Package Insert: Information for the Patient

BENERVA 100 mg/ml Injectable Solution

Thiamine Hydrochloride

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Benerva contains thiamine (Vitamin B1), a water-soluble vitamin that is involved in many human metabolism processes, mainly those of carbohydrates.

It is indicated for adults in:

Prevention and treatment of 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.
• Prolonged infection.
• Gastrointestinal diseases, such as celiac disease or persistent diarrhea.
• High carbohydrate intake.
• Poor nutritional status.

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

No use Benerva

• If you are allergic to thiamine (vitamin B1) or any of the other components of this medication (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 administrations of thiamine. Therefore, when possible, oral administration is recommended. In this case, it would be preferable to use another medication in which the active ingredient is administered orally.

Administer by intravenous route only by a healthcare professional. The administration of the product and the handling of needles should be done with caution.

If you have previously suffered from an allergy to vitamin B1 due to skin contact (contact dermatitis) for professional reasons, for example, you may experience a relapse when treated with this medication.

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

Children

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

Other Medications and Benerva Injectable Solution

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

Benerva injectable solution may interact with the following medications:

- 5-Fluorouracil and capecitabine (for some types of cancer)

- Tegafur (for some types of cancer).

Pregnancy and Breastfeeding and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Benerva injectable solution is not recommended for use during pregnancy or breastfeeding.

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

Driving and Operating Machines

The influence of this medication on the ability to drive and operate machines is negligible or insignificant.

Benerva Injectable Solution Contains Sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor again.

By intramuscular route, or by slow intravenous route or short-duration infusion.

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

The recommended dose is:

- Adults:

50 mg (half ampoule) of vitamin B1 should be administered daily by intramuscular route 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 (avitaminosis) B1 deficiency or severe hypovitaminosis B1, the initial daily dose may be 100 mg or up to 200 mg by parenteral route, for example intramuscular or slow intravenous injection or even short-duration infusion, to obtain as quickly as possible an adequate blood concentration of vitamin B1.

For Wernicke-Korsakoff syndrome due to alcohol abuse, the usual dose is 100 mg by intravenous route followed by 50-100 mg by intramuscular route 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 route daily for three days.

It can be administered by intramuscular route if intravenous is not possible. It can be continued with 100 mg of thiamine by oral route.

If you use more Benerva injectable solution than you should

The rapid intravenous administration and multiple and/or high doses increase the probability 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 Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Benerva

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

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

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

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

The following have been reported:

Reactions at the injection site: 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.

Usual reactions reported after intravenous, intramuscular, or subcutaneous injection include allergic or anaphylactic reactions, hypersensitivity reactions with their respective clinical and laboratory manifestations, including asthma syndrome, mild to moderate reactions in the skin and/or respiratory tract, gastrointestinal tract, and/or cardiovascular system. Symptoms that may include rash, itching, red itchy patches on the skin generally with itching (urticaria), rapid swelling in the skin and mucous membranes (angioedema), and difficulty with breathing, as well as severe reactions that include anaphylactic shock have been reported.

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

Contact dermatitis in predisposed patients.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C.

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.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Benerva injectable solution

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

Each 1 ml ampoule of solution contains 100 mg of thiamine hydrochloride.

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TEOFARMA Srl

Vía F.lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Responsible for manufacturing

CENEXI SAS

Rue Marcel ANDJacques Gaucher, 52 - Fontenay Sous Bois

F-94120 – France

Date of the last review of this leaflet:April 2018.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/