Apulco cohemax 0,28%/14% gas c… leaflet – Spain

Introduction

Leaflet: information for the user

Apulco CoHeMax 0.28%/14% medicinal compressed gas

Carbon monoxide (CO), helium (He)

Read this leaflet carefully before you start using this medicine, because 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 for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What isApulco CoHeMaxand what it is used for

2. What you need to know before starting to useApulco CoHeMax

3. How to useApulco CoHeMax

4. Possible side effects

5. Storage ofApulco CoHeMax

6. Contents of the pack and additional information

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

Apulco CoHeMax isa medicinal gas that is only used for diagnostic purposes. It is used during diagnostic tests of lung function: determination of diffusion capacity/transference factor.

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

Do not use Apulco CoHeMax:

Unless your doctor tells you to undergo pulmonary function tests.

Warnings and precautions

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

Using Apulco CoHeMax with other medications

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

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 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 intend to become pregnant, consult your doctor before inhaling Apulco CoHeMax.

Driving and operating machinery

The use of Apulco CoHeMax during pulmonary function tests should not affect your ability to drive and operate machinery.

3. How to Use Apulco CoHeMax

Inhale Apulco CoHeMax only during pulmonary function tests and exactly as your doctor or the medical staff attending to you have instructed. If in doubt, consult your doctor again.

Only your doctor or themedicalstaff attending to you should decide the duration of the pulmonary function test and the frequency of repeating the test.

4. Possible Adverse Effects

During inhalation of Apulco CoHeMax in pulmonary function tests, possible adverse effects may include dizziness, chest pain, and a feeling of disorientation, although this is very rare. If any of these symptoms appear while using the medicinal gas, Apulco CoHeMax inhalation should be stopped immediately and medical treatment should be administered.

You may need to have a blood sample taken for blood gas analysis after inhaling Apulco CoHeMax.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed 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.

5. Conservation of Apulco CoHeMax

Keep out of sight and reach of children.

Gas cartridges should be stored under cover and protected from adverse weather conditions.

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

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

6. Contents of the packaging and additional information

What Apulco CoHeMax contains

The active principles are carbon monoxide and helium.

The other components are nitrogen and oxygen.

Appearance of Apulco CoHeMax and contents of the packaging

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

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

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

Capacity in liters	Filling pressure (bar)	Volume of gas	m3of gas at 1 bar and 15°C
5	200	904	0.904
10	200	1808	1.808
20	200	3615	3.615
40	200	7231	7.231

Marketing authorization holder

SE of Carburos Metálicos S.A.

Avenida de la Fama, 1

08940 Cornella de Llobregat

Spain

Responsible manufacturer

SE of Carburos Metálicos S.A.

Nord-East Industrial Estate C-35, km59

08470 Sant Celoni

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Netherlands: Apulco CoHeMax.

Germany: Apulco CoHeMax.

Spain: Apulco CoHeMax.

Portugal: Apulco CoHeMax.

Slovenia: Apulco CoHeMax.

Czech Republic: Apulco CoHeMax.

Last review date of this leaflet: March 2021

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.