REMIFENTANIL NORMON 1 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION

2. What you need to know before you start using Remifentanil NORMON

• Do not use Remifentanil NORMON

• If you are allergic (hypersensitive) to remifentanil, to any of the other ingredients of Remifentanil NORMON (listed in section 6) or to fentanyl derivatives (such as alfentanil, fentanyl, sufentanil).
• As the only medicine to initiate anesthesia.
• Remifentanil NORMON should not be used by epidural or intrathecal injection as it contains glycine.

• Warnings and precautions

Tell your doctor or pharmacist before starting treatment with Remifentanil NORMON if:

• you have suffered any side effects during a surgical procedure
• you have ever experienced an allergic reaction or if you are allergic to:
• • any medicine used in surgical procedures
  • opioid medicines (e.g. morphine, fentanyl, pethidine, codeine), see also the previous section “Do not use Remifentanil NORMON”

• you have impaired lung and/or liver function (as you may be more sensitive to respiratory difficulties).
• you or a family member have ever abused or been dependent on alcohol, prescription medicines 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 illnesses.

This medicine contains remifentanil which is an opioid. Repeated use of opioids can make the medicine less effective (you get used to its effect). It can also cause dependence and abuse, which can lead to a potentially life-threatening overdose. If you are concerned that you may become dependent on remifentanil, it is important that you consult your doctor.

Occasionally, withdrawal reactions (e.g. rapid heartbeat, high blood pressure and agitation) have been reported after sudden discontinuation of treatment with this medicine, 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 medicine and gradually reduce the dose.

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

• Children

Remifentanil NORMON is not recommended in neonates and infants (children under 1 year of age). There is limited experience with the use of Remifentanil NORMON for the treatment of children in intensive care units.

• Use in athletes

This medicine contains remifentanil which may give a positive result in doping tests.

• Interaction of Remifentanil NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is especially important with the following medicines, as they may interact with Remifentanil NORMON:

• medicines for blood pressure or heart problems (known as beta-blockers or calcium channel blockers). These medicines may increase the effect of Remifentanil NORMON on your heart (reducing your blood pressure and heart rate)
• medicines for treating depression such as, for example, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) and monoamine oxidase inhibitors (MAOIs). It is not recommended to use these medicines at the same time as remifentanil, as they may increase the risk of serotonin syndrome, a potentially life-threatening disease.

• other sedative medicines, such as benzodiazepines. Your doctor or pharmacist will adjust the dose of these medicines when Remifentanil NORMON is administered to you.

The concomitant use of remifentanil and sedative medicines, such as benzodiazepines or other related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can put the patient's life at risk. Due to this, concomitant use with these medicines should only be considered when other treatment options are not possible. The concomitant use of opioids and other medicines used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, and can be potentially life-threatening.

Still, it may be convenient for you to receive Remifentanil NORMON, your doctor will decide the most appropriate treatment for you.

• Use of Remifentanil NORMON with food and drinks

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

• Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Your doctor will assess whether it is convenient to use this medicine during pregnancy. Remifentanil NORMON is not recommended during labor or during a cesarean section.

If you receive this medicine during labor 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.

In the event that you are administered this medicine during breastfeeding, stop breastfeeding for the next 24 hours.

• Driving and using machines

This medicine is only used in hospitalized patients. Do not drive or use tools or machines after receiving Remifentanil NORMON, as this medicine may affect your reaction ability. Your doctor will tell you how long you should wait before driving or using machines.

3. How to use Remifentanil NORMON

Remifentanil NORMON will only be administered under carefully controlled conditions and an emergency team must always be available. Remifentanil NORMON will be administered by an experienced doctor or under their supervision, as they must be familiar with the use and action of this type of medicine.

This medicine will always be administered by qualified personnel. You will never self-administer this medicine.

Remifentanil NORMON should only be administered by injection or direct infusion into a vein. It should be administered over at least 30 seconds. Remifentanil NORMON should not be injected into the spinal canal (intrathecally or epidurally).

Dosage

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

• Use in children and adolescents

The use of this medicine is not recommended in children under 1 year of age.

• If you use more Remifentanil NORMON than you should

Remifentanil NORMON will always be administered under adequately controlled conditions. However, if you think you have been given too much medicine, tell your doctor or nurse immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Remifentanil NORMON can cause side effects, although not everybody gets them.

Some people may be allergic to medicines. If you have experienced any of the following symptoms immediately after your surgical procedure, tell your doctor immediately:

• Sudden onset of “pitting” and chest pain or tightness.
• Swelling of eyelids, face, lips, mouth or tongue.
• Skin rash or hives anywhere on the body.

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

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

• Slow heart rate
• High blood pressure (hypertension) that can cause headache or feeling of warmth/flushing
• Difficulty breathing
• Shivering after surgery
• Itching
• Coughing

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

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

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

• Somnolence
• Allergic reactions, including anaphylaxis (severe allergic reaction)
• Abnormal heart function (slow heart rate)

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

• Drug dependence
• Seizures
• Atrioventricular block
• Drug tolerance
• Withdrawal syndrome (may manifest with the following side effects: increased heart rate, high blood pressure, feeling of agitation or restlessness, nausea, vomiting, diarrhea, anxiety, shivering, tremors and sweating) Irregular heartbeat (arrhythmia).

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Remifentanil NORMON

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”.

The expiry date is the last day of the month shown.

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

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.

6. Package contents and further information

Composition of Remifentanil NORMON

The active substance is remifentanil. Each vial contains 1 mg of remifentanil (as hydrochloride).

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

Appearance and package contents

Remifentanil NORMON 1 mg is a white or almost white lyophilized powder in vials. Each pack contains 5 vials.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Remifentanil NORMON 2 mg powder for concentrate for solution for injection and infusion EFG.

Remifentanil NORMON 5 mg powder for concentrate for solution for injection and infusion EFG.

Date of last revision of this leaflet: April 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products http://www.aemps.gob.es

This information is intended only for healthcare professionals. For more information on the medicine, consult the Summary of Product Characteristics.

PREPARATION GUIDE for:

Remifentanil NORMON 1 mg powder for concentrate for solution for injection and infusion EFG

Remifentanil NORMON 2 mg powder for concentrate for solution for injection and infusion EFG

Remifentanil NORMON 5 mg powder for concentrate for solution for injection and infusion EFG

Reconstitution

To prepare Remifentanil NORMON for intravenous administration, 1, 2 or 5 ml of the diluent should be added as convenient to obtain a reconstituted solution with a concentration of 1 mg/ml.

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

Further dilution

After reconstitution, Remifentanil NORMON should not be administered by manual controlled infusion without further dilution to achieve concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution in adults and 20 to 25 micrograms/ml in children with 1 or more years of age).

Chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions of the reconstituted solution are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Remifentanil NORMON should not be administered by Target-Controlled Infusion (TCI) without prior dilution (20 to 50 micrograms/ml is the recommended dilution for administration by TCI).

The dilution depends on the technical capabilities of the infusion device and the patient's predicted requirements. The dilution should be performed with one of the following intravenous fluids:

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

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

Remifentanil NORMON has been shown to be compatible with the following intravenous fluids when administered through an intravenous catheter:

• Ringer's lactate solution for injection
• Ringer's lactate and 5% glucose solution for injection

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

Consult the Summary of Product Characteristics for tables that serve as recommendations for remifentanil infusion rates when administered by manual controlled infusion.