BECOZYM 20CPR GASTRORES

BECOZYM COMPRESITION

active ingredients

A gastro-resistant tablet contains: nitrate tiamina (Vit. B₁15 mg, riboflavin (Vit. B₂) 15 mg, nicotinamide 50 mg, pyridoxine hydrochloride (Vit. B₆) 10 mg, calcium pantotenate 25 mg, cyanocobalamin 10 mg (Vit. B₁₂ 0.1%), biotin 150 mg. Excipients with known effects: 49,9 mg lactose and 224,2 mg sucrose For the full list of excipients, see paragraph 6.1.

Excellent

Lactose monohydrate, magnesium oxide light, povidone K90, talc, magnesium stearate, sucrose, copolymer methacrylic-ethyl acid (1:1), macrogol 6000, red oxide iron (E 172), black oxide iron (E 172), yellow oxide iron (E 172), cocoa aroma, etylvanillin, rice starch, glyculate mountain wax.

Therapeutic indications

The administration of Becozym prophylactically is indicated in the case of increased vitamins B (e.g. pregnancy, breastfeeding), insufficient absorption (digestive disorders), dietary imbalances (uniform diets), i.e. in all cases where the organism risks not to take sufficient amounts of vitamin B. Glossite, cheylitis, anorexia (e.g. in the course of fever loss). As a coadjuvant in hepatopathies and nevriti, care of posthumous chronic alcoholism attributable to a vitamin deficiency.

Contraindications

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

Population

Becozym is indicated in adults and children over 12 years old. Posology: Career: 2-3 gastro-resistant tablets per day, attack dose in case of symptoms of net deficiency or insufficient absorption (for example following diarrhea, enteritis, steatorrea, sprue). In antibacterial treatments: prophylactically, 1 gastror 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. Method of administration: Oral use. Garnish the gastro-resistant tablets without chewing them, with some liquid.

Conservation

Do not store at temperature above 30°C

Warnings

Yellow coloring of urine after administration of Becozym is due to vitamin B₂ (reboflavin). Do not exceed the recommended doses. Acute and chronic overdose increases the risk of unwanted effects. You should pay attention to taking the same vitamins from all other sources including fortified foods, food supplements and concomitant medicines (see paragraph 4.9). Patients receiving other mono- or multivitamin preparations, any other medicine or following a limited dietary regimen or are under medical supervision, should consult a doctor before taking this medicine. Becozym must be used to treat vitamin B12 deficiency only if this is of food origin and not in patients with atrophic gastritis, disability of the liium or pancreas and gastrointestinal mal absorption of vitamin B₁₂ or intrinsic factor deficiency. Patients with severe kidney failure should consult the doctor before taking this medicine because a dosage adjustment may be necessary. Special attention should be paid to the daily dosage of Vitamin B6. Interference with clinical laboratory tests: Biotin can interfere with laboratory diagnostic tests based on biotin/streptavidine interaction, producing falsely decreased or falsely increased results, depending on the test used. The risk of interference is greater in children and patients with kidney failure and increases when the dose increases. In the interpretation of the results of laboratory tests, biotin interference should be considered, especially if there is a lack of consistency with clinical presentation (e.g., results of thyroid examinations suggesting Graves disease in asymptomatic patients taking biotin or negative false results of troponin examination in patients with myocardial infarction taking biotin). In cases of suspected interference, alternative diagnostic tests are not sensitive to interference with biotin. It is necessary to consult the laboratory staff when preparing laboratory tests in patients taking biotin. Vitamin B1 and Vitamin B6 can interfere with laboratory tests, leading to false reading of results (see paragraph 4.5). Please inform your doctor if you are taking this medicine and you should run laboratory tests. Information on excipients: The medicine contains 49.9 mg of lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. The drug contains 224,2 mg of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine.

Interactions

Various potential interactions relating to the individual active ingredients of Becozym are reported in literature, so patients receiving any other medicine or therapy should consult a doctor before taking this medicine. Interactions with other medicines by active ingredient contained in Becozym: - Vitamin B6 : vitamin B6 boosts metabolism levodopa reducing the anti-parkinson effects. This interaction however does not occur when the carbidopa is used along with the levodopa. - Vitamin B12 : the chloramphenicol can delay or interrupt the response of reticulocytes to vitamin B12 therefore it is necessary to monitor the hemochrome in case of concomitant intake. Interactions with laboratory tests by 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 ofurobilinogeno in the test with the reagent of Ehrilch.

Effects

The adverse reactions listed below have been identified during the period following the approval of the medicinal product. As these reactions result from spontaneous signals, it is not possible to estimate the frequency. Gastrointestinal diseases: Gastrointestinal and abdominal pain, constipation, vomiting, diarrhea, nausea. Immune system disorders: Allergic reaction, anaphylactic reaction, anaphylactic shock. Hypersensitivity reactions with laboratory and clinical manifestations include asthmatic syndrome, mild to moderate reactions to skin, respiratory tract, gastrointestinal tract and/or cardiovascular system. Symptoms can include: skin rash, hives, facial edema, erythema, itching, sibilo, cardio-respiratory distress and severe reactions that include anaphylactic shock. If an allergic reaction occurs, stop treatment and consult a doctor. Diseases of the nervous systemKefalea. Kidney and urinary disorders: Chromaturia. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

If used correctly, this product does not give rise to overdose. You should pay attention to the concomitant intake of vitamins from all sources. Common manifestations of an overdose can include a confusing state and gastrointestinal disorders such as constipation, diarrhea, nausea and vomiting. If these symptoms occur, stop treatment and consult a doctor. Acute or chronic overdose (e.g. up to 10 times the recommended dose) can cause specific toxicity phenomena associated with Vitamin B6. Specific clinical signs, symptoms, diagnostic results and consequences that may have an overdose are very different and depend on individual susceptibility and the circumstances of the case. The daily intake of more than 40 mg of Vitamin B6 (pyridosin) in children aged 4-8 years, or over 60 mg in children aged 9-13 years, or over 80 mg in teenagers aged 14 to 18 years and over 100 mg in adults increases the risk of axonal sensory neuropathy. Central effects were also described. Symptoms of neuropathy have been reported most commonly after chronic ingestion of daily doses from 200 to 6000 mg for several months or years. Neuropathy is gradually improved in all cases after suspension of treatment with pyridoxin.

Fertility: There is no evidence that suggests that the normal levels of vitamins contained in the medicinal product may have no adverse effect on reproduction in humans. Pregnancy and nursing: Since there are not enough controlled clinical studies that assess the risk of drug therapy during pregnancy and breastfeeding, Becozym must be administered in pregnancy and nursing only when clinically indicated and recommended by the doctor. The recommended dose should not be exceeded since a chronic overdose could be harmful to the fetus and the newborn. Particular attention must be paid to the concomitant intake of vitamins from all other sources. The vitamins contained in the medicine are excrete in breast milk. This must be taken into account.

Source: Farmadati