evaluating the risk of therapy with the medicinal product during pregnancy and lactation, Becozym should be administered during pregnancy and lactation only when clinically indicated and recommended by the physician. The recommended dose should not be exceeded since chronic overdose could be harmful to the foetus and neonate. Particular attention should be paid to concomitant intake of vitamins from all other sources. The vitamins contained in the medicinal product are excreted in breast milk. This should be taken into account.

DRIVING AND USE OF MACHINERY

Take Becozym 20 gastro-resistant tablets before driving or using machines - Does Becozym 20 gastro-resistant tablets affect driving or using machines?

Becozym does not alter the ability to drive vehicles or use machinery.