APULCO COHE 0.28%/9.5% MEDICINAL COMPRESSED GAS

Introduction

Leaflet: information for the user

Apulco CoHe 0.28%/9.5% 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, consult 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 CoHe is and what it is used for
2. What you need to know before starting to use Apulco CoHe
3. How to use Apulco CoHe
4. Possible side effects
5. Storage of Apulco CoHe
6. Package contents and additional information

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

Apulco CoHe 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 starting to use Apulco CoHe

Do not use Apulco CoHe:

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

Warnings and precautions

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

Using Apulco CoHe with other medicines

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

Using Apulco CoHe with food, drinks, and alcohol

When using Apulco CoHe, 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 CoHe.

Driving and using machines

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

3. How to use Apulco CoHe

Inhale Apulco CoHe 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 CoHe 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 CoHe immediately and receive medical treatment.

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

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 Surveillance 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 CoHe

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 CoHe contains

The active ingredients are carbon monoxide and helium.

The other ingredients are nitrogen and oxygen.

Appearance of Apulco CoHe and package contents

Apulco CoHe 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 CoHe.

Germany: Apulco CoHe.

Spain: Apulco CoHe.

Portugal: Apulco CoHe.

Slovenia: Apulco CoHe.

Czech Republic: Apulco CoHe.

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.