MIDAZOLAM INJECTION 1MG/1ML

Active substance: MIDAZOLAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Midazolam Injection 1mg/1 ml
Midazolam

D02753

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. What Midazolam Injection is and what it is used for
2. Before you are given Midazolam Injection
3. How Midazolam Injection will be given
4. Possible side effects
5. How to store Midazolam Injection
6. 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 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 ofthis leaflet.
• you are pregnant unless the benefits outweigh the
potential risks (see section ‘Pregnancy and breastfeeding’)
• you are suffering from diffrculty breathing
Take special care with Midazolam Injection if:
• you suffer from breathing diffrculties
• you are suffering from shock, the symptoms of which
are fainting, cold hands and feet, sweating and an
irregular heartbeat
• you have a dangerously low body temperature
(hypothermia)
• you are elderly
• you suffer from liver or kidney disease
• you suffer from heart problems
• you have a history ofdrug or alcohol abuse
• you suffer from a muscle disorder known as myasthenia
gravis
If any of the 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
• medicines that cause drowsiness (sedatives,
barbiturates)
• anaesthetics e.g. ketamine
• painkillers (opioids) e.g. fentanyl
• medicines used to treat bacterial infections such as
erythromycin and clarithromycin
• medicines used to treat fungal infections e.g
itraconazole, ketoconazole and fluconazole
• medicines used to treat chest pains e.g. diltiazem and
verapamil
• rifampicin, a medicine used to treat tuberculosis
• antihistamines (medicines used to treat allergies)
• medicines used to treat serious mental disorders
(antipsychotics)
• medicines used ot treat high blood pressure
(alpha-blockers)
• lofexidine, a medicine used to treat withdrawal
symptoms caused when stopping taking opioid drugs
such as morphine
• baclofen, a medicine used relax the muscles
• disulfiram, a medicine used to help treat alcoholism
• nabilone, a medicine used to treat feeling or being sick
• cimetidine, a medicine used to treat stomach ulcers
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
If you are pregnant, trying for a baby or breast-feeding
you should discuss with your doctor before being
given Midazolam Injection. Your doctor will only give
you Midazolam Injection if the benefits outweigh the
potential risks.
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

5. How to store Midazolam Injection

Your doctor will administer Midazolam Injection to you
into a vein (intravenously) by slow infusion (drip)
Adults and children over 12 years
To help you to relax during an operation:
The usual initial dose is 2mg followed after 2 minutes by
0.5 -1 mg if necessary until sedation is achieved.

Keep out of the sight and sight of children.

To help you to sleep:
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.
The elderly
To help you to relax during an operation:
The usual initial dose is 1 - 1.5mg followed after 2 minutes
by 0.5 - img if necessary until sedation is achieved.
Children under 12 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 nurse if you have
any concerns.

4. Possible side effects
Like all medicines, Midazolam Injection can cause side
effects, although not everybody gets them.
Repeated use of midazolam can result in tolerance
and addiction.
If any of the following symptoms occur tell your doctor
immediately.
These are symptoms ofa 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

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. Protect from light.

6. Further Information
What Midazolam Injection contains
The active substance is Midazolam 50mg in 50ml.
The other ingredients are hydrochloric acid 10%, 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 Holder
Aurum Pharmaceuticals Ltd.
Bampton Road,
Harold Hill,
Romford,
Essex,
RM3 8UG
Manufacturer
Rotexmedica GMBH Arzneimittel Werk
Bunsenstrasse 4,
D-22946 Trittau
Germany
This leaflet was last approved in January 2014.
PL 12064/0038

Other possible side effects include:
• feeling or being sick
• slower breathing than usual or difficulty breathing
• a slow heartbeat
• low blood pressure, the symptoms of which include
feeling dizzy or light-headed, feeling weak and fainting
• feeling restless or worried
• involuntary movements
• confusion
• slurred speech
• blurred vision
• a lack or energy
• dizziness
• seeing or hearing things that aren’t real (hallucinations).
These hallucinations may be sexual.
• temporary loss of memory for a short time after being
given this medicine
Rarely you may experience
• pain at the site of injection
• blood clots, the symptoms of which include swelling,
redness and pain in the area.
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 pharmacist.
D02753

100mm Measurement Verification Bar

2753-C

DEVELOPMENT ARTWORK
Component Code: D02753
Paper size: 160 x 235mm
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11/02/14 AC

Version C

25/02/14 AC

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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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