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PACKAGE LEAFLET: INFORMATION FOR THE USER    D01366

Fentanyl Injection 50 microgram/ml

Fentanyl Citrate

(referred to as Fentanyl Injection in this leaflet)

Read all of this leaflet carefully before you are given Fentanyl Injection.

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

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

•    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 nurse.

In this leaflet:

1.    What Fentanyl Injection is and what it is used for

2.    Before having Fentanyl Injection

3.    How Fentanyl Injection is given

4.    Possible side effects

5.    Storing Fentanyl Injection

6.    Further information

1.    What Fentanyl Injection is and what it is used for

Fentanyl citrate belongs to a group of medicines called opioid analgesics, often used in anaesthesia or as a painkiller.

Fentanyl Injection 50 micrograms/ml can be used in the following situations:

•    In low doses it is used to provide pain relief during short surgical procedures

•    Where breathing is assisted it is used in higher doses as an anaesthetic and analgesic

•    It may also be given in combination with a tranquilliser to induce both calmness and pain relief

•    For the treatment of severe pain.

2.    Before having Fentanyl Injection

You should not be given Fentanyl Injection if you:

•    are allergic (hypersensitive) to fentanyl citrate or other opioid medicines, or any of the other ingredients listed in section

6 of this leaflet

•    suffer from asthma, shallow breathing or other breathing difficulties

•    are taking or have recently (within the last two weeks) taken any drugs used to treat depression known as Monoamine Oxidase Inhibitors (MAOI's) (see'Taking other medicines)

•    you are in labour or before the cord is clamped during a Caesarean section. Fentanyl injection may affect the baby's breathing

Take special care with Fentanyl Injection

Tell your doctor if you:

•    are pregnant, planning to become pregnant or are breast-feeding

•    have an under active thyroid gland

•    are suffering from lung disease

•    suffer from a muscle disorder known as myasthenia gravis

•    are suffering from liver or kidney disease

•    are receiving opioid therapy or have a history of opioid abuse

•    suffer from alcoholism

•    are suffering from severe undiagnosed headaches or if you have recently suffered a head injury

•    have been told you are suffering from low blood volume

If any of the above apply to you or your child, please consult your doctor.

Special Monitoring

•    Your doctor will take take special care when giving you this medicine if you are elderly or weak due to ill health or if you are in labour.

•    Fentanyl Injection may make you breathe more slowly than usual. You will only be given this medicine where you can be carefully monitored until your breathing returns to normal.

•    Your blood pressure and heart rate may also be monitored.

Taking other medicines:

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

Fentanyl Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you have stopped taking them within the last 2 weeks. These drugs are known as Monoamine Oxidase Inhibitors (MAOI's).

Medicines which may interact with Fentanyl Injection include:

•    CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, anti-histamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.

•    ritonavir, (a medication used to treat or prevent infection by viruses) and other protease inhibitors e.g. itraconazole

•    droperidol (a drug used to treat anxiety and sickness)

•    muscle relaxants

•    medicines used to treat fungal infections such as fluconazole or voriconazole

•    midazolam (a medicine used to make you feel relaxed and sleepy before an operation

The dose of etomidate and midazolam may need to be reduced if given together with Fentanyl Injection.

If you are taking any of the above medicines please tell your doctor as fentanyl citrate may increase the effects of these drugs or prevent them from working properly.

Using Fentanyl Injection with food and drink:

You are advised not to drink alcohol during your treatment with Fentanyl Injection.

Pregnancy and breast-feeding:

Tell your doctor if you are pregnant, or thinkyou may be pregnant or if you are breast-feeding, before being given Fentanyl Injection.

Effects on the ability to drive and use machines:

Fentanyl citrate may affect your ability to drive or operate machinery, if you are discharged soon after receiving Fentanyl Injection and plan to resume these activities, ask your doctor when it will be safe to do so.

3.    How Fentanyl Injection is given

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you need based on your age, body weight, general health and whether you are taking any other medicines.

Fentanyl Injection is given into a muscle or into a vein either by injection or infusion (drip). Under some circumstances your doctor may prescribe a dose higher than those stated here.

Adults:

As pre-medication before surgery

The usual dose is between 50 and 100 micrograms given into a muscle.

During surgery if you are able to breathe on your own

The usual initial dose is between 50 and 200 micrograms, followed by a further dose of 50 micrograms if needed.

During surgery if your breathing is assisted

The usual initial dose is between 300 and 3500 micrograms, followed by a further dose of 100-200 micrograms if needed.

By Infusion (drip)

The usual initial dose is 1 microgram per kilogram every minute for the first 10 minutes, followed by a further dose of 0.1 microgram per kilogram every minute for the duration of your operation.The drip will normally be stopped 40 minutes before the end of your operation.

Elderly:

If you are elderly you will be given a reduced dose.

Children:

During surgery if your child is able to breathe on their own

The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of 1-1.25 microgram per kilogram of body weight if needed.

During surgery if your child's breathing is assisted

The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of between 1 -1.25 micrograms per kilogram of body weight if needed.

If you are given more Fentanyl Injection than you should be:

As Fentanyl Injection will be given to you in hospital by a doctor it is unlikely you will be given too much, however tell your doctor immediately if you thinkyou have been given too much Fentanyl Injection or you begin to experience breathing difficulties, dizziness or symptoms of low blood pressure or muscle stiffness.

4.    Possible side effects

Like all medicines, Fentanyl Injection can causCsiifeielfotalBer/eaf although not everybody gets them.

Repeated use of fentanyl can result in tolerance and addiction

If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction.

•    sudden wheeziness and tightness of chest

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse