PROSPECTO : INFORMATION FOR THE USER

WATER FOR INJECTABLE PREPARATIONS SERRA PAMIES

solvent for parenteral use

Read this prospectus carefully before starting to use the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

2.Before using Water for injectable preparations Serra Pamies

3.How to use Water for injectable preparations Serra Pamies

4.Possible adverse effects

5.Storage of Water for injectable preparations Serra Pamies

6.Additional information

Serra Pamies Sterile Water for Injection is pure sterile water. It is used to dilute medications before use, for example, medications administered through

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

No use Water for Injectable Preparations Serra Pamies:

Do not inject Water for Injectable Preparations Serra Pamies alone. If it is injected alone into the bloodstream, it may cause red blood cells to absorb water and burst (hemolysis). This occurs because Water for Injectable Preparations does not have the same consistency as blood.

Before administering it, a healthcare professional will always mix Water for Injectable Preparations Serra Pamies with one or more medications.

Read the medication or medications' prospectus that will be mixed with Water for Injectable Preparations Serra Pamies. These will tell you if you can or cannot receive the solution.

Be especially careful with Water for Injectable Preparations Serra Pamies:

Water for Injectable Preparations should not be administered alone. Before using Water for Injectable Preparations Serra Pamies:

• it will always be mixed with one or more medications
• your healthcare professional will ensure that the mixture has approximately the same consistency as your blood (isotonic). Depending on the type of medication you are administered, this will mean that:
• • the medication needs to be diluted with Water for Injectable Preparations Serra Pamies
  • before use, another substance needs to be added to the mixture of Water for Injectable Preparations Serra Pamies and the medication

You will have a higher risk of hemolysis if you are administered large volumes of hypotonic solutions of Water for Injectables (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 administering medications mixed with Water for Injectable Preparations Serra Pamies, your doctor will check that:

• the medications are stable in Water for Injectable Preparations Serra Pamies
• the medications do not interact with each other.

Use of other medications:

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those acquired without a prescription.

Medications that are used dissolved in Water for Injectable Preparations Serra Pamies may interact with each other.

Use of Water for Injectable Preparations Serra Pamies with food and meals:

Consult with your doctor about what you can eat or drink.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using a medication.

Inform your doctor if you are pregnant or breastfeeding.

The risks to the fetus or your pregnancy will depend on the medications you use mixed with Water for Injectable Preparations Serra Pamies.

The risks to the baby during breastfeeding will depend on the medications you use mixed with Water for Injectable Preparations Serra Pamies.

Your doctor will be able to inform you about the risks associated with each medication in particular.

Your doctor will administer medications during pregnancy and breastfeeding only if it is essential.

Driving and operating machines:

Water for Injectable Preparations Serra Pamies does not affect the ability to drive or operate machines.

The effects on your ability to drive and operate machines will depend on the medications you use mixed with Water for Injectable Preparations Serra Pamies. Your doctor will advise you about this.

A doctor or nurse will administer Water for Injectable Preparations Serra Pamies to you.

Your doctor will decide how much you need, and when and how it will be administered. This will depend on the medications you need to take with Water for Injectable Preparations Serra Pamies.

Your doctor will consider your age, weight, condition, and any other treatments you are receiving.

You should not receive Water for Injectable Preparations Serra Pamies if there are particles floating in the water or if the container is damaged in any way.

If you receive more Water for Injectable Preparations Serra Pamies than you should:

If you have received too much Water for Injectable Preparations Serra Pamies, you may experience hemolysis. Hemolysis occurs when red blood cells absorb water and burst.

The medications mixed with Water for Injectable Preparations Serra Pamies may also cause symptoms if administered in excessive amounts. The symptoms and signs of overdose will depend on the medications you are using mixed with Water for Injectable Preparations Serra Pamies.

If you are accidentally given an overdose, your treatment will be stopped and you will be given treatment depending on your symptoms.

You should read the prospectus of the medications mixed with Water for Injectable Preparations 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 Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

Like all medications, Serra Pamies Injectable Diluent may have adverse effects, although not all people may experience them.

You may experience hemolysis (swelling and bursting of red blood cells) if:

• You use Serra Pamies Injectable Diluent alone
• Serra Pamies Injectable Diluent is used to make injectable solutions or for perfusion that are not similar in consistency to your blood (isotonic)

If a medication is added to Serra Pamies Injectable Diluent, the added medication may cause adverse effects. These adverse effects will depend on the added medication. You should read the prospectus of the added medication for the list of possible symptoms.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

This medication does not require special conditions for conservation. Keep the ampule in the outer packaging.

Expiration Date:

Do not administer Water for Injectable Preparations Serra Pamies after the expiration date indicated on the packaging and the ampule label.The expiration date is the last day of the month indicated.

Once the packaging is opened, the product must be used immediately.

Medicines should not be thrown away through the drains or in the trash.Dispose of the packaging and medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

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 of the Product and Contents of the Container

Serra Pamies Water for Injections is a transparent solution, free of visible particles, and is available in the following formats:

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

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

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

Only some sizes of containers may be commercially available.

Holder of the Marketing Authorization and Responsible for Manufacturing

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 Reus (Tarragona)

This leaflet was approved in March 2011

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