Midazolam 2mg/Ml Injection In A Prefilled Syringe
PACKAGE LEAFLET: INFORMATION FOR THE USER
Midazolam
Read all of this leaflet carefully before you are given this medicine.
• 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:
1. What Midazolam Injection is and what it is used for
2. Before you are given Midazolam Injection
3. How Midazolam Injection will be given
4. Possible side effects
5. How to store Midazolam Injection
6. Further information
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 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, unless the benefits outweigh the potential risks (see section 'Pregnancy and breast-feeding')
• you suffer with a disease that effects the muscles known as myasthenia gravis
• you suffer from breathing difficulties
• you suffer from a condition known as sleep apnoea, a disorder than 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
Taking other medicines
Please tell your doctor, nurse or anaesthetist 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 to 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
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.
Continued overleaf
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.
3. How Midazolam Injection will be given
Your doctor will administer Midazolam Injection to you slowly 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.
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.
What Midazolam Injection contains
The active substance is Midazolam 2mg 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,
Romford,
Essex,
RM3 8UG United Kingdom
Manufacturer
Federa SC
Avenue Jean Jaureslaan, 71 B-1030 Brussels Belgium
This leaflet was last approved in 05/2008.
PL 12064/0101
Aurum
Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom