Package Insert: Information for the User

Becozyme C Forte Coated Tablets

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

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

It 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) for oral administration.

Vitamins are essential micronutrients that participate in numerous metabolic processes.

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

Do not takeBecozyme C Forte:

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

• if you are being treated with levodopa (a medication used for 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.
• Consider the intake of the same vitamins through other sources such as dietary supplements and concomitant medications.
• If you are prone to kidney stones, be cautious due to the ascorbic acid (vitamin C) content.
• If you have Leber's disease (hereditary optic nerve atrophy), a high dose of cyanocobalamin could worsen the condition.
• If you have vitamin B12 deficiency due to gastric atrophy, intestinal 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 conditions.
• If you have a hereditary disease affecting iron metabolism (hemochromatosis), consult your doctor, as vitamin C increases iron absorption.
• If you have a deficiency of glucose-6-phosphate dehydrogenase (hereditary alteration of red blood cell metabolism), high doses of vitamin C may cause red blood cell destruction (hemolysis).

Interference with diagnostic tests: Inform your doctor if you are to undergo any diagnostic tests (including blood, urine, etc.) as this medication may alter the results. In some determinations of urobilinogen, theophylline, uric acid, or glucose, false results may occur.

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

Children

This medication is not indicated for children under 14 years.

Other medications and Becozyme C Forte

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

This is especially important in the case of:

• Levodopa (Parkinson's disease medication): may reduce its effect.

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

• Deferoxamine (blood disorder medication).
• Carbamazepine (epilepsy medication).
• Flufenazine (for schizophrenia and psychotic symptoms).
• Altretamine (cancer treatment).
• Neuromuscular blocking agents (used in anesthesia, for surgery).
• 5-Fluorouracil (cancer medication).

• The following medications may interfere with pyridoxine (vitamin B6) and 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:

Taking Becozyme C Forte with food, drinks, and alcohol

Excessive alcohol consumption may decrease 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 medication.

This medication is not recommended for pregnant women or breastfeeding women.

Driving and operating machinery

The influence of Becozyme C Forte on the ability to drive and operate machinery is negligible or insignificant.

Becozyme C Forte contains lactose and saccharose

This medication contains lactose and saccharose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Oral administration.

- Adults and adolescents over 14 years old: It is recommended to take 1 tablet per day.

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

Generally, it is recommended to treat 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 must consult your doctor.

If you take more Becozyme C Forte than you should

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

It is recommended to bring the packaging and the 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Becozyme C Forte

Do not take a double dose to compensate for the missed doses.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The adverse effects that have been reported, with unknown frequency, are digestive discomfort, constipation, vomiting, diarrhea, nausea, headaches, allergic reactions, anaphylactic reactions, mild to moderate hypersensitivity reactions that may manifest as: rash, urticaria, facial swelling due to fluid accumulation (facial edema), itching, respiratory sounds from the lungs (sibilance), 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 becomes yellow-orange.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications:https://notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Becozyme C Forte

• The active principles are: thiamine nitrate (vitamin B1), riboflavin (vitamin B2), niacinamide, 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 niacinamide, 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, magnesium oxide, lactose monohydrate, talc, magnesium stearate, povidone K90, heavy magnesium oxide, ethylcellulose, cornstarch, gum arabic, titanium dioxide (E-171), iron oxide red (E172), cera montanglicol.

Appearance of the product and contents of the packaging

This medication is red clear-coated tablets. It is presented in packaging containing 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 – 5

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing

Dragenopharm Apotheker

Püschl GmbH

Göllstrasse 1

D-84529 Tittmoning (Germany)

Last review date of this leaflet:March 2019.

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