AGUA PARA PREPARACIONES INYECTABLES SERRA PAMIES solvent for parenteral use

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

WATER FOR INJECTIONS SERRA PAMIES

solvent for parenteral use

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Water for injections Serra Pamies is and what it is used for
2. Before you use Water for injections Serra Pamies
3. How to use Water for injections Serra Pamies
4. Possible side effects
5. Storing Water for injections Serra Pamies
6. Further information

1. What Water for injections Serra Pamies is and what it is used for

Water for injections Serra Pamies is sterile water. It is used to dilute medicines before use, for example, medicines that are given by:

• injection (using a needle, for example into a vein)
• infusion (slow injection) into a vein, also known as a drip

2. Before you use Water for injections Serra Pamies

Do not use Water for injections Serra Pamies:

You should not be given Water for injections Serra Pamies on its own. If it is given alone into the bloodstream, it can cause red blood cells to absorb water and burst (haemolysis). This happens because the water for injections does not have the same consistency as blood.

Before it is given to you, a healthcare professional will always mix Water for injections Serra Pamies with one or more medicines.

You should read the leaflet for the medicine or medicines that are mixed with Water for injections Serra Pamies. They will tell you if you can or cannot have the solution.

Be especially careful with Water for injections Serra Pamies:

Water for injections should not be given alone. Before using Water for injections Serra Pamies:

• it will always be mixed with one or more medicines
• your healthcare professional will make sure that the mixture has approximately the same consistency as your blood (isotonic). Depending on the type of medicine you are given, this will mean that:
• • the medicine will be diluted with Water for injections Serra Pamies
  • before use, another substance will be added to the mixture of Water for injections Serra Pamies and the medicine

You are more likely to suffer from haemolysis if you are given large volumes of hypotonic solutions of Water for injections (solutions that are not as concentrated as your blood).

To prevent this, your doctor will take a blood sample to monitor the chemical balance in your blood (ionic balance).

Before giving you medicines mixed with Water for injections Serra Pamies, your doctor will check that:

• the medicines are stable in Water for injections Serra Pamies
• the medicines do not interact with each other

Using other medicines:

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those bought without a prescription.

Medicines that are used dissolved in Water for injections Serra Pamies may interact with each other.

Using Water for injections Serra Pamies with food and drink:

Ask your doctor about what you can eat or drink.

Pregnancy and breastfeeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Tell your doctor if you are pregnant or breastfeeding.

The risks to the unborn baby or your pregnancy will depend on the medicines you use mixed with Water for injections Serra Pamies.

The risks to the baby during breastfeeding will depend on the medicines you use mixed with Water for injections Serra Pamies.

Your doctor will be able to tell you about the risks of each medicine.

Your doctor will only give you medicines during pregnancy and breastfeeding if it is essential.

Driving and using machines:

Water for injections Serra Pamies does not affect your ability to drive or use machines.

The effects on your ability to drive or use machines will depend on the medicines you use mixed with Water for injections Serra Pamies. Your doctor will advise you about this.

3. How to use Water for injections Serra Pamies

Water for injections Serra Pamies will be given to you by a doctor or nurse.

Your doctor will decide how much you need, and when and how it will be given to you. This will depend on what medicines you need to take with Water for injections Serra Pamies.

Your doctor will consider your age, weight, condition, and what other treatments you are having.

You should not be given Water for injections Serra Pamies if there are particles floating in the water or if the container is damaged in any way.

If you are given too much Water for injections Serra Pamies:

If you have been given too much Water for injections Serra Pamies, you may suffer from haemolysis. Haemolysis occurs when red blood cells absorb water and burst.

Medicines mixed with Water for injections Serra Pamies may also cause symptoms if they are given in too high a dose. The symptoms and signs of overdose will depend on the medicines you are using mixed with Water for injections Serra Pamies.

If you are accidentally given too much, your treatment will be stopped and you will be given a treatment that depends on your symptoms.

You should read the leaflet for the medicines mixed with Water for injections Serra Pamies for the list of possible symptoms of overdose.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount taken).

4. Possible side effects

Like all medicines, Water for injections Serra Pamies can cause side effects, although not everybody gets them.

You may suffer from haemolysis (swelling and bursting of red blood cells) if:

• you use Water for injections Serra Pamies on its own
• Water for injections is used to make injectable or infusion solutions that are not of similar consistency to your blood (isotonic)

If a medicine is added to Water for injections Serra Pamies, the added medicine may cause side effects. These side effects will depend on the medicine that has been added. You should read the leaflet for the added medicine for the list of possible symptoms.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing Water for injections Serra Pamies

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions. Keep the ampoule in the outer packaging.

Expiry date:

Do not use Water for injections Serra Pamies after the expiry date stated on the container and the label of the ampoule. The expiry date is the last day of the month stated.

Once the container is opened, the product should be used immediately.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and containers to a pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Further information

Composition of Water for injections Serra Pamies

The only active substance is sterile water for injections. Each presentation contains 100% sterile water for injections.

Appearance and packaging of the product

Water for injections Serra Pamies is a clear solution, free from visible particles, and is available in the following formats:

Container of 5 ml containing 1, 10, 100 (clinical container) ampoules.

Container of 10 ml containing 1, 10, 50 (clinical container), 100 (clinical container) ampoules.

Container of 20 ml containing 1, 10, 100 (clinical container) ampoules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

LABORATORIOS SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

This leaflet was approved in March 2011

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/