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Active substance: ETOMIDATE

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Package lea et: Information for the user

© J-C 2013

GB - 10000000097654

. .

Hypnomidate is a registered trademark

Read all of this lea et carefully before
you start using this medicine.

• Keep this lea 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 e ects and they become serious
or if you notice any side e ects not listed in this
lea et, please tell your doctor or nurse

In this lea et
1 What Hypnomidate is and what it is used for
2 Before you are given Hypnomidate
3 How Hypnomidate is given
4 Possible side e ects
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
Also tell your doctor if you are su ering 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

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 e ect 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

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.

Adults and children

How Hypnomidate is given

Elderly patients

• 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

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

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

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© J-C 2013

GB - 10000000097654

. .

4 Possible side e ects
Like all medicines, Hypnomidate can cause side
e ects, although not everybody gets them. If side
e ects occur, they usually do so while you are
asleep. Your doctor will monitor these e ects during
your operation.
The following side e ects have been reported:
Very common (a ects more than 1 in 10 people)
• Muscle twitching or jerking, with di culty moving
your body
Common (a ects 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
• 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 (a ects less than 1 in 100 people)
• Unusual muscle sti ness 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
• Complications with the anaesthetic
• Delayed recovery from the anaesthetic
• Not enough painkiller
Other side e ects
• Allergic reactions including rare cases of serious
allergic reaction which may cause di culty
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
• In ammation of the blood vessels
• Shallow, slow or weak breathing
• Di culty in breathing or wheezing, which could
be fatal
• Rare skin condition, with severe blisters and
bleeding in the lips, eyes, mouth, nose and
• Pinkish, itchy swellings on the skin
• Problems using your jaw muscles
You may still have some of these e ects when
you wake up. If you think you have a side e ect,
or if you notice any other side e ects after your
operation and they are not listed in this lea et,
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.

6 Further information
The active substance in Hypnomidate is etomidate.
Each millilitre (ml) contains 2 milligrams (mg)
of etomidate.
The other ingredients are propylene glycol and
water. It may also contain very small amounts
of sodium hydroxide and hydrochloric acid.

For information in large print,
tape, CD or Braille, telephone
0800 7318450.
This lea et was last revised in January 2013.
March 2013.

What Hypnomidate looks like and
contents of the pack

Hypnomidate is supplied in a clear glass ampoule
containing 10 ml of liquid in packs of 5 ampoules.

The product licence is held by:

JANSSEN-CILAG LTD, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire HP12 4EG, UK

Hypnomidate is made by:

GlaxoSmithKline Manufacturing S.p.A., Strada
Provinciale Asolana N. 90 (loc San Polo), 43056
Torrile (PR), Italy
McGregor Cory Ltd, Middleton Close, Banbury,
Oxfordshire OX16 4RS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.