B. BRAUN MIDAZOLAM
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about B. BRAUN MIDAZOLAM. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits.
Your doctor has weighed the risks of you using B. BRAUN MIDAZOLAM against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What B. BRAUN MIDAZOLAM is used for
B. BRAUN MIDAZOLAM may be injected as a sedative during some short medical procedures.
B. BRAUN MIDAZOLAM may be given to you by injection before an operation to produce sleepiness or drowsiness and to relieve anxiety.
If you are in an intensive care unit, you may receive an infusion of B. BRAUN MIDAZOLAM over several hours or days as a sedative.
B. BRAUN MIDAZOLAM belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals. B. BRAUN MIDAZOLAM can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose.
Your doctor, however, may have prescribed B. BRAUN MIDAZOLAM for another purpose.
Ask your doctor if you have any questions about why B. BRAUN MIDAZOLAM has been prescribed for you.
B. BRAUN MIDAZOLAM is only given by a doctor trained to use this medicine. If you will be receiving B. BRAUN MIDAZOLAM during surgery, your doctor will give you the medicine and closely follow your progress.
This medicine is available only with a doctor's prescription.
Before you receive B. BRAUN MIDAZOLAM
Do not use B. BRAUN MIDAZOLAM if:
- you have had an allergic reaction to B. BRAUN MIDAZOLAM, any other benzodiazepine medicine, or any of the ingredients listed at the end of this leaflet
- you have severe muscle weakness, also known as myasthenia gravis
- you have a condition called acute narrow angle glaucoma
- you are suffering from shock, coma or acute alcoholic intoxication
If you are not sure whether you should be given B. BRAUN MIDAZOLAM, talk to your doctor.
Do not give B. BRAUN MIDAZOLAM to children. The safety or effectiveness of B. BRAUN MIDAZOLAM in children less than eight years of age has not been established.
Before you receive it
Your doctor must know about all the following before you receive B. BRAUN MIDAZOLAM.
- if you are pregnant or plan to become pregnant
It is not known whether B. BRAUN MIDAZOLAM is harmful to an unborn baby when given to a pregnant woman. If there is a need to use B. BRAUN MIDAZOLAM when you are pregnant, your doctor will discuss the risks and benefits to you and the unborn baby.
- if you are breastfeeding or plan to breastfeed
B. BRAUN MIDAZOLAM may pass into the breast milk and cause drowsiness and/or feeding difficulties in the baby. B. BRAUN MIDAZOLAM is not recommended for use while breastfeeding.
- if you have any other health problems including:
- liver, kidney, heart or lung disease
- high or low blood pressure
- mental disorders including; depression, psychosis or schizophrenia
- epilepsy (fits or convulsions)
- history of alcohol or drug abuse
- if you drink alcohol regularly
Be careful when drinking alcohol before receiving B. BRAUN MIDAZOLAM. Combining B. BRAUN MIDAZOLAM and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest that you avoid alcohol for at least 12 hours before you receive B. BRAUN MIDAZOLAM.
- if you are allergic to any other medicines, foods, dyes or preservatives.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or healthfood shop.
Some medicines and B. BRAUN MIDAZOLAM may interfere with each other. These medicines include:
- other sleeping tablets, sedatives or tranquillisers
- medicines for depression
- medicines to control fits such as sodium valproate
- medicines for allergies or colds such as antihistamines
- pain relievers
- muscle relaxants
- cimetidine, a medicine used to treat ulcers
- disulfiram a medicine used in alcohol abuse
- erythromycin, a common antibiotic
- diltiazem and verapamil, medicines used to treat high blood pressure or heart conditions
- ketoconazole, fluconazole and itraconazole, medicines used to treat fungal infections
- ritonavir and saquinavir, medicines used to treat HIV
These medicines may be affected by B. BRAUN MIDAZOLAM or may affect how well B. BRAUN MIDAZOLAM works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. They also know of other medicines to be careful with or avoid while using B. BRAUN MIDAZOLAM.
If you have not told your doctor about any of the above, tell them before you receive B. BRAUN MIDAZOLAM.
How B. BRAUN MIDAZOLAM is given
B. BRAUN MIDAZOLAM may be given to you as an injection into a vein or muscle. It may also be given through an infusion set in an intensive care unit. Other medications may also be given at the same time.
Your doctor will adjust the dose necessary for you. This depends on which medical procedure you will be having, your age, weight and your general health. Elderly patients may need to receive less.
For how long B. BRAUN MIDAZOLAM is given
B. BRAUN MIDAZOLAM may be given once before a medical procedure, or continuously by infusion for patients in an intensive care unit. B. BRAUN MIDAZOLAM will be stopped once there is no further need for sedation.
If you have been given too much (overdose)
If you have received too much B. BRAUN MIDAZOLAM, you may feel drowsy, tired, confused, dizzy, feel weak or become unconscious.
While you are taking B. BRAUN MIDAZOLAM
Things you must do
Do not take any other medicines whether they require a prescription or not without first telling your doctor.
Tell your doctor if you feel B. BRAUN MIDAZOLAM is not helping you.
Things you must not do
Do not drive or operate machinery until you know how B. BRAUN MIDAZOLAM affects you. B. BRAUN MIDAZOLAM may cause drowsiness or dizziness in some people and therefore may affect alertness. Make sure you know how you react to B. BRAUN MIDAZOLAM before you drive a car or operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
Do not have any alcohol for at least 12 hours after you have been given B. BRAUN MIDAZOLAM.
Things to be careful of
Be careful if you are elderly, unwell, drinking alcohol or taking other medicines.
Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.
Tell your doctor or pharmacist as soon as possible if you do not feel well after you have received B. BRAUN MIDAZOLAM.
In addition to the beneficial effects of B. BRAUN MIDAZOLAM it is possible that unwanted effects will occur during treatment, even when it is used as intended. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
All medical procedures which involve the use of an anaesthetic have a very small risk which your doctor will discuss with you.
In elderly, or high risk patients, death has resulted rarely due to a slowdown of the heart and lungs.
Tell your doctor if you notice any of the following and they worry you:
- drowsiness, tiredness
- dizziness, unsteadiness
- loss of memory, inattentiveness, confusion, lack of concentration
- headache, hangover feeling in the morning
- slurred speech
- unpleasant dreams
- blurred vision
- pain, redness or hardness at the injection site
- muscle stiffness or inflammation of the vein,
- coughing, hiccups
- feeling sick with or without vomiting
Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:
- difficulty breathing
- changes in pulse rate and blood pressure
- sudden anxiety or excitation
- hallucinations or delusions
- severe sleep disturbances
These are serious side effects. You may need urgent medical attention. Serious side effects are rare. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you do not understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking B. BRAUN MIDAZOLAM
B. BRAUN MIDAZOLAM will be stored in the pharmacy or on the ward. It is kept in a cool dry place where the temperature stays below 25°C. It should be protected from light.
What B. BRAUN MIDAZOLAM looks like
B. BRAUN MIDAZOLAM is a clear colourless to yellowish solution.
Active ingredient – midazolam
- each ampoule of B. BRAUN MIDAZOLAM 5 mg/5 mL and 5 mg/1 mL contains 5 mg midazolam
- each ampoule of B. BRAUN MIDAZOLAM 15 mg/3 mL contains 15mg midazolam
- each ampoule of B. BRAUN MIDAZOLAM 50 mg/10 mL contains 50 mg midazolam
- each bottle of B. BRAUN MIDAZOLAM 50 mg/50 mL contains 50 mg midazolam
- each bottle of B. BRAUN MIDAZOLAM 100 mg/100 mL contains 100 mg midazolam
B. BRAUN MIDAZOLAM ampoules 5 mg/5 mL come in packs of 4, 10 or 20.
B. BRAUN MIDAZOLAM ampoules 5 mg/1 mL come in packs of 10.
B. BRAUN MIDAZOLAM ampoules 15 mg/3 mL come in packs of 10.
B. BRAUN MIDAZOLAM ampoules 50mg/10 mL come in packs of 4, 10 or 20.
B. BRAUN MIDAZOLAM bottles 50 mg/50 mL and 100 mg/ 100 mL come in packs of 10.
- sodium chloride
- hydrochloric acid
- sodium hydroxide
- water for injection.
B. BRAUN MIDAZOLAM is distributed by:
B. Braun Australia Pty Ltd
Level 5, 7-9 Irvine Place
Bella Vista NSW 2153
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Numbers
AUST R 225700 – B. BRAUN MIDAZOLAM 5 mg/5 mL Solution for Injection ampoule
AUST R 225699 – B. BRAUN MIDAZOLAM 5 mg/1 mL Solution for Injection ampoule
AUST R 225698 – B. BRAUN MIDAZOLAM 15 mg/3 mL Solution for Injection ampoule
AUST R 225701 – B. BRAUN MIDAZOLAM 50 mg/10 mL Solution for Injection ampoule
AUST R 225697 – B. BRAUN MIDAZOLAM 50 mg/50 mL Injection, Intravenous Infusion bottle
AUST R 225696 – B. BRAUN MIDAZOLAM 100 mg/100 mL Injection, Intravenous Infusion bottle
This leaflet was last updated in July 2019.
Published by MIMS December 2019