Active ingredient
- midazolam
Legal Category
POM: Prescription only medicine
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.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0151 .
Midazolam 2 mg/ml solution for injection/infusion in pre-filled syringe
Package leaflet: Information for the user
Midazolam 1 mg/ml solution for injection/infusion in pre-filled syringe
Midazolam 2 mg/ml solution for injection/infusion in pre-filled syringe
midazolam
For use in adults
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Midazolam is and what it is used for
2. What you need to know before you are given 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 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:
2. What you need to know before you are given Midazolam
You must NOT be given Midazolam
You must not be given Midazolam if any of the above apply to you. If you are not sure, talk to your doctor before you are given this medicine.
Warnings and precautions
Administration of midazolam may depress myocardial contractility (ability of heart muscle to contract) and cause apnoea (pauses in breathing). Severe cardio respiratory adverse events have occurred on rare occasions. These have included respiratory depression, apnoea, respiratory and/or cardiac arrest. To avoid such incidents, the injection should be given slowly and the dose should be as low as possible.
Paradoxical reactions and anterograde amnesia (loss of memory for recent events) have been reported to occur with midazolam (see section 4. Possible side effects).
Adults
Talk to your doctor before you are given Midazolam, if
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.
Long term treatment
If you receive long-term midazolam, you may become tolerant (midazolam becomes less effective) or you may be become dependent upon this medicine.
After treatment for a long time (such as in an intensive care unit) the following withdrawal symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, inability to sleep, mood changes, hallucinations and convulsions. Your doctor will reduce your dose gradually to avoid these effects happening to you
Other medicines and Midazolam
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
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:
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.
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.
Midazolam with alcohol
Do not drink alcohol if you have been given Midazolam. This is because alcohol can increase the sedative effect of Midazolam 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 you are given this medicine. Your doctor will decide if this medicine is suitable for you.
Do not breast-feed for 24 hours after being given Midazolam. This is because Midazolam may pass into your breast milk.
Driving and using machines
Midazolam contains sodium
This medicinal product contains 157.36 mg sodium (main component of cooking/table salt) in each pre-filled syringe. This is equivalent to 7.9% of the maximum daily dietary intake of sodium for an adult.
3. How to use Midazolam
Midazolam should be given only by experienced healthcare professionals. 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.
Usual 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 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. The dose will be adjusted specially for you.
Children
Midazolam is not recommended for use in children due to the total amount of midazolam contained in the pre-filled syringes.
Method of administration
Midazolam may be given to you in one of two different ways:
You should always be taken home by a responsible adult after your treatment.
If you receive more Midazolam than you should
Your medicine will be given to you by a doctor or nurse. If you are accidentally given too much Midazolam you may:
If you stop using Midazolam
If you receive long term treatment with Midazolam (are given the medicine for a long time) you may:
Your doctor will reduce your dose gradually to avoid these effects happening to you.
Withdrawal symptoms:
Benzodiazepine medicines, like Midazolam, 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:
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 (frequency not known).
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:
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 (frequency not known)
Not known (cannot be estimated from the available data)
Elderly patients
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 at www.mhra.gov.uk/yellowcard 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
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, foil or pre-filled syringe labels after EXP. The expiry date refers to the last day of that month.
Keep the pre-filled syringe in the outer carton, in order to protect from light.
Your doctor or pharmacist is responsible for storing Midazolam. They are also responsible for disposing of any unused Midazolam correctly.
6. Contents of the pack and other information
What Midazolam contains
Midazolam 1 mg/ml:
Each ml of the solution for injection/infusion contains 1 mg midazolam.
Each pre-filled syringe of 50 ml contains 50 mg midazolam.
Midazolam 2 mg/ml:
Each ml of the solution for injection/infusion contains 2 mg midazolam.
Each pre-filled syringe of 50 ml contains 100 mg midazolam.
What Midazolam looks like and contents of the pack
Midazolam is a clear, colourless to viscous solution for injection/infusion.
Midazolam is available in a pack containing one blister with one pre-filled syringe containing 50 ml solution for injection/infusion.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names
Germany Midazolam SUN
France Midazolam SUN
Italy Midazolam SUN
Poland Midazolam SUN
Romania Midazolam SUN
Spain Midazolam SUN
United Kingdom Midazolam
This leaflet was last revised in April 2019
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