Adco Midazolam 5 mg/5 ml Injection

ADCO MIDAZOLAM INJECTION contains a medicine called midazolam. This belongs to a group of medicines called “benzodiazepines” which can cause sedation (sleepiness) and anaesthesia (keeps you from feeling pain during surgery or other procedures).

ADCO MIDAZOLAM INJECTION is used for:

• Anaesthesia
• Pre-operative sedation (used to help you relax and feel calm before your surgery)
• Sedation of adults and children, in intensive care units
• Conscious sedation (an awake but very relaxed state of calm or drowsiness during a medical test or procedure)
• Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic).

ADCO MIDAZOLAM INJECTION should not be administered to you:

• If you are allergic (hypersensitive) to midazolam, any medicine from the benzodiazepine group or any of the other ingredients of ADCO MIDAZOLAM INJECTION (listed in section 6)
• If you have severe muscle weakness (myasthenia gravis)
• If you have difficulties breathing
• If you suffer from sleep disorders, such as difficulty breathing while asleep (sleep apnoea syndrome)
• If you have severe liver disease
• If you are pregnant or breastfeeding.

Warnings and precautions

Special care should be taken with ADCO MIDAZOLAM INJECTION:

• If you are over 60 years
• If you have a long term illness that makes you feel very weak, run down and short of energy
• If you have any lung disorders or difficulty breathing
• If you have any heart condition or heart failure
• If you suffer from mental disorders including depression, psychosis or schizophrenia
• If you have impaired kidney function or kidney failure
• If you have impaired liver function
• As this medicine may lead to the development of physical and psychological dependence.

There is an increased risk if you have a history of alcohol or drug abuse. Tolerance to ADCO MIDAZOLAM INJECTION may occur.

As withdrawal symptoms may occur. These may include headaches, diarrhoea, muscle pain, extreme anxiety, tension, sleep disturbances, restlessness, confusion, irritability, rebound insomnia, mood changes, hallucinations and convulsions.

Due to the possibility of amnesia, you will only be discharged after at least four hours and only with a responsible person.

ADCO MIDAZOLAM INJECTION will be given to you by a doctor or nurse. It will be given to you in a place that has the equipment needed to monitor you and to treat any side effects. This might be a hospital, clinic or doctor’s surgery. In particular, your breathing, heart and circulation will be monitored.

You will be given ADCO MIDAZOLAM INJECTION in one of the following ways:

• By slow injection into a vein (intravenous injection)
• Through a drip into one of your veins (intravenous infusion)
• By injection into a muscle (intramuscular injection).

The dose of ADCO MIDAZOLAM INJECTION varies from one patient to another. Your doctor will work out how much to give you. It depends on your age, weight, and general health. It also depends on what you need the medicine for, how you respond to treatment, and whether you are going to be given other medicines at the same time.

After your treatment, you must be taken home by an adult who is able to look after you. This is because ADCO MIDAZOLAM INJECTION may make you sleepy or forgetful. It may also affect your concentration and co-ordination.

If you have the impression that the effect of ADCO MIDAZOLAM INJECTION is too strong or too weak, talk to your doctor, nurse or pharmacist.

If you are administered too much ADCO MIDAZOLAM INJECTION Since a healthcare professional will administer ADCO MIDAZOLAM INJECTION, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

ADCO MIDAZOLAM INJECTION can have side effects. Not all side effects reported for ADCO MIDAZOLAM INJECTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ADCO MIDAZOLAM INJECTION, please consult your healthcare provider for advice.

If any of the following happens, ADCO MIDAZOLAM INJECTION treatment should be stopped and you should tell your doctor or nurse immediately or go to the casualty department at your nearest hospital:

• Anaphylactic reaction (a life-threatening allergic reaction) or hypersensitivity. Signs may include a sudden rash, itching or lumpy rash (hives) and swelling of the face, lips, tongue or other parts of the body. You may have shortness of breath, wheezing or troubled breathing or a pale skin, a weak and rapid pulse, or feeling of loss of consciousness. Additionally, you may experience chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Heart attack (cardiac arrest). Signs may include chest pain which may spread to your neck and shoulders and down your left arm.
• Breathing problems or complications (sometimes causing the breathing to stop).
• Choking and sudden blockage of the airway (laryngospasm).

These are all very serious side effects. If you have them, you may have had a serious reaction to ADCO MIDAZOLAM INJECTION. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Feelings are depressed, disorientated and confused.
• Paradoxical reactions: restlessness, agitation, hyperactivity, irritability, aggression, delusion, anger, nightmare.
• Fits (convulsion) in premature infants and new-born babies.
• Amnesia (the loss of memories, such as facts, information and experiences).
• Hallucination (seeing and possibly hearing things that are not really there).
• Clotting in blood vessels (thrombosis).
• Vasodilation (widening of blood vessels) causing low blood pressure (hypotension).
• Dependence: drug dependence, withdrawal syndrome, substance abuse.
• Impaired balance or coordination.
• Thrombophlebitis (inflammation of a vein).
• Rash, hives, itching.
• Falls and fractures.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Pain and redness at the injection site.
• Drowsiness (occurs more commonly in elderly and debilitated patients and in patients receiving high doses).
• Dizziness.
• Oversedation.
• Less frequent side effects:
• Headache.
• Nausea (feeling sick).
• Vomiting (being sick).
• Frequency not known:
• Hiccups.
• Fatigue.
• Dry mouth.
• Constipation.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ADCO MIDAZOLAM INJECTION.

For reporting of side effects directly to the Holder of Certificate of Registration, contact +27 11 635 0134 or email [email protected].

Store all medicines out of reach of children.

Store at or below 25 °C. Protect from light.