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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Remifentanilo Normon 2 mg powder for concentrate for solution for injection and infusion EFG

Remifentanil

Read the entire leaflet carefully before you start using this 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 or pharmacist.
  • If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

1. What Remifentanilo Normon is and what it is used for
2. What you need to know before using Remifentanilo Normon
3. How to use Remifentanilo Normon
4. Possible adverse reactions
5. How to store Remifentanilo Normon
6. Contents of the pack and other information

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

Remifentanil belongs to a group of medicines called opioids. These medicines are widely used for:

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

2. What you need to know before using Remifentanil Normon

• Do not use Remifentanil Normon

• If you are allergic (hypersensitive) to remifentanil, to any of the other components of Remifentanil Normon (listed in section 6), or to fentanyl derivatives (such as alfentanil, fentanyl, sufentanil).

• As the sole medication to initiate anesthesia.

• Remifentanil Normon must not be administered via epidural or intrathecal injection due to the presence of glycine.

• Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Remifentanil Normon if:

• you have experienced any adverse reaction during a surgical procedure

• you have ever had an allergic reaction or are allergic to:

  • any medication used during 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 susceptible to breathing 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 disorders (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 may lead to reduced effectiveness of the medicine (tolerance develops). It may also cause dependence and abuse, which in turn could lead to potentially fatal overdose. If you are concerned about becoming dependent on remifentanil, it is important to consult your doctor.

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

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

• Children

Remifentanil Normon is not recommended in neonates and infants (children under one 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 result in a positive doping test.

• Interaction of Remifentanil Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 enhance the effect of Remifentanil Normon on the heart (reducing blood pressure and heart rate)
• medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (MAOIs). Concomitant use of these medicines with remifentanil is not recommended, as it may increase the risk of serotonin syndrome, a potentially fatal condition.
• other sedative medicines, such as benzodiazepines. Your doctor or pharmacist may adjust the dose of these medicines when Remifentanil Normon is administered.

Concomitant use of remifentanil and sedative medicines such as benzodiazepines or other related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available. 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 may be potentially fatal.

Nevertheless, you may still receive Remifentanil Normon; your doctor will decide the most appropriate treatment for you.

• Use of Remifentanil Normon with food and drink

After receiving Remifentanil Normon, you should not drink alcohol until you have fully recovered.

• Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will assess whether or not it is appropriate to use this medicine during pregnancy. Remifentanil Normon is not recommended during labor or cesarean section.

If you receive this medicine during labor or shortly before delivery, it may affect your baby's breathing. Both you and your baby will be monitored for signs of excessive drowsiness or breathing difficulties.

If you are administered this medicine while breastfeeding, stop breastfeeding for the following 24 hours.

• Driving and using machines

This medicine is only used in hospitalized patients. Do not drive or operate tools or machinery after receiving Remifentanil Normon, as this medicine may affect your reaction ability. Your doctor will advise you how long you should wait before driving or operating machinery.

3. How to use Remifentanil Normon

Remifentanil Normon will only be administered under carefully controlled conditions, and emergency equipment must always be available. Remifentanil Normon will be administered by an experienced physician or under his/her supervision, as the physician must be familiar with the use and effects of this type of medication.

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

Remifentanil Normon must be administered only by intravenous injection or infusion. It should be given over at least 30 seconds. Remifentanil Normon must not be injected into the spinal canal (intrathecal or epidural route).

Dosage

Your doctor will determine the dose and duration of the infusion, as these may vary depending on several factors such as your body weight, age, physical condition, other medications you are taking, and the type of surgical procedure you are undergoing.

• Use in children and adolescents

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

• If you are given more Remifentanil Normon than you should

Remifentanil Normon will always be administered under properly controlled conditions. However, if you think you have been given more medicine than you should have received, inform your doctor or nurse immediately.

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

4. Possible adverse effects

Like all medicines, Remifentanilo Normon can cause adverse effects, although not everyone will experience them.

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

• Sudden onset of "wheezing" and chest pain or tightness.
• Swelling of the 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 adverse effects have been reported:

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

• Dizziness, tiredness or feeling faint
• Muscle rigidity
• Nausea
• Vomiting
• Low blood pressure (hypotension)

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

• Slowed heart rate
• Increased blood pressure (hypertension), which may cause headache or feeling hot/flushed
• Difficulty breathing
• Chills after surgery
• Itching
• Cough

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)

• Sleepiness
• Allergic reactions, including anaphylaxis (severe allergic reaction)
• Heart function disorders (slowed heart rate)

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

• Drug dependence
• Seizures
• Atrioventricular block
• Tolerance to medicines
• Withdrawal syndrome (may manifest with the appearance of the following adverse effects: increased heart rate, high blood pressure, restlessness or agitation, nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating)
• Irregular heartbeat (arrhythmia)

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 stated on the container after "EXP".

The expiry date refers to the last day of the indicated month.

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

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

6. Contents of the pack and other information

Composition of Remifentanilo Normon

The active substance is remifentanil. Each vial contains 2 mg of remifentanil (as hydrochloride).

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

Appearance of the product and pack contents

Remifentanilo Normon 2 mg is a white or almost white lyophilized powder supplied 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

Remifentanilo Normon 1 mg powder for concentrate for solution for injection and infusion EFG.
Remifentanilo Normon 5 mg powder for concentrate for solution for injection and infusion EFG.

Date of the most recent revision of this leaflet: April 2022

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/76234/P76234.html

This information is intended only for healthcare professionals. For further information on this medicine, please refer to the Summary of Product Characteristics.

PREPARATION GUIDE for:

Remifentanilo Normon 1 mg powder for concentrate for solution for injection and infusion EFG
Remifentanilo Normon 2 mg powder for concentrate for solution for injection and infusion EFG
Remifentanilo Normon 5 mg powder for concentrate for solution for injection and infusion EFG

Reconstitution

To prepare Remifentanilo Normon for intravenous administration, add 1, 2 or 5 ml of diluent as appropriate 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 from visible particles.

Further dilution

After reconstitution, Remifentanilo Normon must not be administered by manually controlled infusion without further dilution to achieve concentrations between 20 and 250 micrograms/ml (50 micrograms/ml is the recommended dilution in adults and 20 to 25 micrograms/ml in children aged 1 year or older).

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

Remifentanilo Normon must not be administered by TCI (target-controlled infusion) without prior dilution (20 to 50 micrograms/ml is the recommended dilution for TCI administration).

The required dilution depends on the technical capabilities of the infusion device and the anticipated patient requirements. Dilution must be performed using one of the following intravenous fluids:

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

After dilution, visually inspect the product to ensure it is transparent, colorless, practically free of particles, and that the container is undamaged. Discard any solution showing such defects. All mixtures of Remifentanilo Normon with infusion fluids must be used immediately. Any unused diluted solution must be discarded according to local regulations.

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

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

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

Refer to the Summary of Product Characteristics for tables providing recommended remifentanil infusion rates when administered by manually controlled infusion.