HypnovelAmpoules 10mg/5ml
Midazolam
Roche
This leaflet contains information for patients being treated with Hypnovel.
Please read this leaflet carefully. If you have any questions or are not sure about anything, ask your doctor, dentist, nurse or pharmacist.
In this leaflet:
- 1. What Hypnovel is and what it is used for
- 2. Before you use your medicine
- 3. How to use your medicine
- 4. Possible side effects
- 5. Storing your medicine
Hypnovel contains the active substance midazolam. Each ampoule contains 10mg of midazolam (as the hydrochloride) in a 5ml solution for injection.
The other ingredients in the ampoule are: sodium chloride, hydrochloric acid, sodium hydroxide and water for injection.
Marketing Authorisation Holder and manufacturer is
What Hypnovel Is And What It Is Used For
Hypnovel (midazolam) belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine that is used to induce sedation (a state of calm, drowsiness or sleep) and relieves anxiety, muscular tension and spasms.
Midazolam can be given by injection into a vein (intravenously), by a drip (infusion), injection into a muscle (intramuscular) or via rectal administration.
This medicine is used in adults and children for sedation and anaesthesia during investigations and treatment. It is also used as a premedication to calm patients before treatment, and to sedate patients in intensive care units.
Midazolam can be used alone or with other medicines used in anaesthesia.
Before You Use Your Medicine
This medicine must not be used:
- if you are allergic to the group of medicines known as benzodiazepines or any of the other ingredients of Hypnovel.
- if you have severe difficulty in breathing or are very short of breath and are to undergo conscious sedation (a state of calm or drowsiness where you remain awake).
Take special care with Hypnovel:
Let your doctor know if you
- are over 60 years of age.
- are routinely short of breath.
- have myasthenia gravis (a disease causing muscle weakness).
- have a kidney, liver or heart condition.
- have a history of alcohol or drug abuse.
- are taking any other medicines including those not prescribed by your doctor (see Taking other medicines).
- are, or may be pregnant.
Special care needs to be taken if midazolam is used in babies or children. Let your doctor know if your child has a heart condition.
This is so the doctor knows to monitor you or your child more carefully or adjust the dose specially.
When given intravenously, Hypnovel can slow down your breathing and heart rate. On rare occasions this has caused breathing or the heart to stop. To avoid this, doses are given slowly and are as low as possible.
When given as a premedication, how patients respond to midazolam varies considerably. Therefore you will be checked closely to ensure you receive the right dose for you.
Pregnancy
You must tell your doctor or dentist if you are pregnant, or if you think you are pregnant. They can then decide if this medicine is suitable for you.
If your doctor decides you should be given this medicine during late pregnancy, labour or caesarean section, your baby might have an irregular heart beat, a low body temperature, floppiness and breathing and feeding difficulties. You may be at risk of inhaling vomit into your lungs.
Breastfeeding
Midazolam may pass into breast-milk, therefore, if you are breast feeding you should not do so for 24 hours after receiving this medicine.
Driving and using machines
This medicine may make you sleepy, forgetful or affect your concentration and co-ordination. This may affect your performance at skilled tasks, e.g. driving or operating machinery. Your doctor should advise you when you can start these again.
You should always be accompanied home by a responsible adult after your treatment.
Taking other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed by your doctor.
This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved. For example, the effects of Hypnovel may be intensified by medicines such as tranquilisers, hypnotics (sleep inducing drugs), sedatives, antidepressants, narcotic analgesics (very strong pain killers), antiepileptics (for treating epilepsy), anaesthetics and some antihistamines (for the treatment of allergies).
The effects of midazolam may also be increased by medicines such as antifungals, antibiotics, drugs used to treat blood pressure and digestive problems and some drugs used to treat HIV and AIDS.
Alcohol
Alcohol may increase the sedative effects of midazolam and should therefore be avoided. Do not drink alcohol until your doctor tells you it is all right to do so.
How To Use Your Medicine
Dosage and route of administration
Your doctor or dentist will decide on a suitable dose for you. Doses vary considerably and will depend on the planned treatment and the sedation required. Your weight, age, general condition of health, response to the drug and whether other medicines are required at the same time will also influence the dose that you receive.
If you are to receive strong painkillers, you will receive these first and then have your Hypnovel dose adjusted specially for you.
Hypnovel is given slowly, by injection into a vein (intravenously), by a drip (infusion), injection into a muscle (intramuscular) or via rectal administration.
Long term treatment
Patients who receive long term treatment with midazolam may become tolerant (their medicine becomes less effective) or dependent upon their medicine.
After treatment for a long time (such as in an intensive care unit) the following withdrawal symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, inability to sleep, mood changes, hallucinations and convulsions. Your doctor will reduce your dose gradually to avoid these effects happening to you.
Overdose
Your medicine will be given by a doctor. If you think you have been given too much medicine please tell your doctor.
Possible Side Effects
Like all medicines, midazolam can have side effects. The following undesirable effects have been reported very rarely.
Skin disorders:
rash, allergic reaction, itchiness
Nervous system disorders:
drowsiness and prolonged sedation, reduced alertness, confusion, euphoria (an excessive feeling of wellbeing), hallucinations, tiredness, headache, dizziness, and difficulty co-ordinating muscles. Temporary memory loss has been reported. How long this lasts will depend on how much Hypnovel you were given and you may experience this after your treatment. In isolated cases this has been prolonged.
Reactions such as agitation, muscle spasms and muscle tremors, restlessness, hostility, rages, aggression, excitement and assault, have been reported. These have been observed more when a high dose has been given, or administered too quickly. Children and the elderly are more susceptible to these reactions.
Convulsions have been reported more frequently in premature infants and new-born babies.
Patients can become dependent on midazolam after prolonged intravenous use. It is important that you are withdrawn from your medicine gradually to avoid withdrawal symptoms, including withdrawal convulsions (see 3. How to use your medicine - Long term treatment).
Gastrointestinal disorders:
feeling sick, vomiting, hiccough, constipation, dry mouth.
Heart and breathing disorders:
severe events include breathing complications (sometimes causing the breathing or heart to stop), low blood pressure, changes in heart rate, flushing, fainting and headache, shortness of breath, blockage of airway.
Life-threatening incidents are more likely to occur in the elderly, those already experiencing breathing difficulties or heart problems, particularly when the injection is given too rapidly or at a high dose.
Patients under 6 months old are more likely to develop breathing problems, so they will be dosed very gradually and their breathing and oxygen levels observed.
General disorders:
general allergic reactions: skin reactions (rash, itchiness), heart and blood system reactions, wheezing, anaphylactic shock (a life-threatening allergic reaction).
Injection site disorders:
redness and pain, swelling and redness of veins, blood clots.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing Your Medicine
Keep out of the reach and sight of children.
Keep ampoules in the outer carton in order to protect from light.
Do not use after the expiry date (EXP) printed on the pack.
This medicine should only be administered by a medically qualified person.
Further information
You can get further information on Hypnovel from your doctor, dentist or pharmacist.
Date of Preparation/Last review
January 2006
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