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 ifyou are not sure whether it is safe for you to drive while taking this medicine.

Con tin ued overleaf

3. How Midazolam Injection will be given		5. How to store Midazolam Injection
tour doctor will administer Midazolam Injection to you		<eep out of the sight and sight of children.
nto a vein (intravenously) by slow infusion (drip)		Tou should not be given Midazolam Injection after the
Adults and children over 12 years		expiry date which is printed on the carton and ampoule
To help you to relax during an operation:		abel.The doctor, nurse or anaesthetist will check that
The usual initial dose is 2mg followed after 2 minutes by		:he expiry date on the label has not been passed before
0.5 -1 mg if necessary until sedation is achieved.		administering the injection to you.The expiry date refers
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		:o the last day of that month. Store below 25°C. Protect from light. 6. Further Information
adjust your dose depending on how much sedation you		What Midazolam Injection contains
need.		The active substance is Midazolam 50mg in 50ml.
The elderly		The other ingredients are hydrochloric acid 10%, sodium
To help you to relax during an operation:		chloride, sodium hydroxide and water for injections
The usual initial dose is 1 - 1.5mg followed after 2 minutes		What Midazolam Injection looks like and contents of
oy 0.5 - img if necessary until sedation is achieved.		the pack
Children under 12 years		Midazolam Injection is a clear, colourless solution
Mot recommended		supplied in a clear glass vial containing 50ml of the
If you are given more Midazolam Injection than you		solution.
should be		Marketing Authorisation Holder
As this medicine will be given to you whilst you are in		Aurum Pharmaceuticals Ltd.
aospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.		3ampton Road, Harold Hill, Romford, :ssex,
4. Possible side effects		RM38UG
_ike all medicines, Midazolam Injection can cause side		Manufacturer
effects, although not everybody gets them.		Rotexmedica GMBH Arzneimittel Werk
Repeated use of midazolam can result in tolerance and addiction.		3unsenstrasse 4, D-22946Trittau Germany This leaflet was last approved in January 2014.
f 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		% 12064/0038
		M
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
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.
f 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.

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