Vitagobens B1 B6 B12 30 Coated Tablets

Vitagobens B1 B6 B12 film-coated tablets

thiamine hydrochloride/ pyridoxine hydrochloride/ cyanocobalamin

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

Follow exactly the instructions for administration 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, ask your pharmacist.

-If you experience side effects, talk to your doctor or pharmacist, including side effects not listed in this leaflet. See section 4.

-You should see a doctor if it worsens or if it does not improve after 7 days.

Package leaflet content

1. What Vitagobens is and what it is used for

2. What you need to know before you take Vitagobens

3. How to take Vitagobens

4. Possible adverse effects

5. How to store Vitagobens

6. Contents of the pack and other information

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

Vitagobens is indicated in: prevention and treatment of deficiency of vitamins B1, B6 and B12, due to increased needs, reduced consumption or absorption, which could manifest as symptoms of back pain, in convalescence or insufficient diets.

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

Do not take Vitagobens

• If you are allergic to vitamin B1, B6 or the various forms of vitamin B12, to cobalt, or to any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with levodopa (a medicine for Parkinson's).
• If you suffer from Leber's disease (hereditary disease that causes vision loss) or smoking amblyopia (decreased visual acuity, which can occur in people who abuse tobacco), because they could get worse.

For the doses it contains, do not take this medicine:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Vitagobens.

• You should not take a higher dose than recommended or for a longer period of time than recommended; In your case, regular monitoring by your doctor is recommended since cases of neuropathies have been observed after the intake of high and continuous daily doses of vitamin B6.
• If you suffer from any blood disease, such as anemia, your doctor should check its cause before taking vitamin B12.
• There have been cases of pyridoxine dependence and withdrawal when taking doses of pyridoxine (vitamin B6) for a month even lower than that contained in this medicine.
• You should avoid exposure to the sun and ultraviolet rays, due to a possible risk of photosensitivity (with the appearance of skin lesions such as rash or blisters).
• If you have previously had an allergy to vitamin B1 from contact with your skin (contact dermatitis) for occupational reasons, you may experience a relapse when taking this medicine.

Interferences with analytical tests

If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), tell your doctor that you are taking this medicine, as it may alter the results. In some determinations of urobilinogen, theophylline, uric acid or antibodies against intrinsic factor (IF), false results could be produced.

Kids

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

Other medicines and Vitagobens

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This medication may interact with the following medications:

• Levodopa (medicine for the treatment of Parkinson's).
• Phenobarbital, phenytoin (to treat epilepsy).
• Altretamine and 5-Fluorouracil (for some types of cancers).
• Amiodarone (for the heart).
• Neuromuscular blocking drugs (used in anesthesia, for surgery).
• Several drugs can interfere with pyridoxine (vitamin B6) and can reduce its levels, including: antibiotics to cure tuberculosis (isoniazid, cycloserine, ethionamide and pyrazinamide), penicillamine (for rheumatic diseases), hydralazine (for blood pressure), immunosuppressants such as corticosteroids, cyclosporine (used in organ transplants, among other diseases).
• Several medications can decrease the absorption of vitamin B12 or reduce its effect, such as: ascorbic acid in large doses, antibiotics such as neomycin and chloramphenicol, colchicine (for the treatment of gout), h3 antagonists (medicines against heartburn or ulcer of the stomach), aminosalicylic acid in long courses (for intestinal diseases), omeprazole (for stomach ulcer), medicines for epilepsy, metformin (for diabetes), folic acid in high doses.
• Oral contraceptives can reduce the levels of vitamins B6 and B12.

Taking Vitagobens with alcohol

Excessive alcohol intake reduces the absorption of vitamins.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before using this medicine.

Due to the doses of B vitamins that Vitagobens contains, much higher than those recommended during pregnancy and lactation, this medication is contraindicated during pregnancy and lactation.

Vitagobens is not recommended in women of childbearing potential not using effective contraception.

Driving and using machines

There are no known effects of the product on the ability to drive or use machines. However, this medicine may cause drowsiness in a few patients, who should not drive and/or use dangerous machines during treatment.

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

This medicine contains Ponceau red dye 4R (E-124). May cause allergic-type reactions.

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

Follow exactly the instructions for administration of the medicine 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: 1 tablet per day.

In general, treatment should not exceed 15 days, although your doctor may recommend administration for longer.

If it worsens or if it does not improve after 7 days of treatment, you should see a doctor.

Orally.

It is preferable that the tablets are swallowed whole, with the help of a sufficient amount of water.

Patients with hepatic or renal 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 (diarrhoea, nausea, vomiting) and headache. Due to the pyridoxine content, you could suffer from nervous disorders such as altered or reduced sensitivity, tingling, numbness in the feet and hands, unstable gait, etc; sensitization to sunlight with skin rashes may also appear; drowsiness, lethargy, respiratory distress, 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 can also cause profound sedation, weakness, and respiratory distress.

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or go to a medical center or call the Toxicological Information Service, telephone: 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Vitagobens

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The assessment of the 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 10 people). 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), not known (frequency cannot be estimated from the available data).

Infrequently the following may appear: nausea, vomiting, headache, drowsiness, paraesthesia (tingling sensation in the arms and legs) and skin rash (redness or swelling). Hypersensitivity reactions (allergic reactions) to vitamins B1, B6 and B12 have also been reported.

Other side effects that have been reported, often not exactly known, are: digestive 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; disorder with reduced sensation and tingling, among other symptoms, which generally subside when treatment is stopped; worsening of Leber's disease (an inherited disease that causes vision loss); changes in the color of urine, which usually disappears within 48 hours; occasionally anaphylactic reaction with itching, sweating, shortness of breath, increased heartbeat, etc. 

If an allergic reaction occurs, treatment should be stopped and a doctor should be consulted immediately for appropriate treatment.

Communication of adverse effects

If you get any side effects, talk to your doctor or pharmacist, including possible side effects not listed in this leaflet. You can also notify them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

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

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

<Aluminium/PVC-ACLAR®(PCTFE) blister: Store below 30 ºC>.

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

Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Point   of the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way you will help to protect the environment.

Composition of Vitagobens

• 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 500 micrograms of cyanocobalamin.

• The other ingredients (excipients) are:

Core : pregelatinized corn starch, anhydrous citric acid, sodium citrate dihydrate, colloidal silica, copovidone, type A sodium starch glycolate from potato, and sodium stearyl fumarate.

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

Leaflet Vitagobens B1 B6 B12 30 Coated Tablets