Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about MIDAZOLAM Alphapharm.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks.Your doctor has weighed the risks of you taking MIDAZOLAM Alphapharm against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What MIDAZOLAM Alphapharm is used for
MIDAZOLAM Alphapharm may be injected as a sedative during some short medical procedures.
MIDAZOLAM Alphapharm 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 MIDAZOLAM Alphapharm over several hours or days as a sedative.
MIDAZOLAM Alphapharm belongs to a group of medicines known as benzodiazepines.
They are thought to work by their action on brain chemicals.
MIDAZOLAM Alphapharm can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose.
Ask your doctor if you have any questions about why MIDAZOLAM Alphapharm has been prescribed for you.
Your doctor, however, may have prescribed MIDAZOLAM Alphapharm for another purpose.
MIDAZOLAM Alphapharm is only given by a doctor trained to use this medicine. If you will be receiving MIDAZOLAM Alphapharm 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 are given MIDAZOLAM Alphapharm
When you must not receive it
Do not use MIDAZOLAM Alphapharm if you have an allergy to:
any medicine containing midazolam
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not use MIDAZOLAM Alphapharm if:
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 MIDAZOLAM Alphapharm, talk to your doctor.
Do not give MIDAZOLAM Alphapharm to children.
The safety or effectiveness of MIDAZOLAM Alphapharm in children less than eight years of age have not been established.
Before you receive it
Tell your doctor if you have or have had any of the following before you receive MIDAZOLAM Alphapharm:
1.if you are pregnant or plan to become pregnant
MIDAZOLAM Alphapharm is not recommended for use in pregnant women, especially in the third (last) trimester or during labour. If there is a need to use MIDAZOLAM Alphapharm when you are pregnant, your doctor will discuss the risks and benefits to you and the unborn baby.
2.if you are breastfeeding or plan to breastfeed
MIDAZOLAM Alphapharm may pass into the breast milk and cause drowsiness and/or feeding difficulties in the baby. MIDAZOLAM Alphapharm is not recommended for use while breastfeeding.
3.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
epilepsy (fits or convulsions)
history of alcohol or drug abuse
4.if you drink alcohol regularly or use illicit (illegal) drugs regularly
MIDAZOLAM Alphapharm can cause physical dependency, especially if you have a history of drug or alcohol abuse, when used long-term. Your dose maybe reduced gradually to overcome this effect.
5.if you have allergies to any other medicines, foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell him/her before you start taking MIDAZOLAM Alphapharm.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and MIDAZOLAM Alphapharm may interfere with each other. These medicines include:
other sleeping tablets, sedatives or tranquillisers
medicines for depression such as fluvoxamine and nefazodone
medicines to control fits such as sodium valproate
medicines for allergies or colds such as antihistamines
cimetidine (Tagamet®, Magicul®), a medicine used to treat ulcers
disulfiram (Antabuse®), a medicine used in alcohol abuse
erythromycin and clarithromycin, common antibiotic
diltiazem (Cardizem®), verapamil (Isoptin®, Anpec®, Cordilox®, Veracaps®), medicines used to treat high blood pressure
ketoconazole, fluconazole and itraconazole or other medicines used to treat fungal infections
ritonavir and saquinavir and other HIV protease inhibitors
Bicalutamide, medicine used in the treatment of prostate cancer and excessive hair loss particularly in women
Aprepitant, a medicine used for treatment of nausea (feeling sick) and vomiting associated with chemotherapy
Goldenseal, a complementary medicine
These medicines may be affected by MIDAZOLAM Alphapharm or may affect how well MIDAZOLAM Alphapharm works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How MIDAZOLAM Alphapharm is given
MIDAZOLAM Alphapharm may be given to you as an injection into a vein or muscle, or through an intravenous infusion in an intensive care unit, by a doctor or a nurse.
Other medications may also be given at the same time.
How much is given
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.
How long is MIDAZOLAM Alphapharm given for
MIDAZOLAM Alphapharm may be given once before a medical procedure, or continuously by infusion for patients in an intensive care unit.
MIDAZOLAM Alphapharm will be stopped once there is no further need for sedation.
If you have been given too much (overdose)
Tell the doctor or nurse on duty if you think you have been given an overdose of MIDAZOLAM Alphapharm.
However, if you are given too much MIDAZOLAM Alphapharm, you may experience side effects such as drowsiness, tiredness, confusion, dizziness, weakness or unconsciousness.
Ask your doctor if you have any concerns.
Your doctor has information on how to recognise and treat an overdose.
While you are given MIDAZOLAM Alphapharm
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 MIDAZOLAM Alphapharm not helping you.
Things you must not do
Do not drive or operate machinery until you know how MIDAZOLAM Alphapharm affects you.
MIDAZOLAM Alphapharm may cause drowsiness or dizziness, fatigue, confusion and forgetfulness in some people and therefore may affect alertness.
Make sure you know how you react to MIDAZOLAM Alphapharm 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 MIDAZOLAM Alphapharm.
Things to be careful of
Be careful if you are elderly, drinking alcohol, unwell 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 MIDAZOLAM Alphapharm.
In addition to the beneficial effects of MIDAZOLAM Alphapharm, 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
loss of memory, inattentiveness, confusion, lack of concentration
muscle stiffness or inflammation of the vein
pain, redness or hardness at the injection site
nausea with or without vomiting
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
changes in pulse rate and blood pressure
sudden anxiety or excitation
hallucinations, unusual mood or delusions
severe sleep disturbances
allergic reaction – sudden signs such as rash, itching or hives on the skin, swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing and other parts of the body
The above list includes serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor if you notice anything that is making you feel unwell, even if it is not on this list.
Other side effects not listed above may also occur in some people.
Ask your doctor or pharmacist if you do not understand anything on this list.
Do not be alarmed by this list of side effects.
You may not experience any of them
After using MIDAZOLAM Alphapharm
MIDAZOLAM Alphapharm will be stored in the pharmacy or on the ward. The ampoule is kept in a cool, dry place away from sunlight, where the temperature stays below 25°C. The ampoule should not be stored in the refrigerator.
If you have any further questions on MIDAZOLAM Alphapharm, or are unsure of the information given above, please see your doctor or nurse, who will be able to assist you.
What it looks like
MIDAZOLAM Alphapharm is a clear colourless solution containing MIDAZOLAM in the following strengths:
5 mg/ 5 mL ampoule
5 mg/mL ampoule
15 mg/ 3 mL ampoule
50 mg/ 10 mL ampoule
MIDAZOLAM Alphapharm 5 mg/ 5 mL
MIDAZOLAM Alphapharm 5 mg/mL
MIDAZOLAM Alphapharm 15 mg/ 3 mL
MIDAZOLAM Alphapharm 50 mg/ 10mL
water for injection
small amounts of hydrochloric acid and sodium hydroxide to adjust the acidity of the solution.
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 – 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Phone: 1800 028 365
Australian registration number
MIDAZOLAM Alphapharm 5 mg/ 5 mL – AUST R160206
MIDAZOLAM Alphapharm 5 mg/mL – AUST R 160207
MIDAZOLAM Alphapharm 15 mg/ 3 mL – AUST R 160205
MIDAZOLAM Alphapharm 50 mg/ 10mL – AUST R 160208
This leaflet was prepared on
27 February 2019.