EPISTATUS

Buccal midazolam maleate solution equivalent to midazolam base 10mg in 1mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about EPISTATUS . It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given EPISTATUS against the benefits they expect it will have for you. If you have any concerns about being given this medicine, ask your doctor. Keep this leaflet in a safe place. You may need to read it again.

Before you are given EPISTATUS

When you must not be given it
You should not be given EPISTATUS if you have an allergy to: any medicine containing midazolam any of the ingredients listed at the end of this leaflet any other medicine from the benzodiazepine group of medicines. 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. You should not be given EPISTATUS 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. You should not be given this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy. Do not breast-feed if you are being given this medicine. The active ingredient in EPISTATUS passes into breast milk and there is a possibility that your baby may be affected.

You should not be given EPISTATUS if the solution is discoloured, cloudy, turbid, or a precipitate is present. EPISTATUS is normally clear and thick liquid. You should not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are given this medicine after the expiry date has passed, it may not work as well. If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions: kidney problems heart problems liver problems breathing problems such as asthma, bronchitis or emphysema.

What EPISTATUS is used for

EPISTATUS is used in the
treatment of convulsions, seizures or fits. It is also used as a sedative and hypnotic. This medicine belongs to a group of medicines called benzodiazepines that are thought to work through their action on chemicals in your brain. EPISTATUS can cause sedation, hypnosis, amnesia and/or anaesthesia, depending on the dose. Ask your doctor if you have any questions about why this medicine has been given to you. Your doctor may have prescribed it for another reason.

Tell your doctor if you are, or ever have, suffered from alcoholism. EPISTATUS contains alcohol. Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved. If you have not told your doctor about any of the above, tell them before you are given EPISTATUS

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Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop, naturopath or herbalist. Some medicines and EPISTATUS may interfere with each others actions. These include: sleeping tablets painkillers drugs for epilepsy antihistamines antibiotics or antifungal agents drugs for stomach ulcers such as cimetidine

4. Insert the tip of the dosing dispenser firmly into the hole of the opaque plastic bung on the top of the bottle.

5. Hold the bottle and the dosing dispenser securely. Turn the bottle and the dosing dispenser upside down. 6. Pull the plunger down until you have the required dose of EPISTATUS.

drugs for heart problems

These medicines may be affected by EPISTATUS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor has more information on medicines to be careful with, or avoid, while being given this medicine.

10. If it is very difficult to administer to both cavities, then administer the whole dose, over a period of 4-5 seconds, to one buccal cavity. 11. Recap the bottle and store EPISTATUS out of reach of children.

How EPISTATUS is given

EPISTATUS will be prescribed by your doctor. Your doctor will decide what dose of EPISTATUS you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight. Sometimes only a single dose of EPISTATUS is required. How to administer EPISTATUS 1. Open bottle by pressing down and turning the child resistant cap anticlockwise. 2. Hold the bottle upright. 3. Push the plunger of the empty 1mL dispenser completely down towards its tip.

7. Turn the bottle upright. 8. Pull the tip of the oral dispenser out of the plastic bung of the bottle. 9. Insert the oral dispenser into the patients mouth between the gums and the cheek and administer half the dose over a period of 2-3 seconds. Give the remaining dose to the other side of the mouth.

If you are given too much (overdose)

If you have received too much EPISTATUS , you may feel drowsy, tired, confused, dizzy, weak or become unconscious. Immediately contact your doctor or go to the Accident and Emergency Department at the nearest hospital if you notice the symptoms of an overdose. Contact the Poisons information centre on 13 11 26 for further advice on overdose management.

While you are being given EPISTATUS

Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you have recently taken EPISTATUS .

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Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine. If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery. If you become pregnant while being given this medicine, tell your doctor immediately. If you are about to have any blood tests, tell your doctor that you are being given this medicine. It may interfere with the results of some tests.

Ask your doctor to answer any questions you may have. Tell your doctor or nurse 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 coughing, hiccups feeling sick with, or without, vomiting.

Product description
What it looks like
EPISTATUS is a clear, thick liquid in an amber glass bottle with a plastic top.

Ingredients
EPISTATUS contains 10 mg of midazolam base in 1mL of solution. It also contains: sodium methylhydroxybenzoate nipasol M sodium ethanol saccharin sodium glycerol lycasine.

Things to be careful of
After having EPISTATUS , you may be drowsy or not fully alert, so you should arrange to be accompanied home. As your ability to drive and operate machinery may be affected after being given midazolam, your doctor will decide when you can perform such activities. As your childs ability to ride bicycles or climb trees may be affected after being given midazolam, your doctor will decide when your child can perform such activities. Do not have any alcohol for at least 12 hours after you have been given EPISTATUS .

The above list includes the more common side effects of your medicine. They are usually mild and short-lived. If any of the following happen, tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital: difficulty breathing changes in pulse rate and blood pressure yellowing of the whites of the eyes, skin sudden anxiety or excitation hallucinations or delusions severe sleep disturbances.

It may also contain citric acid.

Supplier
EPISTATUS is supplied in Australia by: Phebra 332 Burns Bay Road, Lane Cove NSW 2066, Australia Available under the Therapeutic Goods Administrations Special Access Schemes. Phebra product code: SOL041 This leaflet was prepared on 12 September 2009. Date of most recent amendment 5th June 2012. Version 03 In Australia and New Zealand EPISTATUS is a registered trademark of Special Products Ltd, UK. Phebra and Phi are both trademarks of Phebra Pty Ltd, 332 Burns Bay Road, Lane Cove, NSW 2066, Australia. Copyright, 2012, Phebra Pty Ltd, All rights reserved.

Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are being given EPISTATUS . This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects. If you are over 65 years of age you may have an increased chance of getting side effects. Do not be alarmed by the following lists of side effects. You may not experience any of them.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare. Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given EPISTATUS

Storage
Store EPISTATUS below 25C. Do not refrigerate. The cap must be replaced immediately after taking a dose to prevent evaporation.

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