Adcopres 200 mcg Solution

ADCOPRES contains an active substance called dexmedetomidine, which belongs to a medicine group called sedatives. ADCOPRES is used to:

• To sedate (a state of calm, drowsiness or sleep) patients in the Intensive care unit (ICU) who are on mechanical ventilation after surgery
• For sedation prior to a minor surgery under local anaesthesia or when a breathing tube is placed in your windpipe to support your breathing.

ADCOPRES should not be administered to you, if:

• You are allergic to dexmedetomidine or to any of the other ingredients of this medicine (listed in section 6)
• Suffer from serious infection
• Had unstable trauma events
• Low blood (plasma) levels
• Abnormal heart rhythm
• Uncontrolled heart failure
• Liver failure
• You are pregnant or breastfeeding

Warnings and precautions

Special care should be taken with ADCOPRES:

• 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
• if you develop dry eyes when being administered ADCOPRES, lubrication should be considered.

Taking other medicines with ADCOPRES:

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) ADCOPRES may have an effect on other medicines or other medicines may have an effect on ADCOPRES. Tell your doctor if you are using medicines:

• which lower your blood pressure and heart rate, co-administration with ADCOPRES may enhance this effect.
• that cause temporary paralysis (the inability to move your muscles).

ADCOPRES is diluted and it is given to you as an infusion (drip) into your veins. You will not be expected to give yourself ADCOPRES. It will be given to you by a person who is qualified to do so. Your doctor will decide on a suitable dose for you. The amount of ADCOPRES 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.

If you are given more ADCOPRES than you should:

Since a health care provider will administer ADCOPRES, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdose.

If you forget to use ADCOPRES

Since a health care provider will administer ADCOPRES, it is unlikely that the dose will be missed.

ADCOPRES can have side effects. Not all side effects reported for ADCOPRES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop receiving ADCOPRES and tell your doctor immediately or go to the casualty department at your nearest hospital:

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

These are very serious side effects. If you have them, you may have had a serious allergic reaction to ADCOPRES. 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:

• change in breathing pattern or stopping breathing
• slower or faster heart rate
• chest pain or heart attack
• swelling of the stomach
• yellowing of the skin and eyes, also called jaundice

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:

• restlessness
• low or high blood pressure
• nausea, vomiting or dry mouth
• high temperature
• unpleasant feeling/symptoms after stopping the medicine
• agitation

Less frequent side effects:

• a condition where there is too much acid in the body
• low levels of the protein albumin in blood
• reduced heart function
• difficulty in breathing
• abdominal discomfort
• infections or sepsis
• blood problems (such as abnormal clotting, low white or red blood cells)
• low or high blood sugar
• anxiety, confusion
• depression, nervousness
• hallucination (seeing something that is not really there)
• convulsion (fits), dizziness, headache
• nerve pain, numbness
• an abnormal sensation (pins and needles) in the fingers, hands, toes, or feet
• speech problems
• disturbances in vision
• coughing
• increased saliva
• lung and breathing problems
• stomach pain, diarrhoea
• ulcers
• liver function problems
• kidney function problems
• increased sweating
• muscle weakness
• swelling
• pain
• chills and shivers
• increased urination
• difficulty in breathing
• thirst

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

Reporting of suspected adverse reactions

If you get 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 via “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of this medicine. For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected]

Store below 25°C. Keep the vials in the outer carton in order to protect from light. After dilution ADCOPRES should be used immediately. If not used immediately, ADCOPRES it may be stored at 2 - 8 °C and used within 24 hours.