Hypnomidate 20mg/10ml solution for injection ampoules

Hypnomidate is a medicine that is used to induce a deep sleep during surgical procedures. It is used in combination with other medicines.

Hypnomidate is given to you by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose.

If you feel unwell after having the medicine then talk to your prescriber or someone involved in your medical care.

The person with responsibility for giving you your medicine will make sure that you have your medicine at the prescribed times.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Hypnomidate, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

The person responsible for giving you this medicine will stop giving you this medicine when you no longer need it.

This medicine will be stored by the medical team.

Hypnomidate is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

During your general anaesthetic you will be continuously assessed and monitored by a member of the anaesthetic team. Over time it is possible that Hypnomidate can become unsuitable for some people, or they may become unsuitable for it. You should discuss your current medical history with your anaesthetist before each general anaesthetic.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Hypnomidate:

• abnormal muscle movements or problems controlling muscle movement

Common: More than 1 in 100 people who have Hypnomidate:

• apnoea
• faster breathing rate
• injection site problems such as vein pain
• lowered blood pressure
• muscle twitching
• nausea
• skin rash or rashes
• stridor
• vomiting

Uncommon: More than 1 in 1000 people who have Hypnomidate:

• complications with the anaesthetic
• cough
• delayed recovery from the anaesthetic
• heart rhythm problems
• hiccups
• hypoventilation
• increased muscle tone
• increased need for pain killer
• increased salivation
• injection site pain
• involuntary eye movement
• muscle problems
• muscle rigidity
• phlebitis
• raised blood pressure
• redness of the skin
• slower heart rate

The frequency of these side-effects is unknown:

• adrenal problems
• anaphylactic reactions or anaphylactic shock
• bronchospasm - this may be fatal
• cardiac arrest
• convulsions
• heart problems
• hypersensitivity reactions
• respiratory depression
• shock
• spasms of the jaw muscles
• Stevens-Johnson syndrome
• thrombophlebitis such as deep vein thrombosis
• urticaria

If you feel unwell or if you have concerns about a side-effect, tell the person looking after you immediately.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Hypnomidate:

The following types of medicine may interact with Hypnomidate:

If you are taking Hypnomidate and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Hypnomidate.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Hypnomidate:

You should ask a member of your medical team how long you need to wait before you can drive or operate machinery after you have had Hypnomidate.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Hypnomidate:

Alcohol can interact with certain medicines.

In the case of Hypnomidate:

You may have to avoid alcohol for some time before and after having Hypnomidate. For more information, ask a member of your medical team.

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Hypnomidate:

You need to discuss your specific circumstances with your doctor to weigh up the overall risks and benefits of taking this medicine. You and your doctor can make a decision about whether you are going to take this medicine during pregnancy.

If the decision is that you should not have Hypnomidate, then you should discuss whether there is an alternative medicine that you could take during pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Hypnomidate:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. You should only breast-feed your baby while taking this medicine on the advice of your doctor or midwife.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Hypnomidate contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Hypnomidate before, do not have Hypnomidate. Talk to your prescriber, pharmacist or nurse as soon as possible.