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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Remifentanil

Read all of this leaflet carefully before you start

using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Remifentanil is and what it is used for

2.    Before Remifentanil is used

3.    How to use Remifentanil

4.    Possible side effects

5.    How to store Remifentanil

6.    Further information

1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR

Remifentanil belongs to a group called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action.

•    Remifentanil may be used to stop you feeling pain before or while you are having an operation.

•    Remifentanil may be used to relieve pain while you are under controlled mechanical ventilation in an Intensive Care Unit (for patients 18 years of age and over).

2. BEFORE REMIFENTANIL IS USED

Remifentanil should not be used

•    if you are allergic (hypersensitive) to remifentanil, any of the other ingredients (see list of ingredients in Section 6) or fentanyl derivates (such as alfentanil, fentanyl, sufentanil). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience

•    as injection into the spinal canal

•    as sole medicine to initiate anaesthesia

Take special care with Remifentanil

Before you receive Remifentanil, tell your doctor if you:

•    ever had any adverse reactions during an operation

•    ever had any allergic reactions or if you have been told that you are allergic to:

•    any medicines used during an operation

•    opioid medicines (e.g., morphine, fentanyl, pethidine, codeine), see also section above “Remifentanil should not be used”

•    suffer from impaired lung and/or liver function (you may be more sensitive for breathing difficulties)

Elderly or weak patients (caused by decreased blood volume and/or low blood pressure) are more sensitive to suffer from cardiac or circulatory disturbances.

As with other opioids remifentanil may produce dependency.

Following anaesthesia with Remifentanil, you should leave home only accompanied and you should not drink alcohol.

Remifentanil should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic medicines and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation.

In ventilated intensive care patients the use of Remifentanil for more than 3 days is not recommended.

Due to the rapid offset of action of remifentanil, patients may emerge rapidly from anaesthesia and no residual opioid activity will be present within 5-10 minutes after the discontinuation of Remifentanil. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of Remifentanil.

At the doses recommended muscle rigidity may occur.

As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus injections should be administered over not less than 30 seconds.

Hypotension and bradycardia may be managed by reducing the rate of infusion of Remifentanil or the dose of concurrent anaesthetics or by using intravenous fluids, vasopressor or anticholinergic agents.

Drug Abuse

As with other opioids remifentanil may produce dependency.

Children

Remifentanil is not recommended in neonates and infants (children under the age of one year). There is little experience of use of Remifentanil to treat children in intensive care units.

Elderly

If used for an operation under general anaesthesia, the initial dose of Remifentanil should be appropriately reduced in elderly patients.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is especially important with the following medicines as they may interact with your Remifentanil:

•    medicines for blood pressure or heart problems (known as beta-blockers or calcium channel blockers). These medicines may increase the effect of Remifentanil on your heart (lowering of your blood pressure and your heart beat).

•    other sedative medicines, such as benzodiazepines. Your doctor or pharmacist will alter the dose of these medicines when you are being given Remifentanil.

It may still be all right for you to receive Remifentanil and your doctor will be able to decide what is suitable for you.

Remifentanil is not metabolized by plasmacholinesterase, therefore, interactions with medicines metabolized by this enzyme are not anticipated.

Using Remifentanil with food and drink

After having received Remifentanil you should not drink alcohol until fully recovered.

Pregnancy and breast-feeding

Remifentanil should not be given to pregnant women unless medically justified. Remifentanil is not recommended during labour or a Caesarian section.

It is recommended that you stop breast-feeding for 24 hours after Remifentanil has been given to you.

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will discuss the possible risks and benefits of being given Remifentanil if you are pregnant or breast-feeding.

Driving and using machines

This medicine is only used in hospitalized patients. If you are discharged early, after you have been given Remifentanil, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone. Your doctor will advise you when it is safe to resume these activities.

This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law.

Important information about some ingredients of Remifentanil

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free’.

3. HOW TO USE REMIFENTANIL

Remifentanil is always used by healthcare professionals and only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic medicines and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation.

The recommended dosage is always determined by the doctor dependent on the patient’s individual condition and his response to the drug.

Remifentanil is for intravenous use only and must not be administered by epidural or intrathecal injection.

Dilution should be adjusted to the technical equipment of the infusion system and the expected patient requirements.

Remifentanil should not be mixed with other therapeutic agents prior to administration and for intravenous use it should only be admixed with one of the following fluids:

•    Glucose 50 mg/ml (5%) solution for injection

•    Glucose 50 mg/ml (5%) solution for injection and sodium chloride 9 mg/ml (0.9%) solution for injection

•    Sodium chloride 9 mg/ml (0.9%) solution for injection

•    Sodium chloride 4.5 mg/ml (0.45%) solution for injection

Paediatric patients

Remifentanil Target Control Infusion (TCI) is not recommended for paediatric patients aged 1 - 12 years due to lack of clinical trial experience.

Newborns and infants

There are limited data from clinical trials available on administration to newborns and infants younger than 1 year. The administration of remifentanil is not recommended for this age group.

The limited clinical trial experience of remifentanil for Total Intravenous Anaesthesia (TIVA) in infants is insufficient to make dosage recommendations.

Dosage in special patient groups

In obese or critically ill patients the initial dose will be appropriately reduced and enhanced due to the response.

In patients with impaired liver or kidney function and in patients undergoing neurosurgery a dose reduction will not be necessary.

If you receive more Remifentanil than you should or if you miss a dose of Remifentanil

Since Remifentanil will usually be given to you by a doctor or nurse under carefully controlled conditions, it is unlikely that you will be given too much or that you will miss a dose.

If you have received too much Remifentanil, or if it is suspected, that you may have received too much, appropriate action will be taken promptly by your healthcare specialist team.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Remifentanil can cause side effects, although not everybody gets them.

The following side effects have been reported:

Very common (affects more than 1 user in 10)

•    muscle stiffness

•    feeling sick (nausea)

•    being sick (vomiting)

•    low blood pressure (hypotension)

Common (affects 1 to 10 users in 100)

•    slow heart beat (bradycardia)

•    shallow breathing (respiratory depression)

•    breathing stops (apnoea)

•    itching

•    shivering after the operation

•    high blood pressure (hypertension) after the operation

Uncommon (affects 1 to 10 users in 1,000)

•    constipation

•    pain after the operation

•    oxygen deficiency (hypoxia)

Rare (affects 1 to 10 users in 10,000)

•    slow heart beat followed by heart block in patients receiving remifentanil with one or more anaesthetic medicines

•    sleepiness (during recovering from the operation)

•    severe allergic reactions including shock, circulatory failure and heart attack in patients receiving remifentanil with one or more anaesthetic medicines

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

•    fi ts

•    abnormal heart rhythm due to heart block

•    remifentanil having less effect than normal (drug tolerance)

As with other medicines of this class (opioids), long-term use of Remifentanil can lead to dependence. Please ask your doctor for advice.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE REMIFENTANIL

Keep out of the reach and sight of children.

Do not use Remifentanil after the expiry date which is stated on the carton / vial after “EXP”. The expiry date refers to the last day of that month.

1    mg: Do not store above 25°C.

2    mg: Do not store above 30°C.

The following information is intended for medical or healthcare professionals only:

Instructions on use/handling of Remifentanil 1, 2 and 5 mg powder for concentrate for solution for injection/infusion

Remifentanil should be prepared for intravenous use by adding the appropriate volume (as stated in the table below) of one of the below listed diluents to give a reconstituted solution with a concentration of approximately 1 mg/ml.

Following reconstitution, the product must be inspected visually (as far as supported by the vial) for solids, discoloration or damage to the vials. If such changes are detected, the solution must be discarded. The finished solution is for single use only. Unused solution must be discarded.

For manually-controlled infusion, Remifentanil should be administered following further dilution to a concentration of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution for adults and 20 to 25 micrograms/ml for paediatric patients aged 1 year and over).

For target controlled infusion (TCI), Remifentanil should be administered following further dilution to a concentration of 20 to 50 micrograms/ml.

Dilution should be adjusted to the technical equipment of the infusion system and the expected patient requirements.

For dilution, one of the following IV fluids listed below should be used:

•    Water for Injections

•    Glucose 50 mg/ml (5%) solution for Injection

•    Glucose 50 mg/ml (5%) and sodium chloride 9 mg/ml (0.9%) solution for injection

•    Sodium chloride 9 mg/ml (0.9%) solution for injection

•    Sodium chloride 4.5 mg/ml (0.45%) solution for injection

Remifentanil has been shown to be compatible with the following IV fluids when administered into a running IV catheter:

•    Lactated Ringer’s solution for injection

•    Lactated Ringer’s and Glucose 50 mg/ml (5%) solution for injection

Remifentanil has been shown to be compatible with propofol when administered into a running IV catheter.

Any unused product or waste material should be disposed of in accordance with local requirements.

For full prescribing information refer to the Summary of Product Characteristics.

Q77161