BENEXOL B1-B6-B12 FILM-COATED TABLETS

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

Do not takeBenexol B1-B6-B12 tablets:

• if you are allergic to the active ingredients, to cobalamins (e.g., hydroxocobalamin), to cobalt, or to any of the other components of the medication (listed in section 6).
• if you are being treated with levodopa (a medication used in Parkinson's disease).
• it should not be administered to patients with Leber's disease (hereditary optic nerve atrophy) or with tobacco amblyopia (decreased 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, 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 high doses of pyridoxine (vitamin B6) are administered continuously, adverse effects of a neurological type (headache, tingling sensation, etc.) may occur.
• If you suffer from a blood disease, such as anemia, your doctor should check its cause before taking vitamin B12.
• If you have a predisposition to suffer from gout, you should be cautious because it could be produced due to the content of vitamin B12.
• If you have conditions such as uremia (accumulation of urea in the blood), infections, iron or folic acid deficiency, or are being treated with medications that have a suppressive effect on the bone marrow (e.g., chloramphenicol), the effect of vitamin B12 may decrease.
• Cases of dependence and withdrawal have been reported when taking doses of 200 mg of pyridoxine for a month.
• You should be cautious with the sun or avoid exposure to it, as pyridoxine can produce photosensitivity, with the appearance of a skin rash.
• If you have previously suffered from an allergy to vitamin B1 on skin contact (contact dermatitis) for professional reasons, you may suffer a relapse when taking this medication.

• Interference with analytical tests: If you are going to undergo any diagnostic test (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 the intrinsic factor (FI), false results may occur.

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 recently used, 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 decrease its effect.
  • Phenobarbital, phenytoin (medications for epilepsy).
  • Amiodarone (for the heart).
  • Altretamine (for cancer treatment).
  • Neuromuscular blocking medications (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: tuberculosis antibiotics (isoniazid, cycloserine, ethionamide, pyrazinamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), immunosuppressants such as corticosteroids (anti-inflammatory medications), and alcohol.

• Several medications may decrease the absorption of cyanocobalamin (vitamin B12) or reduce its effect, such as: ascorbic acid (vitamin C) in high doses, aminoglycoside antibiotics such as neomycin, colchicine (for gout treatment), H2 antagonists (medications against acidity or stomach ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), proton pump inhibitors such as omeprazol (for stomach ulcers), epilepsy medications, metformin (for diabetes), sustained-release potassium preparations, or cobalt radiation. The need for vitamin B12 may be increased in patients receiving these medications.
  • Chloramphenicol: may delay or interrupt the response to red blood cell formation to vitamin B12. Close monitoring of the blood count should be performed if this combination cannot be avoided.

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

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

Excessive alcohol consumption decreases 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.

This product is contraindicated in pregnant or breastfeeding women.

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

Driving and using machines

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

Benexol contains sodium

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

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

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of 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 route.

It is recommended to take Benexol B1-B6-B12 tablets without chewing with the help of 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.

Patient with hepatic or renal 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 dose in the leaflet or as indicated by your doctor, due to the content of pyridoxine, you may experience nervous disorders such as alterations or reduction of sensitivity, tingling, numbness in feet and hands, unsteady gait, etc.; in case of overdose, you may experience symptoms such as gastrointestinal disorders (diarrhea, nausea, and vomiting) and headache. You may also experience photosensitivity with skin lesions, drowsiness, 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, the accidental ingestion of very high doses of vitamin B6 can also produce deep sedation, weakness, and difficulty breathing.

The effects are generally reversible when treatment is discontinued.

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 forget to take Benexol B1-B6-B12 tablets.

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

If you have any other doubts 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 experiences 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).

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

Other side effects that have been reported, with an unknown frequency, are: gastrointestinal disorders, diarrhea, loss of appetite, photosensitivity with skin lesions such as blisters; very occasionally, a decrease in platelet count (thrombocytopenia); dizziness, restlessness, insomnia; disorder with reduced sensitivity and tingling, unsteady gait, numbness of feet or hands, which generally decrease when treatment is discontinued; a pyridoxine withdrawal syndrome more likely with higher doses, memory impairment with high doses; changes in urine color, swelling, and eye irritation; occasionally, anaphylactic reaction with rash, itching, swelling, difficulty breathing, etc.; some cases of affection with nodules and pus on the face and neck.

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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Benexol B1-B6-B12 tablets.

Store below 25°C.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information.

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

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

Appearance of the product and package contents.

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

Contents: 30 film-coated tablets.

Marketing authorization holder and manufacturer.

Marketing authorization 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 last revision of this leaflet:February 2025.

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