WATER FOR INJECTABLE PREPARATIONS BEXEN SOLVENT FOR PARENTERAL USE

Introduction

Package Leaflet: Information for the User

Water for Injection Bexen Solvent for Parenteral Use

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Water for Injection Bexen is and what it is used for
2. What you need to know before starting to use Water for Injection Bexen
3. How to use Water for Injection Bexen
4. Possible side effects
5. Storage of Water for Injection Bexen
6. Package Contents and Additional Information

1. What Water for Injection Bexen is and what it is used for

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

2. What you need to know before starting to use Water for Injection Bexen

Do not use

Water for Injection Bexen intravenously alone.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Water for Injection Bexen:

• Do not administer intravenously without checking that the solution has the same concentration as blood (isotonicity), as otherwise, it may cause hemolysis of red blood cells (destruction of red blood cells).
• The characteristics of the drug to be dissolved must be checked.

Using Water for Injection Bexen with other medications

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

Water for Injection Bexen is only incompatible with medications that are insoluble in water.

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.

3. How to use Water for Injection Bexen

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

The recommended dose depends on the medication to be dissolved in Water for Injection Bexen.

If you use more Water for Injection Bexen than you should

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

If you use more Water for Injection Bexen than you should, it may cause hemolysis (rupture of red blood cells).

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

4. Possible side effects

Like all medications, Water for Injection Bexen can cause side effects, although not everyone experiences them.

No side effects are expected if used correctly.

Intravenous administration of Water for Injection Bexen may cause hemolysis (destruction of red blood cells) if administered alone.

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

Reporting side effects

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

5. Storage of Water for Injection Bexen

No special storage conditions are required.

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

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

Discard any remaining contents after opening the packaging.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Water for Injection Bexen

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

Appearance of the Product and Package Contents

Water for Injection Bexen is a clear and colorless solution, presented in 5ml polyethylene ampoules.

Package size: 1 package of 5ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OIARSO SOCIEDAD COOPERATIVA

Barrio Zikuñaga 57-F. Polígono Ibarluze.

20128 Hernani (Guipúzcoa)

Manufacturer

• Braun Medical, S.A

Ctra. de Terrassa, 121

1. Rubí (Barcelona)

Date of last revision of this package leaflet: March 1998

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/