APULCO ACOMETH 0.3%/0.3%/0.3% MEDICINAL COMPRESSED GAS

Introduction

Leaflet: Information for the user

Apulco Acometh 0.3%/0.3%/0.3% compressed medical gas

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

Read the entire leaflet carefully before starting to use this medication, 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 medication 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 Acometh is and what it is used for
2. What you need to know before starting to use Apulco Acometh
3. How to use Apulco Acometh
4. Possible side effects
5. Storage of Apulco Acometh
6. Package contents and additional information

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

Apulco Acometh is a medical gas used solely for diagnostic purposes. It is administered during pulmonary function tests and is used primarily to measure the lungs' ability to absorb inhaled gas into the bloodstream, and it can also be used to measure lung volume and pulmonary blood flow.

2. What you need to know before starting to use Apulco Acometh

Do not use Apulco Acometh:

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

Warnings and precautions

Consult your doctor before starting to use Apulco Acometh for pulmonary function tests.

Using Apulco Acometh with other medications

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

Using Apulco Acometh with food, drinks, and alcohol

When using Apulco Acometh, you should not be in a state that would prevent you from performing the pulmonary 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 Acometh.

Driving and using machines

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

3. How to use Apulco Acometh

Inhale Apulco Acometh only during diagnostic pulmonary function tests 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 pulmonary function test and the frequency of repeating the test.

4. Possible side effects

During inhalation of Apulco Acometh in pulmonary 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 Acometh immediately and receive medical treatment.

A blood sample may need to be drawn for blood gas analysis after inhaling Apulco Acometh.

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 medication.

5. Storage of Apulco Acometh

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 Acometh contains

The active ingredients are carbon monoxide and helium.

The other ingredients are nitrogen and oxygen.

Appearance of Apulco Acometh and package contents

Apulco Acometh 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 medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Apulco Acometh.

Germany: Apulco Acometh.

Spain: Apulco Acometh.

Portugal: Apulco Acometh.

Date of the last revision of this leaflet: March 2021

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