BenerVa 300 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
BENERVA® 300 mg film-coated tablets
Thiamine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for administration contained in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet
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What Benerva 300 mg is and what it is used for
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What you need to know before taking Benerva 300 mg
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How to take Benerva 300 mg
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Possible adverse effects
- How to store Benerva 300 mg
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Contents of the pack and other information
1. What Benerva 300 mg is and what it is used for
Benerva contains Thiamine (Vitamin B1), a water-soluble vitamin involved in numerous processes in human metabolism.
It is indicated for:
Treatment of significant deficiency of Vitamin B1 due to increased requirements, reduced intake, or reduced absorption.
Situations frequently associated with Vitamin B1 deficiencies and requiring supplementation include: regular excessive alcohol consumption, and poor nutritional status.
Benerva 300 mg is indicated in adults aged 18 years and older.
2. What you need to know before taking Benerva 300 mg
Do not take Benerva:
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
Do not take this medicine:
- If you are pregnant or breastfeeding
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Benerva 300 mg.
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If you have previously experienced an allergy to vitamin B1 upon skin contact (contact dermatitis), for example due to occupational exposure, you may have a recurrence when taking this medicine.
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Interference with laboratory tests: If you are undergoing any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results. False results may occur in certain assays for uric acid, urobilinogen, or theophylline.
Children
This medicine is not recommended for children under 18 years of age.
Taking Benerva with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or might need to take/use any other medicines.
Benerva may interact with the following medicines:
- 5-Fluorouracil (used for certain types of cancer)
- Neuromuscular blocking agents (used in anaesthesia)
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Benerva 300 mg must not be taken by pregnant women or women of childbearing potential who are not using a contraceptive method.
You should not use this medicine if you are breastfeeding.
Driving and using machines
The effect of Benerva tablets on the ability to drive and use machines is none or negligible.
3. How to take Benerva 300 mg
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Oral use.
- Adults from 18 years of age:
Take 1 tablet daily for the treatment of clear deficiency symptoms.
Treatment should generally not exceed 2 weeks of continuous use.
It is recommended to take the tablets with sufficient water, preferably before a meal.
If you take more Benerva than you should
Large doses do not produce noticeable effects.
In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone 91 562 04 20, or consult your doctor, or go to a medical center, indicating the medication and the amount ingested.
If you forget to take Benerva
Do not take a double dose to make up for missed doses.
If you stop taking Benerva
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 produce adverse effects, although not everyone will experience them.
These reactions have been reported voluntarily and therefore their frequency is not known exactly:
- Allergic reaction, hypersensitivity reactions with symptoms that may involve the respiratory system (such as wheezing), mild to moderate skin reactions, and/or symptoms affecting the gastrointestinal or cardiovascular systems. Symptoms may include skin rashes, itching, urticaria (a type of reddish, itchy rash), rapid swelling of the skin and mucous membranes (angioedema), and cardio-respiratory difficulty.
If an allergic reaction occurs, treatment must be discontinued and a healthcare professional should be consulted.
- Mild gastrointestinal reactions such as nausea, vomiting, diarrhea, and abdominal or gastrointestinal pain.
- Contact dermatitis in predisposed patients.
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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Benerva
Keep the container tightly closed to protect it from moisture.
Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after “EXP”. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Benerva 300 mg tablets
- The active substance is Thiamine hydrochloride (Vitamin B1). Each coated tablet contains 300 mg of thiamine hydrochloride.
- The other components (excipients) are: Talc, magnesium stearate, povidone K 90, macrogol 6000, polymethacrylic acid, ethyl acrylate copolymer dispersion 30%, sodium carmellose, and purified water.
Appearance of the product and contents of the pack
Film-coated tablets; the tablets are round, biconvex, and white to yellow in colour.
Benerva is presented in boxes containing 20 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV) - Italy
Fax 0039/0382/525845
e-mail: [email protected]
Manufacturer
DELPHARM EVREUX
5, Rue du Guesclin 27000 Evreux Cedex, France
DELPHARM GAILLARD
Rue de l'Industrie 33 (Gaillard) - 74240 - France
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia - Italy
Date of the most recent revision of this leaflet: 05/2015.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/