WATER FOR INJECTABLE PREPARATIONS SERRA PARENTERAL SOLVENT

Introduction

Package Leaflet: Information for the User

Water for Injections Serra, Solvent for Parenteral Use

Water for Injections

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 further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Water for Injections Serra is and what it is used for
2. What you need to know before you start using Water for Injections Serra
3. How to use Water for Injections Serra
4. Possible side effects
5. Storage of Water for Injections Serra
6. Contents of the pack and further information

1. What Water for Injections Serra is and what it is used for

Water for Injections Serra is a special type of sterile water. This means it is very clear and can be injected.

Water for Injections Serra is used to dissolve or dilute certain medicines so they can be administered by injection or infusion (drip) into the veins, muscles, or other tissues in the body.

2. What you need to know before you start using Water for Injections Serra

Warnings and Precautions

Water for Injections Serra is hypotonic (more diluted than your blood) and should not be administered alone, as it may cause hemolysis (destruction of your red blood cells).

Using Water for Injections Serra with other medicines

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

No interactions are known when Water for Injections Serra is administered with other medicines. Please read the package leaflets of all your medicines, as Water for Injections Serra is added to other medicines to dissolve or dilute them.

Pregnancy and Breastfeeding

It is not known if Water for Injections Serra causes problems during pregnancy or breastfeeding.

Since Water for Injections Serra is administered with other medicines, it is essential that:

• You inform your doctor if you are pregnant or think you might be pregnant.
• You inform your doctor if you are breastfeeding a baby.

Your doctor will advise whether you should use this medicine.

3. How to use Water for Injections Serra

Usually, this medicine will be administered by a doctor or nurse. This product is a solvent for injectable use.

The doctor or nurse will use the correct amount to dissolve or dilute another medicine you are receiving as an injection or drip (your doctor or nurse may refer to this as an infusion).

Water for Injections Serra should not be mixed with oily liquids.

Your doctor will decide the amount (dose) of medicine you should receive and for how long.

The dose will depend on the other medicine being dissolved or diluted.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Remember, you may also have side effects related to the other medicines for which Water for Injections Serra is used to dissolve or dilute.

The expected benefit of your medicine will generally be greater than the risk of you suffering harmful side effects.

Important: Side effects or symptoms to look out for, and what to do if you are affected.

The first signs of having too much water in your blood are feeling tired and pale. If you have any of these symptoms, you should see a doctor urgently.

No side effects of Water for Injections Serra are known; therefore, please read the package leaflets of your other medicines to which water is added to dissolve or dilute them.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Water for Injections Serra

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

After the first opening:

Use your medicine only if it is a clear, colorless liquid. Open and use it immediately. The unused part of the product should be discarded after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Water for Injections Serra

• The active ingredient is Water for Injections. 1 ml contains 1 g of water for injections, 5 ml contains 5 g of water for injections, 10 ml contains 10 g of water for injections, 20 ml contains 20 g of water for injections.
• This medicine does not contain any other ingredients.

Appearance and packaging of the product

Water for Injections Serra is a solvent for parenteral use.

Water for Injections Serra is a clear, colorless liquid.

Each plastic ampoule contains 5 ml (milliliters), 10 ml, or 20 ml of your medicine.

The 5 ml ampoules are packaged in boxes of 20 or 50 ampoules.

The 10 ml ampoules are packaged in boxes of 20, 50, or 100 ampoules.

The 20 ml ampoules are packaged in boxes of 20 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

Demo S.A.

21st Km National Road Athens-Lamia

14568 Athens

Greece.

This medicine is authorized in the Member States of the European Economic Area under the following names:

UK: Water for Injections Ph.Eur.

DK: Sterilt vand Noridem.

ES: Agua para preparaciones inyectables Serra, disolvente para uso parenteral.

IE: Water for Injections Ph Eur.

SE: Vatten för injektiosvätskor Noridem.

DE: Wasser für Injektionszwecke Noridem 1mg/ml Lösungsmittel zur Herstellung von Parenteralia.

AT: Wasser für Injektionszwecke Noridem Lösungsmittel zur Herstellung von Parenteralia.

NO: Sterilt vann Noridem.

PT: Água para preparacoes Injectáveis Noridem.

ΕΛ: Water for Injections/Noridem, Διαλυτής για παρεντερική χρήση 100%(v/v)

NL: Water voor injecties Noridem, oplosmiddel voor parenteraal gebruik

Date of last revision of this leaflet: February 2018

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.es/