Dexmedetomidine 4 micrograms/ml solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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.

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

• if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
• if you have some disorders of heart rhythm (heart block grade 2 or 3).
• if you have very low blood pressure which does not respond to treatment.
• if you have recently had a stroke or other serious condition affecting blood supply to the brain.

Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine should be used cautiously:

• if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness), as it may increase the risk for cardiac arrest
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• if you have certain heart disorders
• if you are elderly
• if you have a neurological disorder (for instance head or spinal cord injury or stroke)
• if you have severe liver problems
• if you have ever developed a serious fever after some medicines, especially anaesthetics

This medicine may cause large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.

An increased risk of mortality has been observed in patients 65 years of age and younger when using this medication, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe illness on admission to the care unit intensive and with a younger age. The doctor will decide if this medicine is still suitable for you. The doctor will consider the benefits and risks of this medicine for you, in comparison with treatment with other sedatives.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

The following medicines may enhance the effect of Dexmedetomidine

• medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
• strong pain medicines (e.g. opioids such as morphine, codeine)
• anaesthetic medicines (e.g. sevoflurane, isoflurane)

If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine may enhance this effect. Dexmedetomidine should not be used with medicines that cause temporary paralysis.

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Dexmedetomidine should not be used during pregnancy or breast-feeding unless clearly necessary.

Dexmedetomidine has major impact on the ability to drive and use machines.

After you have been given Dexmedetomidine you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.

Dexmedetomidine contains 5.5 g glucose per 100 ml. This should be taken into account in patients with diabetes mellitus.

• The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
• You should not go home unaccompanied.
• Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been Dexmedetomidine. Talk to your doctor about the use of these medicines and about the use of alcohol.

If you are given too Dexmedetomidine, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system 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.

The active substance Dexmedetomidine is dexmedetomidine. Each ml contains dexmedetomidine hydrochloride equivalent to 4 micrograms dexmedetomidine.

The other ingredients are: glucose monohydrate and water for injection.

Dexmedetomidine is supplied as a solution in a clear, colorless bag. One bag contains 100 ml solution.

Dexmedetomidine is supplied as

• 100 ml solution in a 100 ml flexible Polypropylene bag with an aluminium overpouch

Each Polypropylene bag contains one non PVC point for filling and closure of the bag port and one non PVC administration port.

Pack sizes:

Polypropylene bag: 1 x 100 ml, 4 x 100 ml

Not all pack sizes may be marketed.

Manufacturer:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder