APULCO COHEMAX 0.28%/14% MEDICINAL COMPRESSED GAS

Introduction

Leaflet: information for the user

Apulco CoHeMax 0.28%/14% compressed medical gas

Carbon monoxide (CO), helium (He)

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

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

Contents of the leaflet

1. What Apulco CoHeMax is and what it is used for
2. What you need to know before using Apulco CoHeMax
3. How to use Apulco CoHeMax
4. Possible side effects
5. Storage of Apulco CoHeMax
6. Package contents and additional information

1. What Apulco CoHeMax is and what it is used for

Apulco CoHeMax is a medical gas that is only used for diagnostic purposes. It is used during diagnostic tests of lung function: determination of diffusion capacity/transfer factor.

2. What you need to know before using Apulco CoHeMax

Do not use Apulco CoHeMax:

• Unless your doctor has asked you to undergo lung function tests.

Warnings and precautions

Consult your doctor before starting to use Apulco CoHeMax for lung function tests.

Using Apulco CoHeMax with other medicines

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

Using Apulco CoHeMax with food, drinks, and alcohol

When using Apulco CoHeMax, you should not be in a state that would prevent you from performing the lung function test correctly according to your doctor's or medical staff's instructions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before inhaling Apulco CoHeMax.

Driving and using machines

Using Apulco CoHeMax during lung function tests should not affect your ability to drive and use machines.

3. How to use Apulco CoHeMax

Inhale Apulco CoHeMax only during diagnostic tests of lung function and exactly as your doctor or medical staff has instructed you. If in doubt, consult your doctor again.

Only your doctor or medical staff should decide the duration of the diagnostic lung function test and the frequency of repeating the test.

4. Possible side effects

During inhalation of Apulco CoHeMax in lung function tests, side effects such as dizziness, chest pain, and a feeling of disorientation may occur, although this is very rare. If any of these symptoms appear while using the medical gas, you should stop inhaling Apulco CoHeMax immediately and receive medical treatment.

A blood sample may need to be taken for blood gas analysis after inhaling Apulco CoHeMax.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Apulco CoHeMax

Keep out of sight and reach of children.

Gas cylinders should be stored indoors and protected from adverse weather conditions.

Do not use this medical gas after the expiration date shown on the label.

Do not dispose of this medical gas. Return it to the supplier. This will help protect the environment.

6. Package contents and additional information

What Apulco CoHeMax contains

The active ingredients are carbon monoxide and helium.

The other ingredients are nitrogen and oxygen.

Appearance of Apulco CoHeMax and package contents

Apulco CoHeMax is a colorless and odorless gas compressed in aluminum gas cylinders.

The body of the gas cylinder is white and the top of the gas cylinder is bright green.

Package sizes in liters (200 bar): 5L, 10L, 20L, and 40L.

Marketing authorization holder

S.E. de Carburos Metálicos S.A.

Avda. de la Fama, 1

08940 Cornella de Llobregat

Spain

Manufacturer

S.E. de Carburos Metálicos S.A.

Pol. Nord-Este C-35, km 59

08470 Sant Celoni

Spain

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

Netherlands: Apulco CoHeMax.

Germany: Apulco CoHeMax.

Spain: Apulco CoHeMax.

Portugal: Apulco CoHeMax.

Slovenia: Apulco CoHeMax.

Czech Republic: Apulco CoHeMax.

Date of last revision of this leaflet: March 2021

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