Bester Complex hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bester Complex hard capsules
Thiamine hydrochloride / Pyridoxine hydrochloride / Hydroxocobalamin acetate
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for taking this medicine as described in this leaflet or as given 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 side effects not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 7 days.
Contents of this leaflet
- What Bester Complex is and what it is used for
- What you need to know before taking Bester Complex
- How to take Bester Complex
- Possible side effects
- How to store Bester Complex
- Contents of the pack and other information
1. What Bester Complex is and what it is used for
Bester Complex is a combination of water-soluble B vitamins: thiamine (vitamin B1), pyridoxine (vitamin B6), and hydroxocobalamin (vit inflammamin B12), which are involved in numerous processes of human metabolism.
It is indicated for: Prevention and treatment of deficiency states of vitamins B1, B6 and B12 due to increased requirements, reduced intake or impaired absorption, which may manifest as symptoms including back pain, among others; convalescence; inadequate 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 ingredients of this medicine (listed in section 6).
- if you are being treated with levodopa (a medicine 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, neurological adverse effects (such as headache, tingling sensations, etc.) may occur.
- If you suffer from blood disorders such as anemia, your doctor should determine the cause before you take vitamin B12.
- If you have conditions such as uremia (accumulation of urea in the blood), infections, iron or folic acid deficiency, or are being treated with medicines that have a suppressive effect on the bone marrow (e.g., chloramphenicol), the effect of vitamin B12 may be reduced.
- Cases of dependence and withdrawal have been reported after taking 200 mg doses of pyridoxine for one month.
- You should be cautious about sunlight or avoid exposure to it and to ultraviolet (UVA) lamps while using this medicine, because pyridoxine may cause sensitivity to sunlight (photosensitivity).
- If you have previously experienced an allergic reaction to vitamin B1 upon skin contact (contact dermatitis) for occupational reasons, you may experience a relapse when taking this medicine.
- Interference with diagnostic tests: If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results. False results may occur in certain tests for urobilinogen, theophylline, and uric acid.
Children
- Bester Complex is contraindicated in children under 14 years of age (see section "Do not take Bester Complex").
Other medicines and Bester Complex
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Bester Complex may interact with the following medicines:
- Levodopa (a medicine for the treatment of Parkinson's disease): may reduce its antiparkinsonian effect.
- Phenobarbital, phenytoin (medicines for epilepsy).
- Amiodarone (a medicine used for heart conditions).
- Altretamine or 5-fluorouracil (used for cancer treatment).
- Neuromuscular blocking agents (used in anesthesia for surgery).
- Several medicines may interfere with pyridoxine (vitamin B6) and may reduce its levels, including: antibiotics for the treatment of tuberculosis (isoniazid, cycloserine, ethionamide), penicillamine (for rheumatic diseases), hydralazine (for hypertension), theophylline (for the treatment of asthma and other respiratory diseases), immunosuppressants such as corticosteroids or cyclosporine (used in organ transplantation).
- Several medicines may reduce the absorption of vitamin B12 or reduce its effect, such as: ascorbic acid (vitamin C), aminoglycoside antibiotics like neomycin, colchicine (for the treatment of gout), H-2 antagonists (medicines for acidity or stomach ulcers, such as ranitidine, cimetidine, etc.), aminosalicylic acid (for intestinal diseases), omeprazole (for acidity or stomach ulcers), antiepileptic medicines, metformin (for diabetes), chloramphenicol (an antibiotic), or cobalt radiation.
- Oral contraceptives may reduce levels of both vitamin B6 and vitamin B12.
Taking Bester Complex with food and drinks
Excessive alcohol intake 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 medicine.
Due to the doses of vitamin B contained in this medicine, which are considerably higher than those recommended during pregnancy and breastfeeding, it is contraindicated during these periods.
Driving and using machines
This medicine may cause drowsiness in a small proportion of patients; such patients should not drive and/or operate machinery during treatment.
3. How to take Bester Complex
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in 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 longer than 15 days.
If symptoms do not improve after 7 days of treatment, you should consult your doctor.
Oral use.
It is recommended to swallow the capsules with water.
Patients with hepatic or renal insufficiency
These patients must 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 gastrointestinal discomfort (diarrhea, nausea, and vomiting) and headache. Sensitivity to sunlight with skin lesions, drowsiness, breathing difficulties, and other effects may also occur, depending on the dose, along with increased liver enzymes and decreased blood levels of folic acid.
In rare cases, a severe allergic reaction (anaphylactic shock) may occur.
Prolonged treatment may also cause sensory disturbances, tingling sensations, etc.
In children, accidental ingestion of very high doses of vitamin B6 may additionally cause deep sedation, weakness, and breathing difficulties.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Uncommon adverse effects (may affect up to 1 in 100 people): nausea, vomiting, headache, drowsiness, skin tingling sensation (paraesthesia), sensory disturbances, and skin rash. Allergic reactions (hypersensitivity reactions) to vitamins B1, B6, and B12 have also been reported.
Other adverse effects that have been reported, with frequency not exactly known (cannot be estimated from available data), include: gastrointestinal discomfort, diarrhoea, loss of appetite, photosensitivity with skin lesions such as blisters; changes in urine colour, dizziness, restlessness, occasionally insomnia; sensory disturbance with reduced sensitivity and tingling, numbness of hands or feet, which usually decreases upon discontinuation of treatment; a pyridoxine withdrawal syndrome, more likely with high doses and treatments lasting more than one month; rarely, anaphylactic reaction with itching, swelling, breathing difficulties, etc., and delayed allergic reaction to vitamin B1 (see section 2, Warnings and precautions).
If an allergic reaction occurs, treatment must be discontinued and symptomatic treatment should be administered.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bester Complex
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bester Complex
- The active substances 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 carboxymethylstarch, microcrystalline cellulose, magnesium stearate, colloidal silica, corn starch; the capsule colorants are: erythrosine (E127), indigotine (E132), quinoline yellow (E104), titanium dioxide (E171).
Appearance of the product and contents of the container
Bester Complex is presented as hard capsules, orange and brown in color.
Each pack contains 30 capsules.
Marketing Authorization Holder and Manufacturer
LABORATORIOS SALVAT, S.A.
Gall, 30-36.
08950 Esplugues de Llobregat (Barcelona), Spain
Date of the most recent revision of this leaflet: October/2017.
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/