Becozyne C Forte film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Becozyme C Forte Coated Tablets

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Becozyme C Forte is and what it is used for
2. What you need to know before taking Becozyme C Forte
3. How to take Becozyme C Forte
4. Possible adverse effects
5. How to store Becozyme C Forte
6. Contents of the pack and other information

1. What Becozyme C Forte is and what it is used for

Becozyme C Forte is a combination of water-soluble vitamins: thiamine (vitamin B1), riboflavin (vitamin B2), nicotinamide, pyridoxine (vitamin B6), calcium pantothenate, biotin, cyanocobalamin (vitamin B12), and ascorbic acid (vitamin C), intended for oral administration.

Vitamins are essential micronutrients that participate in numerous processes of human metabolism.

Becozyme C Forte is indicated for the prevention and treatment of deficiencies of B-complex vitamins and vitamin C when adequate dietary intake of these vitamins is not achieved, during convalescence, or in special dietary regimens in adults and adolescents over 14 years of age.

2. What you need to know before taking Becozyme C Forte

Do not take Becozyme C Forte:

• if you are allergic to thiamine, riboflavin, nicotinamide, pyridoxine, calcium pantothenate, biotin, cyanocobalamin, ascorbic acid, cobalt, or any of the other ingredients of this medicine (listed in section 6).

• if you are being treated with levodopa (a medicine used in Parkinson's disease).

Warnings and precautions

Talk to your doctor or pharmacist before taking Becozyme C Forte.

• Do not take a higher dose than recommended or for a longer period than recommended, as this increases the risk of adverse reactions.
• Consider intake of the same vitamins from other sources such as dietary supplements and concomitant medications.
• If you are prone to kidney stones, caution is advised due to the ascorbic acid (vitamin C) content.
• If you have Leber's disease (hereditary optic nerve atrophy), an overdose of medicines containing cyanocobalamin could worsen your condition.
• If you have vitamin B12 deficiency due to atrophic gastritis, disorders of the ileum or pancreas, gastrointestinal malabsorption of vitamin B12, or intrinsic factor deficiency, consult your doctor, as this medicine does not contain a sufficient dose for these conditions.
• If you suffer from a hereditary disease affecting iron metabolism (hemochromatosis), consult your doctor, as vitamin C increases iron absorption.
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited disorder of red blood cell metabolism), high doses of vitamin C may cause destruction of red blood cells (hemolysis).

Interference with laboratory tests: If you are scheduled for any diagnostic tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results. False results may occur in certain tests for urobilinogen, theophylline, uric acid, or glucose.

Becozyme C Forte contains 0.15 g of biotin per tablet. If you are undergoing laboratory tests, you must inform your doctor or laboratory personnel that you are currently taking or have recently taken Becozyme C Forte, as biotin may affect test results. Depending on the test, results may show false elevations or false reductions due to biotin. Your doctor may instruct you to stop taking Becozyme C Forte before laboratory testing. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin and affect laboratory test results. Inform your doctor or laboratory personnel if you are taking such products.

Children

This medicine is not indicated for children under 14 years of age.

Other medicines and Becozyme C Forte

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is especially important in the case of:

• Levodopa (a medicine for the treatment of Parkinson's disease): its effect may be reduced.

• Iron: its absorption may be increased by vitamin C, which may be significant in patients with hemochromatosis.

• Deferoxamine (a medicine for blood disorders).

• Carbamazepine (a medicine for epilepsy).

• Flufenazine (used to treat schizophrenia and psychotic symptoms).

• Altretamine (used for cancer treatment).

• Neuromuscular blocking agents (used in anesthesia for surgery).

• 5-Fluorouracil (a medicine for certain types of cancer).

• The following medicines may interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for tuberculosis (isoniazid, ethionamide, etc.), penicillamine (for rheumatic diseases), hydralazine (for hypertension).

  • Several medicines may decrease the absorption of cyanocobalamin (vitamin B12) or reduce its effect, such as: high-dose ascorbic acid (vitamin C), colchicine (for gout treatment), aminosalicylic acid (for intestinal diseases), and medicines like omeprazole (for stomach ulcers). The need for vitamin B12 may be increased in patients taking these medications.

Taking Becozyme C Forte with food, drinks, and alcohol

Excessive alcohol consumption reduces vitamin absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is not recommended for pregnant or breastfeeding women.

Driving and using machines

The influence of Becozyme C Forte on the ability to drive and use machines is none or negligible.

Becozyme C Forte contains lactose and sucrose

This medicine contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Becozyme C Forte

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Oral use.

• Adults and adolescents over 14 years of age: The recommended dose is one tablet per day.

It is recommended to swallow this medicine without chewing, with a little water.

Treatment is generally recommended for two weeks, although your doctor may recommend administration for longer than 15 days.

If symptoms do not improve after 7 days of treatment, you should consult your doctor.

If you take more Becozyme C Forte than you should

If you take more than the recommended dose stated in this leaflet or prescribed by your doctor, you may experience confusion and gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting.

It is recommended to bring the medicine package and leaflet to the healthcare professional.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center right away, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Becozyme C Forte

Do not take a double dose to make up for missed doses.

If you have forgotten a dose, take it as soon as possible and then continue with your usual dosing schedule, as indicated in section 3.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The adverse effects reported, with frequency not known, include gastrointestinal discomfort, constipation, vomiting, diarrhea, nausea, headache, allergic reactions, anaphylactic reactions, and mild to moderate hypersensitivity reactions that may manifest as: rash, urticaria, facial swelling due to fluid accumulation (facial edema), itching, wheezing (whistling sounds from the lungs), flushing, cardio-respiratory difficulty, and severe reactions including anaphylactic shock.

The presence of vitamin B₂ in the medicine may cause changes in the color of urine, turning it orange-yellow.

If an allergic reaction occurs, treatment must be discontinued and a healthcare professional should be consulted.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Becozyme C Forte

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Becozyme C Forte

• The active substances are: thiamine nitrate (vitamin B1), riboflavin (vitamin B2), nicotinamide, pyridoxine hydrochloride (vitamin B6), calcium pantothenate, biotin, cyanocobalamin (vitamin B12), and ascorbic acid (vitamin C). Each tablet contains 15 mg of thiamine nitrate, 15 mg of riboflavin, 50 mg of nicotinamide, 10 mg of pyridoxine hydrochloride, 25 mg of calcium pantothenate, 0.15 mg of biotin, 10 micrograms of cyanocobalamin, and 200 mg of ascorbic acid.

The other components (excipients) are: sucrose, light magnesium oxide, lactose monohydrate, talc, magnesium stearate, povidone K90, heavy magnesium oxide, ethylcellulose, corn starch, gum arabic, titanium dioxide (E-171), iron oxide red (E172), montanglycol wax.

Appearance of the medicine and contents of the pack

This medicine consists of light red coated tablets. It is available in packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Manufacturer

Dragenopharm Apotheker

Püschl GmbH

Göllstrasse 1

D-84529 Tittmoning (Germany)

Date of the most recent review of this leaflet: March 2019.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/