HYDROXIL B1-B6-B12 FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Hidroxil B1-B6-B12film-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 administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Hidroxil is and what it is used for.
2. What you need to know before taking Hidroxil.
3. How to take Hidroxil.
4. Possible side effects.
5. Storage of Hidroxil.

1. Contents of the pack and further information.

1. What Hidroxil is and what it is used for

The active ingredients of Hidroxil are the water-soluble vitamins B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin) that are involved in numerous human metabolic processes.

Hidroxil 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 convalescences, or insufficient diets.

Hidroxil B1-B6-B12 film-coated tablets are indicated in adults and adolescents over 14 years of age.

2. What you need to know before taking Hidroxil

Do not take Hidroxil:

• If you are allergic to vitamin B1, B6, or the various forms of vitamin B12, cobalt, or any of the other components of this medicine (listed in section 6).
• If you are being treated with levodopa (a medicine for Parkinson's disease).
• If you have Leber's disease (hereditary optic nerve atrophy) or 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 medicine:

• 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 or pharmacist before starting to take Hidroxil.

• Do not take a higher dose than recommended or for a longer period than recommended.
• If you have a blood disease, such as anemia, your doctor should check the cause before taking vitamin B12.
• There have been cases of dependence and withdrawal when taking pyridoxine (vitamin B6) for a month, even at doses lower than those contained in this medicine.
• You should avoid exposure to the sun due to a possible risk of photosensitivity (with skin lesions such as rash or blisters).
• If you have previously had an allergy to vitamin B1 through skin contact (contact dermatitis) for professional reasons, you may experience a relapse when taking this medicine.

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 medicine, as it may alter the results. In some determinations of urobilinogen, theophylline, uric acid, or antibodies against intrinsic factor (IF), false results may occur.

Children

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

Other medicines and Hidroxil

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

This medicine may interact with the following medicines:

• Levodopa (a medicine for the treatment of Parkinson's disease).
• Phenobarbital, phenytoin (for the treatment of epilepsy).
• Altretamine (for the treatment of cancer).
• Amiodarone (for the heart).
• Neuromuscular blocking agents (used in anesthesia for surgery).
• 5-Fluorouracil (for some types of cancer).
• Several medicines can interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for the treatment of tuberculosis (isoniazid, cycloserine, ethionamide, and pyrazinamide), penicillamine (for rheumatic diseases), hydralazine (for high blood pressure), immunosuppressants such as corticosteroids, cyclosporine (used in organ transplantation, among other diseases).
• Several medicines can decrease the absorption of vitamin B12 or reduce its effect, such as: high doses of ascorbic acid, antibiotics such as neomycin and chloramphenicol, colchicine (for the treatment of gout), H2 antagonists (medicines against acidity or stomach ulcers), aminosalicylic acid in long-term treatments (for intestinal diseases), omeprazole (for stomach ulcers), medicines for epilepsy, metformin (for diabetes), high doses of folic acid.
• Oral contraceptives may reduce the levels of vitamins B6 and B12.

Taking Hidroxil with alcohol

Excessive alcohol consumption reduces 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 medicine.

Due to the doses of vitamins B contained in Hidroxil, which are much higher than those recommended during pregnancy and breastfeeding, this medicine is contraindicated during pregnancy and breastfeeding.

Hidroxil is not recommended in women of childbearing age who do not use an effective contraceptive method.

Driving and using machines

The influence of Hidroxil on the ability to drive and use machines is negligible or nonexistent. This medicine can cause drowsiness in a few patients, who should not drive and/or operate hazardous machinery during treatment.

Hidroxil contains sodium

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

3. How to take Hidroxil

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of 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 a longer period.

If it worsens or does not improve after 7 days of treatment, you should consult your doctor.

Oral route.

It is preferable to swallow the tablets whole, with enough water.

Patient with hepatic or renal insufficiency

These patients should not take Hidroxil (see section 2).

Use in children

This medicine is contraindicated in children under 14 years of age (see section 2).

If you take more Hidroxil than you should

If you have taken more Hidroxil than you should, you may experience symptoms such as: gastrointestinal disorders (diarrhea, nausea, vomiting) and headache. Due to the content of pyridoxine, you may experience nervous disorders such as altered or reduced sensitivity, paresthesia, numbness in hands and feet, unsteady gait, etc.; you may also experience photosensitivity with skin lesions such as blisters; drowsiness, lethargy, 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, accidental ingestion of very high doses of vitamin B6 can also cause deep sedation, weakness, and difficulty breathing.

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

If you forget to take Hidroxil

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

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

4. Possible side effects

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

The assessment of side effects that can 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, paresthesia (tingling sensation in arms and legs), and skin rash (redness or swelling). 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 (with high doses), photosensitivity with skin lesions such as blisters; very occasionally, a decrease in the number of platelets (thrombocytopenia); dizziness, restlessness, insomnia; disorders with reduced sensitivity and paresthesia, among other symptoms, which usually decrease when treatment is discontinued; changes in urine color, occasionally anaphylactic reaction with itching, difficulty breathing; vitamin B1 can rarely cause delayed hypersensitivity.

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

Reporting of side effects

If you experience any side effects, 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 Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidroxil

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 CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Hidroxil B1-B6-B12film-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 500 micrograms of cyanocobalamin.

• The other ingredients (excipients) are: copovidone, sodium carboxymethyl starch (potato), sodium stearyl fumarate, modified cornstarch, citric acid, trisodium citrate, silicon dioxide, hypromellose, titanium dioxide (E-171), natural wax, glycerol, medium-chain triglycerides, and carmine (E-120).

Appearance of the product and contents of the pack

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

Packs of 15 and 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca (Barcelona) (Spain)

Date of the last revision of this leaflet:January 2022.

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