Water for preparations for injection Bexen solvent for parenteral use

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Water for Injections Bexen solvent for parenteral use

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

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

Leaflet contents:

1. What Water for Injections Bexen is and what it is used for
2. What you need to know before using Water for Injections Bexen
3. How to use Water for Injections Bexen
4. Possible adverse effects
5. How to store Water for Injections Bexen
6. Contents of the pack and other information

1. What Agua para preparaciones inyectables Bexen is and what it is used for

Agua para preparaciones inyectables Bexen is used as a solvent and vehicle for medicines that must be administered by the parenteral route, that is, by intravenous injection.

2. What you need to know before using Agua para preparaciones inyectables Bexen

Do not use

Agua para preparaciones inyectables Bexen intravenously on its own.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Agua para preparaciones inyectables Bexen:

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

Use of Agua para preparaciones inyectables Bexen with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Agua para preparaciones inyectables Bexen is only incompatible with medicines 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 medicine.

3. How to use Agua para preparaciones inyectables Bexen

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If you use more Agua para preparaciones inyectables Bexen than you should

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine used.

If you use more Agua para preparaciones inyectables Bexen than you should, hemolysis (breakdown of red blood cells) may occur.

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

4. Possible adverse effects

Like all medicines, Bexen Water for Injections may cause adverse effects, although not everyone will experience them.

Adverse reactions are unlikely to occur if the product is used correctly.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Water for Injections Bexen

No special storage conditions are required.

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

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

Discard any residual contents remaining after opening the container.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Water for Injections Bexen

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

Appearance of the medicine and contents of the container

Water for Injections Bexen is a clear, colourless solution supplied in polyethylene ampoules containing 5 ml of water for injections.

Pack size: 1 container of 5 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: March 1998

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