Patient Information Leaflet

BENERVA?300 mg Film-Coated Tablets

Hydrochloride Thiamine

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 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 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 Benerva 300 mg and what it is used for

2.What you need to knowbefore starting to take Benerva 300 mg

3.How to take Benerva 300 mg

4.Possible side effects

1. Storage of Benerva 300 mg

6.Contents of the pack and additional information

Benervacontains Thiamine (Vitamin B1), a water-soluble vitamin that is involved in many human metabolic processes.

It is indicated for:

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

Situations frequently accompanied by Vitamin B1 deficiency and requiring supplementation include: regular excessive alcohol consumption, deteriorated nutritional status.

Benerva 300 mgis indicated for adults aged 18 years and above.

Do not take Benerva:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

Do not take this medication:

• if you are pregnant or breastfeeding

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 upon contact with your skin (contact dermatitis) for professional reasons, for example, you may experience a relapse when taking this medication.

-Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, 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 individuals under 18 years of age.

Taking Benerva with other medications

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

Benerva may interact with the following medications:

- 5-Fluorouracil (for certain types of cancer)

- Muscle relaxant medications (used in anesthesia).

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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.

This medication should not be used if you are breastfeeding.

Driving and operating machinery

The influence of Benerva tablets on the ability to drive and operate machinery is negligible or insignificant.

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.

The recommended dose is:

Oral administration.

- Adults 18 years and older:

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

The treatment in general should not exceed 2 weeks of continuous administration.

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

Large doses do not produce noticeable effects.

In case of overdose or accidental ingestion, consult the Toxicological 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 forgot to take Benerva

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Benerva

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications,this medicationcan produce adverse effects, although not all people experience them.

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

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

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

- Mild gastrointestinal reactions such as nausea, vomiting, diarrhea, abdominal pain, and gastrointestinal pain.

- Contact dermatitis in predisposed patients.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep the packaging perfectly closed to protect it from humidity.

Store below 30°C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the label and the box after “CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longerneed. This way, you will help protect the environment.

Composition ofBenerva 300 mg tablets

• The active ingredient 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, methacrylic acid polymerized, ethyl acrylate (1:1) dispersion at 30%, sodium carmellose and purified water.

Appearance of the product and contents of the packaging

Coated tablets; the tablets are round, biconvex and white to yellow in color.

Benerva is presented in boxes containing 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) - Italy

Fax 0039/0382/525845

e-mail:[email protected]

Responsible for manufacturing

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

Last review date of this leaflet:05/2015.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/