Midazolam 50 mg/10 ml Solution

MIDAZOLAM 50 mg/10 mL PHARMC contains midazolam. Midazolam belongs to a group of medicines called benzodiazepines which can cause sedation (sleepiness) and relieve anxiety.

It is used for:

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

MIDAZOLAM 50 mg/10 mL PHARMC should not be administered to you:

• If you are hypersensitive (allergic) to midazolam, other medicines containing benzodiazepine or any of the other ingredients of MIDAZOLAM 50 mg/10 mL PHARMC (listed in section 6).
• If you were told that you have myasthenia gravis (a chronic disorder resulting in weakness of the skeletal muscles).
• If you have severe liver disease.
• If you are pregnant or breastfeeding (see Pregnancy and Breastfeeding).
• If you have severe breathing problems and you are going to have MIDAZOLAM 50 mg/10 mL PHARMC for conscious sedation.
• If you suffer from sleeping disorders, such as difficulty breathing while asleep.

Warnings and precautions

Tell your doctor or healthcare provider before being given the 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 breathing or lung problems.
• If you have problems with your kidneys or liver (you should not be given MIDAZOLAM 50 mg/10 mL PHARMC if you have severe liver problems).
• If you have problems with your heart.

When you use any other medication, e.g. strong painkillers (e.g. opioids), alcohol or medicines that slows down your brain activity, which causes your muscles to relax, and calms and soothes you. See Other medicines and MIDAZOLAM 50 mg/10 mL PHARMC. Your doctor might monitor you more closely and adjust the dosage of MIDAZOLAM 50 mg/10 mL PHARMC according to your condition.

Children

Talk to your doctor or healthcare provider if any of the above applies to your child. Your child will be carefully monitored, and the dose will be adjusted specially.

Other medicines and MIDAZOLAM 50 mg/10 mL PHARMC

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor or healthcare provider if you are using or have recently used any of the following medicines. This is extremely important because these medicines can strengthen the effect of MIDAZOLAM 50 mg/10 mL PHARMC and your doctor might adjust the dosage and/or monitor you more closely.

• Ketoconazole, voriconazole, fluconazole, posaconazole (used to treat fungal infections)
• Erythromycin, clarithromycin, telithromycin roxithromycin, etc. (used to treat bacterial infections).
• Saquinavir, ritonavir, delavirdine, etc. (used to treat human immunodeficiency virus (HIV).
• Boceprevir and telaprevir (used to treat hepatitis C).
• Cimetidine (used to treat ulcers or gastroesophageal reflux disease (GERD)).
• Diltiazem or verapamil (used for angina or high blood pressure, verapamil may also be used to control irregular heartbeats).

You will not be expected to give yourself MIDAZOLAM 50 mg/10 mL PHARMC. It will be given to you by experienced doctors and trained people in a place that has the equipment needed for life support and to monitor and to treat any side effects.

MIDAZOLAM 50 mg/10 mL PHARMC may be administered by intravenous injection (injection into a vein), by intravenous infusion (given by a drip into a vein) or by intramuscular injection (injection into a muscle).

The dose of MIDAZOLAM 50 mg/10 mL PHARMC 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. You should always be taken home by a responsible adult after your treatment.

If you are given MIDAZOLAM 50 mg/10 mL PHARMC for a long time, such as in intensive care, your body may start to get used to the medicine. This means it may not work as well. If you have the impression that the effect of MIDAZOLAM 50 mg/10 mL PHARMC it is too strong or too weak, talk to your doctor, nurse, or pharmacist.

If more MIDAZOLAM 50 mg/10 mL PHARMC is given than it should

Since a healthcare professional will administer MIDAZOLAM 50 mg/10 mL PHARMC, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If MIDAZOLAM 50 mg/10 mL PHARMC treatment is stopped

If you are given MIDAZOLAM 50 mg/10 mL PHARMC for a long time:

• Your body may start to get used to the medicine (tolerant). The medicine becomes less effective and does not work as well for you.
• You may become dependent upon this medicine and get withdrawal symptoms (see below).

Your doctor will reduce your dose gradually to avoid these effects happening to you.

Withdrawal symptoms

If MIDAZOLAM 50 mg/10 mL PHARMC was given to you over a long period, you may become dependent and if you stop treatment suddenly, or lower the dose too quickly, you may get withdrawal symptoms. These symptoms can include headache; muscle pain; feeling very worried (anxious), tense, restless, confused, or bad-tempered (irritable); problems with sleeping (insomnia); mood changes; hallucinations (seeing and possibly hearing things that are not there); fits (convulsions).

If you have any further questions on the use of MIDAZOLAM 50 mg/10 mL PHARMC, ask your doctor or pharmacist.

MIDAZOLAM 50 mg/10 mL PHARMC can have side effects. Not all side effects reported for MIDAZOLAM 50 mg/10 mL PHARMC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MIDAZOLAM 50 mg/10 mL PHARMC, please consult your health care provider for advice.

If any of the following happens, MIDAZOLAM 50 mg/10 mL PHARMC 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. Symptoms 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.
• Heart attack (cardiac arrest). Symptoms may include chest pain which may spread to your neck and shoulders and down your left arm.
• Kounis syndrome, a coronary artery disease that have similar symptoms than a heart attack.
• 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 MIDAZOLAM 50 mg/10 mL PHARMC. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following

Frequent side effects

• Drowsiness (occurs more common in elderly and debilitated patients and in patients receiving high doses)

Less frequent side effects

• Angioedema (swelling most often around the eyes and lips)
• Feelings are depressed, disorientated, and confused
• Ataxia (difficulty coordinating muscles), or uncontrolled movement e.g. sudden jerky movements
• Headache
• Hallucination (seeing and possibly hearing things that are not there)
• Amnesia (the loss of memories, such as facts, information, and experiences)
• Convulsions
• Problems with your heart
• Low blood pressure (feeling dizzy or fainting)
• Redness of face and neck (flushing)
• Inflammation of veins, clotting in blood vessels (thrombophlebitis and thrombosis)
• Hiccups
• Nausea and/or vomiting
• Constipation, dry mouth
• Rash, red hives, itching
• Lethargy (lack of energy and enthusiasm)
• Pain and redness at the injection site
• Falls and fractures

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. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on the SAHPRA website. In addition, side effects can also be reported to [email protected]. By reporting side effects, you can help provide more information on the safety of MIDAZOLAM 50 mg/10 mL PHARMC.

Store all medicines out of reach of children.

• Store at or below 25 °C
• Do not refrigerate.
• For single use only. Discard any unused portion.
• Protect from light. Do not remove from carton unless required for use.
• Precipitation can occur at room temperature, which dissolves on shaking.
• Do not use after the expiry date stated on the label.
• Do not use MIDAZOLAM 50 mg/10 mL PHARMC if the ampoule is damaged, or the contents are discoloured.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).