Remifentanil 5 mg powder for concentrate for solution for injection/infusion – patient leaflet, side effects, dosage

1. What Remifentanil is and what it is used for

Remifentanil powder for concentrate for solution for injection/infusion contains a medicine called remifentanil. This belongs to a group of medicines known as opioids.

Remifentanil is used together with other medicines called anaesthetics

• to help put you to sleep before an operation
• to keep you asleep and stop you feeling pain during an operation
• to make you feel sleepy and stop you feeling pain while you receive treatment in an Intensive Care Unit.

2. What you need to know before you are given Remifentanil

Do not have Remifentanil if:

• you are allergic (hypersensitive) to remifentanil or any of the other ingredients of Remifentanil (listed in section 6)
• you are allergic (hypersensitive) to any other pain-relieving medicines which are similar to fentanyl and which are related to the class of medicines known as opioids.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given remifentanil. Tell your doctor before using remifentanil if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“ad-diction”).
• ou are a smoker.
• You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psy-chiatrist for other mental illnesses.

This medicine contains remifentanil which is an opioid medicine. Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on this medicine, it is important that you consult your doctor. Withdrawal reactions including rapid heartbeat, high blood pressure and restlessness have occasionally been reported when treatment with this medicine is stopped suddenly, particularly when treatment has lasted more than 3 days (see also section

1. 4. Possible side effects). If you experience these symptoms, your doctor may re-introduce the medicine and gradually reduce the dose.

Warnings and precautions

Check with your doctor or pharmacist before you are given remifentanil if:

• you are allergic (hypersensitive) to any other opioid medicines, such as morphine or codeine
• you are over 65 years of age
• you are dehydrated or have lost a lot of blood
• you have been feeling weak or unwell

• if you are overweight

  If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given remifentanil. Other medicines and Remifentanil

  Please tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because remifentanil can work with other medicines to cause side effects.

  In particular tell your doctor or pharmacist if you are taking:

  • medicines for your heart or blood pressure, such as beta-blockers (these include atenolol, metoprolol, carvedilol, propanolol and bisoprolol) or calcium channel blockers (these include amlodipine, diltiazem and nifedipine).
  • medicines for the treatment of depression such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) and Monoamine Oxidase Inhibitors (MAOIs). It is not recommended to use these medicines at the same time as this medicine as they may increase the risk of serotonin syndrome, a potentially life-threatening condition. Concomitant use of remifentanil and sedative medicines such as benzodiazepines or related drugs increases the risk of drows-iness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.

However if your doctor does prescribe remifentanil together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

This medicine with alcohol

After receiving this medicine, you should not drink alcohol until you have fully recovered.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

If you are given this medicine during labour or close to childbirth, it can affect your baby’s breathing. You and your baby will be monitored for signs of excessive sleepiness and difficulty breathing.

Driving and using machines

If you are only staying in hospital for the day, your doctor will tell you how long to wait before leaving the hospital or driving a car. It can be dangerous to drive too soon after having an operation.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

-Do not drive while taking this medicine until you know how it affects you.

-It is an offence to drive if this medicine affects your ability to drive.

-However, you would not be committing an offence if:

• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3. How Remifentanil is given

How your injection is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so. Remifentanil can be given:

• as a single injection into your vein
• as a continuous infusion into your vein. This is where the drug is slowly given to you over a longer period of time. The way you are given the drug and the dose you receive will depend on:
• your weight
• the operation you have
• how much pain you will be in
• how sleepy the medical staff want you to be in the Intensive Care Unit. The dose varies from one patient to another. If you are given too much

The effects of Remifentanil are carefully monitored throughout your operation and in intensive care, and appropriate action will be taken promptly if you receive too much.

After your operation

Tell your doctor or nurse if you are in pain. If you are in pain after your procedure, they will be able to give you other painkillers.

The following information is intended for medical or healthcare professionals only: Remifentanil 1 mg powder for concentrate for solution for injection/infusion Remifentanil 2 mg powder for concentrate for solution for injection/infusion Remifentanil 5 mg powder for concentrate for solution for injection/infusion Instructions for handling and use

This medicinal product should be reconstituted by adding 1, 2 or 5 ml of the solution for injection in order to obtain a reconstituted solution with a remifentanil concentration of approximately 1 mg/ml. The solution should not be administered after reconstitution without further dilution.

Remifentanil is for single use.

For manually-controlled infusions, remifentanil may be diluted to concentrations ranging from 20 to 250 micrograms/ml (recommended dilution for adults is 50 micrograms/ml and 20 to 25 micrograms/ml for children aged 1 year old or more). For administration via TCI, recommended remifentanil dilution is 25 to 50 micrograms/ml.

For dilution of the remifentanil solution, one of the following solutions for injection listed below should be used:

• 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

Dilution should be adjusted to the technical equipment of the infusion system and the expected patient requirements. This medicinal product has been shown to be compatible with lactated Ringer’s solution for injection, with lactated Ringer’s and glucose 50 mg/ml (5%) solution for injection, and with propofol when administered into a running IV catheter. Posology

For full prescribing information refer to the Summary of Product Characteristics. Depending on the indications, recommended posology is given for adults and/or children (from 1 to 12 years old) and adjustments for special patient populations are suggested.

Treatment of overdose

Due to the very short duration of action, the potential for deleterious effects due to overdose is limited to the immediate time period following drug administration. Response to discontinuation of the drug is rapid, with return to baseline within ten minutes.

In the event of overdose or suspected overdose, the following actions should be taken:

• discontinue administration of the medicinal product
• maintain a patent airway
• initiate assisted or controlled ventilation with oxygen
• establish haemodynamic stability

If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent may be required to facilitate respiration.

To maintain adequate cardiovascular function, certain drugs (vasopressor agents) for the treatment of hypotension and other supportive measures may be employed.

Intravenous administration of an opioid antagonist such as naloxone may be given to manage severe respiratory depression and muscle rigidity. The duration of respiratory depression following overdose is unlikely to exceed the duration of action of the opioid antagonist.

Stability and storage conditions

Remifentanil is free from preservatives and is for single use. Any unused material must be discarded. Zedicinal products must not be disposed of in drains or refuse.

Incompatibilities

Remifentanil must only be reconstituted or diluted with the recommended solutions for injection. It must not be reconstituted or admixed with lactated Ringer’s solution for injection or with lactated Ringer’s and glucose 50 mg/ml (5%) solution for injection.

This medicinal product should not be mixed with propofol in the same intravenous admixture solution. Administration of this medicinal product into the same intravenous line with blood/serum/plasma is not recommended. This medicinal product must not be mixed with other medicinal products before administration. GUIDELINES FOR INFUSION RATES

The tables below give guidelines for infusion rates of Remifentanil for manually-controlled infusion:

Table 1. Remifentanil injection Infusion Rates (ml/kg/h)

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Some people can be allergic to remifentanil. You must tell your doctor or nurse immediately if you have: Rare (may affect up to 1 in 1,000 people)

-sudden wheeziness and chest pain or chest tightness

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

-a lumpy skin rash or ‘hives’ anywhere on the body

-a collapse.

Severe allergic reactions can progress to life-threatening anaphylactic shock; Frequency not known (cannot be estimated from the available data) which include worsening of allergic signs, severe drop in blood pressure, heart beats quickly and/or fainting.

Tell your doctor as soon as possible if you notice any of the following:

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

• muscle stiffness
• low blood pressure
• feeling sick or being sick

Common (may affect up to 1 in 10 people)

• slow heartbeat
• shallow breathing or temporarily stop breathing
• itching
• cough

Uncommon (may affect up to 1 in 100 people)

• problems breathing (hypoxia)
• constipation

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

• allergic reactions
• heart stops beating

Not known (frequency cannot be estimated from the available data)

-physical need for Remifentanil (drug dependency) or the need for increasing doses over time to get the same effect (drug tolerance)

-fits (seizures)

-a type of irregular heartbeat (atrioventricular block)

-irregular heartbeat (arrhythmia)

-withdrawal syndrome (may manifest by the occurrence of the following side effects: increased heart rate, high blood pressure, feeling restless or agitated, nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating)

Other side effects that can happen when you wake up after having an anaesthetic include: Common (may affect up to 1 in 10 people)

-shivering

-increases in blood pressure

Uncommon (may affect up to 1 in 100 people)

-aches

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

-feeling very calm or drowsy (sedation)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Remifentanil

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

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

Unopened vial

1 mg: Do not store above 25 ºC.

2mg and 5mg: Do not store above 30 ºC.

Reconstitued and diluted solutions

After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C with the following solvents:

• Water for injection
• Glucose 5% solution for injection
• Glucose 5% and sodium chloride 0.9% solution for injection
• Sodium chloride 0.9% solution for injection
• Sodium chloride 0.45% solution for injection

After dilution, chemical and physical in-use stability has been demonstrated for 4 hours at 25 °C with the following solvents:

• Water for injection
• Glucose 5% solution for injection
• Glucose 5% and sodium chloride 0.9% solution for injection
• Sodium chloride 0.9% solution for injection
• Sodium chloride 0.45% solution for injection

From the microbiological point of view, the product should be used immediately. If not used immediately, storage times and conditions are the responsibility of the user and normally should not be more than 24 hours at 2-8 ºC, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.

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

When Remifentanil is made up it should be used straight away. Any unused solution should not be disposed of via wastewater or household waste. Your doctor or nurse will throw away any medicine that is no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Remifentanil contains

• The active substance is remifentanil hydrochloride.
• The other ingredients are glycine and hydrochloric acid (for pH adjustment).
• After reconstitution as directed each ml contains 1 mg remifentanil.

What Remifentanil looks like and contents of the pack

Remifentanil is a white or almost white powder for concentrate for solution for injection or infusion. Remifentanil is available in the following strenghts:

• 1 mg Remifentanil for injection, in 3 ml glass vials
• 2 mg Remifentanil for injection, in 3 ml glass vials
• 5 mg Remifentanil for injection, in 6 ml glass vials

Each pack contains 5 vials.

Marketing authorisation holder

Reig Jofre UK Ltd

Follaton House, Plymouth Road

Totnes, Devon, TQ9 5NE

United Kingdom

Manufacturer

Laboratorio Reig Jofré, S.A.

C/ Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information:

Product name

Remifentanil 1 mg powder for concentrate for solution for injection/infusion Remifentanil 2 mg powder for concentrate for solution for injection/infusion Remifentanil 5 mg powder for concentrate for solution for injection/infusion

Reference number PL 44095-0057

PL 44095-0058

PL 44095-0059

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 06/2026

B1XXXX-01

Table 2. Remifentanil injection Infusion Rates (ml/h) for a 20 micrograms/ml Solution

Table 3. Remifentanil injection Infusion Rates (ml/h) for a 25 micrograms/ml Solution

Table 4. Remifentanil injection Infusion Rates (ml/h) for a 50 micrograms/ml Solution

Table 5. Remifentanil injection Infusion Rates (ml/h) for a 250 micrograms/ml Solution