Dormicum ® 5 mg

Dormicum contains a medicine called midazolam. This belongs to a group of medicines called “benzodiazepines”. Dormicum works quickly to make you feel sleepy or to put you to sleep. It also makes you calm and relaxes your muscles. Dormicum is used for :

• Anaesthesia in adults.
• 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) in adults and children.
• Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children.

You must not be given Dormicum if:

• You are allergic (hypersensitive) to midazolam or any of the other ingredients of this medicine.
• You are allergic to other benzodiazepine medicines, such as diazepam or nitrazepam.
• You have severe breathing problems and you are going to have Dormicum for “conscious sedation”.

You must not be given Dormicum if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Take special care with Dormicum: Check with your doctor or nurse before you are given Dormicum if:

• You are over 60 years of age.
• You have a long term illness, such as breathing problems or kidney, liver or heart problems.
• You have an illness that makes you feel very weak, run down or short of energy.
• You have something called “myasthenia gravis” where your muscles are weak.
• You have ever had alcohol problems.
• You have ever had drug problems.
• If you have sleep apnoea (repetitive periods without breathing, occurring during sleep).
• Dormicum can cause withdrawal symptoms if it is stopped abruptly. See “How Dormicum is given, Effects with Dormicum is stopped” below.

If any of the above apply to you (or you are not sure), talk to your doctor or nurse before you are given Dormicum.

If your child is going to be given this medicine:

• Talk to your doctor or nurse if any of the above applies to your child. In particular, tell your doctor or nurse if your child has heart or breathing problems, as your child will have to be monitored while Dormicum is being administered.

Using Dormicum with food and drink: Drinking alcohol: Do not drink alcohol if you have been given Dormicum. This is because it may make you feel very sleepy and cause problems with your breathing.

Pregnancy and Breast feeding

• Talk to your doctor before you are given Dormicum if you are pregnant or think you may be pregnant. Your doctor will decide if this medicine is suitable for you.
• Dormicum can cause harm to the foetus (unborn baby), if taken by a pregnant woman.
• After you have been given Dormicum, do not breast feed for 24 hours. This is because Dormicum may pass into your breast milk.

If you are pregnant or breast feeding your baby please consult your doctor, pharmacist or other health care professional for advice before being given Dormicum.

Driving and using machinery

• After having Dormicum, do not drive or use tools or machines until your doctor says you can.
• This is because Dormicum may make you feel sleepy or forgetful. It may also affect your concentration and co-ordination. This may affect you being able to drive or use tools and machines.
• After your treatment, you must be taken home by an adult who can look after you.

Important information about some of the ingredients of Dormicum: Dormicum is essentially “sodium free” as it contains less than 1 mmol sodium (23 mg) per small glass bottle (ampoule).

Dormicum 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.

Dormicum is not recommended for use for infants and babies under 6 months of age. However, if the doctor feels that it is necessary, it can be given to an infant or baby under 6 months who is in intensive care.

How Dormicum will be given to you:

• 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).

How much Dormicum will be given to you:

The dose of Dormicum 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 being given Dormicum:

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

If you are given Dormicum 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 Dormicum is too strong or too weak, talk to your doctor, nurse or pharmacist.

If you are given too much Dormicum:

Your medicine will be given to you by a doctor or a nurse. If you are given too much by mistake, you may notice the following:

• Feeling sleepy and losing your co-ordination and reflexes.
• Problems with speaking and unusual eye movements.
• Low blood pressure. This may make you feel dizzy or light-headed.
• Slow or stopping of your breathing and heart beat and being unconscious (coma).

Long term use of Dormicum for sedation in intensive care:

If you are given Dormicum for a long time, the following may happen:

• It may start to work less well.
• You may become dependent on the medicine and get withdrawal symptoms when you stop having it. See “Stopping Dormicum” below.

Dormicum can cause side effects. The following side effects have been reported. Stop having Dormicum and see a doctor straight away if you notice any of the following side effects. They can be life-threatening and you may need urgent medical treatment:

• A severe allergic reaction (anaphylactic shock). The 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 also have shortness of breath, wheezing or trouble breathing.
• Heart attack (cardiac arrest). The signs may include chest pain.
• Breathing problems, sometimes causing the breathing to become laboured.
• Muscle spasm around the voice box, causing choking.

The side effects are also more likely if the injection is given too fast or at a high dose.

Other possible side effects:

Nervous system and mental problems:

• Being less alert.
• Feeling confused.
• Feeling very happy or excited (euphoria).
• Feeling tired or sleepy or being sedated for a long time.
• Seeing or possibly hearing things that are not really there (hallucinations).
• Headache.
• Feeling dizzy.
• Difficulty co-ordinating muscles.
• Fits (convulsions) in premature and new-born babies.
• Temporary memory loss. How long this lasts depends on how much Dormicum you were given. Occasionally this has lasted for a long time.
• Feeling agitated, restless, angry or aggressive. You may also have muscle spasms or shaking of your muscles that you cannot control (tremors). These effects are more likely if you have been given a high dose of Dormicum or if it has been given too quickly. It is also more likely in children and elderly people.

Heart and circulation:

• Fainting.
• Slow heart rate.
• Redness of the face and neck (flushing).
• Low blood pressure. This may make you feel dizzy or light-headed.

Breathing:

• Hiccups.
• Being short of breath.

Mouth, stomach and gut:

• Dry mouth.
• Constipation.
• Feeling sick (nausea) or being sick (vomiting).

Skin:

• Feeling itchy.
• Rash, including a lumpy rash (hives).
• Redness, pain, blood clots or swelling of the skin where the injection was given.

Injury:

• Patients taking Dormicum are at risk of falling and breaking bones. This risk is increased in the elderly and those taking other sedatives (including alcohol).

General:

• Allergic reactions including skin rash and wheezing.
• Angioedema (an allergic skin disease characterised by patches of confined swelling involving the skin, the layers beneath the skin or mucous membranes).
• Withdrawal symptoms. See “Stopping Dormicum” above.

Elderly people:

• Life-threatening side effects are also more likely to happen in adults over 60 years.

If you notice any side effects not listed in this leaflet, please tell your doctor or nurse. Not all side effects reported for Dormicum are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while being given Dormicum, please consult your doctor, pharmacist or other health care professional for advice.

Store at or below 30 °C. Keep ampoule in outer carton in order to protect from light. Dormicum ampoules should not be frozen because they can burst. Furthermore, precipitation can occur which dissolves on shaking at room temperature. Store out of reach of children. This medicine should not be used after the expiry date (EXP) shown on the pack.