BENERVA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

BENERVA?300 mg film-coated tablets

Thiamine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for 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 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 Benerva 300 mg and what is it used for
2. What you need to know before taking Benerva 300 mg
3. How to take Benerva 300 mg
4. Possible side effects
   1. Storage of Benerva 300 mg

1. Package contents and additional information

1. What is Benerva 300 mg and what is it used for

Benerva contains Thiamine (Vitamin B1), a water-soluble vitamin that plays a role in many human metabolic processes.

It is indicated in:

Treatment of significant Vitamin B1 deficiency due to increased requirements, reduced intake, or reduced absorption.

Situations that are often accompanied by Vitamin B1 deficiencies and require supplementation include: regular excessive alcohol consumption, deteriorated nutritional status.

Benerva 300 mg is indicated for 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 medication (listed in section 6)

Do not take this medication:

Warnings and precautions

Consult your doctor or pharmacist before starting to take Benerva 300 mg.

• If you have previously suffered from an allergy to Vitamin B1 on skin contact (contact dermatitis) for professional reasons, for example, you may experience a relapse when taking this medication.

• Interference with laboratory tests: If you are going to undergo any diagnostic tests (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 uric acid, urobilinogen, or theophylline, false results may be produced.

Children

This medication is not recommended for children under 18 years of age.

Taking Benerva with other medications

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

Benerva may interact with the following medications:

• 5-Fluorouracil (for certain types of cancer)
• Neuromuscular blocking agents (used in anesthesia).

Pregnancy, breastfeeding, and fertility

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.

Benerva 300 mg should not be taken by pregnant women or women of childbearing age who are not using a contraceptive method.

You should not use this medication if you are breastfeeding.

Driving and using machines

The influence of Benerva tablets on the ability to drive and use machines is negligible or nonexistent.

3. How to take Benerva 300 mg

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

The recommended dose is:

Oral route.

• Adults aged 18 years and older:

It is recommended to take 1 tablet per day for the treatment of clear symptoms of deficiency.

Treatment should not generally exceed 2 weeks of continuous use.

It is recommended to take the tablets with a sufficient amount of water, preferably before a meal.

If you take more Benerva than you should

High doses do not produce noticeable effects.

In case of overdose or accidental ingestion, consult 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 use a double dose to make up for forgotten doses.

If you interrupt treatment with Benerva

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.

As these reactions are reported voluntarily, their frequency is not known with precision:

• Allergic reactions, hypersensitivity reactions with symptoms that can be respiratory (such as wheezing), mild to moderate skin reactions, symptoms in the digestive system and/or cardiovascular system have been reported. Symptoms may include rash, itching, urticaria (a type of red rash on the skin, usually with itching), rapid swelling of the skin and mucous membranes (angioedema), and cardio-respiratory difficulty.

If an allergic reaction occurs, treatment should be discontinued and a healthcare professional consulted.

• Mild gastrointestinal reactions such as nausea, vomiting, diarrhea, abdominal pain, and gastrointestinal pain.
• Contact dermatitis in predisposed patients.

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: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Benerva

Keep the container perfectly closed to protect it from moisture.

Store below 30°C.

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

Do not use this medication after the expiration date shown on the label and carton after "EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofBenerva 300 mg tablets

• The active substance is Thiamine hydrochloride (Vitamin B1). Each film-coated tablet contains 300 mg of thiamine hydrochloride.
• The other components (excipients) are: talc, magnesium stearate, povidone K 90, macrogol 6000, methacrylic acid polymer, ethyl acrylate (1:1) dispersion at 30%, sodium carmellose, and purified water.

Appearance of the product and package contents

Film-coated tablets; the tablets are round, biconvex, and white to yellow in color.

Benerva is presented in cartons containing 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Fax 0039/0382/525845

e-mail: servizioclienti@teofarma.it

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 last revision of this package leaflet:05/2015.

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