Label: information for the user

Hidroxil B1-B6-B12film-coated tablets

thiamine hydrochloride / pyridoxine hydrochloride / cyanocobalamin

Read this label carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions of the medication contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• Ifyou need advice or more informationconsult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

6. Contents of the pack and additional information.

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

Hydroxil is indicated for: Prevention and treatment of deficiencies in vitamins B1, B6and B12, due to increased needs, reduced consumption or absorption, which may manifest as symptoms of back pain, in convalescence or insufficient diets.

Hydroxil B1-B6-B12tablets are indicated for adults and adolescents over 14 years old.

Do not take Hidroxil:

• If you are allergic to vitamin B1, B6, or B12, or to cobalt, or to 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 (hereditary optic nerve atrophy) or tobacco amblyopia (a decrease in 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 disease.
• If you are pregnant or breastfeeding.
• Children under 14 years old.

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 disorder, such as anemia, your doctor should check the cause before taking vitamin B12.
• Cases of dependence and withdrawal have been reported when taking pyridoxine (vitamin B6) for a month, even at doses lower than those contained in this medication.
• Avoid exposure to the sun, as there may be a risk of photosensitivity (appearance of skin lesions such as rashes or blisters).
• If you have previously had an allergy to vitamin B1 due to skin contact (contact dermatitis) for professional reasons, you may experience a recurrence 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 Hidroxil

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

This medication may interact with the following medications:

• Levodopa (a medication for Parkinson's disease).
• Phenobarbital, phenytoin (for epilepsy).
• Altretamine (for cancer treatment).
• Amiodarone (for the heart).
• Neuromuscular blocking agents (used in anesthesia, for surgery).
• 5-Fluorouracil (for certain types of cancer).
• 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 transplantation, among other diseases).
• Various medications may 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 gout treatment), H2 antagonists (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 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the high doses of vitamins B contained in Hidroxil, this medication is contraindicated during pregnancy and breastfeeding.

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

Driving and operating machinery

The influence of Hidroxil 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 hazardous machinery during treatment.

Hidroxil contains sodium

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 old

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, consult your doctor.

Oral route.

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 Hydroxil (see section 2).

Use in children

This medication is contraindicated in children under 14 years old (see section 2).

If you take more Hydroxil than you should

If you have taken more Hydroxil 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, unsteady gait, etc.; you may also experience photosensitivity 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 B6 may also produce deep sedation, weakness, and respiratory difficulty.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, 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 Hydroxil

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

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).

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 an exact frequency unknown, are: digestive discomfort, diarrhea, loss of appetite (with high doses), 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, among other symptoms, which generally decrease when treatment is interrupted; changes in urine color, occasionally anaphylactic reaction with itching, difficulty breathing; vitamin B1may cause late hypersensitivity in rare cases.

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 for Pharmacovigilance of Medicines for Human Use:https://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 in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hidroxil B 1 -B 6 -B 12 film-coated tablets

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

Appearance of the product and contents of the packaging

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

Packaging of 15 and 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

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

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

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