Dexithera Solution

DEXITHERA 100 μg/mL contains the active substance dexmedetomidine that belongs to a group of medicines called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care (ICU) settings or awake sedation during surgical procedures. Awake sedation is a state where a person remains awake and aware without feeling discomfort or pain.

DEXITHERA 100 μg/mL should not be administered to you if:

• You are hypersensitive (allergic) to dexmedetomidine or any of the other ingredients of DEXITHERA 100 μg/mL listed in section 6 of this leaflet.
• You have sepsis.
• You are an unstable trauma patient.
• You have a low blood volume.
• You have heart block (a disorder of your heart rhythm).
• You have uncontrolled cardiac failure.
• You have liver problems.

Warnings and precautions

Tell your doctor or heath care provider before being given DEXITHERA 100 μg/mL:

• If you have an abnormally slow heart rate (either due to illness or high levels of physical fitness).
• 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.
• If you suffer from dry eyes.

Avoid use of any other sedative medicines and substances (such as alcohol, opioid medicine or benzodiazepines) for at least 24 hours after you have been given DEXITHERA 100 μg/mL.

Children and adolescents

DEXITHERA 100 μg/mL should not be given to children and adolescents under the age of 18.

Other medicines and DEXITHERA 100 μg/mL

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) The following medicines may enhance the effect of DEXITHERA 100 μg/mL:

• Medicines to help you sleep or cause sedation (such as midazolam, propofol).
• Strong pain medicines (e.g., opioids, such as morphine, codeine).
• Anaesthetic medicines (such as sevoflurane, isoflurane).
• Medicine to lower your blood pressure.
• Medicine to lower your heart rate (such as beta-blockers).

DEXITHERA 100 μg/mL with food, drink and alcohol

The use of alcohol during and after treatment with DEXITHERA 100 μg/mL should be avoided for at least 24 hours.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being given DEXITHERA 100 μg/mL. DEXITHERA 100 μg/mL should not be administered during pregnancy, labour and breastfeeding.

Driving and using machines

DEXITHERA 100 μg/mL has a major impact on the ability to drive and use machines. After you have been given DEXITHERA 100 μg/mL, you must refrain from driving, operating machines, doing any other hazardous tasks or making legal decisions for at least 24 hours.

DEXITHERA 100 μg/mL contains sodium. DEXITHERA 100 μg/mL contains less than 1 mmol sodium (23 mg) per ampoule or vial, that is to say essentially 'sodium-free'. DEXITHERA 100 μg/mL contains 37 mg sodium (main component of cooking/table salt) in each 10 mL vial. This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

You will not be expected to give yourself DEXITHERA 100 μg/mL. It will be given to you by a person who is qualified to do so.

Procedural sedation/awake sedation

DEXITHERA 100 μg/mL is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation. DEXITHERA 100 μg/mL is diluted and it is given to you as an infusion (drip) into your veins. Before being given DEXITHERA 100 μg/mL, your health care provider may give you fluid supplementation to ensure that your blood volume is normal. Your doctor will decide on a suitable dose for you. The amount of DEXITHERA 100 μg/mL depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.

After sedation/wake-up

• 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 given DEXITHERA 100 μg/mL. Talk to your doctor about the use of these medicines and about the use of alcohol.

If you receive more DEXITHERA 100 μg/mL than you should Since a health care provider will administer DEXITHERA 100 μg/mL, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If you are given too much DEXITHERA 100 μg/mL, your blood pressure may go up or down, your heartbeat may slow down, you may breathe more slowly and you may feel more drowsy.

If you forget to use DEXITHERA 100 μg/mL Since a health care provider will administer DEXITHERA 100 μg/mL, it is unlikely that the dose will be missed.

If you stop using DEXITHERA 100 μg/mL Withdrawal symptoms may occur following prolonged use and abrupt discontinuation of DEXITHERA 100 μg/mL. Withdrawal symptoms include feeling agitated and developing a temporary high blood pressure, headache and nervousness.

DEXITHERA 100 μg/mL can have side effects. Not all side effects reported for DEXITHERA 100 μg/mL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DEXITHERA 100 μg/mL, please consult your health care provider for advice. If any of the following happens, tell your doctor immediately as infusion with DEXITHERA 100 μg/mL should be stopped:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DEXITHERA 100 μg/mL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• changes in the way your heart beats, if you notice it beating slower or faster;
• chest pain, heart attack or cardiac arrest (pain in the chest, back, jaw and other areas of your upper body that lasts more than a few minutes or that goes away and comes back, shortness of breath);
• shortness of breath, wheezing, slow or rapid breathing, difficulty breathing;

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• hypovolaemia (decreased blood volume, causing fatigue, a rapid heartrate, cool and clammy skin);
• high fever, headache, flushing of your skin and chills;
• withdrawal syndrome (causing agitation, headaches and nervousness);
• abnormal bleeding following surgery;
• high or low blood sugar;
• an increase or decrease of your blood pressure;
• anaemia (feeling tired, shortness of breath and a pale colour of your skin);
• nausea (feeling sick), vomiting (being sick) and dry mouth;
• feeling agitated.

Less frequent side effects:

• hypoalbuminaemia (low albumin level in the blood);
• metabolic acidosis (a condition where there is too much acid in the body);
• fluid retention (causing swelling of your hands, ankles and feet);
• decrease in urine volume;
• changes in your blood calcium levels when monitored;
• hallucinations (seeing or hearing things that aren’t real); abdominal distention (swelling of your stomach); thirst.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Side effects with unknown frequency:

Urinating more than usual.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your Health care provider. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DEXITHERA 100 μg/mL.

• Store at or below 30 °C.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the ampoule, vial or carton.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).