BECOZYME C FORTE COATED TABLETS

Introduction

Package Leaflet: Information for the User

Becozyme C Forte Coated Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Becozyme C Forte and what is it used for
2. What you need to know before taking Becozyme C Forte
3. How to take Becozyme C Forte
4. Possible side effects
5. Storage of Becozyme C Forte
6. Package Contents and Additional Information

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

It is an association 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) for oral administration.

Vitamins are essential micronutrients that intervene in numerous human metabolic processes.

Becozyme C Forte is indicated for the prevention and treatment of deficiency states of vitamins of the B group and vitamin C when there is not an adequate intake of these vitamins, convalescence, or dietary regimens in adults and adolescents over 14 years of age.

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

Do not takeBecozyme C Forteif:

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

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take 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.
• The intake of the same vitamins through other sources, such as dietary supplements and concomitant medications, should be considered.
• If you have a predisposition to kidney stones, due to the content of ascorbic acid (vitamin C), you should exercise caution.
• If you suffer from Leber's disease (hereditary optic nerve atrophy), an overdose of medications containing cyanocobalamin could worsen the situation.
• If you have a vitamin B12 deficiency due to atrophic gastritis, ileal disorders, or pancreatic disorders, and gastrointestinal malabsorption of vitamin B12 or intrinsic factor deficiency, consult your doctor, as this medication does not contain a sufficient dose for these disorders.
• If you suffer from a hereditary disease that affects iron metabolism (hemochromatosis), consult your doctor, as vitamin C increases iron absorption.
• If you have a deficiency of glucose-6-phosphate dehydrogenase (a hereditary alteration of red blood cell metabolism), high doses of vitamin C may cause red blood cell destruction (hemolysis).

Interference with analytical tests: If you are going to undergo any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results. In some determinations of urobilinogen, theophylline, uric acid, or glucose, false results may be produced.

Becozyme C Forte contains 0.15 g of biotin per tablet. If you are going to undergo laboratory tests, you should inform your doctor or the laboratory staff that you are taking or have recently taken Becozyme C Forte, as biotin may influence the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor may indicate that you stop taking Becozyme C Forte before undergoing laboratory tests. 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 influence the results of laboratory tests. Inform your doctor or the laboratory staff if you are taking this type of product.

Children

This medication is not indicated in children under 14 years of age.

Other Medications and Becozyme C Forte

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

This is especially important in the case of:

• Levodopa (medication for the treatment of Parkinson's disease): may decrease its effect.

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

• Deferoxamine (medication for blood disorders).
• Carbamazepine (medication for epilepsy).
• Flufenazine (for the treatment of schizophrenia and symptoms of psychosis).
• Altretamine (for the treatment of cancer).
• Neuromuscular blocking agents (used in anesthesia for surgery).
• 5-Fluorouracil (medication for some types of cancer).

• The following medications 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 medications may decrease the absorption of cyanocobalamin (vitamin B12) or reduce its effect, such as: ascorbic acid (vitamin C) in high doses, colchicine (for the treatment of gout), aminosalicylic acid (for intestinal diseases), medications of the type of omeprazole (for stomach ulcers). The need for vitamin B12 may be increased in patients receiving these medications.

Taking Becozyme C Forte with Food, Drinks, and Alcohol

Excessive alcohol consumption decreases the absorption of vitamins.

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 medication.

This medication is not recommended in pregnant or breastfeeding women.

Driving and Using Machines

The influence of Becozyme C Forte on the ability to drive and use machines is nil or insignificant.

Becozyme C Forte Contains Lactose and Sucrose

This medication contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Use Becozyme C Forte

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Oral route.

• Adults and adolescents over 14 years of age: it is recommended to take 1 tablet per day.

It is recommended to take this medication without chewing, with the help of a little water.

In general, treatment is recommended for two weeks, although your doctor may recommend administration for more than 15 days.

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

If You Take More Becozyme C Forte Than You Should

If you take more than the recommended amount in the package leaflet or as indicated by your doctor, you may experience confusion and gastrointestinal discomfort such as constipation, diarrhea, nausea, and vomiting.

It is recommended to take the package and package leaflet of the medication to the healthcare professional.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Becozyme C Forte

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The side effects that have been reported, with unknown frequency, are gastrointestinal disorders, constipation, vomiting, diarrhea, nausea, headache, allergic reactions, anaphylactic reactions, hypersensitivity reactions from mild to moderate that may manifest with: rash, urticaria, facial swelling due to fluid accumulation (facial edema), itching, wheezing, flushing, cardio-respiratory difficulty, and severe reactions including anaphylactic shock.

The presence of vitamin B2 in the medication may cause changes in the color of the urine, which turns orange-yellow.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Becozyme C Forte

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Becozyme C Forte

• The active ingredients 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), red iron oxide (E172), montanglicol wax.

Appearance of the Product and Package Contents

This medication is light red coated tablets. It is presented in packages 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 Last Revision of this Package Leaflet:March 2019.

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