MIDAZOLAM INJECTION BP 2MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: MIDAZOLAM

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Colours Used

Artwork No.
Customer

Accord

Description

Midazolam 2 mg/ml & 5 mg/ml (TARO PRODUCTS)

Market

UK • Ireland

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

13 (Page 1 of 2)

Date

13_11_13 (MIDAZ-INJ(ACC-UK-IE)NEW-PIL)

Prepared By
Regulatory Affairs

Pantone Black

Checked By
Regulatory Affairs

Package leaflet: Information for the user

Midazolam 2 mg/ml
Solution for Injection or
Infusion
Midazolam 5 mg/ml
Solution for Injection or
Infusion
Midazolam (as Midazolam hydrochloride)

Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Midazolam Injection is and what it is
used for
2. What you need to know before you use
Midazolam Injection
3. How to use Midazolam Injection
4. Possible side effects
5. How to store Midazolam Injection
6. Contents of the pack and other information

1. What Midazolam Injection is
and what it is used for
Midazolam Injection belongs to a group of
medicines known as benzodiazepines. It is a
short- acting medicine that is used to induce
sedation (a very relaxed state of calm,
drowsiness or sleep) and relieves anxiety and
muscle tension.
This medicine is used for:
• Conscious sedation (an awake but very relaxed
state of calm or drowsiness during a medical
test or procedure) in adults and children.
• Sedation of adults and children, in intensive
care units.
• Anaesthesia in adults, used alone or with other
medicines.
• Premedication (medicine used to cause
relaxation, calm and drowsiness before an
anaesthetic) in adults and children.

2. What you need to know before
you use Midazolam Injection
You must not be given Midazolam Injection:
• if you are allergic to any of the ingredients of the
medicine (listed in section 6).
• if you are allergic to other benzodiazepine
medicines, such as diazepam or nitrazepam.
• if you have severe breathing problems and you
are going to have Midazolam Injection for
conscious sedation. You must not be given
Midazolam Injection if any of the above apply to
you. If you are not sure, talk to your doctor or
nurse before you are given this medicine.
Warnings and precautions
Talk to your doctor or nurse before using
Midazolam Injection
Children and babies
If your child is going to be given this medicine:
• It is particularly important to tell your doctor or
nurse if your child has cardiovascular disease
(heart problems). Your child will be carefully
monitored and the dose will be adjusted
specially.
• Children must be carefully monitored. For
infants and babies under 6 months this will
include monitoring of breathing and oxygen
levels.
Adults
Before Midazolam Injection is given, let your
doctor or nurse knows if:
• You are over 60 years of age.
• You have a long term illness (such as breathing
problems or kidney, liver or heart problems).
• You are debilitated (have an illness that makes
you feel very weak, run down and short of
energy).
• You have myasthenia gravis (a neuromuscular
disease causing muscle weakness).
• You regularly drink large amounts of alcohol or
you have had problems with alcohol use in the
past.
• You regularly take recreational drugs or you
have had problems with drug use in the past.
• You are pregnant or think you may be pregnant
(see ‘Pregnancy and breast-feeding’).
If any of the above apply to you, or if you are not
sure, talk to your doctor or nurse before you are
given Midazolam Injection.
Other medicines and Midazolam Injection
Tell your doctor or nurse if you are taking, or have
recently taken or might take any other medicines.

The following information is intended for
medical or healthcare professionals only
Midazolam 2 mg/ml Solution for Injection or
Infusion
Midazolam 5 mg/ml Solution for Injection or
Infusion
Midazolam (as Midazolam hydrochloride)
Please refer to the Summary of Product
Characteristics for full prescribing information.
Presentation
Midazolam 2 mg/ml Solution for Injection or
Infusion contains 2 mg of the active ingredient
midazolam (as hydrochloride) in each millilitre
(ml). Midazolam 5 mg/ml Solution for Injection or
Infusion contains 5 mg of midazolam (as
hydrochloride) in each ml. Both strengths of

Approved By
Quality Assurance

This is extremely important, as using more than
one medicine at the same time can strengthen or
weaken the effect of the medicines involved.
In particular, tell your doctor or nurse if you are
taking any of the following medicines:
• tranquilisers (for anxiety or to help you sleep)
• hypnotics (medicines to make you sleep)
• sedatives (to make you feel calm or sleepy)
• antidepressants (medicines for depression)
• narcotic analgesics (very strong pain killers)
• antihistamines (used to treat allergies)
• medicines to treat fungal infections
(ketoconazole, voriconazole, fluconazole,
itraconazole, posaconazole)
• macrolide antibiotics (such as erythromycin or
clarithromycin)
• diltiazem (used to treat high blood pressure)
• medicines for HIV called protease inhibitors
(such as saquinavir)
• atorvastatin (used to treat high cholesterol)
• rifampicin (used to treat mycobacterial
infections such as tuberculosis)
• herbal medicine St John’s Wort.
If any of the above apply to you, or if you are not
sure, talk to your doctor or nurse before you are
given Midazolam Injection.
Operations
If you are going to have an inhaled anaesthetic
(one that you breathe in) for an operation or for
dental treatment, it is important to tell your doctor
or dentist that you have been given Midazolam
Injection.
Midazolam Injection with alcohol
Do not drink alcohol if you have been given
Midazolam Injection. This is because alcohol can
increase the sedative effect of Midazolam Injection
and may cause problems with your breathing.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or nurse for advice before taking
this medicine.
Do not breast-feed for 24 hours after being given
Midazolam Injection. This is because Midazolam
Injection may pass into your breast milk.
Driving and using machines
• Do not drive or use machinery until you are
completely recovered. Your doctor should
advise you when you can start these again.
• Midazolam Injection may make you sleepy,
forgetful or affect your concentration and
co-ordination. This may affect your
performance at skilled tasks such as driving or
using machines.
• You should always be taken home by a
responsible adult after your treatment.
Midazolam Injection contains Sodium
Midazolam Injection is essentially ‘sodium free’
as it contains less than 1 mmol sodium (23 mg)
per ampoule (small glass bottle).

3. How to use Midazolam
Injection
Midazolam Injection should be given only by
experienced healthcare professionals (doctor or
nurse). It should be given in a place (hospital,
clinic or surgery) equipped to monitor and
support the patient’s breathing, heart and
circulation (cardiovascular function) and
recognise the signs of and manage the expected
side effects of anaesthesia.
Normal adult dose
Your doctor will decide on a suitable dose for
you. The dose you are given will depend on why
you are being treated and the type of sedation
needed. Your weight, age, your state of health,
how you respond to Midazolam Injection and
whether other medicines are needed at the same
time will also influence the dose that you are
given.
If you need strong painkillers, you will be given
these first and then be given Midazolam Injection.
The dose will be adjusted specially for you.
Midazolam Injection may be given to you in
one of four different ways:
• by slow injection into a vein (intravenous
injection)
• through a tube into one of your veins
(intravenous infusion)
• by injection into a muscle (intramuscular
injection)
• into your back passage (rectum).
You should always be taken home by a
responsible adult after your treatment.
Children and babies
• In infants and babies under 6 months of age
Midazolam Injection is only recommended for
sedation in intensive care units. The dose will
be given gradually into a vein.
• Children 12 years and under will usually be
given Midazolam Injection into a vein. When
Midazolam Injection is used for premedication
(to cause relaxation, calm and drowsiness
before an anaesthetic) it may be given into the
back passage (rectum).

solution also contain the inactive ingredients
sodium chloride, hydrochloric acid, sodium
hydroxide and water for injections.
The other ingredients in both strengths are
sodium chloride, hydrochloric acid, sodium
hydroxide and water for injections.
Midazolam Solution for Injection or Infusion is a
clear, colourless or slightly yellow solution for
injection or infusion.
Midazolam 5 mg/ml Solution for Injection or
Infusion is available in 1 ml, 2 ml and 5 ml Type I
glass ampoules. Midazolam 2 mg /ml Solution for
Injection or Infusion is available in 5 ml Type I
glass ampoules. The Type I glass ampoules
come in pack sizes of 10 or 20’s. Not all pack
sizes may be marketed.

Colours Used

Artwork No.
Customer

Accord

Description

Midazolam 2 mg/ml & 5 mg/ml (TARO PRODUCTS)

Market

UK • Ireland

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

13 (Page 2 of 2)

Date

13_11_13 (MIDAZ-INJ(ACC-UK-IE)NEW-PIL)

Prepared By
Regulatory Affairs

Pantone Black

Checked By
Regulatory Affairs

If you receive more Midazolam Injection than
you should
Your medicine will be given to you by a doctor or
nurse. If you are accidentally given too much
Midazolam Injection you may:
• Feel drowsy.
• Lose your co-ordination (ataxia) and reflexes.
• Have problems with your speech (dysarthria).
• Have involuntary eye movements (nystagmus).
• Develop low blood pressure (hypotension).
• Stop breathing (apnoea) and suffer
cardiorespiratory depression (slowed or
stopped breathing and heart beat) and coma.
Stopping Midazolam Injection
If you receive long term treatment with
Midazolam Injection (are given the medicine for a
long time) you may:
• Become tolerant to Midazolam Injection. The
medicine becomes less effective and does not
work as well for you.
• Become dependent upon this medicine and get
withdrawal symptoms (see below). Your doctor
will reduce your dose gradually to avoid these
effects happening to you.
Withdrawal symptoms:
Benzodiazepine medicines, like Midazolam Injection,
may make you dependent if used for a long time (for
instance in intensive care). This means that if you
stop treatment suddenly, or lower the dose too
quickly, you may get withdrawal symptoms.
The symptoms can include:
• headache
• muscle pain
• feeling very worried (anxious), tense, restless,
confused or bad-tempered (irritable)
• problems with sleeping (insomnia)
• mood changes
• hallucinations (seeing and possibly hearing
things that are not there)
• fits (convulsions).

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following undesirable effects have been
reported (frequency not known).
Stop having Midazolam Injection and see a
doctor straight away if you notice any of the
following side effects. They can be
life-threatening and you may need urgent
medical treatment:
• Anaphylactic shock (a life-threatening allergic
reaction). Signs may include a sudden rash,
itching or lumpy rash (hives) and swelling of the
face, lips, tongue or other parts of the body. You
may also have shortness of breath, wheezing or
trouble breathing.
• Heart attack (cardiac arrest). Signs may
include chest pain which may spread to your
neck and shoulders and down your left arm.
• Breathing problems or complications
(sometimes causing the breathing to stop).
• Choking and sudden blockage of the airway
(laryngospasm).
Life-threatening side effects are more likely to
occur in adults over 60 years of age and those
who already have breathing difficulties or heart
problems, particularly if the injection is given too
fast or at a high dose
Other possible side effects
Immune system problems:
• general allergic reactions (skin reactions, heart
and blood system reactions, wheezing)
Effects on behaviour:
• agitation
• restlessness
• hostility, rage or aggression
• excitement.
Muscle problems:
• muscle spasms and muscle tremors (shaking
of your muscles that you cannot control).
Mental and Nervous system problems:
• confusion
• euphoria (an excessive feeling of happiness or
excitement)
• hallucinations (seeing and possibly hearing
things that are not really there)
• drowsiness and prolonged sedation
• reduced alertness
• headache
• dizziness
• difficulty co-ordinating muscles
• fits (convulsions) in premature infants and
new-born babies
• temporary memory loss. How long this lasts
depends on how much Midazolam Injection you
were given.
You may experience this after your treatment. In
isolated cases this has been prolonged (lasted
for a long time).

Approved By
Quality Assurance

Stomach, gut and mouth problems:
• feeling sick or being sick
• constipation
• dry mouth.
Skin problems:
• rash
• hives (lumpy rash)
• itchiness.
Injection site problems:
• redness
• swelling of the skin
• blood clots or pain at the injection site.
Injury:
• Patients taking benzodiazepine medicines have
a higher risk of falling and breaking bones.
General:
• tiredness (fatigue).
Elderly patients:
• Life-threatening side effects are more likely to
occur in adults over 60 years of age and those
who already have breathing difficulties or heart
problems, particularly when the injection is
given too quickly or at a high dose.
If you get any side effects, talk to your doctor or
nurse. This includes any side effects not listed in
this leaflet.

5. How to store Midazolam
Injection
Your doctor or pharmacist is responsible for
storing Midazolam Injection. They are also
responsible for disposing of any unused
Midazolam Injection correctly.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
(EXP) which is stated on the pack. The expiry
date refers to the last day of that month.
This medicinal product does not require any
special temperature storage conditions. Keep the
ampoules (small glass bottle) in the outer carton
in order to protect from light.
Do not use this medicine if you notice that the
solution is discoloured

6. Contents of the pack and
other information
What Midazolam Injection contains
The active substance in Midazolam Injection is
midazolam (as midazolam hydrochloride).
Midazolam Injection comes in two different
strengths
Midazolam 2 mg/ml solution for injection or
infusion contains 2 mg of the active ingredient
midazolam (as hydrochloride) in each millilitre
(ml). Midazolam 5 mg/ml solution for injection or
infusion contains 5 mg of midazolam (as
hydrochloride) in each ml. Both strengths of
solution also contain the inactive ingredients
sodium chloride, hydrochloric acid, sodium
hydroxide and water for injections.
The other ingredients in both strengths are
sodium chloride, hydrochloric acid, sodium
hydroxide and water for injections.
What Midazolam Injection looks like and
contents of the pack
Midazolam 2 mg/ml solution for injection or
infusion is a clear, colourless or slightly yellow
solution for injection or infusion.
Midazolam 5 mg/ml solution for injection or
infusion is available in 1 ml, 2 ml and 5 ml Type I
glass ampoules. Midazolam 2 mg /ml solution for
injection or infusion is available in 5 ml Type I
glass ampoules. The Type I glass ampoules
come in pack sizes of 10 or 20’s. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited
Sage House,
319 Pinner Road,
North Harrow
Middlesex, HA1 4HF
United Kingdom
This leaflet was last revised in June 2013.

Heart and circulation problems:
• low blood pressure
• slow heart rate
• redness of the face and neck (flushing), fainting
or headache.
Breathing problems:
• shortness of breath
• hiccup.

Shelf life and storage
For single use only.
Midazolam Solution for Injection or Infusion is
stable, both physically and chemically, for up to
24 hours at 2°C-8°C when mixed aseptically with
500 ml infusion fluids containing Dextrose 4%
with Sodium Chloride 0.18%, Dextrose 5% or
Sodium Chloride 0.9%. Diluted product should be
discarded if not used within 24 hours.
Do not use the product if the solution is
discoloured.
From a microbiological point of view, the product
should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2

to 8ºC, unless dilution has taken place in
controlled and validated aseptic conditions.
Incompatibilities
Admixture with Hartmann’s solution is not
recommended as the potency of midazolam
decreases.
Special precautions for storage
This medicinal product does not require any
special temperature storage conditions Keep the
container in the outer carton in order to protect
from light.
This healthcare professional leaflet was last
revised in June 2013.

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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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