MEDIKARB 100% V/V MEDICINAL GAS LIQUID

2. What you need to know before you start using Medikarb

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

Do not use Medikarb

• if you have high acidity in the blood or tissues.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Medikarb.

Be particularly careful with Medikarb

• if you have any condition that causes difficulty breathing
• if you have previously undergone surgery or suffered trauma to the body to prevent the formation of bubbles in the body
• in case of hypovolemia

Other medicines and Medikarb

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

Do not use this medicine with epinephrine or similar medicines.

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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and breastfeeding

Medikarb should not be used during pregnancy.

Breastfeeding should be avoided during the use of Medikarb or if you are near this medicine.

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines after using Medikarb if your healthcare professional considers you are in good condition and able to do so.

3. How to use Medikarb

Your doctor, pharmacist, or nurse will ensure that your Medikarb supply is suitable for you and that the equipment is correctly set up for you to receive the correct amount of gas.

Administration of Medikarb 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 airways).

Special medical equipment will be used:

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

If you use more Medikarb than you should

When this medicine is administered at concentrations above 5%, it can cause extreme difficulty breathing, increased blood pressure, nausea, vomiting, and occasionally loss of consciousness. In case of overdose, your doctor, pharmacist, or nurse will stop administration and provide appropriate care. Contact with the product can cause burns or frostbite.

If you have any questions, talk to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are:

• difficulty breathing, dry cough, increased blood pressure and heart rate, headache, tingling, alteration of taste, and nausea, if administered at a concentration below 5%;
• dizziness, sweating, alteration of 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%.

Less common side effects are:

• cardiac arrest, which means the heart stops beating temporarily. It can be fatal if the cardiac arrest is not treated immediately;
• alteration of heart rhythm, when high levels of carbon dioxide enter the blood during laparoscopy;
• heart attacks due to gas bubbles in the bloodstream.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Medikarb

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

The gas cylinders should 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 medicinal gases;
• separated from gas cylinders containing other gases or different in composition;
• protected from falls and other types of impact;
• away from heat sources. The valves of the gas cylinders are equipped with a rupture disc to prevent the cylinder from cracking due to excessive pressure. The rupture disc may fail in case of excessive temperature. This would cause the release of the entire contents of the cylinder. In that case, do not enter the storage area and ventilate the area well until an expert certifies it is safe.

Empty gas cylinders should be stored separately. Return empty gas cylinders to the supplier.

6. Contents of the pack and further information

Composition of Medikarb

• The active substance is medicinal carbon dioxide, 100% V/V.
• It does not contain excipients.

Appearance of Medikarb and contents of the pack

Medikarb is a medicinal liquid gas, colorless and odorless. This medicine is stored under pressure in gas cylinders made of steel or aluminum. The body of the cylinder is white and the valve is gray.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturers:

S.E. de 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Medikarb 100% V/V medicinal liquid gas

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

Date of last revision of this leaflet: 12/2022

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/