Leaflet: information for the user

Benexol B1-B6-B12 film-coated tablets

Read this leaflet carefully before you start to take this medicine,because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4
• You should consult a doctor if you get worse or do not improve after 7 days.

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

Vitamins are essential nutrients that intervene in numerous human metabolism processes.

It is indicated for: Prevention and treatment of deficiency states of vitamins B1, B6and B12due to the increase in needs, reduction in consumption or reduction in absorption, which may manifest as cases of back pain, in convalescences or insufficient diets.

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

Do not takeBenexolB1-B6-B12 tablets:

- if you are allergic to the active ingredients, cobalamins (e.g. hydroxocobalamin), cobalt, or any of the other components of the medication (listed in section 6).

- if you are being treated with levodopa (a medication used for Parkinson's disease)

- do not administer to patients with Leber's disease (hereditary optic nerve atrophy) or tobacco amblyopia (decreased visual acuity that can occur in people who abuse tobacco), as it may worsen.

Do not take this medication for the doses it contains:

- if you have kidney or liver diseases

- if you are pregnant or breastfeeding

- children under 14 years of age.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Benexol B1-B6-B12 tablets.

• Do not take a higher dose than recommended or for a longer period than recommended. When large doses of pyridoxine (vitamin B6) are administered continuously, neurological side effects (headache, tingling sensation, etc.) may occur.
• If you have any blood disorders, such as anemia, the doctor should check the cause before taking vitamin B12.
• If you are prone to gout, be cautious as it may cause it, due to the content of vitamin B12.
• If you have conditions such as uremia (accumulation of urea in the blood), infections, iron deficiency, or folate deficiency, or are being treated with medications that suppress bone marrow (e.g. chloramphenicol), the effect of vitamin B12 may be reduced.
• Cases of dependence and withdrawal have been reported when taking 200 mg of pyridoxine for a month.
• Be cautious in the sun or avoid exposure to it, as pyridoxine may cause photosensitivity, with skin eruption.
• If you have previously had an allergy to vitamin B1 contact with your skin (contact dermatitis) due to professional reasons, you may experience a relapse when taking this medication.

- Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, skin tests using 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 (FI), false results may be produced.

Children

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

Taking Benexol B1-B6-B12 tablets with other medications

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

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

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

• Fenobarbital, phenytoin (medications for epilepsy).
• Amiodarone (for the heart).
• Altretamine (for cancer treatment).
• Medications blocking neuromuscular transmission (used in anesthesia, for surgery).
• 5-Fluorouracil (for some types of cancer)

• The following medications 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), and alcohol.

- Varios medicamentos pueden disminuir la absorción de cianocobalamina (vitamina B12) o reducir su efecto, como por ejemplo: ácido ascórbico (vitamina C) en grandes dosis, antibióticos aminoglucósidos como neomicina, la colchicina (para el tratamiento de la gota), antagonistas H2 (medicamentos contra la acidez o úlcera de estómago, como ranitidina, cimetidina, etc.), ácido aminosalicílico (para enfermedades intestinales), inhibidores de la bomba de protones como omeprazol (para la úlcera de estómago), medicamentos para la epilepsia, metformina (para la diabetes), preparados de potasio de liberación sostenida o radiaciones de cobalto.Las necesidades devitamina B12pueden verse incrementadas en pacientes que reciben estas medicaciones.

• Cloranfenicol: puede retrasar o interrumpir la respuesta para la formación de glóbulos rojos a la vitamina B12.

• The following medications may reduce the levels of both vitamin B6 and vitamin B12, including: oral contraceptives.

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

Excessive alcohol consumption may reduce the absorption of the vitamins.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This product is contraindicated in pregnant women or those breastfeeding.

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

Driving and operating machinery

The influence of Benexol tablets on the ability to drive and operate machinery is negligible or insignificant. This medication may cause drowsiness in a few patients, who should not drive and/or operate machinery during treatment.

Benexol contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those 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

It is recommended to take 1 tablet per day.

Oral administration.

It is recommended to swallow Benexol B1-B6-B12 tablets without chewing with the help of a little water.

Generally, 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 liver or kidney insufficiency

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

Use in children

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

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

No cases of overdose have been reported.

If you take more than the recommended amount in the leaflet or what your doctor has indicated, due to the content of pyridoxine, you may experience nervous system disturbances such as alterations or reduction of sensitivity, tingling, numbness in feet and hands, unstable gait, etc.; in case of overdose, you may suffer symptoms such as gastrointestinal discomfort (diarrhea, nausea, and vomiting) and headache. You may also experience sun sensitivity with skin lesions, drowsiness, difficulty breathing, among other effects, depending on the dose, increase in serum concentrations of AST (SGOT) (a transaminase) and decrease in 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 may also produce deep sedation, weakness, and difficulty breathing.

Effects are generally reversible when treatment is interrupted.

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

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

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The assessment of adverse effects that may occur is based on the following frequencies: very frequent (may affect more than 1 in 10 people), frequent (may affect up to 1 in 10 people), infrequent (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).

Infrequently, the following may appear: nausea, vomiting, headache, drowsiness, paresthesias (tingling sensation in arms and legs) or sensory alterations (alterations in touch) and skin rash (redness). Reactions of hypersensitivity (allergic reactions) to vitamins B1, B6, and B12 have also been described.

Other adverse effects that have been reported, with frequency not exactly known as these reactions are voluntarily notified, are: digestive discomfort, diarrhea, loss of appetite, photosensitivity with skin lesions such as blisters; very occasionally, a reduction in the number of platelets (thrombocytopenia); dizziness, restlessness, insomnia; disorder with reduced sensitivity and tingling, unstable gait, numbness of feet or hands, which generally decrease when treatment is interrupted; a pyridoxine withdrawal syndrome is more likely to occur 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, difficulty breathing, etc.; some cases of a condition with nodules and pus on the face and neck.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 25°C.

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

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.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Benexol B1-B6-B12 coated tablets

• The active principles 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), Colloidal anhydrous silica, Povidone K90, Magnesium stearate, Pre-gelatinized potato starch, Copolymer of methacrylic acid and ethyl acrylate (1:1), Sodium carmellose, Macrogol 6000, Talc and Triacetin.

Appearance of the product and content of the packaging

Benexol B1-B6-B12 is presented in the form of coated tablets, round and pink in color.

Content: 30 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Bayer Hispania, S.L.

Av. BaixLLobregat, 3-5.

08970 Sant Joan Despí (Barcelona)

Responsible for manufacturing:

DelpharmGaillard

33 rue de l’Industrie

74240 Gaillard (France)

ROCHE, S.P.A.

Via Morelli, 2 Segrate, Milan I 20090 Italy

Last review date of this leaflet: February 2025

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