Remifentanil Normon 5 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 5 mg powder for concentrate for solution for infusion EFG

Remifentanil

Read all of this 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, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects 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 side effects
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

Remifentanilo Normon 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 in patients receiving 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

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

• You have previously experienced any adverse reaction during surgery.

• 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 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 disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for mental health conditions.

This medicine contains remifentanil, which is an opioid. Repeated use of opioids may lead to reduced effectiveness of the medicine (tolerance). It may also cause dependence and abuse, which in turn can lead to potentially fatal overdose. If you are concerned about becoming dependent on remifentanil, it is important to speak with your doctor.

Occasionally, withdrawal symptoms (e.g., rapid heartbeat, high blood pressure, and agitation) have been reported after abrupt discontinuation of this medicine, especially when treatment has lasted 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 weakened patients (due to reduced blood volume and/or blood pressure) are more sensitive to cardiac or circulatory disturbances.

• Children

Remifentanil Normon is not recommended for 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 increase the effect of Remifentanil Normon on your heart (reducing your blood pressure and heart rate).
• Medicines for 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 life-threatening 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 with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. Concomitant use of opioids with 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, it may still be appropriate for you to receive Remifentanil Normon; your doctor will decide the most suitable 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 are planning 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 receive this medicine while breastfeeding, stop breastfeeding for the next 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 capabilities. Your doctor will advise you how long you should wait before driving or operating machinery again.

3. How to use Remifentanilo Normon

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

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

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

Dosage

The dose and duration of the infusion will be determined by your doctor, as they 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

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

• If you use more Remifentanilo Normon than you should

Remifentanilo Normon will always be administered under properly controlled conditions. However, if you think you have been given more medicine than you should have, 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, Remifentanil Normon can cause adverse effects, although not everyone experiences 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 pain or tightness in the chest.
• 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 a sensation of warmth/flushing
• Difficulty breathing
• Shivering 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)

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

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

• Drug dependence
• Seizures
• Atrioventricular block
• Drug tolerance
• Withdrawal syndrome (may manifest as the following adverse effects: increased heart rate, high blood pressure, restlessness or agitation, nausea, vomiting, diarrhea, anxiety, shivering, 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 packaging after "EXP".

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

Once reconstituted or diluted, it must be used immediately. Any unused portion of the 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. Package contents and other information

Composition of Remifentanilo Normon

The active substance is remifentanil. Each vial contains 5 mg of remifentanil (as hydrochloride).

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

Appearance of the product and contents of the pack

Remifentanilo Normon 5 mg is a white or almost white lyophilized powder presented 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 injectable solution and for infusion EFG.
Remifentanilo Normon 2 mg powder for concentrate for injectable solution and for infusion EFG.

Date of the most recent revision of this package 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 internet address: https://cima.aemps.es/cima/dochtml/p/76236/P_76236.html

This information is intended exclusively for physicians or healthcare professionals. For further information on the medicinal product, please consult the Summary of Product Characteristics.

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 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 must be clear, colourless, and free from visible particles.

Further dilution

After reconstitution, Remifentanilo Normon must not be administered via manually controlled infusion without further dilution to 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 has been demonstrated for the reconstituted solution for 24 hours at 25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.

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

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, colourless, practically free from 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 via manually controlled infusion.