Leaflet: information for the user

Medikarb, 100% V/V medicinal medical gas

Carbon dioxide

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, pharmacist, or nurse.

-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 adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this leaflet. See section 4.

1.What Medikarb is and for what it is used

2.What you need to know before starting to use Medikarb

3.How to use Medikarb

4.Adverse effects

1. Storage of Medikarb

6.Contents of the pack and additional information

Medikarb is a medicinal liquefied gas, which is supplied in high-pressure gas cartridges. This medication is used in the following situations:

-to stimulate breathing after a period of respiratory failure or controlled breathing

-to prevent a reduced concentration of carbon dioxide in the blood during hyperventilation

-to inflate body cavities during a surgical intervention (such as laparoscopic surgery)

-during complementary body explorations

-to create a foam for use in the treatment of varicose veins

If Medikarb is administered via the respiratory route, it will always be administered together with medicinal oxygen.

Medikarb is administered exclusively in hospitals or medical centers under the supervision of medical, pharmacy, or nursing staff. Ensure that your healthcare professional is aware of any conditions you have.

Do not use Medikarb

- if you have elevated acidity in the blood or tissues.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Medikarb.

Be especially careful with Medikarb

- if you have any condition that causes difficulty breathing

- if you have undergone previous surgery or suffered a body trauma to prevent bubble formation in the body

- in case of hypovolemia

Other medications and Medikarb

Medikarb may affect other medications in the body, such as those used to treat hypertension, anticonvulsants, analgesics, and muscle relaxants.

Do not use this medication with epinephrine or similar medications.

Medikarb should not be used with nitrous oxide or similar anesthetics.

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

Pregnancy and breastfeeding

It is not recommended to use Medikarb during pregnancy.

It is recommended to avoid breastfeeding during the use of Medikarb or if you are close to this medication.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

You may drive and operate machines after using Medikarb, if your healthcare professional considers you to be in good condition and capable of it.

Your doctor, pharmacist, or nurse will ensure that your Medikarb supply is adequate for you and that the equipment has been set up correctly so that you receive the right amount of gas.

Medikarb administered by inhalation in the form of a mixture with other medicinal gases is applied using a respiratory mask, a mouthpiece, or an endotracheal tube (which is inserted into the respiratory tract).

Special medical equipment will be used:

• to inflate parts of your body during a laparoscopic surgery or gynecological procedures,
• to treat varicose veins

If you use more Medikarb than you should

When this medication is administered at concentrations above 5%, it may cause extreme difficulty breathing, increased blood pressure, nausea, vomiting, and, in some cases, loss of consciousness. In the event of an overdose, your doctor, pharmacist, or nurse will stop administration and apply the necessary care. Contact with the product may cause burns or frostbite.

If you have any doubts, consult your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The possible adverse effects are:

-difficulty breathing, dry cough, increased blood pressure and heart rate, headache, tingling, altered taste, and nausea, if administered at a concentration below 5%;

-dizziness, sweating, altered vision and hearing, anxiety, and confusion, if administered at a concentration above 5%;

-seizures and loss of consciousness, if administered at a concentration above 10%.

The less frequent adverse effects are:

-cardiac arrest, which involves the heart temporarily stopping. It can be fatal if not treated immediately;

-alteration of heart rhythm, when high levels of carbon dioxide enter the blood during laparoscopy;

-heart attacks caused by gas bubbles in the circulatory system.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,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:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Gas cartridges must be stored:

-at a temperature between −20°C and +65°C;

-covered and protected from adverse weather conditions;

-in a well-ventilated area, used exclusively for the storage of medical gases;

-separated from gas cartridges containing other gases or different in composition;

-protected from falls and other types of impact;

-away from heat sources. Gas cartridges are equipped with a breaking plate to prevent the gas cartridge from cracking due to excessive pressure. The breaking plate may fail at excessive temperatures. This would cause the release of the entire contents of the gas cartridge. In this case, do not enter the storage area and ventilate the area well until a certified expert confirms it is safe.

Empty gas cartridges must be stored separately. Return empty gas cartridges to the supplier.

Medikarb Composition

• The active principle is medicinal carbon dioxide, 100% V/V.
• No contains excipients.

Appearance of Medikarb and packaging contents

Medikarb is a medicinal liquid gas, transparent and odorless. This medicationis preserved under pressure in steel or aluminum gas cartridges. The body of the gas cartridge is white and the tip is gray.

The gas cartridges with a capacity of x liters provide and (unit of volume) of gaseous carbon dioxide at 15°C and 1bar (see table).

Not all packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

SE of Carburos Metálicos, S.A., Av. De la Fama, 1, 08940 Cornellà de Llobregat, Spain

Manufacturers:

SE of Carburos Metálicos, S.A., Carretera de Toledo, 7, 28300 Aranjuez, Spain

Air Products S.A.S., 21 Rue de l'Epinoy, Zone Industrielle de l'Epinoy, 59175 Templemars, France

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

Spain: Medikarb 100 % V/V liquid medicinal gas

Portugal: Medikarb, 100% V/V, medicinal gas, liquefied

Last review date of this leaflet: 12/2022

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/