MIDAZOLAM 2MG/ML SOLUTION FOR INJECTION

Active substance: MIDAZOLAM

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hameln

PACKAGE LEAFLETPACKAGE LEAFLET:
INFORMATION FOR THE USER
Midazolam 1 mg/ml solution for injection
Midazolam 2 mg/ml solution for injection
Midazolam 5 mg/ml solution for injection

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.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
Midazolam
What is in this leaflet
1. What Midazolam is and what it is used for
2. What you need to know before you use Midazolam
3. How to use Midazolam
4. Possible side effects
5. How to store Midazolam
6. Contents of the pack and other information

1. WHAT MIDAZOLAM IS AND WHAT IT IS USED
FOR
Midazolam belongs to a group of medicines called
‘benzodiazepines’. Midazolam works quickly to make
you feel sleepy or to put you to sleep. It also makes you
calm and relaxes your muscles.
Midazolam is used in adults:
• as a general anaesthetic to put them to sleep or to keep
them asleep.
Midazolam is also used in adults and children:
• to make them feel calm and sleepy if they are in
intensive care. This is called ‘sedation’.
• before and during a medical test or procedure where
they are going to stay awake. It makes them feel calm
and sleepy. This is called ‘conscious sedation’.
• to make them feel calm and sleepy before they are
given an anaesthetic.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE MIDAZOLAM
Do not use Midazolam:
• if you are allergic (hypersensitive) to midazolam or
any of the other ingredients of this 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 for ‘conscious sedation’.
You must not use Midazolam if any of the above applies
to you. If you are not sure, talk to your doctor or nurse
before you use this medicine.
Warnings and precautions
Talk to your doctor or nurse before using Midazolam:
• if you are over 60 years of age.
• if you have a long term illness, such as breathing
problems or kidney, liver or heart problems.
• if you have an illness that makes you feel very weak,
run down and short of energy.
• if you have something called ‘myasthenia gravis’ where
your muscles are weak.
• if you have ever had alcohol problems.
• if you have ever had drug problems.
If any of the above applies to you (or you are not sure),
talk to your doctor or nurse before you use Midazolam.
Children
• Talk to your doctor or nurse if any of the above applies
to your child.
• In particular, tell your doctor or nurse if your child has
heart or breathing problems.
Other medicines and Midazolam
Tell your doctor or nurse if you are taking,have recently
taken or might take any other medicines. This includes
medicines that you buy without a prescription and herbal
medicines. This is because Midazolam can affect the way
some other medicines work. Also some other medicines
can affect the way Midazolam works.
In particular, tell your doctor or nurse if you are taking any
of the following medicines:
• Medicines for depression
• Hypnotic medicines (to help you sleep)
• Sedatives (to make you feel calm or sleepy)
• Tranquilliser medicines (for anxiety or to help you
sleep)
• Carbamazepine or phenytoin (these may be used for
fits or seizures)
• Rifampicin (for tuberculosis)
• Medicines for HIV called ‘protease inhibitors’ (such as
saquinavir)
• Antibiotics called ‘macrolides’ (such as erythromycin or
clarithromycin)
• Medicines to treat fungal infections (such as
ketoconazole, voriconazole, fluconazole, itraconazole,
posaconazole)
• Strong pain killers
• Atorvastatin (for high cholesterol)
• Anti-histamines (for allergic reactions)
• St John’s Wort (a herbal medicine for depression)
• Medicines for high blood pressure called ‘calcium
channel blockers’ (such as diltiazem)
If any of the above applies to you (or you are not
sure), talk to your doctor or nurse before you are given
Midazolam.

Midazolam with alcohol
Do not drink alcohol if you have been given Midazolam.
This is because it may make you feel very sleepy and
cause problems with your breathing.
Pregnancy and breast-feeding
Talk to your doctor before you are given Midazolam if you
are pregnant or think you may be pregnant. Your doctor
will decide if this medicine is suitable for you.
After you have been given Midazolam, do not breastfeed for 24 hours. This is because Midazolam may pass
into your breast milk.
Driving and using machines
After having Midazolam, do not drive or use tools or
machines until your doctor says you can.
This is because Midazolam may make you feel sleepy
or forgetful. It may also affect your concentration and coordination. This may affect you being able to drive or use
tools and machines. After your treatment, you must be
taken home by an adult who can look after you.
The medicine can affect your ability to drive 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.
Midazolam contains sodium
Midazolam contains up to 3.47 milligrams of sodium
in each millilitre of solution. This should be taken into
consideration for patients on a controlled sodium diet.

3. HOW TO USE MIDAZOLAM
Midazolam will be given to you by a doctor or nurse. It will
be given to you in a place that has the equipment needed
to monitor you and to treat any side effects. This might
be a hospital, clinic or doctor’s surgery. In particular, your
breathing, heart and circulation will be monitored.
Midazolam is not recommended for use in infants and
babies under 6 months of age. However, if the doctor
feels that it is necessary, it can be given to an infant or
baby under 6 months who is in intensive care.
How Midazolam will be given to you
You will be given Midazolam in one of the following ways:
• By slow injection into a vein (intravenous injection).
• Through a drip into one of your veins (intravenous
infusion).
• By injection into a muscle (intramuscular injection).
• Into your back passage (rectum).
How much Midazolam will be given to you
The dose of Midazolam varies from one patient to
another. The doctor will work out how much to give you. It
depends on your age, weight and general health. It also
depends on what you need the medicine for, how you
respond to treatment, and whether you are going to be
given other medicines at the same time.
After being given Midazolam
After your treatment, you must be taken home by an adult
who is able to look after you. This is because Midazolam
may make you sleepy or forgetful. It may also affect your
concentration and co-ordination.
If you are given Midazolam for a long time, such as in
intensive care, your body may start to get used to the
medicine. This means it may not work as well.
If you use more Midazolam than you should
Your medicine will be given to you by a doctor or nurse.
This means it is unlikely that you will be given too much.
However, if you are given too much by mistake, you may
notice the following:
• Feeling sleepy and losing your co-ordination and
reflexes.
• Problems with speaking and unusual eye movements.
• Low blood pressure. This may make you feel dizzy or
light-headed.
• Slowing or stopping of your breathing or heart beat and
being unconscious (coma).
Long term use of Midazolam for sedation in intensive
care
If you are given Midazolam for a long time, the following
may happen:

--------------------------------------------------------------------------------------------------------------------The following information is intended for
healthcare professionals only:

hameln

PREPARATION GUIDE FOR:

Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml solution for injection
This is a summary of the information regarding the
preparation of Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml
solution for injection.
It is important that you read the entire contents of this
guide prior to the preparation of this medicinal product.
Please refer to the Summary of Product Characteristics
for full prescribing and other information.

1. PRESENTATION
Midazolam 1 mg/ml is supplied as a clear and colourless
solution for injection in clear glass ampoules containing 2
ml, 5 ml, 10 ml and in clear glass vials containing 50 ml.
Midazolam 2 mg/ml is supplied as a clear and colourless
solution for injection in clear glass ampoules containing
5 ml or 25 ml and in clear glass vials containing 50 ml.
Midazolam 5 mg/ml is supplied as a clear and colourless

solution for injection in clear glass ampoules containing
1 ml, 2 ml, 3 ml, 5 ml, 10 ml or 18 ml.

2. PREPARATION
Dilution Instructions
This medicinal product must not be diluted with other
solutions for parenteral use than those mentioned below.
With continuous intravenous infusion, midazolam
injection solution may be diluted in a ratio of 15 mg
midazolam to 100-1000 ml with one of the following
infusion solutions: 0.9% NaCl, 5% and 10% dextrose and
Ringer’s solution.
Chemical and physical in-use stability of the dilutions has
been demonstrated for 3 days at room temperature.
From the microbiological point of view, the dilutions
should be used immediately.

• It may start to work less well.
• You may become dependent on the medicine and get
withdrawal symptoms when you stop having it (see
“Stopping Midazolam” below).
If you stop using Midazolam
If you are given Midazolam for a long time, such as in
intensive care, you may get withdrawal symptoms when
you stop being given the medicine. These include:
• Mood changes
• Fits (convulsions)
• Headache
• Muscle pain
• Problems with sleeping (insomnia)
• Feeling very worried (anxious), tense, restless,
confused or bad tempered (irritable).
• Seeing and possibly hearing things that are not really
there (hallucinations).
Your doctor will lower your dose gradually. This will help
to stop withdrawal symptoms from happening to you.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side
effects have been reported but their frequency is not
known and cannot be estimated from the available data.
Stop having Midazolam 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:
• A severe allergic reaction (anaphylactic shock). The
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). The signs may include
chest pain.
• Breathing problems, sometimes causing the breathing
to stop.
• Muscle spasm around the voice box, causing choking.
Life-threatening side effects are more likely in adults over
60 years, and in people who already have breathing or
heart problems. These side effects are also more likely if
the injection is given too fast or at a high dose.
Other possible side effects
Nervous system and mental problems
• Being less alert
• Feeling confused
• Feeling very happy or excited (euphoria).
• Feeling tired or sleepy or being sedated for a long time.
• Seeing or possibly hearing things that are not really
there (hallucinations).
• Disturbance of consciousness (delirium)
• Headache
• Feeling dizzy
• Difficulty co-ordinating muscles
• Fits (convulsions) in premature and new-born babies.
• Temporary memory loss. How long this lasts depends
on how much Midazolam you were given. Occasionally
this has lasted for a long time.
• Feeling agitated, restless, angry or aggressive. You
may also have muscle spasms or shaking of your
muscles that you cannot control (tremors). These
effects are more likely if you have been given a high
dose of Midazolam or if it has been given too quickly. It
is also more likely in children and elderly people.
Heart and circulation
• Fainting
• Slow heart rate
• Redness of the face and neck (flushing)
• Low blood pressure. This may make you feel dizzy or
light-headed.
Breathing
• Hiccups
• Being short of breath
Mouth, stomach and gut
• Dry mouth
• Constipation
• Feeling sick (nausea) or being sick (vomiting)
Skin
• Feeling itchy
• Rash, including a lumpy rash (hives)
• Redness, pain, blood clots or swelling of the skin where
the injection was given.
General
• Allergic reactions including skin rash and wheezing.
• Withdrawal symptoms (see ‘Stopping Midazolam’ in
Section 3 above)
Elderly people
• Older people taking benzodiazepine medicines, like
Midazolam, have a higher risk of falling and breaking
bones.
• Life-threatening side effects are also more likely to
happen in adults over 60 years.

5. HOW TO STORE MIDAZOLAM
• Your doctor or pharmacist is responsible for storing
Midazolam. They are also responsible for disposing of
any unused Midazolam correctly.
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date which is
stated on the label/carton after “EXP:”. The expiry date
refers to the last day of that month.
• Do not use this medicine if the small glass bottle
(ampoule/vial) or packaging is damaged.
• Keep the ampoules/vials in the outer carton in order to
protect from light.
• Do not store above 25°C. Do not freeze.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Midazolam contains
• The active substance is midazolam (as midazolam
hydrochloride).
In Midazolam 1 mg/ml, each 1 ml of liquid contains
1 mg of midazolam (as midazolam hydrochloride).
In Midazolam 2 mg/ml, each 1 ml of liquid contains
2 mg of midazolam (as midazolam hydrochloride).
In Midazolam 5 mg/ml, each 1 ml of liquid contains
5 mg of midazolam (as midazolam hydrochloride).
• The other ingredients are sodium chloride, hydrochloric
acid and water for injections.
What Midazolam looks like and contents of the pack
Midazolam comes in a colourless glass ampoule/vial
(small bottle). It is a clear, colourless, liquid (solution for
injection/infusion or rectal solution).
The following pack sizes are available for Midazolam
1 mg/ml solution for injection:
• 2 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 10 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 50 ml glass vials, closed with a bromobutyl rubber
stopper: packs of 1, 5 or 10
The following pack sizes are available for Midazolam
2 mg/ml solution for injection:
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 25 ml glass ampoules: packs of 5, 10, 10x5, 5x10.
• 50 ml glass vial: packs of 1, 5 or 10
The following pack sizes are available for Midazolam
5 mg/ml solution for injection:
• 1 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 2 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 3 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 5 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 10 ml glass ampoules: packs of 5, 10, 25, 50 or 100
• 18 ml glass ampoules: packs of 5, 10, 25, 50 or 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG
United Kingdom
Manufacturer
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
HBM Pharma s.r.o
Sklabinská 30
03680 Martin
Slovak Republic
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK

Midazolam 1 mg/ml, 2 mg/ml, 5 mg/ml, solution
for injection

DE

Midazolam-hameln 1 mg/ml, 2 mg/ml, 5 mg/ml
Injektions-/Infusionslösung oder Rektallösung

DK

Midazolam ”Hameln”

EL

Damizol

FI

Midazolam Hameln 1 mg/ml, 5 mg/ml injektio-/
infuusioneste, liuos tai peräruiskeliuos

NL

Midazolam 1 mg/ml, 2mg/ml, 5 mg/ml Hameln,
oplossing voor injectie/infuus of rectale
oplossing

SE

Midazolam Hameln 1 mg/ml, 5 mg/ml
injektionsvätska, lösning

This leaflet was last revised in 23.01.2014

Reporting of side effects
If you get any side effects, talk to your doctor or nurse:
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme - Website: www.mhra.gov.uk/
yellowcard. Alternatively you can call Freephone 0808
100 3352 (available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from your local
pharmacy.
By reporting side effects you can help provide more
information on the safety of this medicine.
47435/12/14

--------------------------------------------------------------------------------------------------------------------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
8°C, unless dilution has taken place in controlled and
validated aseptic conditions.

3. INCOMPATIBILITIES
Compatibility must be checked before administration, if
intended to be mixed with other drugs.
Midazolam precipitates in solutions containing
bicarbonate. Theoretically, the midazolam injection
solution is likely to be unstable in solutions of neutral
or alkaline pH. If midazolam is mixed with albumin,
amoxicillin sodium, ampicillin sodium, bumetanide,
dexamethasone sodium phosphate, dimenhydrinate,
floxacillin sodium, furosemide, hydrocortisone sodium
succinate,
pentobarbital
sodium,
perphenazine,
prochlorperazine edisylate, ranitidine or thiopental
sodium or trimethoprim-sulfamethoxazole, a white
precipitate forms immediately.
A haze is formed immediately followed by a white
precipitate with nafcillin sodium. With ceftazidime a haze
is formed.

With methotrexate sodium a yellow precipitate forms.
With clonidine hydrochloride an orange discoloration
forms. With omeprazole sodium a brown discoloration
forms, followed by a brown precipitate. With foscarnet
sodium a gas is produced.
Midazolam should not be mixed with aciclovir, albumin,
alteplase, acetazolam disodium, diazepam, enoximone,
flecainide acetate, fluorouracil, imipenem, mezlocillin
sodium, phenobarbital sodium, phenytoin sodium,
potassium canrenoate, sulbactam sodium, theophylline,
trometamol, urokinase.

47435/12/14

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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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