Remifentanil Sala 1 mg powder for concentrate for solution for injection or infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Remifentanilo SALA 1 mg powder for concentrate for solution for injection or 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, including any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Remifentanilo Sala is and what it is used for
2. What you need to know before Remifentanilo Sala is administered to you
3. How Remifentanilo Sala is administered
4. Possible side effects
5. How to store Remifentanilo Sala
6. Contents of the pack and other information

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

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

Remifentanilo Sala is used for:

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

2. What you need to know before using Remifentanilo Sala

Do not use Remifentanilo Sala

• if you are allergic to remifentanil or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to fentanyl analogues (analgesic medicines similar to fentanyl and belonging to the class of medicines known as opioids).
• as an injection into the spinal canal.
• as the sole medicine to initiate anesthesia.

Warnings and precautions

Talk to your doctor before starting treatment with Remifentanilo Sala

• if you are allergic to any other opioid medicine, such as morphine or codeine.
• if you have lung problems (you may be more sensitive to experiencing difficulty breathing).
• if you are over 65 years old, are frail, or have low blood volume and/or hypotension (you may be more sensitive to cardiac disturbances).

Talk to your doctor before starting remifentanil if:

• You or someone in your family has 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 speak with your doctor.

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

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

Other medicines and Remifentanilo Sala

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This includes herbal medicines.

This is because remifentanil may interact with other medicines and cause adverse effects.

In particular, inform your doctor or pharmacist if you are taking:

• Medicines for heart conditions or blood pressure such as beta-blockers (including atenolol, metoprolol, carvedilol, propranolol, and bisoprolol) or calcium channel blockers (including amlodipine, diltiazem, and nifedipine).
• Medicines for depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or 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.

The concomitant use of Remifentanilo Sala and sedative medicines, such as benzodiazepines or other 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 alternative treatment options are available. 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 may be potentially fatal.

However, if your doctor prescribes Remifentanilo Sala together with sedative medicines, they will limit the dose and duration of treatment.

Inform your doctor about all sedative medicines you are taking and closely follow the dosing recommendations provided by your doctor. It may be helpful for you to inform a family member or close friend about the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will weigh the benefit to you against the risk to your baby of receiving this medicine during pregnancy.

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

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.

Driving and use of machines

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

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

3. How Remifentanilo Sala is administered

This medicine must never be self-administered. This medicine will always be administered by qualified personnel.

Remifentanil may be administered:

• as a single intravenous injection
• as a continuous intravenous infusion. This is when the drug is administered slowly over a longer period of time.

The way in which the medicine is administered and the dose you receive will depend on:

• the procedure or treatment you are undergoing in the Intensive Care Unit
• how much pain you have.

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

If you receive more Remifentanil Sala than you should

The effects of Remifentanil Sala are closely monitored throughout the operation and during intensive care, and appropriate measures will be taken immediately if an excessive amount is administered.

After your operation

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine.

Allergic reactions including anaphylaxis: These are rare (may affect up to 1 in 1,000 people receiving Remifentanil Sala). Signs include:

• sudden attacks of sneezing and pain or a feeling of tightness in the chest
• swelling of the eyelids, face, lips, mouth or tongue
• hives with lumps or rash anywhere on the body
• fainting

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

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

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

• muscle rigidity
• low blood pressure
• nausea or vomiting

Common (may affect up to 1 in 10 people)

• slow heart rate
• shallow breathing or temporary breathing stop
• 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 Remifentanil Sala together with other anaesthetic medicines, cardiac arrest/heart stoppage has been reported, usually preceded by a slow heart rate.

Not known (cannot be estimated from the available data)

• physical need for Remifentanil Sala (dependence) or need to increase doses over time to achieve the same effect (tolerance)
• seizures
• a type of irregular heart rhythm (atrioventricular block)
• irregular heartbeat (arrhythmia)

Adverse effects that may occur after your surgery:

Common

• shivering
• increased blood pressure

Uncommon

• pain

Rare

• feeling of extreme calmness or drowsiness (sedation)

Not known

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Remifentanilo Sala

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

Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Chemical and physical in-use stability has been demonstrated for the reconstituted solution for 24 hours at 25°C when using the following solvents:

• Water for injections
• Glucose 50 mg/ml (5%) solution for injection
• Glucose 50 mg/ml (5%) and sodium chloride 0.9 mg/ml (0.9%) solution for injection
• Sodium chloride 0.9 mg/ml (0.9%) solution for injection
• Sodium chloride 0.45 mg/ml (0.45%) solution for injection

Chemical and physical in-use stability has also been demonstrated for the diluted solution for 24 hours at 25°C when using the following solvents:

• Water for injections
• Glucose 50 mg/ml (5%) solution for injection
• Glucose 50 mg/ml (5%) and sodium chloride 0.9 mg/ml (0.9%) solution for injection
• Sodium chloride 0.9 mg/ml (0.9%) solution for injection
• Sodium chloride 0.45 mg/ml (0.45%) solution for injection

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage duration and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions.

Do not use Remifentanilo Sala if any signs of deterioration are observed after reconstitution.

Once reconstituted, Remifentanilo Sala must be used immediately. Any unused diluted solution must be discarded. Medicines must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Package contents and other information

Composition of Remifentanilo Sala

• The active substance is remifentanil hydrochloride.
• The other components are: glycine and hydrochloric acid 37% (for pH adjustment).

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

Appearance of the product and contents of the container

Remifentanil is a white or almost white powder for concentrate for injectable or infusion solution.

Pack of 5 vials.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofré, S.A.
C/ Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Remifentanil Reig Jofre 1 mg pulver til koncentrat til injektions-/infusionsvæske, opløsning
Norway: Remifentanil Reig Jofre 1 mg pulver til konsentrat til injeksjons-/infusjonsvæske, oppløsning
Spain: Remifentanilo Sala 1 mg polvo para concentrado para solución inyectable o perfusión EFG
Sweden: Remifentanil Reig Jofre 1 mg pulver till koncentrat till injektions-/infusionsvätska, lösning

Date of the most recent review of this leaflet: February 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

Remifentanilo Sala 1 mg powder for concentrate for injectable or infusion solution

Instructions for handling and use

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

Remifentanilo Sala is for single use only.

For manually administered infusions, remifentanil may 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 by TCI (Target Controlled Infusion), the recommended dilution of remifentanil is 25 to 50 micrograms/ml.

Dilution of the remifentanil solution may be performed using one of the following injection solvents:

• Water for injections
• Glucose 50 mg/ml (5%) injection solution
• Glucose 50 mg/ml (5%) and sodium chloride 0.9 mg/ml (0.9%) injection solution
• Sodium chloride 0.9 mg/ml (0.9%) injection solution
• Sodium chloride 0.45 mg/ml (0.45%) injection solution

The choice of dilution depends on the technical capabilities of the infusion device and the anticipated patient requirements.

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

Dosage

Refer to the Summary of Product Characteristics for information on dosage.

Depending on the indication, dosage recommendations are provided for adults and/or children (aged 1 to 12 years), with adjustments proposed for special populations.

Management of overdose

Due to the very short duration of action, the potential for harmful effects following an overdose is limited to the immediate period after administration. Discontinuation of the drug results in a rapid response, with return to the baseline state within 10 minutes.

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

• Discontinue administration of the drug,
• Maintain a patent airway,
• Initiate assisted ventilation with oxygen,
• Establish hemodynamic stability.

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

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

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 overdose will exceed the duration of action of the opioid antagonist.

Incompatibilities

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

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

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

It is not recommended to administer this medicine through the same intravenous line as blood, serum, or plasma.

This medicine must not be mixed with other medicinal products prior to administration.