Leaflet: information for the user

Water for injectable preparations Bexen solvent for parenteral use

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Bexen Injectable Water for Preparations is used as a solvent and vehicle for medications that must be administered parenterally, that is, by intravenous injection.

Do not use

Bexen Injectable Diluent by itself via intravenous route.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Bexen Injectable Diluent:

• Do not administer by intravenous route without ensuring the solution has the same concentration as blood (isotonicity) as otherwise it may cause hemolysis of erythrocytes (destruction of red blood cells).
• The characteristics of the drug to be dissolved must be checked.

Use of Bexen Injectable Diluent with other medications

Inform your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

Bexen Injectable Diluent is only incompatible with those medications that are insoluble in water.

Pregnancy, 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.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose depends on the medication to be dissolved in water for injectable preparations.

If you use more Water for injectable preparations Bexen than you should

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication used.

If you use more Water for injectable preparations Bexen than you should, hemolysis (rupture of red blood cells) may occur.

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

Like all medications, Bexen Injectable Preparation Water may produce adverse effects, although not everyone will experience them.

It is not expected that adverse reactions will occur if used correctly.

The intravenous administration of Bexen Injectable Preparation Water may cause hemolysis (destruction of red blood cells) if administered alone.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required.

Do not use if the container shows visible signs of deterioration.

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

Dispose of any residual content that may have remained once the container is opened.

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

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Water for Injections Bexen

The active ingredient is water for injections. Each ampoule contains 5ml of water for injections.

Appearance of the product and contents of the packaging

Water for injections Bexen is a transparent and colorless solution, presented in 5ml polyethylene ampoules of water for injections.

Packaging size: 1 pack of 5ml.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

OIARSO COOPERATIVE SOCIETY

Zikuñaga 57-F. Industrial Estate Ibarluze.

20128 Hernani (Guipúzcoa)

Manufacturer responsible

B. Braun Medical, S.A

Terrassa Road, 121

08191. Rubí (Barcelona)

Last review date of this leaflet: March 1998

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