Prospect: information for the user

ICOMAS 0.3%/ 0.3%/ 0.3% medicinal compressed gas

Carbon monoxide (CO), methane (CH4) and acetylene (C2H2).

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section 4.

1. What isICOMASand how it is used

2. What you need to know before starting to useICOMAS

3. How to useICOMAS

4. Possible adverse effects

5. Storage ofICOMAS

6. Contents of the package and additional information

This medicationis solely for diagnostic use in lung function tests. ICOMAS should be used only in patients capable of performing the test, regardless of age.

Children and adolescents

This product should be used with caution in children. Ask your doctor or nurse before taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before taking this medication.

ICOMAS should be used during pregnancy only when absolutely necessary.

ICOMAS can be used during breastfeeding, but should not be used at the same time as breastfeeding.

ICOMASshould be used only for diagnostic tests of lung function. You must follow exactly the instructions given by your doctor or the nursing staff attending to you. In case of doubt, consult your doctor or nurse again.

If you take more ICOMAS than you should

If you have taken too much of the product, you may experience symptoms of low oxygen in the blood, such as altered consciousness, headache, dizziness, nausea, vomiting, and blurred vision; chest pain, difficulty breathing, weakness, or other vague symptoms.

If you experience any of these symptoms, report them immediately to the healthcare professional and discontinue ICOMAS inhalation.

Safety Information

• ICOMAS isexclusively for medicinal use.
• You are not allowed to smoke or light flames in the room where you are using this product.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No known adverse effect has been associated with the use ofICOMAS.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store the cartridges in areas with restricted access, reserved for medical gases. Do not expose to high temperatures.

In case of fire, if possible, move the cartridges to a safe place. Handle with caution. Return used cartridges to the supplier with a minimum residual pressure (5 bar overpressure).

Store and transport the cartridges with the valve closed and the protective cap in place.

Do not use ICOMAS after the expiration date appearing on the cartridge label.

What ICOMAS contains

The active principles are carbon monoxide (CO), acetylene (C2H2) and methane (CH4).

The other components are nitrogen (N2) and oxygen (O2).

Appearance of the product and contents of the container

ICOMASis an colourless, odourless and tasteless gas.

Pharmaceutical form: medicinal gas, compressed.

The top (crown) of the gas cylinders have light green marks (inert gas). The body of the gas cylinder is white (medicinal gas).

Containers (including materials) and valves:

10-liter aluminum cylinder with a closing valve.

20-liter aluminum cylinder with a closing valve.

40-liter aluminum cylinder with a closing valve.

50-liter aluminum cylinder with a closing valve.

Holder of the marketing authorization and responsible manufacturer

Linde Sverige AB

Rättarvägen 3

169 68 Solna

Sweden.

Manufacturer

Linde Gas AB

Baltzar von Platens gata 4-6

749 47Enköping

Sweden

Last review date of this leaflet:September 2020

Detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/<, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)}.

The following information is directed exclusively to healthcare professionals:

Safety instructions

• Connect only to medicinal use connections.
• Keep the cylinder clean and dry and free of grease and oil.
• Switch off/disconnect the equipment when not in use.
• In case of fire, switch off/disconnect the equipment.
• The pressure regulator must be opened slowly and carefully.
• ICOMAS should only be used in well-ventilated areas.

• When the cylinder is in use, it must be securely fixed.
• This product should not be used with a pressure below 5 bars. This residual pressure protects the cylinder from possible contamination.

After use, the valve of the cylinder should be closed using a normal manual pressure. Depressurize the regulator or connector.