Remifentanil 1 mg Powder for Concentrate for Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to Remifentanil or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any medicine used in operations or if you had a side effect during an operation.
• Remifentanil must not be administered by epidural or intrathecal injection, because this medicine contains glycine.
• as sole medicine to initiate anaesthesia.

Tell your doctor before you are given Remifentanil:

• If you are allergic to any other opioid medicines, such as morphine or codeine
• If you are over 65 years of age
• If you are dehydrated or have lost a lot of blood
• If you are feeling weak or unwell
• If you are overweight
• If you or anyone in your family have ever abused or been dependant on alcohol, prescription medicines or illegal drugs (“addiction”)
• If you are a smoker
• If you have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist 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 Remifentanil, 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 4. Possible side effects). If you experience these symptoms, your doctor may re-introduce the medicine and gradually reduce the dose.

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 if you are taking, have recently taken or might take any 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, propranolol 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 Remifentanil 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 drowsiness, 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.

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 taking this medicine.

Your doctor will assess if having this medicine is necessary during pregnancy or breastfeeding.

The safety of this medicine has not fully been established in pregnant women. This medicine should only be given to pregnant women if the doctor considers that the benefit for the mother exceeds any possible risk to the foetus.

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.

In case of having this medicine, breast-feeding must be stopped during the following 24 hours.

After anaesthesia with Remifentanil you should not drive or operate machinery. The physician should decide when these activities may be resumed. It is advisable that you are accompanied when returning home and that alcoholic drink is avoided.

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 http://www.gov.uk/drug-driving-law

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.

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.

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)

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The active substance is Remifentanil. Each vial contains 1 mg, 2 mg or 5 mg of Remifentanil (as hydrochloride).

After reconstitution the solution contains 1 mg/ml if prepared as recommended.

The other ingredients are: glycine and hydrochloric acid 37% (for pH-adjustment).

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

Each carton of Remifentanil 1 mg contains 5 vials of 3 ml.

Each carton of Remifentanil 2 mg contains 5 vials of 3 ml.

Each carton of Remifentanil 5 mg contains 5 vials of 6 ml.

Not all pack sizes may be marketed.

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Product Name Reference Number

Remifentanil 1 mg powder for concentrate for solution for injection or infusion PL29831/0482

Remifentanil 2 mg powder for concentrate for solution for injection or infusion PL29831/0483

Remifentanil 5 mg powder for concentrate for solution for injection or infusion PL29831/0484