Leaflet: information for the user

Vitagobens B1 B6 B12 film-coated tablets

thiamine hydrochloride / pyridoxine hydrochloride / cyanocobalamin

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

Follow exactly the administration instructions for 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.

1. What is Vitagobens and what it is used for

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

3. How to take Vitagobens

4. Possible side effects

5. Storage of Vitagobens

6. Contents of the pack and additional information

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.

Do not take this medication at the doses it contains:

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

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 this case, regular monitoring by your doctor is recommended, as cases of neuropathy have been observed after the ingestion of high and continuous daily doses of vitamin B6.
• If you have a blood disease, such as anemia, your doctor should check its cause before taking vitamin B12.
• Cases of dependence and withdrawal have been reported with the use of pyridoxine (vitamin B6) for a month, even at doses lower than those contained in this medication.
• Avoid exposure to the sun and ultraviolet rays, as there is a possible risk of photosensitivity (appearance of skin lesions such as rashes or blisters).
• If you have previously had an allergy to vitamin B1due to skin contact (contact dermatitis) for 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 old.

Other medications and Vitagobens

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

This medication may interact with the following medications:

• Levodopa (a medication for Parkinson's disease).
• Phenobarbital, phenytoin (for epilepsy).
• Altretamine and 5-fluorouracil (for certain types of cancer).
• Amiodarone (for the heart).
• Neuromuscular blocking agents (used in anesthesia, for surgery).
• Various medications may interfere with pyridoxine (vitamin B6) and 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 transplants, among other diseases).
• Various medications may decrease the absorption of vitamin B12or reduce its effect, such as: high doses of ascorbic acid, antibiotics such as neomycin and chloramphenicol, colchicine (for gout), H2antagonists (medications for acid reflux or stomach ulcers), long-term use of aminosalicylic acid (for intestinal diseases), omeprazole (for stomach ulcers), medications for epilepsy, metformin (for diabetes), high doses of folic acid.
• Oral contraceptives may reduce levels of vitamins B6and B12.

Taking Vitagobens with alcohol

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you 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 lactation, this medication is contraindicated during pregnancy and lactation.

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

Driving and operating machinery

No effects of the product on the ability to drive or operate machinery have been reported. However, this medication may cause drowsiness in a few patients, who should not drive and/or operate hazardous machinery during treatment.

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

This medication contains 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".

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:1 tablet per day.

Generally, treatment should not exceed 15 days in duration, although your doctor may recommend administration for a longer period.

If symptoms worsen or do not improve after 7 days of treatment, you must consult your doctor.

Oral administration.

It is preferable to swallow the tablets whole, with the help of a sufficient amount of water.

Patients with liver or kidney 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 discomfort (diarrhea, nausea, vomiting) and headache. Due to the content of pyridoxine, you may suffer from nervous system disorders such as alterations or reduction of sensitivity, paresthesia, numbness in feet and hands, unstable gait, etc.; you may also experience sun sensitivity with skin eruptions; drowsiness, lethargy, respiratory difficulty, among other effects, depending on the dose, increase in serum AST (SGOT) concentrations (a transaminase) and decrease in serum folate concentrations. In rare cases, a severe allergic reaction (anaphylactic shock) may occur.

In children, accidental ingestion of very high doses of vitamin B6may produce, in addition, deep sedation, weakness, and respiratory difficulty.

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: 915 62 04 20, indicating the medication and the amount taken.

If you forget to take Vitagobens

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 everyone will 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), unknown frequency (cannot be estimated from available data).

Infrequently, the following may appear: nausea, vomiting, headache, drowsiness, paresthesias (tingling sensation in arms and legs) and skin rash (redness or swelling). Reactions of hypersensitivity (allergic reactions) to vitamins B1, B6, and B12have also been described.

Other adverse effects that have been reported, with unknown frequency, are: digestive discomfort, diarrhea, loss of appetite with high doses, photosensitivity with skin lesions such as blisters, redness, itching; very occasionally, a reduction in the number of platelets (thrombocytopenia); insomnia; disorder with reduced sensitivity and tingling, among other symptoms, which generally decrease when treatment is interrupted; worsening of Leber's disease (hereditary disease that causes loss of vision); changes in urine color, which usually disappear in 48 hours; occasionally, anaphylactic reaction with itching, sweating, difficulty breathing, increased heart rate, etc. Repeated administration of vitamin B1may cause relapses in skin allergic reactions in people allergic to this vitamin.

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

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 of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Vitagobens

• The active principles are: thiamine hydrochloride (vitamin B 1 ), pyridoxine hydrochloride (vitamin B 6 ) and cyanocobalamin (vitamin B 12 ).

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 glycolate from potato type A and sodium stearoyl fumarate.

Covering : hypromellose, titanium dioxide (E171), glycerol, propylene glycol dicaprylate, red food color Ponceau 4R (E124) and carnauba wax.

Appearance of the product and content of the packaging

This medicine is presented in the form of coated tablets with a pink film, elliptical and biconvex.

Packaging of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Last review date of this leaflet: August 2021 .

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.