POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
Midazolam 1mg in 1ml Injection
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Midazolam 1mg/ml Solution for Injection
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
This product will be referred to as Midazolam Injection from here on.
What is in this leaflet
1. What Midazolam Injection is and what it is used for
2. What you need to know before you are given Midazolam Injection
3. How you will be given 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 for injection contains Midazolam. Midazolam belongs to a group of medicines called benzodiazepines which can cause sedation (sleepiness) and relieve anxiety.
It is used:
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MIDAZOLAM INJECTION
You must not be given Midazolam Injection if
You must not be given midazolam injection if any of the above applies 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 pharmacist before being given Midazolam Injection if:
If any of the above applies to you, or if you are not sure, talk to your doctor or nurse before you are given this medicine.
Other medicines and Midazolam Injection:
Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
This is extremely important because some medicines can strengthen or weaken the effects of others.
In particular, tell your doctor or nurse if you are taking any of the following medicine:
Concomitant use of Midazolam Injection and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Midazolam Injection together with opioids the dose and duration of concomitant treatment should be limited by your doctor.
If you are already taking one of these medicines, speak to your doctor before you receive Midazolam Injection.
If you are going to have an inhaled anaesthetic (one that you breath in) for an operation or for dental treatment, it is important to tell your doctor or dentist that you have been given this medicine.
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 for advice before taking this medicine.
If you have passed through prolonged treatment during last phase of pregnancy with this medicine, your baby may develop physical dependence and risk of withdrawal symptoms after birth.
Do not breast-feed for 24 hours after being given midazolam injection. This is because midazolam may pass into your breast milk.
Driving and using machines
Midazolam Injection will affect your ability to drive and operate machinery. You should speak to your doctor for advice on when you will be able to drive, operate machines or resume normal activities.
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, if you have received midazolam injection.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or nurse if you are not sure whether it is safe for you to drive after receiving this medicine.
Midazolam Injection contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. HOW YOU WILL BE GIVEN MIDAZOLAM INJECTION
Midazolam Injection will be given only by experienced doctors and trained people in a setting fully equipped for life support and who will recognize and be able to treat known side effects if they happen.
Midazolam Injection may be administered by intravenous injection (injection into a vein) or by intravenous infusion (given by a drip into a vein).
Your doctor will give this medicine to you and decide the dose to be given based on the particular procedure they are doing, the degree of sleep (sedation) required, your weight, your response to the medication. Severe problems with heart and breathing are most likely to occur when the injection is given too rapidly or when too high dose is used.
You should always be taken home by a responsible adult after your treatment.
Use in Children
If you think you have been given more Midazolam Injection than you should have.
This is unlikely as your injection will be administered by a doctor or nurse. If you are concerned about the dose, discuss it with your doctor.
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.
If you stop using Midazolam injection:
Your doctor will reduce your dose gradually to avoid these effects happening to you.
Benzodiazepine medicines, like midazolam injection, may make you dependent if used for a long time. 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).
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everyone gets them.
Serious side effects
Stop having midazolam injection and see your doctor straight away if you notice any of the following side effects. They can be life threatening and you may need urgent medical treatment:
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:
Not known (frequency cannot be estimated from the available data):
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
or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MIDAZOLAM INJECTION
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 carton and label after “Exp”. The expiry date refers to the last day of that month.
Keep the ampoules (small bottles) in the outer carton in order to protect from light.
Do not store above 25°C.
Do not use the ampoule if it is damaged or the contents are discoloured.
If only part used, discard the remaining solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Midazolam Injection contains
The active substance is midazolam.
The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What Midazolam Injection looks like and contents of pack
Midazolam Injection 1mg in 1ml is a clear, colourless or slightly yellow, sterile solution contained in clear glass ampoules (small bottles). Each 1ml of this solution contains 1mg of midazolam.
The injection is available in packs of 10 ampoules containing 2ml or 5ml of solution.
Marketing authorization holder
This leaflet was last revised in December 2018.
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