Vitagobens B1 B6 B12 film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vitagobens B1 B6 B12 film-coated tablets

thiamine hydrochloride / pyridoxine hydrochloride / cyanocobalamin

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

• You should consult a doctor if you get worse or do not improve after 7 days.

Contents of the leaflet

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

1. What Vitagobens is and what it is used for

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

Vitagobens is indicated for: prevention and treatment of deficiency of vitamins B1, B6, and B12 due to increased requirements, reduced intake, or impaired absorption, which may manifest as symptoms of back pain, during convalescence, or in inadequate diets.

Vitagobens B1 B6 B12 tablets are indicated in adults and adolescents over 14 years of age.

2. What you need to know before starting to take Vitagobens

Do not take Vitagobens

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

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

• 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 such cases, regular monitoring by your doctor is advised, as cases of neuropathy have been observed following prolonged intake of high daily doses of vitamin B6.
• If you suffer from any blood disorder, such as anemia, your doctor should determine its cause before you take vitamin B12.
• Cases of dependence and withdrawal symptoms related to pyridoxine have been reported after taking doses of this substance (vitamin B6) for one month, even at doses lower than those contained in this medicine.
• Avoid exposure to sunlight and ultraviolet rays due to a possible risk of photosensitivity (which may lead to skin lesions such as rash or blisters).
• If you have previously experienced an allergic reaction to vitamin B1 following skin contact (contact dermatitis) for occupational reasons, you may experience a relapse when taking this medicine.

Interference with laboratory tests

If you are undergoing any diagnostic tests (including blood and urine analyses, skin tests using allergens, 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 antibodies against intrinsic factor (IF).

Children

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

Other medicines and Vitagobens

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

This medicine may interact with the following medicines:

• Levodopa (a medicine used to treat Parkinson's disease).
• Phenobarbital, phenytoin (used to treat epilepsy).
• Altretamine and 5-Fluorouracil (for certain types of cancer).
• Amiodarone (for heart conditions).
• Neuromuscular blocking agents (used in anesthesia, for surgery).
• Various medicines may interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for treating 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 conditions).
• Various medicines may decrease vitamin B12 absorption or reduce its effect, for example: high-dose ascorbic acid, antibiotics such as neomycin and chloramphenicol, colchicine (for the treatment of gout), H2 antagonists (medicines for acidity or stomach ulcers), aminosalicylic acid in long-term treatments (for intestinal diseases), omeprazole (for stomach ulcers), antiepileptic medicines, metformin (for diabetes), high-dose folic acid.
• Oral contraceptives may reduce vitamin B6 and B12 levels.

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Vitagobens is not recommended for women of childbearing age who are not using an effective method of contraception.

Driving and operating machinery

The product's effects on the ability to drive or operate machinery are unknown. However, this medicinal product may cause drowsiness in some patients, who should therefore avoid driving and/or operating heavy machinery during treatment.

Vitagobens contains the red dye Ponceau 4R (E-124) and sodium

This medicine contains the red dye Ponceau 4R (E-124), which may cause allergic-type reactions.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which means it is essentially "sodium-free".

3. How to take Vitagobens

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.

Recommended dose:

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.

For oral use.

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

Patients with hepatic or renal impairment

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

If you take more Vitagobens than you should

If you have taken more Vitagobens than recommended, you may experience symptoms such as gastrointestinal discomfort (diarrhea, nausea, vomiting) and headache. Due to its pyridoxine content, you might also develop neurological disorders such as altered or reduced sensitivity, tingling, numbness in the feet and hands, unsteady gait, etc.; photosensitivity with skin rashes may also occur, as well as drowsiness, lethargy, breathing difficulty, and other effects depending on the dose, increased serum concentrations of AST (SGOT) (a transaminase), and decreased serum concentrations of folic acid. Rarely, a severe allergic reaction (anaphylactic shock) may occur.

In children, accidental ingestion of very high doses of vitamin B6 may additionally cause profound sedation, weakness, and respiratory difficulty.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number: 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 missed doses.

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

4. Possible adverse effects

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

The assessment of possible adverse effects 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).

Uncommonly reported adverse effects include: nausea, vomiting, headache, somnolence, paraesthesia (tingling sensation in arms and legs), and skin rash (redness or swelling). Hypersensitivity reactions (allergic reactions) to vitamins B1, B6, and B12 have also been described.

Other adverse effects reported, with frequency not known exactly, include: gastrointestinal discomfort, diarrhoea, loss of appetite with high doses, photosensitivity with skin lesions such as blisters, redness, itching; very occasionally, reduction in the number of platelets (thrombocytopenia); insomnia; neurological disorders with reduced sensation and tingling, among other symptoms, which generally improve upon discontinuation of treatment; worsening of Leber's disease (a hereditary condition causing vision loss); changes in urine colour, which usually disappear within 48 hours; occasionally, anaphylactic reaction with itching, sweating, breathing difficulty, increased heart rate, etc. Repeated administration of vitamin B1 may provoke relapses of allergic skin reactions in individuals allergic to this vitamin.

If an allergic reaction occurs, treatment must be discontinued and medical advice should be sought immediately for appropriate management.

Reporting of adverse reactions

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

5. Storage of Vitagobens

Keep this medicine out of sight and reach of children.

<PVDC-PE and aluminum blister: Store below 25 °C>.

<Aluminum/PVC-ACLAR® (PCTFE) blister: Store below 30 °C>.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Vitagobens

• The active substances 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 corn starch, anhydrous citric acid, sodium citrate dihydrate, colloidal silicon dioxide, copovidone, sodium starch glycolate type A from potato, and sodium stearyl fumarate.

Coating: hypromellose, titanium dioxide (E171), glycerol, propylene glycol dicaprylocaprate, Ponceau 4R red dye (E124), and carnauba wax.

Appearance of the product and contents of the pack

This medicine is presented as pink, oval, biconvex film-coated tablets.

Pack of 30 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the most recent review of this leaflet: August 2021.

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