BENERVA 100 mg/ml INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

BENERVA 100 mg/ml injectable solution

Thiamine hydrochloride

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Benerva injectable solution is and what it is used for
2. What you need to know before using Benerva injectable solution
3. How to use Benerva injectable solution
4. Possible side effects
5. Storage of Benerva injectable solution
6. Package contents and additional information

1. What Benerva injectable solution is and what it is used for

Benerva contains thiamine (vitamin B1), a water-soluble vitamin that plays a role in many human metabolic processes, mainly carbohydrate metabolism.

It is indicated in adults for:

Prevention and treatment of vitamin B1 deficiency due to increased requirements, reduced intake, or reduced absorption.

Situations often accompanied by vitamin B1 deficiency and requiring supplementation include:

• Regular excessive alcohol consumption.
• Prolonged infection.
• Intestinal diseases, such as celiac disease or persistent diarrhea.
• High carbohydrate intake.
• Poor nutritional status.

Treatment of beriberi (characterized by intense fatigue and slow movement, affecting mainly the nervous and cardiovascular systems), Wernicke's disease (affecting the nervous system), and Korsakoff's syndrome (caused by excessive alcohol consumption, with effects on the brain).

2. What you need to know before using Benerva injectable solution

Do not use Benerva

• if you are allergic to thiamine (vitamin B1) or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Benerva injectable solution.

The risk of hypersensitivity reactions increases with repeated intravenous or intramuscular administration of thiamine. Therefore, when possible, oral administration is recommended. In this case, another medicine with the active ingredient administered orally would be preferable.

Administer intravenously only by a healthcare professional. The administration of the product and the handling of needles must be done with caution.

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 treated with this medicine.

Interference with laboratory tests: If you are going to undergo any diagnostic test (including blood, urine, etc.), inform your doctor that you are being treated with this medicine, as it may alter the results. In some determinations of uric acid, urobilinogen, or theophylline, false results may occur.

Children

Do not use this medicine in children, as there is no data available for them.

Other medicines and Benerva injectable solution

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

Benerva injectable solution may interact with the following medicines:

• 5-Fluorouracil and capecitabine (for certain types of cancer)
• Tegafur (for certain types of cancer).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It is not recommended to use Benerva injectable solution if you are pregnant or breastfeeding.

This medicine is not recommended for women of childbearing age who do not use an effective contraceptive method.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible.

Benerva injectable solution contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml of injectable solution; it is essentially "sodium-free".

3. How to use Benerva injectable solution

Follow exactly the administration instructions of this medicine indicated by your doctor.

In case of doubt, consult your doctor again.

Intramuscularly, or by slow intravenous injection or short-duration perfusion.

The contents of the ampoule should not be mixed with any other parenteral product or injection fluid. The injection should be administered by a qualified healthcare professional.

The recommended dose is:

• Adults:

50 mg (half an ampoule) of vitamin B1 should be administered daily by intramuscular injection for several days when absorption is significantly affected and also for the treatment of Wernicke-Korsakoff syndrome and beriberi.

For the initial treatment of vitamin B1 deficiency or severe hypovitaminosis B1, the initial daily dose may be 100 mg or up to 200 mg by parenteral route, for example, intramuscularly or by slow intravenous injection or even by short-duration perfusion, to achieve an adequate blood concentration of vitamin B1 as quickly as possible.

For Wernicke-Korsakoff syndrome due to alcohol abuse, the usual dose is 100 mg by intravenous injection followed by 50-100 mg by intramuscular injection daily until the patient consumes a balanced diet.

For emergency treatment, 100 mg (or 200 mg if necessary, or up to 1000 mg in the first 12 hours if necessary) by slow intravenous injection daily for three days.

Intramuscular administration can be used if intravenous administration is not possible. Treatment can be continued with 100 mg of thiamine orally.

If you use more Benerva injectable solution than you should

Rapid intravenous administration and multiple and/or high doses increase the likelihood of adverse reactions, such as anaphylactoid reactions and injection site reactions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Benerva

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As these reactions are reported voluntarily, it is not possible to estimate their frequency.

The following have been reported:

Injection site reactions: frequently (may affect up to 1 in 10 people), pain at the injection site after rapid intravenous injection; this reaction can be avoided by slow administration.

Allergic or anaphylactic reactions, hypersensitivity reactions with their respective clinical and laboratory manifestations, including asthmatic syndrome, mild to moderate skin and/or respiratory tract reactions, gastrointestinal tract and/or cardiovascular system reactions, have been reported after intravenous, intramuscular, or subcutaneous injection of thiamine. Symptoms that may include rash, itching, urticaria, angioedema, and cardio-respiratory difficulty, as well as severe reactions including anaphylactic shock, have been communicated.

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

Contact dermatitis in predisposed patients.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Benerva injectable solution

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible particles, the solution is not transparent, or the container is damaged.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Benerva injectable solution

• The active ingredient is thiamine hydrochloride (Vitamin B1).

Each 1 ml ampoule contains 100 mg of thiamine hydrochloride.

• The other ingredients (excipients) are: glycerol, phenol, sodium phosphate, sodium hydrogen carbonate, and water for injectable preparations.

Appearance and package contents

Injectable solution, transparent, colorless or slightly yellowish, contained in 1 ml glass ampoules.

6 and 10 ampoules of 1 ml.

• Other presentations

Benerva 300 mg film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

TEOFARMA Srl

Via F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Manufacturer

CENEXI SAS

Rue Marcel et Jacques Gaucher, 52 - Fontenay Sous Bois

F-94120 – France

Date of last revision of this leaflet:April 2018.

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