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Active substance(s): MIDAZOLAM / MIDAZOLAM

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Package leaflet: information for the user


Midazolam 1mg/ml Injection
in a Prefilled Syringe
Read all of this leaflet carefully before you are given this
• 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:
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

Your doctor will administer Midazolam Injection to you into a vein
(intravenously) either by injection or by slow infusion (drip).
Adults and children over 7 years
Your doctor will decide on the appropriate dose for your needs.
The elderly
If you are elderly you may feel the effects of Midazolam Injection
more than other adults therefore you will be given a reduced dose.
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.

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 to 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 are pregnant.
• you suffer with a disease that affects the muscles known as
myasthenia gravis.
• you suffer from breathing difficulties.
• you suffer from a condition known as sleep apnoea, a disorder
that causes you to stop breathing in your sleep.
• you have severe liver problems.
• you have raised pressure in the eye (glaucoma).
Take special care with Midazolam Injection if:
• 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 are suffering from liver disease.
If any of the above apply to you or your child please tell your doctor
before you are given Midazolam Injection.
If any of the above applies to you or your child, please consult
your doctor.
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.
• erythromycin, a medicine used to treat bacterial infections.
• 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 to 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.

Possible side effects include:
• feeling or being sick
• slower breathing than usual
• a slow heartbeat
• low blood pressure
• feeling restless or worried
• involuntary movements
• confusion
• seeing or hearing things that aren’t real (hallucinations). These
hallucinations may be sexual
• slurred speech
• blurred vision
• a lack of energy
• dizziness
Rarely you may experience:
• pain at the site of injection
• blood clots
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 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.

6. Further information
What Midazolam Injection contains
The active substance is Midazolam 1mg in 1ml
The other ingredients are 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 5ml,
10ml and 50ml prefilled syringes.
Marketing Authorisation Holder
Aurum Pharmaceuticals Ltd
Bampton Road,
Harold Hill,
United Kingdom
Agila Specialties Polska Sp. z o.o.
10 Daniszewska St.
03-230 Warsaw Poland
This leaflet was last revised in July 2013
PL 12064/0100

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.
Continued overleaf

100mm Measurement Verification Bar



3. How Midazolam Injection will be given


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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.