What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00031/0189.


Hypnovel 10mg/2ml Solution for Injection

Package leaflet: Information for the patient

Hypnovel® 10mg/2ml solution for injection

Midazolam (as midazolam hydrochloride)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Hypnovel is and what it is used for
2. What you need to know before you are given Hypnovel
3. How Hypnovel is given
4. Possible side effects
5. How to store Hypnovel
6. Contents of the pack and other information

1. WHAT HYPNOVEL IS AND WHAT IT IS USED FOR

Hypnovel contains the active substance midazolam, which belongs to a group of medicines known as benzodiazepines. It is a short-acting medicine that is used to induce sedation (a very relaxed state of calm, drowsiness or sleep) and relieves anxiety and muscle tension.

This medicine 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.
  • Sedation of adults and children, in intensive care units.
  • Anaesthesia in adults, used alone or with other medicines.
  • Premedication (medicine used to cause relaxation, calm and drowsiness before an anaesthetic) in adults and children.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HYPNOVEL

You must not be given Hypnovel if:

  • You are allergic (hypersensitive) to midazolam or any of the other ingredients of the medicine (listed in section 6).
  • You are allergic to other benzodiazepine medicines, such as diazepam or nitrazepam.
  • You have severe breathing problems and you are going to have Hypnovel for conscious sedation.

You must not be given Hypnovel 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.

Warnings and precautions

Children and babies

If your child is going to be given this medicine:

  • It is particularly important to tell your doctor or nurse if your child has cardiovascular disease (heart problems). Your child will be carefully monitored and the dose will be adjusted specially.
  • Children must be carefully monitored. For infants and babies under 6 months this will include monitoring of breathing and oxygen levels.

Adults

Talk to your doctor or nurse before you are given Hypnovel 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 are debilitated (have an illness that makes you feel very weak, run down and short of energy).
  • You have a condition called ‘sleep apnoea syndrome’ (where your breathing stops when you are asleep), so you may be closely monitored.
  • You have myasthenia gravis (a neuromuscular disease causing muscle weakness).
  • You regularly drink large amounts of alcohol or you have had problems with alcohol use in the past. Alcohol can increase the effects of Hypnovel, possibly leading to severe sedation that could result in coma or death.
  • You regularly take recreational drugs or you have had problems with drug use in the past.
  • You are pregnant or think you may be pregnant (see ‘Pregnancy and breast-feeding’).

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

Other medicines and Hypnovel

Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines. This includes medicines obtained without a prescription and herbal medicines.

This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines involved.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

  • tranquilisers (for anxiety or to help you sleep)
  • hypnotics (medicines to make you sleep)
  • sedatives (to make you feel calm or sleepy)
  • antidepressants (medicines for depression)
  • narcotic analgesics (very strong pain killers)
  • antihistamines (used to treat allergies)
  • medicines to treat fungal infections (ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole)
  • macrolide antibiotics (such as erythromycin or clarithromycin)
  • diltiazem (used to treat high blood pressure)
  • medicines for HIV (protease inhibitors such as saquinavir)
  • medicines for hepatitis C (protease inhibitors such as boceprevir and telaprevir)
  • atorvastatin (used to treat high cholesterol)
  • rifampicin (used to treat mycobacterial infections such as tuberculosis)
  • ticagrelor (used to prevent heart attack)
  • the herbal medicine St John’s Wort.

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

Operations

If you are going to have an anaesthetic for an operation or for dental treatment (including inhaled anaesthetics that you breathe in), it is important to tell your doctor or dentist that you have been given Hypnovel.

Hypnovel with alcohol

Do not drink alcohol if you have been given Hypnovel. This is because alcohol can increase the sedative effect of Hypnovel and may cause problems with your breathing.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Your doctor will decide if this medicine is suitable for you.

Hypnovel may harm your unborn baby when used in early pregnancy. When high doses are administered during late pregnancy, labour or caesarean section, you might have an inhalation risk and your baby might have an irregular heartbeat, state of low muscle tone (hypotonia), feeding difficulties, a low body temperature and difficulty in breathing. With prolonged administration during late pregnancy, your baby may develop a physical dependence and risk of withdrawal symptoms after birth.

Do not breast-feed for 24 hours after being given Hypnovel. This is because Hypnovel may pass into your breast milk.

Driving and using machines

Hypnovel may make you sleepy, dizzy, forgetful or affect your concentration and co-ordination. This may affect your performance at skilled tasks such as driving or using machines.

Do not drive or use machinery until you are completely recovered. Your doctor should advise you when you can start these again.

Do not drive while taking this medicine until you know how it affects you.

  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence if:
    • The medicine has been prescribed to treat a medical or dental problem and
    • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
    • It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

  • Lack of sleep or alcohol consumption may further impair your alertness.
  • You should always be taken home by a responsible adult after your treatment.

Important information about some of the ingredients of Hypnovel

Hypnovel is essentially ‘sodium free’ as it contains less than 1 mmol sodium (23 mg) per ampoule (small glass bottle).

3. HOW HYPNOVEL IS GIVEN

Hypnovel should be given only by experienced healthcare professionals (doctor or nurse). It should be given in a place (hospital, clinic or surgery) equipped to monitor and support the patient’s breathing, heart and circulation (cardiovascular function) and recognise the signs of and manage the expected side effects of anaesthesia.

How much Hypnovel is given

Your doctor will decide on a suitable dose for you. The dose you are given will depend on why you are being treated and the type of sedation needed. Your weight, age, your state of health, how you respond to Hypnovel and whether other medicines are needed at the same time will also influence the dose that you are given.

If you need strong painkillers, you will be given these first and then be given Hypnovel. Your doctor will decide on a suitable dose for you.

How Hypnovel is given

Hypnovel may be given to you in one of four different ways:

  • by slow injection into a vein (intravenous injection)
  • through a tube into one of your veins (intravenous infusion)
  • by injection into a muscle (intramuscular injection)
  • into your back passage (rectum).

You should always be taken home by a responsible adult after your treatment.

Children and babies

  • In infants and babies under 6 months of age Hypnovel is only recommended for sedation in intensive care units. The dose will be given gradually into a vein.
  • Children 12 years and under will usually be given Hypnovel into a vein. When Hypnovel is used for premedication (to cause relaxation, calm and drowsiness before an anaesthetic) it may be given into the back passage (rectum).

If too much Hypnovel is given

Your medicine will be given to you by a doctor or nurse. If you are accidentally given too much Hypnovel you may:

  • Feel drowsy.
  • Lose your co-ordination (ataxia) and reflexes.
  • Have problems with your speech (dysarthria).
  • Have involuntary eye movements (nystagmus).
  • Develop low blood pressure (hypotension).
  • Stop breathing (apnoea) and suffer cardiorespiratory depression (slowed or stopped breathing and heart beat) and coma.

Stopping treatment with Hypnovel

If you receive long term treatment with Hypnovel (are given the medicine for a long time) you may:

  • Become tolerant to Hypnovel. The medicine becomes less effective and does not work as well for you.
  • 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.

The following effects have been seen with Hypnovel use, particularly in children and the elderly; restlessness, agitation, irritability, involuntary movements, hyperactivity, hostility, delusion, anger, aggressiveness, anxiety, nightmares, hallucinations (seeing and possibly hearing things that are not really there), psychoses (losing contact with reality), inappropriate behaviour, excitement and assault (these are also known as paradoxical reactions, which are outcomes that are opposite to the effects normally expected for the drug). If you experience these, your doctor will consider stopping Hypnovel treatment.

Withdrawal symptoms:

Benzodiazepine medicines, like Hypnovel, may make you dependent if used for a long time (for instance in intensive care). This means that if you stop treatment suddenly, or lower the dose too quickly, you may get withdrawal symptoms. The symptoms can include:

  • headache
  • diarrhoea
  • muscle pain
  • feeling very worried (anxious), tense, restless, confused or bad-tempered (irritable)
  • problems with sleeping
  • mood changes
  • hallucinations (seeing and possibly hearing things that are not there)
  • fits (convulsions).

In severe cases of withdrawal, the following can occur: a feeling of losing contact with reality, numbness and tingling of the extremities (e.g. hands and feet), feeling sensitive to light, noise and touch.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with this medicine (frequency not known).

Stop having Hypnovel 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:

  • Anaphylactic shock (a life-threatening allergic reaction). 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). 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).

Life-threatening side effects are more likely to occur in adults over 60 years of age and those who already have breathing difficulties or heart problems, particularly if the injection is given too fast or at a high dose.

Other possible side effects

Immune system problems:

  • general allergic reactions (skin reactions, heart and blood system reactions, wheezing).

Effects on behaviour:

  • restlessness, agitation, irritability
  • nervousness, anxiety
  • hostility, anger or aggression
  • excitement
  • hyperactivity
  • changes in libido
  • inappropriate behaviour.

Muscle problems:

  • muscle spasms and muscle tremors (shaking of your muscles that you cannot control).

Mental and Nervous system problems:

  • confusion, disorientation
  • emotional and mood disturbances
  • involuntary movements
  • nightmares, abnormal dreams
  • hallucinations (seeing and possibly hearing things that are not really there)
  • psychoses (losing contact with reality)
  • drowsiness and prolonged sedation
  • reduced alertness
  • headache
  • dizziness
  • difficulty co-ordinating muscles
  • fits (convulsions) in premature infants and new-born babies
  • temporary memory loss. How long this lasts depends on how much Hypnovel you were given. You may experience this after your treatment. In isolated cases this has been prolonged (lasted for a long time)
  • drug dependence, abuse.

Heart and circulation problems:

  • low blood pressure
  • slow heart rate
  • redness of the face and neck (flushing), fainting or headache.

Breathing problems:

  • shortness of breath
  • hiccup.

Stomach, gut and mouth problems:

  • feeling sick or being sick
  • constipation
  • dry mouth.

Skin problems:

  • rash
  • hives (lumpy rash)
  • itchiness.

Injection site problems:

  • redness
  • swelling of the skin
  • blood clots or pain at the injection site.

Injury:

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

General:

  • tiredness (fatigue).

Elderly patients:

  • life-threatening side effects are more likely to occur in adults over 60 years of age and those who already have breathing difficulties or heart problems, particularly when the injection is given too quickly or at a high dose.

Patients with severe kidney disease:

  • patients with severe kidney disease are more likely to experience side effects.

If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE HYPNOVEL

Your doctor or pharmacist is responsible for storing Hypnovel. The storage details are as follows:

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
  • Keep ampoules (small glass bottle) in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hypnovel contains

  • The active substance is midazolam (as midazolam hydrochloride): each 1 ml of liquid medicine contains 5 mg (milligrams) of midazolam. Each ampoule (small glass bottle) contains 10 mg of midazolam (in 2 millilitres of liquid).
  • The other ingredients are sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What Hypnovel looks like and contents of the pack

Hypnovel is a clear colourless liquid (‘solution for injection’). This liquid may be further diluted to make it weaker before it is given to you.

Hypnovel is supplied in clear glass ampoules in packs of 10.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

This leaflet was last revised in November 2017.