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MIDAZOLAM INJECTION BP 2MG/ML

Active substance(s): MIDAZOLAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Midazolam Injection BP 2mg/1ml
Midazolam

D02755

Read all of this leaflet carefully before you are given
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
nurse.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Midazolam Injection is and what it is used for
Before you are given Midazolam Injection
How Midazolam Injection will be given
Possible side effects
How to store Midazolam Injection
Further information

1. What Midazolam Injection is and what it
is used for
Midazolam is one ofa group of medicines known as
benzodiazepines. Benzodiazepines are sedatives, meaning
that they are used relax you and help you to sleep.
Midazolam Injection is used to help you to relax before an
operation and is used to relax and calm you during
operations where you are awake. It may also be used to
help patients in intensive care units to sleep.

2. Before you are given Midazolam Injection
You should not be given Midazolam Injection if:
• you know you are allergic to Midazolam or to medicines
like Midazolam (benzodiazepines), or to any of the other
ingredients of this medicine, listed in section 6 of this
leaflet.
• you suffer with a disease that effects the muscles known
as myasthenia gravis
• you suffer from breathing diffrculties
• you are suffering from lung problems
Take special care with Midazolam Injection.Tell your
doctor if:
• you suffer from liver or kidney problems
• you have a history ofa type of mental illness known as a
personality disorder
• you suffer from heart disease
• you suffer from lung disease
If you are elderly or ill, or this medicine is being given to
your child, special care will be taken.
Midazolam Injection should not be used for prolonged
periods of time.
If any ofthe above apply to you or your child please tell
your doctor before you are given Midazolam Injection
Taking other medicines
Please tell your doctor or pharmacist ifyou are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Medicines which may interact with Midazolam Injection
include:
• alcohol
• anaesthetics e.g. ketamine
• medicines that cause drowsiness (sedatives,
barbiturates)
• painkillers (opioids) e.g.fentanyl
• medicines used to treat bacterial infections such as
erythromycin, clarithromycin, quinupristin/dalfopristin
and telithromycin

• cimetidine, a medicine used to treat stomach ulcers
• medicines used to treat chest pains e.g. diltiazem and
verapamil
• medicines used to treat fungal infections e.g itraconazole,
ketoconazole and fluconazole
• nifedipine, a medicine used to treat a disease of the
blood vessels known as Raynauds disease
• ciclosporin, a medicine used to treat a variety ofdifferent
conditions including psoriasis and arthritis
• medicines used to treat high blood pressure (ace
inhibitors, adrenergic neurone blockers, alpha-blockers,
angiotension II receptor agonists, betablockers, calcium
channel blockers) such as ramipril, reserpine, indoramin,
losartan, propranolol, nifedipine, clonidine, diazoxide,
methyldopa, moxonidine, hydralazine, minoxidil and
sodium nitroprusside
• medicines used to treat epilepsy (fits) such as phenytoin
and carbamazapine
• medicines used to treat allergies (antihistamines) such as
desloratadine and promethazine hydrochloride
• medicines used to treat serious mental disorders
antipsychotics) such as chlorpromazine, haloperidol and
clozapine
• medicines used to treat HIV (the virus that causes AIDS
such as amprenavir, atazanavir, efavirenz, indinavir,
nelfinavir, ritonavir and saquinavir
• disulfiram, a medicine used to treat alcoholism
• medicines that make you pass more urine than usual
(diuretics)
• levodopa, a medicine used to treat Parkinsons disease
• lofexidine, a medicine used to treat opiate withrawal
• medicines used to relax the muscles such as baclofen and
tizanidine
• nabilone, a medicine used to treat feeling or being sick
• sodium oxybate, a medicine used to treat narcolepsy
• theophylline, a medicine used to treat lung problems
such as asthma and chronic obstructive pulmonary
disease (COPD)
If you have any doubts about whether you should be given
Midazolam Injection please discuss these with the doctor,
anaesthetist or nurse before use.
Pregnancy and breast-feeding
Ifyou are pregnant or trying for a baby you should discuss
this with your doctor before being given Midazolam
Injection. Your doctor will only give you Midazolam
Injection if the benefits outweigh the potential risks.
Midazolam may pass into breast milk. If you are breastfeeding you should not do so for 24 hours after being given
Midazolam Injection.
Driving and using machines
Midazolam Injection will cause drowsiness. do not drive
or use machinery until you have checked with your doctor
that it is safe to do so.
This medicine can affect your ability to drive and operate
machinery as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know
how it affects you.
• It is an offence to drive if this medicine affects your ability
to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical
or dental problem and
• You have taken it according to the instructions given
by the prescriber or in the information provided with
the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Continued overleaf

3. How Midazolam Injection will be given
Your doctor will administer Midazolam Injection to you
into a vein (intravenously) either by injection or by slow
infusion(drip)
Adults
To help you to sleep:
The usual initial dose is 1-2mg given by injection, followed
after 2 minutes by 0.5 - 1mg if necessary until sedation is
achieved.
If you are to be given an infusion (drip) the usual initial dose
is 30-300 micrograms per kilogram of body weight given
over 5 minutes, then 30-200 micrograms per kilogram
every hour. The doctor may adjust your dose depending on
how much sedation you need.
To help you to relax before an operation:
The usual dose is 200-300 micrograms per kilogram of
bodyweight depending on your fitness and general health.
The elderly
To help you to relax before an operation:
The usual dose is 100-200 micrograms per kilogram of
body weight.
Children over 7 years
To help you to relax before an operation:
The usual dose is 150 micrograms per kilogram of body
weight
Children under 7 years
Not recommended
If you are given more Midazolam Injection than you
should be
As this medicine will be given to you whilst you are in
hospital, it is unlikely that you will be given too little or too
much, however, tell your doctor or pharmacist if you have
any concerns.

4. Possible side effects
Like all medicines, Midazolam Injection can cause side
effects, although not everybody gets them.
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
If any of the following symptoms occur tell your doctor or
nurse immediately. These are symptoms of a heart attack.
• sudden chest pains
• shortness of breath
• sweating
• anxiety
Other possible side effects include:
• slower breathing than usual, difficulty breathing or
stopping breathing
• feeling restless or worried
• feeling confused or disoriented
• seeing or hearing things that aren’t real (hallucinations).
These hallucinations may be sexual
• headache
• hiccups
• temporary loss of memory
• pain at the site ofinjection, or swelling, redness or
damage to the skin around the injection site
• blood clots
• increased appetite
• feeling or being sick
• flatulence (passing wind)
• heartburn (acid reflux)

• constipation
• diarrhoea
• yellowing of the skin (jaundice)
- low blood pressure, the symptoms of which include
feeling dizzy or lightheaded and fainting
• drowsiness
• feeling ‘high’
• a feeling ofdizziness or spinning (vertigo)
• involuntary muscle movements
• difficulty speaking
• difficulty passing urine
• involuntary passing ofurine or faeces (incontinence)
• changes in sex drive
• blurred vision or difficulty focusing
• changes in the amount of saliva you produce
• dry skin, flushing, rash or other skin reactions
• feeling excited or aggressive, particularly in children and
the elderly
• blood disorders (this can be checked using blood tests)
• muscle weakness
• difficulty catching your breath
• fits, particularly in infants and young children
• an unusually fast, slow or irregular heartbeat
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or nurse.

5. How to store Midazolam Injection
Keep out of the sight and reach of children.
You should not be given Midazolam Injection after the
expiry date which is printed on the carton and ampoule
label. The doctor, nurse or anaesthetist will check that
the expiry date on the label has not been passed before
administering the injection to you. The expiry date refers to
the last day of that month.
Store below 25°C.
Keep in the outer carton and protect from light.
6. Further Information
What Midazolam Injection contains
The active substance is Midazolam 100mg in 50ml
The other ingredients are dilute hydrochloric acid, sodium
chloride, sodium hydroxide and water for injections
What Midazolam Injection looks like and contents of
the pack
Midazolam Injection is a clear, colourless solution supplied
in a clear glass vial containing 50ml of the solution.
Marketing Authorisation Manufacturer
Holder
Rotexmedica GMBH
Aurum Pharmaceuticals Ltd. Arzneimittel Werk
Bampton Road,
Bunsenstrasse 4,
Harold Hill, Romford,
D-22946 Trittau
Essex, RM3 8UG
Germany
This leaflet was last approved in January 2014.
PL 12064/0077

D02755

100mm Measurement Verification Bar

2755-C

DEVELOPMENT ARTWORK
Component Code: D02755
Paper size: 160 x 235mm
Version Control Date

By

Version A Created 21/01/14 AC
Version B

11/02/14 AC

Version C

25/02/14 AC

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www.grand-fromage.co.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.

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