VITAGOBENS B1 B6 B12 FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vitagobens B1 B6 B12 Film-Coated Tablets

Thiamine hydrochloride / Pyridoxine hydrochloride / Cyanocobalamin

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 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 of treatment.

Contents of the Package Leaflet

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

1. What is Vitagobens and what is it used for

The active ingredients of Vitagobens are the water-soluble vitamins B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin), which are involved in numerous human metabolic processes.

Vitagobens is indicated for: prevention and treatment of deficiencies in vitamins B1, B6, and B12, due to increased needs, reduced consumption, or absorption, which may manifest as symptoms such as back pain, during convalescence, or with insufficient diets.

Vitagobens B1 B6 B12 film-coated tablets are indicated for adults and adolescents over 14 years of age.

2. What you need to know before taking Vitagobens

Do not take Vitagobens

• If you are allergic to vitamin B1, B6, or the various forms of vitamin B12, cobalt, or any of the other components of this medication (listed in section 6).
• If you are being treated with levodopa (a medication for Parkinson's disease).
• If you have Leber's disease (a hereditary disease that causes vision loss) or tobacco amblyopia (a decrease in visual acuity that can occur in people who abuse tobacco), as they may worsen.

Due to the doses it contains, do not take this medication:

• If you have kidney or liver disease.
• If you are pregnant or breastfeeding.
• Children under 14 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Vitagobens.

• Do not take a higher dose than recommended or for a longer period than recommended; in any case, regular monitoring by your doctor is recommended, as cases of neuropathy have been observed after taking high daily doses of vitamin B6 for extended periods.
• If you have a blood disease, such as anemia, your doctor should check the cause before taking vitamin B12.
• There have been cases of dependence and withdrawal from pyridoxine when taking doses of this vitamin (even lower than those contained in this medication) for a month.
• You should avoid exposure to the sun and ultraviolet rays due to a possible risk of photosensitivity (with skin lesions such as eruptions or blisters).
• If you have previously suffered from an allergy to vitamin B1 through skin contact (contact dermatitis) for professional reasons, you may experience a relapse when taking this medication.

Interference with analytical tests

If you are going to undergo any diagnostic tests (including blood tests, urine tests, skin tests that use allergens, 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 antibodies against intrinsic factor (IF), false results may occur.

Children

This medication is contraindicated in children under 14 years of age.

Other Medications and Vitagobens

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

This medication may interact with the following medications:

• Levodopa (a medication for the treatment of Parkinson's disease).
• Phenobarbital, phenytoin (for the treatment of epilepsy).
• Altretamine and 5-Fluorouracil (for certain types of cancer).
• Amiodarone (for the heart).
• Neuromuscular blocking agents (used in anesthesia for surgery).
• Several medications can interfere with pyridoxine (vitamin B6) and may reduce its levels, including antibiotics for tuberculosis (isoniazid, cycloserine, ethionamide, and pyrazinamide), penicillamine (for rheumatic diseases), hydralazine (for high blood pressure), immunosuppressants such as corticosteroids, cyclosporine (used in organ transplantation, among other diseases).
• Several medications can decrease the absorption of vitamin B12 or reduce its effect, such as high doses of ascorbic acid, antibiotics like neomycin and chloramphenicol, colchicine (for the treatment of gout), H2 antagonists (medications against acidity or stomach ulcers), aminosalicylic acid in long-term treatments (for intestinal diseases), omeprazole (for stomach ulcers), medications for epilepsy, metformin (for diabetes), high doses of folic acid.
• Oral contraceptives may reduce the levels of vitamins B6 and B12.

Taking Vitagobens with Alcohol

Excessive alcohol consumption reduces 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.

Due to the high doses of vitamins B contained in Vitagobens, which are much higher than those recommended during pregnancy and breastfeeding, this medication is contraindicated during pregnancy and breastfeeding.

Vitagobens is not recommended for women of childbearing age who do not use an effective contraceptive method.

Driving and Using Machines

No effects of the product on the ability to drive or use machines are known. However, this medication may cause drowsiness in a few patients, who should not drive or operate hazardous machinery during treatment.

Vitagobens Contains Red Ponceau 4R (E-124) and Sodium

This medication contains the colorant Red Ponceau 4R (E-124). It may cause allergic reactions.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Vitagobens

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

The recommended dose is:

Adults and adolescents over 14 years of age: 1 tablet per day.

In general, treatment should not exceed 15 days, although your doctor may recommend administration for a longer period.

If your condition worsens or does not improve after 7 days of treatment, you should consult your doctor.

Oral administration.

It is preferable to swallow the tablets whole, with enough water.

Patient with hepatic or renal insufficiency

These patients should not take Vitagobens (see section 2).

If You Take More Vitagobens Than You Should

If you have taken more Vitagobens than you should, you may experience symptoms such as gastrointestinal disorders (diarrhea, nausea, vomiting) and headache. Due to the pyridoxine content, you may suffer from nervous system disorders such as altered or reduced sensitivity, paresthesia, numbness in hands and feet, unsteady gait, etc.; you may also experience increased sensitivity to sunlight with skin eruptions; drowsiness, lethargy, difficulty breathing, among other effects, depending on the dose, increased serum concentrations of AST (SGOT) (a transaminase) and decreased serum concentrations of folic acid. In rare cases, a severe allergic reaction (anaphylactic shock) may occur.

In children, accidental ingestion of very high doses of vitamin B6 can also cause deep sedation, weakness, and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicology Information Service, phone: 915 62 04 20, indicating the medication and the amount taken.

If You Forget to Take Vitagobens

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

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

The assessment of side effects that may occur is based on the following frequencies: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), and very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

Uncommon side effects may include: nausea, vomiting, headache, drowsiness, paresthesia (tingling sensation in arms and legs), and skin rash (redness or swelling). Allergic reactions to vitamins B1, B6, and B12 have also been reported.

Other side effects that have been reported, with an unknown frequency, are: gastrointestinal disorders, diarrhea, loss of appetite with high doses, photosensitivity with skin lesions such as blisters, redness, itching; very occasionally, a reduction in platelet count (thrombocytopenia); insomnia; disorder with reduced sensitivity and paresthesia, among other symptoms, which usually decrease when treatment is discontinued; worsening of Leber's disease (a hereditary disease that causes vision loss); changes in urine color, which usually disappear within 48 hours; occasionally, anaphylactic reaction with itching, sweating, difficulty breathing, increased heart rate, etc. Repeated administration of vitamin B1 may cause relapses in skin allergic reactions in people allergic to this vitamin.

If an allergic reaction occurs, treatment should be discontinued and your doctor consulted immediately to apply appropriate treatment.

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 Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Vitagobens

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

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Do not use this medication after the expiration date stated on the packaging 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 packaging and any unused medication in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Vitagobens Composition

• The active ingredients are: thiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), and cyanocobalamin (vitamin B12).

Each tablet contains 250 mg of thiamine hydrochloride, 250 mg of pyridoxine hydrochloride, and 500 micrograms of cyanocobalamin.

• The other components (excipients) are:

Core: pregelatinized cornstarch, anhydrous citric acid, sodium citrate dihydrate, colloidal silica, copovidone, sodium starch glycolate type A from potato, and sodium stearyl fumarate.

Coating: hypromellose, titanium dioxide (E171), glycerol, propylene glycol dicaprylate, Red Ponceau 4R (E124) colorant, and carnauba wax.

Product Appearance and Package Contents

This medication is presented in the form of film-coated tablets, pink in color, elliptical, and biconvex.

Package of 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the Last Revision of this Package Leaflet:August 2021

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