Label: information for the user

Remifentanilo NORMON 1 mg powder for concentrate for solution

injectable and for infusion EFG

Remifentanilo

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

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

2. What you need to know before starting to use Remifentanilo NORMON

3. How to use Remifentanilo NORMON

4. Possible adverse effects

5. Storage of Remifentanilo NORMON

6. Contents of the package and additional information

Remifentanilo belongs to a group of medications known as opioids. These medications are used extensively for:

• producing anesthesia and/or relieving pain before or during a surgical procedure
• to relieve pain while under controlled mechanical ventilation in an Intensive Care Unit (in patients 18 years of age and older).

• No use Remifentanilo NORMON

• If you are allergic (hypersensitive) to remifentanilo, to any of the other components of Remifentanilo NORMON (listed in section 6) or to fentanyl derivatives (such as alfentanilo, fentanilo, sufentanilo).
• As the sole medication for initiating anesthesia.
• Remifentailo NORMON should not be used by epidural or intrathecal injection due to the presence of glycine.

• Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Remifentanilo NORMON if:

• You have experienced any adverse effects during a surgical procedure.
• You have ever had an allergic reaction or are allergic to:
• Any medication used in surgical procedures.
• Opiate medications (e.g. morphine, fentanilo, petidina, codeína), see also the previous section “Do not use Remifentanilo NORMON”

• You have impaired pulmonary and/or hepatic function (as you may be more susceptible to respiratory difficulties).
• 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 experienced mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental health conditions.

This medication contains remifentanilo, which is an opiate. Repeated use of opiates can make the medication less effective (you become accustomed to its effect). It can also cause dependence and abuse, which can lead to a potentially fatal overdose. If you are concerned about becoming dependent on remifentanilo, consult your doctor.

Occasionally, withdrawal reactions (e.g. rapid heart rate, hypertension, 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 adverse effects). If you experience these symptoms, your doctor may restart treatment with the medication and gradually reduce the dose.

Older or debilitated patients (due to decreased blood volume and/or blood pressure) are more susceptible to cardiac or circulatory changes.

• Children

Remifentanilo NORMON is not recommended for neonates and infants (children under one year). There is limited experience with the use of Remifentanilo NORMON for the treatment of children in intensive care units.

• Use in athletes

This medication contains remifentanilo, which may result in a positive test in doping control tests.

• Interaction of Remifentanilo NORMON with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important with the following medications, as they may interact with Remifentanilo NORMON:

The concomitant use of remifentanilo and sedatives, such as benzodiazepines or other related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put the patient's life at risk. Due to this, concomitant use with these medications should only be considered when other treatment options are not possible. The concomitant use of opiates and other medications used to treat epilepsy, nerve pain, or anxiety (gabapentina and pregabalina) increases the risk of opiate overdose and respiratory depression, and may be potentially fatal.

However, it may be advisable for you to receive Remifentanilo NORMON, and your doctor will decide on the most appropriate treatment for you.

• Use of Remifentanilo NORMON with food and beverages

After receiving Remifentanilo NORMON, you should not drink alcohol until you are fully recovered.

• Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will assess whether it is advisable to use this medication during pregnancy. Remifentanilo NORMON is not recommended during delivery or during a cesarean section.

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.

If you are breastfeeding, stop breastfeeding for 24 hours after receiving this medication.

• Driving and operating machinery

This medication is only used in hospitalized patients. Do not drive or operate machinery after receiving Remifentanilo NORMON, as this medication may affect your reaction time. Your doctor will inform you how long you should wait before driving or operating machinery.

Remifentanilo NORMON will only be administered under carefully controlled conditions and should always be available an emergency team. Remifentanilo NORMON will be administered by a doctor with experience or under their supervision, as they should be familiar with the use and action of this type of medication.

This medication will always be administered by qualified individuals. You will never self-administer this medication.

Remifentanilo NORMON should only be administered by injection or direct infusion into a vein. It should be administered for at least 30 seconds. Remifentanilo NORMON should not be injected into the spinal canal (intrathecal or epidural route).

Dosage

The dose and duration of infusion will be established by your doctor, as these may vary depending on different factors such as your body weight, age, physical condition, other medications you are taking, and the type of surgical procedure you will undergo.

• Use in children and adolescents

This medication is not recommended for use in children under 1 year of age.

• If you use more Remifentanilo NORMON than you should

Remifentanilo NORMON will always be administered under adequately controlled conditions. However, if you consider that you have been administered more medication than you should have, inform your doctor or nurse immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Remifentanilo NORMON may cause side effects, although not everyone will experience them.

Some people may be allergic to medications. If you have presented any of the following symptoms immediately after your surgical procedure, inform your doctor immediately:

• Sudden appearance of "pops" and pain or pressure in the chest.
• Swelling of eyelids, face, lips, mouth, or tongue.
• Rash on the skin or urticaria in any part of the body.

Inform your doctor as soon as possible if you experience any of the following symptoms:

The following side effects have been reported:

Very common:(may affect more than 1 in 10 patients)

• Dizziness, fatigue, or feeling of fainting
• Muscle stiffness
• Nausea
• Vomiting
• Low blood pressure (hypotension)

Common:(may affect up to 1 in 10 patients)

• Slowing of heart rate
• Increased blood pressure (hypertension) that may cause headache or sensation of heat/flushing
• Difficulty breathing
• Chills after the surgical procedure
• Itching
• Coughing

Uncommon:(may affect up to 1 in 100 patients)

• Postoperative pain
• Constipation
• Decreased amount of oxygen in the blood (hypoxia)

Rare:(may affect up to 1 in 1,000 patients)

• Drowsiness
• Allergic reactions, including anaphylaxis (severe allergic reaction)
• Heart function abnormalities (slowing of heart rate)

Frequency not known:(cannot be estimated from available data)

• Drug dependence
• Seizures
• Atrioventricular block
• Tolerance to medications
• Abstinence syndrome (may manifest with the appearance of the following side effects: increased heart rate, hypertension, sensation of agitation or restlessness, nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating)Irregular heartbeat (arrhythmia).

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD”.

The expiration date is the last day of the month indicated.

Once reconstituted or diluted, it must be used immediately. Any remaining unused solution should be discarded.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Composition of Remifentanilo NORMON

The active ingredient is remifentanil. Each vial contains 1 mg of remifentanil (in the form of hydrochloride).

The other components are: glycine and hydrochloric acid (for pH adjustment).

Appearance of the product and contents of the package

Remifentanilo NORMON 1 mg is a lyophilized powder of white or almost white color that is presented in vials. Each package contains 5 vials.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Remifentanilo NORMON 2 mg powder for concentrate for injectable solution and for infusion EFG.

Remifentanilo NORMON 5 mg powder for concentrate for injectable solution and for infusion EFG.

Last review date of this leaflet: April 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es

This information is intended solely for doctors or healthcare professionals. For further information on the medicine, consult the Technical Dossier.

PREPARATION GUIDE for:

Remifentanilo NORMON 1 mg powder for concentrate for injectable solution and for infusion EFG

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

Remifentanilo NORMON 5 mg powder for concentrate for injectable solution and for infusion EFG

Reconstitution

To prepare the administration of Remifentanilo NORMON by intravenous route, 1, 2 or 5 ml of the diluent will be added as needed to obtain a reconstituted solution with a concentration of 1 mg/ml.

Shake until completely dissolved. The reconstituted solution must be clear, colorless and free of visible particles.

Additional dilution

After reconstitution, Remifentanilo NORMON should not be administered through manually controlled infusion without further diluting to obtain concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution in adults and 20 to 25 micrograms/ml in children over 1 year of age).

Chemical and physical stability has been demonstrated during the use of the reconstituted solution for 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 person using it and are normally not to exceed 24 hours at 2-8°C, unless the reconstitution was carried out in controlled and validated aseptic conditions.

Remifentanilo NORMON should not be administered through TCI without prior dilution (20 to 50 micrograms/ml is the recommended dilution for administration through TCI).

The dilution depends on the technical capacity of the infusion device and the patient's requirements. The dilution should be made with one of the following intravenous administration fluids:

• Water for injection preparations
• 5% glucose injectable solution
• 5% glucose injectable solution and 0.9% sodium chloride
• 0.9% sodium chloride injectable solution
• 0.45% sodium chloride injectable solution

After dilution, visually inspect the product to ensure it is transparent, colorless, and practically free of particles and that the container is not damaged. Discard any solution showing such defects. All mixtures of Remifentanilo NORMON with infusion fluids should be used immediately. Any unused diluted solution should be discarded in accordance with local regulations.

Remifentanilo NORMON is compatible with the following intravenous administration fluids when administered through an intravenous catheter:

• Ringer lactate injectable solution
• Ringer lactate injectable solution and 5% glucose

Remifentanilo NORMON has shown to be compatible with propofol when administered through an intravenous catheter.

Consult the Technical Dossier for the tables that serve as recommendations for infusion rates of remifentanil when administered through manually controlled infusion.