PATIENT INFORMATION LEAFLET

Remifentanilo Noridem 2 mg powder for concentrate for injectable solution and for EFG infusion

Remifentanil hydrochloride

Read this leaflet carefully before you start using the 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, pharmacist or nurse.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of your medicine isRemifentanilo Noridem2mgpowder for concentrate for injectable solution and for EFG infusion.

In the rest of this leaflet, your medicinewill be calledRemifentaniloNoridem.

1.What Remifentanilo Noridem is and what it is used for

2.What you need to know before you start using Remifentanilo Noridem

3.How to use Remifentanilo Noridem

4.Possible side effects

5.Storage of Remifentanilo Noridem

6.Contents of the pack and additional information

Remifentanilo Noridem contains a medication called remifentanilo thatbelongs to a group of medications called opiates.

Remifentanilo Noridem isused in combination with other medications called anesthetics:

• to help you fall asleepbeforea surgical operation
• to prevent you from feeling pain and keep you asleepduringa surgical operation

to keep you drowsy and prevent you from feeling pain while receiving treatment in an Intensive Care Unit.

Do not use Remifentanilo Noridem if:

• You are allergic (hypersensitive) to remifentanilo or to any of the other components of this medication (listed in section 6)
• You are allergic (hypersensitive) to any other medicationAnalgésico similar to fentanilo and related to the class of medications known as opiáceos

If you are unsure if you fall into any of the above cases, consult with your doctor, pharmacist or healthcare professional before using Remifentanilo Noridem.

Warnings and precautions:

Consult your doctor or pharmacist before starting to useRemifentanilo Noridem if:

• You are allergic (hypersensitive) to any other opioid medication, such as morphine or codeine

• You are over 65 years old
• You are dehydrated or have lost a lot of blood
• You have not been feeling wellor have felt weak.
• You are overweight
• You or a family member have ever abused or had dependence on alcohol, prescription medications or illegal drugs (“addiction”)
• You are a smoker
• You have ever had mood problems (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you are unsure if you fall into any of the above cases, consult with your doctor, pharmacist or healthcare professional before using Remifentanilo Noridem.

This medication contains remifentanilo which is an opioid. The repeated use of opioids can make the medication lose its effectiveness (become accustomed to its effect). It can also cause dependence and abuse, which can lead to a potentially fatal overdose. If you are concerned that you may become dependent on Remifentanilo Noridem, it is essential to consult your doctor.

Occasionally, withdrawal reactions (e.g., rapid heartbeats, high blood pressure and agitation) have been reported after sudden discontinuation of treatment with this medication, especially when treatment was administered for more than 3 days (see also section 4. Possible side effects). If you experience these symptoms, your doctor may restart treatment with the medication and gradually reduce the dose.

Use of Remifentanilo Noridem with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, including those purchased without a prescription and herbal medications. This is because Remifentanilo Noridem may interact with other medications causing adverse effects.

It is especially important to inform your doctor or pharmacist if you are taking:

• Blood pressure medications or heart problems medications, such as beta-blockers (including atenolol, metoprolol, carvedilol, propanololand bisoprolol) or calcium channel blockers (including amlodipino, diltiazem and nifedipino).
• Depression medications, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) and monoamine oxidase inhibitors (MAOIs). It is not recommended to use these medications at the same time as Remifentanilo Noridem, as they may increase the risk of serotonin syndrome, a potentially fatal condition.

The concomitant use of opioids and other medications used to treat epilepsy, nerve pain or anxiety (gabapentina and pregabalina) increases the risk of opioid overdose and respiratory depression, and may be potentially fatal.

Pregnancy and breastfeeding

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

If you receive this medication during delivery or shortly before delivery, it may affect your baby's breathing. You and your baby will be monitored for signs of excessive sleepiness or difficulty breathing.

Driving and operating machinery

If you are hospitalized only during the day, your doctor will inform you how long to wait before leaving the hospital or driving vehicles. It may be hazardous to drive too soon after undergoing surgery.

This medication may affect your ability to drive because it can make you feel drowsy or dizzy.

• Do not drive while taking this medication until you know how it affects you.

Consult your doctor or pharmacist if you are unsure if you can drive safely while taking this medication.

Administration by Injection

This medication should never be administered by yourself. This medication will always be administered by qualified healthcare personnel.

Remifentanilo Noridem may be administered:

• as a single injection into a vein
• as a continuous infusion (drip) into a vein, if you need to receive the medication over a longer period of time.

The way you will be administered the medication and the dose you receive will depend on:

• your weight

• the type of operation you are undergoing
• the level of pain expected from the operation
• the level of sedation that healthcare personnel deem most appropriate for you in the Intensive Care Unit.

The dose may vary from one patient to another.

If you use more Remifentanilo Noridem than you should

The effects of Remifentanilo Noridem are closely monitored throughout the operation and in intensive care. If you have received too much, appropriate measures will be taken promptly.

If you believe you have been given more Remifentanilo than you should have, consult your doctor or pharmacist immediately.

After surgery

Inform your doctor or healthcare personnel if you experience pain. If you experience pain after surgery, they may administer other pain relievers to alleviate it.

Like all medications, Remifentanilo Noridem may cause side effects, although not everyone will experience them. With this medication, the following side effects may occur.

Some people may be allergic to Remifentanilo.You must inform your doctor or healthcare staff immediately if you feel:

Rare(may affect up to 1 user in every 1,000)

• Sudden onset of sneezing and chest pain or sensation of compression
• Swelling of the eyelids, face, lips, mouth, or tongue
• Hives with bumps or rash on any part of your body
• Loss of consciousness.

Inform your doctoras soon as possibleif you feel any of the following side effects:

Very common(may affect more than 1 user in every 10)

• Muscle stiffness
• Low blood pressure
• Nausea or vomiting

Common(may affect up to 1 user in every 10)

• Slow heart rate
• Shallow breathing or temporary cessation of breathing
• Itching
• Coughing

Uncommon(may affect up to 1 user in every 100)

• Respiratory problems (hypoxia)
• Constipation

Rare(may affect up to 1 user in every 1,000)

• Allergic reactions
• Cardiac arrest

Unknown(cannot be estimated from available data)

• Physical need for remifentanilo (dependence) or need to increase doses over time to achieve the same effect (tolerance)
• Seizures
• A type of irregular heart rhythm (atrioventricular block)
• Irregular heartbeat (arrhythmia)
• Abstinence syndrome (may manifest with the following side effects: increased heart rate, hypertension, feeling of agitation or restlessness, nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating)

Other side effects that may occur when you wake up after being under anesthesia:

Common(may affect up to 1 user in every 10)

• Chills
• Increased blood pressure

Uncommon(may affect up to 1 user in every 100)

• Pain

Rare(may affect up to 1 user in every 1,000)

• Extreme feeling of calmness or drowsiness (sedation)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side 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 Remifentanil Noridem after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use the reconstituted product if you observe that the solution is not transparent, colorless and practically free of particles.

Do not conserve at a temperature above 25°C.Conserve the vial in its original packaging to protect it from light.

Once reconstituted, use Remifentanil Noridem immediately. The unused solutionshould not be discarded down the drain or in the trash. Your doctor or healthcare personnel will dispose of the medications you do not need. This will help protect the environment.

Composition of Remifentanil Noridem

• The active ingredient is remifentanil hydrochloride.
• The other components are glycine and hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the container

Remifentanil Noridem is a white or almost white, lyophilized, sterile powder, free of bacteria. This powder must be mixed with an appropriate fluid before injection. Once mixed, the resulting solution of Remifentanil Noridem is transparent and colorless.

Remifentanil Noridem powder for concentrate for solution for injection or infusion is distributed in glass vials with bromobutyl rubber stoppers, which contain 1 mg of remifentanil (as remifentanil hydrochloride).

Each of these two concentrations of Remifentanil Noridem is distributed in carton containers with 5 and 10 vials.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Manufacturer:DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Attica, Greece.

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:05/2022.

The detailed and updated 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/

This information is intended exclusively for medical or healthcare professionals: Consult the complete prescribing information in the Product Technical File. The information provided in this section are the instructions for the preparation of Remifentanil Noridem before its administration and the guidelines for the infusion rates of Remifentanil Noridem for controlled manual infusion. PREPARATION GUIDE for Remifentanil Noridem 1 mg Powder for Concentrate for Solution for Injection or Infusion Remifentanil Noridem is a sterile, lyophilized, endotoxin-free, preservative-free powder, white or almost white, which must be reconstituted before use. Remifentanil Noridem is available in glass vials containing 1 mg of remifentanil base. The vials should not be stored above 25°C. When reconstituted according to the recommendations, the solutions of Remifentanil Noridem are transparent and colorless and contain 1 mg/ml of remifentanil base, as remifentanil hydrochloride. Remifentanil Noridem should not be administered without additional dilution after reconstitution of the lyophilized powder. Please read the entire content of this guide before preparing this medicinal product. This information can also be found in sections 6.4 and 6.6 of the Product Technical File. Reconstitution of the lyophilized powder Remifentanil Noridem must be prepared for intravenous use by adding, as necessary, 1, 2, or 5 ml of diluent (see the list of diluents in "Additional dilution") to obtain a reconstituted solution with a concentration of 1 mg/ml of remifentanil. This reconstituted solution is transparent, colorless, and practically free of particles. After reconstitution, visually inspect the product (if the container allows it) to determine the presence of particles, coloration, or deterioration of the container. Discard any solution in which these defects are observed. The reconstituted product is for single use only. Any unused material must be discarded. Additional dilution Once reconstituted, Remifentanil Noridem should not be administered by controlled manual infusion without performing additional dilution to concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution for adults and 20 to 25 micrograms/ml for pediatric patients aged 1 year or more, when used for maintenance of anesthesia). Remifentanil Noridem should not be used in pediatric patients under 18 years old for analgesia in intensive care unit patients with mechanical ventilation. Once reconstituted, Remifentanil Noridem should not be administered by TCI infusion without additional dilution (the recommended dilution for TCI is 20 to 50 micrograms/ml). The chosen dilution depends on the technical capabilities of the infusion device and the expected needs of the patient. For dilution, one of the IV fluids listed below must be used: Water for injection Glucose 5% injection Glucose 5% and sodium chloride 0.9% injection Sodium chloride 0.9% injection Sodium chloride 0.45% injection After dilution, visually inspect the product to ensure it is transparent, colorless, practically free of particles, and the container does not show deterioration. Discard any solution in which these defects are observed. Chemical and physical stability has been demonstrated for use over 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions of the reconstituted solution, prior to use, are the responsibility of the user and are normally not to exceed 24 hours at 2-8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions. However, Remifentanil Noridem does not contain any antimicrobial preservative and, therefore, care must be taken to ensure the sterility of the prepared solutions, and the reconstituted product should be used promptly and any unused material discarded. Compatibility of Remifentanil Noridem has been demonstrated with the following IV fluids, when administered through a central venous catheter: Ringer's lactate injection Ringer's lactate and glucose 5% injection Compatibility of Remifentanil Noridem with propofol has been demonstrated when administered through a central venous catheter. INFUSION RATE GUIDELINES The following tables provide recommendations on infusion rates of Remifentanil Noridem for controlled manual infusion: Table 1. Infusion rates (mL/kg/h) of Remifentanil Noridem powder for concentrate for solution for injection or infusion Infusion rate of the drug (micrograms/kg/min) Infusion rate of the infusion (mL/kg/h) for solutions of: 20 micrograms /mL 1 mg/50 mL 25 micrograms /mL 1 mg/40 mL 50 micrograms /mL 1 mg/20 mL 250 micrograms /mL 10 mg/40 mL 0.0125 0.038 0.03 0.015 Not recommended 0.025 0.075 0.06 0.03 Not recommended 0.05 0.15 0.12 0.06 0.012 0.075 0.23 0.18 0.09 0.018 0.1 0.3 0.24 0.12 0.024 0.15 0.45 0.36 0.18 0.036 0.2 0.6 0.48 0.24 0.048 Table 2. Infusion rates (mL/h) for a solution of 20 micrograms/mL of Remifentanil Noridem powder for concentrate for solution for injection or infusion Infusion rate (micrograms/kg/min) Patient body weight (kg) 5 10 20 30 40 50 60 0.0125 0.188 0.375 0.75 1.125 1.5 1.875 2.25 0.025 0.375 0.75 1.5 2.25 3.0 3.75 4.5 0.05 0.75 1.5 3.0 4.5 6.0 7.5 9.0 0.075 1.125 2.25 4.5 6.75 9.0 11.25 13.5 0.1 1.5 3.0 6.0 9.0 12.0 15.0 18.0 0.15 2.25 4.5 9.0 13.5 18.0 22.5 27.0 0.2 3.0 6.0 12.0 18.0 24.0 30.0 36.0 0.25 3.75 7.5 15.0 22.5 30.0 37.5 45.0 0.3 4.5 9.0 18.0 27.0 36.0 45.0 54.0 0.35 5.25 10.5 21.0 31.5 42.0 52.5 63.0 0.4 6.0 12.0 24.0 36.0 48.0 60.0 72.0 Table 3. Infusion rates (mL/h) for a solution of 25 micrograms/mL of Remifentanil Noridem powder for concentrate for solution for injection or infusion Infusion rate (micrograms/kg/min) Patient body weight (kg) 10 20 30 40 50 60 70 80 90 100 0.0125 0.3 0.6 0.9 1.2 1.5 1.8 2.1 2.4 2.7 3.0 0.025 0.6 1.2 1.8 2.4 3.0 3.6 4.2 4.8 5.4 6.0 0.05 1.2 2.4 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 0.075 1.8 3.6 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 0.1 2.4 4.8 7.2 9.6 12.0 14.4 16.8 19.2 21.6 24.0 0.15 3.6 7.2 10.8 14.4 18.0 21.6 25.2 28.8 32.4 36.0 0.2 4.8 9.6 14.4 19.2 24.0 28.8 33.6 38.4 43.2 48.0 Table 4. Infusion rates (mL/h) for a solution of 50 micrograms/mL of Remifentanil Noridem powder for concentrate for solution for injection or infusion Country of registration Spain Active substance Remifentanilo hidrocloruro Prescription required Yes Manufacturer Noridem Enterprises Limited This information is for reference only and does not constitute medical advice. 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Get started Follow us on social media ServicesDoctorsHelp Search Infusion rate (micrograms/kg/min) Patient body weight (kg) 30 40 50 60 70 80 90 100 0.025 0.9 1.2 1.5 1.8 2.1 2.4 2.7 3.0 0.05 1.8 2.4 3.0 3.6 4.2 4.8 5.4 6.0 0.075 2.7 3.6 4.5 5.4 6.3 7.2 8.1 9.0 0.1 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 0.15 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 0.2 7.2 9.6 12.0 14.4 16.8 19.2 21.6 24.0 0.25 9.0 12.0 15.0 18.0 21.0 24.0 27.0 30.0 0.5 18.0 24.0 30.0 36.0 42.0 48.0 54.0 60.0 0.75 27.0 36.0 45.0 54.0 63.0 72.0 81.0 90.0 1.0 36.0 48.0 60.0 72.0 84.0 96.0 108.0 120.0 1.25 45.0 60.0 75.0 90.0 105.0 120.0 135.0 150.0 1.5 54.0 72.0 90.0 108.0 126.0 144.0 162.0 180.0 1.75 63.0 84.0 105.0 126.0 147.0 168.0 189.0 210.0 2.0 72.0 96.0