BESTER COMPLEX Hard Capsules

Introduction

Package Leaflet: Information for the User

Bester Complex Hard Capsules

Thiamine Hydrochloride / Pyridoxine Hydrochloride / Hydroxocobalamin Acetate

Read the entire package leaflet 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Bester Complex and what is it used for
2. What you need to know before taking Bester Complex
3. How to take Bester Complex
4. Possible side effects
5. Storage of Bester Complex
6. Package Contents and Additional Information

1. What is Bester Complex and what is it used for

It is an association of the water-soluble vitamins of the B group: thiamine (vitamin B1), pyridoxine (vitamin B6), and hydroxocobalamin (vitamin B12), which are involved in numerous human metabolic processes.

It is indicated in: Prevention and treatment of states of deficiency of vitamins B1, B6, and B12, due to increased needs, reduced consumption, or absorption, which could manifest as symptoms such as back pain, among others; convalescences; insufficient diets.

Bester Complex is indicated for adults and adolescents over 14 years of age.

2. What you need to know before taking Bester Complex

Do not take Bester Complex

• if you are allergic to thiamine, pyridoxine, hydroxocobalamin, or other cobalamins (e.g., cyanocobalamin), cobalt, or any of the other components of this medication (listed in section 6).
• if you are being treated with levodopa (a medication used for Parkinson's disease).

Due to the high doses it contains:

• 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 Bester Complex.

• 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 have a blood disease, such as anemia, your doctor should check the cause before taking vitamin B12.
• If you have conditions such as uremia (urea accumulation 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 be reduced.
• There have been cases of dependence and withdrawal when taking 200 mg of pyridoxine for a month.
• You should be cautious with sun exposure or avoid it and ultraviolet (UVA) lamp exposure while using this medication, as pyridoxine can cause sun sensitivity (photosensitivity).
• If you have previously had an allergy to vitamin B1 on skin contact (contact dermatitis) for professional reasons, you may experience 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 using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results. In some determinations of urobilinogen, theophylline, and uric acid, false results may be produced.

Children

• Bester Complex is contraindicated in children under 14 years of age (see "Do not take Bester Complex" section).

Other Medications and Bester Complex

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

Bester Complex may interact with the following medications:

• Levodopa (medication for Parkinson's disease): may decrease its antiparkinsonian effect.
• Phenobarbital, phenytoin (medications for epilepsy).
• Amiodarone (medication used for the heart).
• Altretamine or 5-fluorouracil (for cancer treatment).
• Neuromuscular blocking medications (used in anesthesia for surgery).
• Various medications can interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for tuberculosis treatment (isoniazid, cycloserine, ethionamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), theophylline (for asthma and other respiratory diseases), immunosuppressants such as corticosteroids or cyclosporine (used in organ transplantation).
• Various medications can decrease the absorption of vitamin B12 or reduce its effect, such as: ascorbic acid (vitamin C), aminoglycoside antibiotics like neomycin, colchicine (for gout treatment), H-2 antagonists (medications against stomach acidity or ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), omeprazole (for stomach acidity or ulcers), medications for epilepsy, metformin (for diabetes), chloramphenicol (antibiotic), or cobalt radiation.
• Oral contraceptives can reduce the levels of both vitamin B6 and vitamin B12.

Taking Bester Complex with Food and Drinks

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy and Breastfeeding

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.

Due to the high doses of vitamin B in this medication, which are much higher than those recommended during pregnancy and breastfeeding, it is contraindicated during these periods.

Driving and Using Machines

This medication can cause drowsiness in a small proportion of patients, who should not drive and/or operate machines during treatment.

3. How to Take Bester Complex

Follow exactly the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults and Adolescents Over 14 Years of Age

The recommended dose is 1 capsule per day.

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.

Oral route.

It is recommended to take the capsules with the help of water.

Patient with Hepatic or Renal Insufficiency

These patients should not take Bester Complex.

If You Take More Bester Complex Than You Should

If you have taken more Bester Complex than you should (high doses), you may experience symptoms such as: digestive disorders (diarrhea, nausea, and vomiting) and headache. You may also experience sun sensitivity with skin lesions; drowsiness, difficulty breathing, among other effects, depending on the dose, increased liver enzyme levels, decreased folic acid levels in the blood.

In rare cases, a severe allergic reaction (anaphylactic shock) may occur.

You may also experience sensitivity alterations, tingling, etc., in prolonged treatments.

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 or go to a medical center, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Bester Complex

Do not take a double dose to make up for 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.

Uncommon side effects (may affect up to 1 in 100 people): nausea, vomiting, headache, drowsiness, tingling sensation in the skin (paresthesia) or sensitivity alterations, 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 (cannot be estimated from available data), are: digestive disorders, diarrhea, loss of appetite, photosensitivity with skin lesions such as blisters; changes in urine color, dizziness, restlessness, occasional insomnia; disorder with reduced sensitivity and tingling, numbness of feet or hands, which generally decrease when treatment is discontinued; a pyridoxine withdrawal syndrome more likely at high doses and in treatments of more than one month; in rare cases, anaphylactic reaction with itching, swelling, difficulty breathing, etc., late allergic reaction to vitamin B1 (see "Warnings and Precautions" in section 2).

If an allergic reaction occurs, you should discontinue treatment and receive treatment for the symptoms.

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

5. Storage of Bester Complex

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Bester Complex Composition

• The active ingredients are Thiamine Hydrochloride (vitamin B1), Pyridoxine Hydrochloride (vitamin B6), and Hydroxocobalamin Acetate (vitamin B12). Each capsule contains 100 mg of thiamine hydrochloride, 150 mg of pyridoxine hydrochloride, and 1,500 micrograms of hydroxocobalamin acetate.
• The other components are dibasic calcium phosphate dihydrate, sodium carboxymethylcellulose, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, cornstarch; the capsule colorants are: erythrosine (E127), indigotine (E132), quinoline (E104), titanium dioxide (E171).

Product Appearance and Package Contents

Bester Complex is presented in hard capsules, orange and brown in color.

Each package contains 30 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS SALVAT, S.A.

Gall, 30-36.

08950 Esplugues de Llobregat (Barcelona) Spain

Date of the Last Revision of this Package Leaflet:October/2017.

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/