


Ask a doctor about a prescription for APULCO HE 9% COMPRESSED GAS TABLETS
Package Leaflet: Information for the User
Apulco He 9% Compressed Medical Gas
Helium (He)
Read this package leaflet carefully before starting to use this medical gas, as it contains important information for you.
Contents of the Package Leaflet
Apulco He is for diagnostic use only. It is used in various respiratory function tests with helium and is used to measure lung volume.
Do not use Apulco He:
Warnings and Precautions
Consult your doctor before starting to use Apulco He for pulmonary function tests.
Using Apulco He with Other Medicines
Tell your doctor if you are using, have recently used, or may need to use any other medicine.
Using Apulco He with Food, Drinks, and Alcohol
When using Apulco He, 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 He.
Driving and Using Machines
Using Apulco He during pulmonary function tests should not affect your ability to drive and use machines.
Inhale Apulco He 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.
None have been documented.
Reporting Side Effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package 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.
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.
Composition of Apulco He
The active ingredient is helium.
The other components are nitrogen and oxygen.
Appearance of Apulco He and Package Contents
Apulco He is an odorless and colorless gas, supplied compressed in an aluminum gas cylinder.
The body of the gas cylinder is white, and the top of the gas cylinder is light blue.
Package sizes in liters (200 bar): 5L, 10L, 20L, and 40L.
Capacity in Liters | Filling Pressure (bar) | Gas Liters | m3of Gas at 1 bar and 15°C |
5 | 200 | 918 | 0.918 |
10 | 200 | 1837 | 1.837 |
20 | 200 | 3673 | 3.673 |
40 | 200 | 7346 | 7.346 |
Marketing Authorization Holder
S.E. de Carburos Metálicos S.A.
Avda. de la Fama, 1
08940 Cornellà 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 He.
Germany: Apulco He.
Spain: Apulco He.
Portugal: Apulco He.
Date of Last Revision of this Package 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.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for APULCO HE 9% COMPRESSED GAS TABLETS – subject to medical assessment and local rules.