Leaflet: information for the user

Remifentanilo SALA 1 mg powder for concentrate for injectable solution or infusion EFG

Remifentanilo

Read 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, consult your doctor or pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, including those not listed in this leaflet. See section 4.

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

2. What you need to know before you are given Remifentanilo Sala

3. How Remifentanilo Sala is administered

4. Possible side effects

5. Storage of Remifentanilo Sala

6. Contents of the pack and additional information

Remifentanilo Sala contains an active ingredient called remifentanilo. This belongs to a group of medicines called opioids, which are used to relieve pain. Remifentanilo Sala differs from other medicines in its group due to its very rapid onset and very short duration of action.

Remifentanilo Sala is used for:

• stopping pain before and during surgery
• stopping pain during controlled mechanical ventilation in an Intensive Care Unit (for patients 18 years of age and older).

No use Remifentanilo Sala

• If you are allergic to remifentanilo or any of the other components of this medication (listed in section 6).
• If you are allergic to fentanilo analogues (similar pain-relieving medications that belong to the class of medications known as opiates).
• As a spinal canal injection
• As the only medication to initiate anesthesia.

Advertencias y precauciones

Consult your doctor before starting to use Remifentanilo Sala

• If you are allergic to any other opioid medication, such as morphine or codeine
• If you have respiratory problems (you may be more sensitive to difficulty breathing)
• If you are over 65 years old, weak, or have a low blood volume and/or hypotension (you are more sensitive to cardiac changes).

Consult your doctor before starting to take remifentanilo if:

- You or a family member have ever abused or had a dependence on alcohol, prescription medications, or illegal drugs (“addiction”).

-You are a smoker.

-You have ever experienced mood problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

This medication contains remifentanilo, which is an opioid. Repeated use of opioids 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 that you may become dependent on remifentanilo, it is important that you 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 the treatment with the medication and gradually reduce the dose.

If you are unsure whether any of the above applies to you, consult with your doctor or nurse before Remifentanilo Sala is administered to you.

Otros medicamentos y Remifentanilo Sala

Inform your doctor if you are using, have used recently, or may need to take any other medication, including those purchased without a prescription. This includes herbal medications.

This is because remifentanilo may interact with other medications and cause adverse effects.

Particularly, inform your doctor or pharmacist if you take:

• Medications for the heart or blood pressure, such as beta-blockers (including atenolol, metoprolol, carvedilol, propranolol, and bisoprolol) or calcium channel blockers (including amlodipine, diltiazem, and nifedipine).
• Medications to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs). It is not recommended to use these medications at the same time as remifentanilo, as they may increase the risk of serotonin syndrome, a potentially fatal condition.

The concomitant use of Remifentanilo Sala 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 opioids and other medications 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.

However, if your doctor prescribes Remifentanilo Sala along with sedatives, they will limit the dose and duration of treatment.

Inform your doctor about all sedatives you are taking and follow the dose recommendations provided by your doctor. It may be helpful to inform a family member or close friend of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

Embarazo y lactancia

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.Your doctor will weigh the benefits for you against the risk to your baby of receiving this medication while pregnant.

You should stop breastfeeding your baby for 24 hours after receiving this medication. If you express milk during this period, you should discard it and not give it to your baby.

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.

Conducción y uso de máquinas

If you are only in the hospital during the day, your doctor will tell you how long to wait before leaving the hospital or driving again. It may be dangerous to drive too soon after surgery.

After receiving Remifentanilo Sala, do not drink alcohol until you have fully recovered.

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

Remifentanilo can be administered:

-as a single injection into a vein

-as a continuous infusion into a vein. This is when the medication is administeredslowly over a longer period of time.

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

- the procedure or treatment you are undergoing in the Intensive Care Unit

- the amount of pain you are experiencing.

The dose varies from one patient to another.No dose adjustment is required in patients with kidney and liver problems.

If you receive more Remifentanilo Sala than you should

The effects of Remifentanilo Sala are closely monitored throughout the operation and in intensive care, and appropriate measures will be taken immediately if you receive an excessive amount.

After your operation

Inform your doctor or nurse if you have pain. If you have pain after your procedure, you may be given other pain relievers.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine.

Allergic reactions including anaphylaxis: These are rare (may affect up to 1 in 1,000 people who use Remifentanilo Sala). The signs include:

-sudden onset of sneezing and pain or sensation of compression in the chest

-swelling of the eyelids, face, lips, mouth, or tongue

-hives with bumps or rash in any part of your body

-loss of consciousness

›If you experience any of these symptoms, contact a doctor urgently.

Inform your doctor as soon as possible if you feel any of the following side effects:

Very common (may affect more than 1 in 10 people)

- muscle stiffness

- low blood pressure

- nausea or vomiting

Common (may affect up to 1 in 10 people)

- slow heart rate

-shallow breathing or temporary cessation of breathing

- itching

- cough

Uncommon (may affect up to 1 in 100 people)

- lack of oxygen

- constipation

Rare (may affect up to 1 in 1,000 people)

- In patients receiving Remifentanilo Sala along with other anesthetic medications, cardiac arrest/heart stoppage has been detected, usually preceded by a decrease in heart rate.

Unknown(cannot be estimated from available data)

-physical need for Remifentanilo Sala (dependence) or need to increase doses over time to achieve the same effect (tolerance)

-seizures (convulsions)

-type of irregular heart rhythm (atrioventricular block)

-irregular heartbeat (arrhythmia)

Side effects that may occur after your operation:

Common

-chills

-increase in blood pressure

Uncommon

-pain

Rare

-extreme feeling of calmness or drowsiness (sedation)

Unknown

Abstinence syndrome (may manifest with the appearance of the following side effects: increased heart rate, high blood pressure, feeling of agitation or restlessness, nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear 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 medicine.

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

Do not use this medication after the expiration date that appears on the vial and the box after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Chemical and physical stability has been demonstrated during the use of the reconstituted solution for 24 hours at 25°C.

Chemical and physical stability has been demonstrated during the use of the diluted solution for 4 hours at 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the person using it and should normally not exceed 24 hours at 2-8°C, unless reconstitution/dilution was performed in controlled and validated aseptic conditions.

Do not use Remifentanil if you detect any signs of deterioration after reconstitution.

Once reconstituted, Remifentanil must be used immediately. Any unused diluted solution must be discarded. Medications should not be thrown down the drain or in the trash. Your doctor or nurse will dispose of any medication that is no longer needed. This will help protect the environment.

Remifentanil Solution Composition

- The active ingredient is remifentanil hydrochloride.

- The other components are: glycine and hydrochloric acid 37% (to adjust the pH).

After reconstituting as indicated, each ml contains 1 mg of remifentanil.

Product Appearance and Packaging Contents

Remifentanil is a white or off-white powder for concentrated solution for injection or infusion.

5-vial packaging.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

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

Dinamarca: Remifentanil Reig Jofre 1 mg powder for concentrate for solution for injection/infusion, solution

Noruega: Remifentanil Reig Jofre 1 mg powder for concentrate for solution for injection/infusion, solution

España: Remifentanilo Sala 1 mg powder for concentrate for solution for injection or infusion EFG

Suecia: Remifentanil Reig Jofre 1 mg powder for concentrate for solution for injection/infusion, solution

Last review date of this leaflet:May 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended solely for healthcare professionals:

Remifentanil Solution 1 mg powder for concentrate for solution for injection or infusion

Handling and Use Instructions

This medicine must be reconstituted by adding 1 ml of injection solution to obtain a reconstituted solution with a remifentanil concentration of approximately 1 mg/ml. After reconstitution, the solution must not be administered as is, but must be diluted again.

Remifentanil is for single use.

For manual infusions, remifentanil can be diluted to concentrations ranging from 20 to 250 micrograms/ml (the recommended dilution is 50 micrograms/ml in adults and 20 to 25 micrograms/ml in children aged 1 year or older).

For administration via TCI, the recommended dilution of remifentanil is 25 to 50 micrograms/ml.

The dilution of the remifentanil solution can be made with one of the following injection solutions:

- Water for injection preparations

- Injection solution of glucose 50 mg/ml (5%)

- Injection solution of glucose 50 mg/ml (5%) and sodium chloride 0.9 mg/ml (0.9%)

- Injection solution of sodium chloride 0.9 mg/ml (0.9%)

- Injection solution of sodium chloride 0.45 mg/ml (0.45%)

The dilution depends on the technical capacity of the infusion device and the patient's requirements.

This medicine is compatible with lactated Ringer's injection solution, with lactated Ringer's injection solution and glucose 50 mg/ml (5%), and with propofol when administered through an intravenous catheter.

Dosage

Refer to the Product Characteristics Summary for information on dosage.

Depending on the indications, the recommended dosages are given for adults and/or children (1 to 12 years old) and proposed adjustments for special populations.

Overdose Treatment

Due to the very short duration of action, the potential for adverse effects from an overdose is limited to the immediate period following administration. The response to discontinuation of the drug is rapid, returning to the initial state within 10 minutes.

In case of overdose or suspected overdose, the following protocol should be followed:

- Interrupt the administration of the medication,

- Maintain an open airway,

- Begin assisted ventilation with oxygen,

- and establish hemodynamic stability.

If respiratory depression is associated with muscle rigidity, a neuromuscular blocker may be required to facilitate ventilation.

To maintain active vascular filling, administration of certain drugs (vasopressors) to correct hypotension and other supportive measures may be useful.

An opioid antagonist such as naloxone may be administered intravenously to treat severe respiratory depression and muscle rigidity. It is unlikely that the duration of respiratory depression following an overdose will be longer than the duration of the antagonist opioid.

Incompatibilities

Remifentanil must be reconstituted or diluted only with the recommended injection solutions.

It should not be reconstituted or mixed with lactated Ringer's injection solution or with lactated Ringer's injection solution and glucose 50 mg/ml (5%).

This medicine should not be mixed with propofol in the same solution for intravenous administration.

It is not recommended to administer this medicine within the same intravenous route of blood, serum, or plasma.

This medicine should not be mixed with other medications before administration.