MIDAZOLAM INJECTION 1MG/1ML

Active substance: MIDAZOLAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

C*****

Midazolam
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 of a 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 of this
leaflet.
• you are pregnant unless the benefits outweigh the
potential risks (see section ‘Pregnancy and breast-feeding’)
• you are suffering from difficulty breathing
Take special care with Midazolam Injection if:
• you suffer from breathing difficulties
• 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 of drug 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 if you 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.

3. How Midazolam Injection will be given
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 1mg if necessary until sedation is achieved.
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 - 1mg if necessary until sedation is achieved.

4. Possible side effects

6. Further Information

Like all medicines, Midazolam Injection can cause side effects,
although not everybody gets them.

Midazolam Injection 1mg/1ml

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

Repeated use of midazolam can result in tolerance and
addiction.
If any of the following symptoms occur tell your doctor
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
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.

5. How to store Midazolam Injection
Keep out of the reach and sight 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. Protect from light.

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.
Continued overleaf

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 08/2008.
PL 12064/0038

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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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