Rapifen (Alfentanil Hydrochloride)

Rapifen 500 micrograms/ml solution for injection or infusion. Alfentanil hydrochloride

What Rapifen is and what it is used for

Rapifen contains a medicine called alfentanil hydrochloride. It belongs to a group of medicines called ‘opioid analgesics’. Rapifen is a strong painkiller that works for a short period of time.

Rapifen is used to prevent or relieve pain during different types of surgery. It can be used for:

• Short operations, where you go home on the same day
• Longer operations, where you may stay in hospital for a number of days

Before you are given Rapifen

Do not have Rapifen if:

• You are allergic to anything in Rapifen
• You are allergic to strong medicines for pain called ‘opioid analgesics’
• You suffer from breathing difficulties called ‘obstructive airway disease’ or ‘respiratory depression’. You may only be able to have Rapifen if your breathing is helped by a machine called a ventilator
• You are in labour or before the cord is clamped during a Caesarean section. Rapifen may affect the baby’s breathing

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Rapifen.

Take special care with Rapifen

Check with your doctor or nurse before using this medicine if you have ever had:

• Problems with your lungs, liver or kidneys
• Problems with alcohol (alcoholism)
• Long-term treatment with strong painkillers

Your doctor will carefully monitor the amount of Rapifen given to you. If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Rapifen.

Special monitoring

• Rapifen may make you breathe more slowly. Your breathing will be carefully monitored until it returns to normal
• Your blood pressure and heart rate will also be monitored

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular, do not have this medicine and tell your doctor or nurse if:

• You have taken medicines for depression called ‘monoamine oxidase inhibitors’ (MAOIs) in the past two weeks
• If this applies to you, do not have Rapifen.

The effects of Rapifen may last longer if you are taking:

• Cimetidine – for ulcers, stomach ache and heartburn
• Erythromycin – an antibiotic
• Diltiazem – for a heart problem

Talk to your doctor before having Rapifen if you are taking any of these medicines.

The effects of Rapifen or any of these medicines may be increased when they are taken together

• Other strong medicines for pain called ‘opioid analgesics’ such as morphine or codeine
• Medicines for high blood pressure or heart problems called ‘beta-blockers’
• Medicines for putting you to sleep called ‘anaesthetic agents’
• Medicines for anxiety or to help you sleep such as tranquillisers or sleeping pills
• Medicines for epilepsy such as clobazam, clonazepam or phenobarbital Talk to your doctor before having Rapifen if you are taking any of these medicines. They may have to change the amount of Rapifen or the other medicines you are given.

Certain medicines may affect the way Rapifen works

• Medicines for fungal infections called fluconazole, voriconazole, ketoconazole or itraconazole
• Medicines for HIV infection (called antiviral protease inhibitors) such as ritonavir, indinavir or saquinivir

Talk to your doctor before having Rapifen if you are taking any of these medicines. They may have to change the amount of Rapifen you are given.

Pregnancy and breast-feeding

You must tell your doctor before having Rapifen if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to have Rapifen if your doctor thinks you need to.

Rapifen may get into breast milk. Do not breast-feed for 24 hours after having Rapifen.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Do not drive or use any tools or machines for 24 hours after having Rapifen. You may be less alert than usual.

Important information about an ingredient of Rapifen

If you need to control your salt intake (controlled sodium diet) be aware that:

• Each Rapifen vial (10 ml) contains 1.55 mmol sodium (35.4 mg)
• The contents of the vial may be diluted in a salt solution before being given to you. This salt solution also contains sodium

How Rapifen is given

Rapifen is given by a doctor experienced in using this type of medicine. Check with your doctor or nurse if you are not sure about anything.

How Rapifen is given

• Rapifen is given as a drip (infusion) or injection into a vein
• You will be given an anaesthetic at the same time

How much Rapifen is given

Your doctor will decide how much Rapifen you need. This may depend on:

• Your body weight in kilograms
• Your general health
• Your age
• The type of operation you are having

Rapifen given as a drip (infusion)

• The dose of Rapifen is based on body weight in kilograms
• You will usually be given an initial dose of 50 to100 micrograms per kilogram
• If necessary, this may be followed by 0.5 to 1 micrograms per kilogram during each minute of your operation
• The drip will normally be stopped 30 minutes before the end of your operation

Rapifen given by injection

If you are to breathe by yourself – adults:

• You will usually be given an initial dose of 500 micrograms
• It will be given slowly, over about 30 seconds
• If necessary, you will be given further injections of 250 micrograms during the operation

When your breathing is helped by a machine (ventilator) – adults and children:

• The dose of Rapifen is based on body weight in kilograms
• The initial dose will be 30-50 micrograms per kilogram
• If necessary, further injections of 15 micrograms per kilogram will be given during the operation
• The last injection will be given no later than 10 minutes before the end of the operation

Elderly or ill patients

Less Rapifen may be used in patients that are elderly or weak due to ill health.

If you have been given too much Rapifen

It is unlikely that you will be given too much Rapifen. This will be monitored during your operation.

Possible side effects

Like all medicines, Rapifen can cause side effects, although not everybody gets them. Your doctor will monitor these effects during your operation.

Very common

(affects more than 1 in 10 people)

Feeling sick (nausea) or being sick (vomiting)

Common

(affects less than 1 in 10 people)

• Slower or weaker breathing or your breathing may stop for a short period of time. If necessary, your breathing will be helped by a machine (ventilator)
• Dizziness and fainting. These are signs of lowered blood pressure
• Raised blood pressure
• Feeling tired or sleepy
• Feeling cold or shivering
• Feeling excited or unusually carefree
• Muscle twitching or stiffness (which may involve your chest muscles)
• Fast or slow heartbeat
• Blurred or double vision
• Pain where the injection was given

Uncommon

(affects less than 1 in 100 people):

• Hiccups
• Choking caused by cramping (spasm) of the muscles in your throat
• Headache
• Sweating or skin rash
• An irregular heartbeat
• Feeling agitated or disoriented
• Slower or weaker breathing returning

Other possible side effects:

• Serious allergic reaction which may cause difficulty in breathing, wheezing or coughing, and hives or nettle rash (urticaria)
• Heart attack
• Fits or seizures
• Pupils of the eye much smaller than normal
• Loss of consciousness after your operation
• Fever or high temperature
• Breathing can stop completely, which may be fatal

If you notice any other side effects after your operation and they are not listed in this leaflet, please tell your doctor or nurse.

How Rapifen is stored

Rapifen is kept out of the reach and sight of children. It is stored in a Controlled Drug Store in the hospital pharmacy. Rapifen is stored at or below 25°C. Rapifen ampoules are for single use only. Any unused contents should be discarded.

When Rapifen is given, it can be mixed with:

• Sodium chloride solution
• Dextrose solution
• Compound sodium lactate solution (Hartmann’s solution) These mixtures are used within 24 hours of preparation.

Rapifen will not be used after the expiry date stated on the label. The expiry date refers to the last day of that month.

Further information

The active substance in Rapifen is alfentanil hydrochloride. Each millilitre (ml) contains 500 micrograms of alfentanil (as the hydrochloride).

The other ingredients are sodium chloride and water.

What Rapifen looks like and contents of the pack

Rapifen is supplied in a clear glass vial containing 2 ml (packs of 10) or 10 ml (packs of 5 and 10) of liquid.