Benexol B1-B6-B12 film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Benexol B1-B6-B12 film-coated tablets

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

Follow exactly the instructions for use provided 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 Benexol B1-B6-B12 tablets are and what they are used for
2. What you need to know before taking Benexol B1-B6-B12 tablets
3. How to take Benexol B1-B6-B12 tablets
4. Possible adverse effects
5. How to store Benexol B1-B6-B12 tablets
6. Contents of the pack and other information

1. What Benexol B1-B6-B12 tablets are and what they are used for

It is a combination of water-soluble B-complex vitamins: thiamine (vitamin B1), pyridoxine (vitamin B6), and cyanocobalamin (vitamin B12), intended for oral administration.

Vitamins are essential nutrients that participate in numerous human metabolic processes.

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

Benexol B1-B6-B12 is indicated in adults and adolescents over 14 years of age.

2. What you need to know before taking Benexol B1-B6-B12 tablets

Do not take Benexol B1-B6-B12 tablets:

• if you are allergic to the active substances, to cobalamins (e.g. hydroxocobalamin), 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).
• it should not be given to patients with Leber's disease (hereditary optic nerve atrophy) 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

Talk to your doctor, pharmacist, or nurse before taking Benexol B1-B6-B12 tablets.

• Do not take a higher dose than recommended or for longer than recommended. When high doses of pyridoxine (vitamin B6) are administered continuously, neurological adverse effects may occur (e.g. headache, tingling sensations, etc.).

• If you suffer from a blood disorder such as anaemia, your doctor should determine its cause before you take vitamin B12.

• If you are predisposed to gout, use with caution, as vitamin B12 content may trigger an attack.

• If you have conditions such as uraemia (accumulation of urea in the blood), infections, iron or folic acid deficiency, or are being treated with medicines that suppress bone marrow function (e.g. chloramphenicol), the effect of vitamin B12 may be reduced.

• Cases of dependence and withdrawal symptoms have been reported after taking 200 mg doses of pyridoxine for one month.

• Be cautious with sunlight or avoid exposure, as pyridoxine may cause photosensitivity, leading to skin rashes.

• If you have previously experienced skin allergy to vitamin B1 (contact dermatitis) due to occupational exposure, you may have a recurrence when taking this medicine.

• Interference with laboratory tests: If you are scheduled for any diagnostic tests (including blood and urine tests, 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.

Taking Benexol B1-B6-B12 tablets with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Benexol B1-B6-B12 may interact with the following medicines:

• Levodopa (a medicine used to treat Parkinson's disease): may reduce its effect.

  • Phenobarbital, phenytoin (medicines for epilepsy).
  • Amiodarone (for heart conditions).
  • Altretamine (used in cancer treatment).
  • Neuromuscular blocking agents (used in anaesthesia for surgery).
  • 5-Fluorouracil (used for certain types of cancer).

• The following medicines may interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for tuberculosis (isoniazid, cycloserine, ethionamide, pyrazinamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), immunosuppressants such as corticosteroids (anti-inflammatory agents), and alcohol.

• Several medicines may reduce the absorption of cyanocobalamin (vitamin B12) or reduce its effect, such as: high-dose ascorbic acid (vitamin C), aminoglycoside antibiotics like neomycin, colchicine (for gout treatment), H2 antagonists (medicines for acidity or stomach ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), proton pump inhibitors like omeprazole (for stomach ulcers), antiepileptic medicines, metformin (for diabetes), sustained-release potassium preparations, or cobalt radiation. The need for vitamin B12 may be increased in patients taking these medicines.

  • Chloramphenicol: may delay or interrupt the red blood cell response to vitamin B12. Close monitoring of blood counts is required if this combination cannot be avoided.

• Oral contraceptives may reduce levels of both vitamin B6 and vitamin B12.

Taking Benexol B1-B6-B12 tablets with food and drink

Excessive alcohol intake reduces vitamin absorption.

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.

This product is contraindicated in pregnant or breastfeeding women.

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

Driving and using machines

The effect of Benexol tablets on the ability to drive and use machines is none or negligible. This medicine may cause drowsiness in a few patients; such patients should not drive or operate machinery during treatment.

Benexol contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Benexol B1-B6-B12 tablets

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

Recommended dose:

Adults and adolescents over 14 years of age

The recommended dose is 1 tablet per day.

Oral use.

Benexol B1-B6-B12 tablets should be taken whole, without chewing, with a little water.

In general, treatment should not exceed 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 your doctor.

Patients with hepatic or renal impairment

These patients must not take Benexol B1-B6-B12 tablets.

Use in children

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

If you take more Benexol B1-B6-B12 tablets than you should

Cases of overdose have not been reported.

If you take a higher dose than recommended in the leaflet or prescribed by your doctor, due to the pyridoxine content, you may experience neurological disorders such as altered or reduced sensitivity, tingling, numbness in hands and feet, unsteady gait, etc. In case of overdose, symptoms such as gastrointestinal disturbances (diarrhea, nausea, and vomiting) and headache may occur. Other possible effects depending on the dose include photosensitization with skin lesions, somnolence, breathing difficulties, 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 deep sedation, weakness, and respiratory difficulty.

These effects are generally reversible when treatment is discontinued.

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

If you forget to take Benexol B1-B6-B12 tablets

Do not take a double dose to make up for forgotten 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 will experience 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).

Uncommonly, the following may occur: nausea, vomiting, headache, drowsiness, paresthesia (tingling sensation in arms and legs), sensory disturbances (altered sense of touch), and skin rash (redness). Hypersensitivity reactions (allergic reactions) to vitamins B1, B6, and B12 have also been reported.

Other adverse effects that have been reported, with frequency not known exactly since these reactions have been reported voluntarily, include: gastrointestinal discomfort, diarrhea, loss of appetite, photosensitivity with skin lesions such as blisters; very occasionally, reduction in the number of platelets (thrombocytopenia); dizziness, restlessness, insomnia; neurological disorders with reduced sensation and tingling, unsteady gait, numbness in feet or hands, which generally improve when treatment is discontinued; a pyridoxine withdrawal syndrome, more likely with higher doses; memory impairment with high doses; changes in urine color, swelling and irritation in the eyes; occasionally, anaphylactic reaction with rash, itching, swelling, breathing difficulty, etc.; and isolated cases of facial and neck lesions with nodules and pus.

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 may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Benexol B1-B6-B12 tablets

Store below 25 °C.

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

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Benexol B1-B6-B12 film-coated tablets

• 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 1,000 micrograms of cyanocobalamin.
• The other components (excipients) are: mannitol (E-421), anhydrous colloidal silica, povidone K90, magnesium stearate, pregelatinized starch (from potato), methacrylic acid and ethyl acrylate copolymer (1:1), sodium carboxymethylcellulose, macrogol 6000, talc and glyceryl triacetate.

Appearance of the product and contents of the pack

Benexol B1-B6-B12 is presented as pink, round, film-coated tablets.

Contents: 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5.

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Delpharm Gaillard

33 rue de l’Industrie

74240 Gaillard (France)

ROCHE, S.P.A.

Via Morelli, 2 Segrate, Milan I 20090 Italy

Date of the most recent review of this leaflet: February 2025

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