Leaflet: information for the user

Bester Complex hard capsules

Tiamina hidrocloruro/ Piridoxina hidrocloruro/ Hidroxocobalamina acetato

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

Follow exactly the administration instructions 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 Bester Complex and what it is 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. Contents of the pack and additional information

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

It is indicated for: Prevention and treatment of states of deficiency of vitamins B1, B6and B12,due to the increase in needs, reduction in consumption or absorption, which could manifest as symptoms of back pain, among others; convalescences; insufficient diets.

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

Do not take Bester Complex

• If you are allergic to thiamine, pyridoxine, hydroxocobalamin, or other cobalamins (e.g., cyanocobalamin), cobalt, or any other component 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 contained:

• 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 takeBester Complex.

• Do not take a higher dose than recommended or for a longer period than recommended. When large doses of pyridoxine (vitamin B6) are administered continuously, neurological side effects (headache, tingling sensation, etc.) may occur.
• If you have a blood disorder, 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 suppress bone marrow (e.g., chloramphenicol), the effect of vitamin B12may be reduced.
• Cases of dependence and withdrawal have been reported when taking 200 mg of pyridoxine for a month.
• Be cautious with the sun or avoid exposure to it and UVA lamps while using this medication, as pyridoxine may cause sun sensitivity (photosensitivity).
• If you have previously had an allergy to vitamin B1contact dermatitis due to professional reasons, you may experience a relapse when taking this medication.
• Interference with diagnostic tests: Inform your doctor that you are taking this medication, as it may alter test results. In some determinations of urobilinogen, theophylline, and uric acid, false results may occur.

Children

• Bester Complex is contraindicated in children under 14 years old (see Do not take Bester Complex).

Other medications and Bester Complex

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

Bester Complex may interact with the following medications:

• Levodopa (Parkinson's disease medication): may reduce its antiparkinsonian effect.
• Phenobarbital, phenytoin (epilepsy medications).
• Amiodarone (heart medication).
• Altretamine or 5-fluorouracil (cancer treatment medications).
• Neuromuscular blocking agents (used in anesthesia, for surgery).
• Several medications may interfere with pyridoxine (vitamin B6) and reduce its levels, including: tuberculosis antibiotics (isoniazid, cycloserine, ethionamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), theophylline (for asthma and other respiratory diseases), immunosuppressants like corticosteroids or cyclosporine (used in organ transplantation).
• Several medications may reduce the absorption of vitamin B12or its effect, such as: ascorbic acid (vitamin C), aminoglycoside antibiotics like neomycin, colchicine (for gout), H-2 antagonists (stomach acid or ulcer medications like ranitidine, cimetidine, etc.), salicylic acid (for intestinal diseases), omeprazole (for stomach acid or ulcers), epilepsy medications, metformin (for diabetes), chloramphenicol (antibiotic) or cobalt radiation.
• Oral contraceptives may reduce levels of both vitamin B6and vitamin B12.

Taking Bester Complex with food and drinks

Excessive alcohol consumption may reduce the absorption of vitamins.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 operating machinery

This medication may cause drowsiness in a small proportion of patients, who should not drive or operate machinery during treatment.

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.

Adults and adolescents over 14 years old

The recommended dose is 1 capsule per day.

Generally, 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 must consult your doctor.

Oral administration.

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

Patients with liver or kidney 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 (large doses), you may experience symptoms such as: digestive discomfort (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 levels of some liver enzymes, decreased blood folate levels.

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

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

In children, accidental ingestion of very high doses of vitamin B6may 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 forgot to take Bester Complex

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 all people may experience them.

Infrequent adverse effects (may affect up to 1 in 100 people): nausea, vomiting, headache, drowsiness, skin tingling sensation (paresthesias) or sensory alterations and skin rash. Allergic reactions (hypersensitivity reactions) to vitamins B1, B6, and B12have also been described.

Other adverse effects that have been reported, with frequency unknown exactly (cannot be estimated from available data), are: digestive discomfort, diarrhea, loss of appetite, photosensitivity with skin lesions such as blisters; changes in urine color, dizziness, restlessness, occasionally insomnia; disorder with reduced sensitivity and tingling, numbness of feet or hands, which generally decrease when treatment is interrupted; a pyridoxine withdrawal syndrome more likely at high doses and in treatments lasting more than a month; in rare cases anaphylactic reaction with itching, swelling, difficulty breathing, etc., late allergy reaction to vitamin B1(see section 2, Warnings and Precautions).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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.

No special storage conditions are required.

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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bester Complex

• The active principles 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 calcium phosphate dibasic dihydrate, carboxymethylcellulose sodium, microcrystalline cellulose, magnesium stearate, colloidal silica, cornstarch; the capsule colorants are: erythrosine (E127), indigotin (E132), quinoline (E104), titanium dioxide (E171).

Appearance of the product and contents of the packaging

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

Each package contains 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Salvat, S.A.

Gall, 30-36.

08950 Esplugues de Llobregat (Barcelona) Spain

Last review date of this leaflet:October/2017.

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