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Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion

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.

•    The full name of this medicine is Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion but within the leaflet it will be referred to as Remifentanil.

In this leaflet:

j What Remifentanil is and what it is used for

^ Before Remifentanil is used How to use

3 Possible side effects How to store Further information

j What Remifentanil is and what it is used for

Remifentanil belongs to a group of medicines 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).

Continued top of next column ^ 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 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 to 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 anesthesia with Remifentanil you should leave for home only accompanied and you should not drink alcohol.

Drug abuse

As with other opioids remifentanil may

produce dependency.

Continued top of next column

Children

Remifentanil is not recommended in new born babies 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.

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.

Continued over page

AAAG5806

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

Instructions on use/handling of Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion

Following reconstitution, the product should 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 has to be discarded. The finished solution is for single use only. Unused solution has to be discarded.

Continued top of next column

For manually-controlled infusion, Remifentanil should be administered following further dilution to a concentration of 20 to 250pg/ml (50pg/ml is the recommended dilution for adults and 20 to 25pg/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 50pg/ml.

Continued over page

It is recommended that you stop breastfeeding 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 hospitalised 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.

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.

Important information about some ingredients of Remifentanil

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

31 How to use

Remifentanil is always given by a doctor or nurse. The dose will be calculated by a doctor depending on your condition and response to treatment. Remifentanil is for intravenous use (into a vein) and must not be given by epidural or intrathecal injection (into the spine).

Newborns and infants

There is no data available on administration to newborns and infants younger than 1 year.

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 of 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.

Possible side effects

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

Tell your doctor or nurse immediately if you experience symptoms of an allergic reaction such as

•    swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, skin rash or itchy skin

•    shock, circulatory failure or heart attack.

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 recovery from the operation)

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.

Jl How to store

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.

1mg: Do not store above 25°C.

Do not refrigerate or freeze.

Keep the vial in the outer carton in order to protect from light.

2mg and 5mg: Do not store above 30°C. Do not refrigerate or freeze.

After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Following dilution, the solution should be inspected visually to ensure that it is clear, colourless and virtually free from solids, and that there is no damage to the vials. If such changes are detected, the solution has to be discarded. Unused solution should be discarded.

The diluted solution is for single use only. Any unused solution has to be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information What Remifentanil contains

The active substance is: remifentanil (as hydrochloride)

•    1 vial contains 1mg remifentanil (as remifentanil hydrochloride).

•    1 vial contains 2mg remifentanil (as remifentanil hydrochloride).

•    1 vial contains 5mg remifentanil (as remifentanil hydrochloride).

After reconstitution the solution contains 1mg/ml remifentanil (as hydrochloride), if prepared as recommended.

The other ingredients are: glycine; hydrochloric acid 37% (for pH adjustment); sodium hydroxide 17% (for pH adjustment).

What Remifentanil looks like and contents of the pack

Remifentanil 1mg, 2mg and 5mg is a lyophilized white to slightly yellow cake or powdery mass for concentrate for solution for injection/infusion.

Each carton of Remifentanil 1mg contains 5 vials of 3.5ml.

Each carton of Remifentanil 2mg contains 5 vials of 3.5ml.

Each carton of Remifentanil 5mg contains 5 vials of 8ml.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavfkurvegi 76-78 220 HafnarfjorQur Iceland

Manufacturer

Elaiapharm

2881 route des Cretes, BP 205 Valbonne, 06904 Sophia Antipolis Cedex France

This leaflet was last revised in February 2014

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 50mg/ml (5%) solution for Injection

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

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

•    Sodium chloride 4.5mg/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 50mg/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.