Package leaflet: Information for the user

Hypnomidate®

Etomidate

Hypnomidate is a registered trademark

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaf I et. You may need to read it again

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

•    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 you get side effects and they become serious or if you notice any side effects not listed in this leaf I et, please tell your doctor or nurse

In this leaflet

1    What Hypnomidate is and what it is used for

2    Before you are given Hypnomidate

3    How Hypnomidate is given

4    Possible side effects

5    How Hypnomidate is stored

6    Further information

1 What Hypnomidate is and what it is used for

Hypnomidate contains a medicine called etomidate.

It is a general anaesthetic and is used for short surgical procedures (such as in a day clinic) and for heart surgery.

2 Before you are given Hypnomidate

Do not have Hypnomidate if:

•    You are allergic to anything in Hypnomidate (listed in section 6 below)

If you are not sure if this applies to you, talk to your doctor or nurse before having Hypnomidate.

Take special care with Hypnomidate

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

•    Problems with your liver

•    Low blood pressure

•    Long-term treatment with strong painkillers

•    Problems with your drinking (alcoholism)

•    Problems with your adrenal glands not working properly

Also tell your doctor if you are suffering from a serious infection in your blood (sepsis).

Your doctor will carefully monitor the amount of Hypnomidate they give you or you may need other medication. If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Hypnomidate.

Before your anaesthetic, you will normally be given another medicine, known as a ‘pre-med’. This will probably make you feel drowsy and will also help stop any uncontrollable muscle twitches which can occur.

Special monitoring

Hypnomidate may make you breathe more slowly. Your breathing will be carefully monitored until it returns to normal.

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.

The effect of Hypnomidate may be altered when it is received together with

•    Strong medicines for pain called ‘opioid analgesics’ such as morphine, codeine, fentanyl or alfentanil

•    Medicines to calm you down (also called ‘sedatives’)

•    Medicines to improve thoughts, feelings and/or behaviour (also called ‘neuroleptics’)

•    Alcohol

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

Pregnancy and breast-feeding

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

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

Hypnomidate may get into breast milk.

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

Driving and using machines

Do not drive or use any tools or machines for 24 hours after having Hypnomidate. You may be less alert than usual. Ask your doctor or pharmacist for advice.

Important information about an ingredient of Hypnomidate

•    Hypnomidate contains propylene glycol that may cause alcohol-like symptoms

3 How Hypnomidate is given

Hypnomidate 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 Hypnomidate is given

•    Hypnomidate is given into a vein by slow injection or as a drip (infusion).

•    It may be diluted before use with a sodium chloride or a dextrose solution

•    Hypnomidate does not stop pain so you may be given a painkiller at the same time

How much Hypnomidate is given

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

•    Your body weight in kilograms

•    Your general health

•    Your age

•    The type of operation you are having

Adults and children

The usual dose is 0.3 mg/kg. No more than 3 ampoules will be used.

Elderly patients

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

If you have too much Hypnomidate

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

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4 Possible side effects

Like all medicines, Hypnomidate can cause side effects, although not everybody gets them. If side effects occur, they usually do so while you are asleep. Your doctor will monitor these effects during your operation.

The following side effects have been reported:

Very common (affects more than 1 in 10 people)

•    Muscle twitching or jerking, with difficulty moving your body

Common (affects less than 1 in 10 people)

•    Pain or discomfort along the vein where the injection was given

•    Dizziness and fainting. These are signs of lowered blood pressure but are mild and do not usually last long

•    Breathing stops for a short period of time.

If necessary, your breathing will be helped by a machine (ventilator)

•    Breathing faster and/or deeper than normal

•    Noisy breathing

•    Being sick

•    Feeling sick

•    Rash

Uncommon (affects less than 1 in 100 people)

•    Unusual muscle stiffness causing poor control of movement

•    Vision problems

•    Heart beats more slowly

•    Extra heartbeats

•    Unusual fast heartbeat

•    Swelling, redness and clotting in a vein, which is extremely tender when touched

•    High blood pressure

•    Breathing more slowly or weakly than usual

•    Hiccups

•    Cough

•    Too much saliva

•    Redness of the skin

•    Pain where the injection was given. To prevent this happening, your doctor or nurse may inject a small amount of painkiller just before giving you Hypnomidate

•    Complications with the anaesthetic

•    Delayed recovery from the anaesthetic

•    Not enough painkiller

Other side effects

•    Allergic reactions including rare cases of serious allergic reaction which may cause difficulty

in breathing, wheezing or coughing, and hives or nettle rash (urticaria)

•    Adrenal glands not working properly - you may feel weak, more tired than usual and lose weight

•    Fits or convulsions

•    Heart attack

•    Heart problems

•    A dangerous decrease of blood pressure which,

if untreated, may lead to collapse, coma and death

•    Inf I ammation of the blood vessels

•    Shallow, slow or weak breathing

•    Difficulty in breathing or wheezing, which could be fatal

•    Rare skin condition, with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals

•    Pinkish, itchy swellings on the skin

•    Problems using your jaw muscles

You may still have some of these effects when you wake up. If you think you have a side effect, or if you notice any other side effects after your operation and they are not listed in this leaflet, please tell your doctor or nurse.

5 How Hypnomidate is stored

Hypnomidate is kept out of the reach and sight of children. It is stored in the hospital pharmacy. Do not store above 25°C.

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

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