Remifentanil 1 mg Solution

REMIFENTANIL B. BRAUN belongs to a group of medicines called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action.

• REMIFENTANIL B. BRAUN may be used to stop you feeling pain or while you are having an operation.
• REMIFENTANIL B. BRAUN may be used to relieve pain while you are under controlled mechanical ventilation in an Intensive Care Unit.

REMIFENTANIL B. BRAUN should not be administered to you:

• if you are hypersensitive (allergic) to remifentanil, or any of the other ingredients of REMIFENTANIL B. BRAUN (listed in Section 6) or fentanyl derivates (such as alfentanil, fentanyl, sufentanil). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.
• as injection into the spinal canal
• as sole medicine to initiate anaesthesia
• In pregnancy and lactation
• Together with nitrous oxide and oxygen alone at altitudes above sea level
• Without artificial ventilation

Warnings and precautions

Before you receive REMIFENTANIL B. BRAUN, tell your doctor if you:

• ever had any adverse reactions during an operation
• ever had any allergic reactions or if you have been told that you are allergic to:
• any medicine used during an operation
• opioid medicine (e.g. morphine, fentanyl, pethidine, codeine), see also section above "you should not be given REMIFENTANIL B. BRAUN"
• suffer from impaired lung and/or liver function (you may be more sensitive for breathing difficulties)

Take special care with REMIFENTANIL B. BRAUN and tell your doctor:

• if you have a fast heart rate or feel agitated when the treatment is stopped;
• if you have stiff muscles;
• If you struggle to breath;
• If you feel faint or dizzy or have a very slow heart beat.

Elderly

If used for an operation under general anaesthesia, the initial dose of REMIFENTANIL B. BRAUN should be appropriately reduced in elderly patients. Elderly or weak patients (caused by decreased blood volume and/or low blood pressure) are more sensitive to suffer from cardiac or circulatory disturbances.

Children

REMIFENTANIL B. BRAUN is not recommended in neonates and infants (children under the age of one year). There is little experience of use of REMIFENTANIL B. BRAUN to treat children of this age in intensive care units.

Other medicine and REMIFENTANIL B. BRAUN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) This is especially important with the following medicine as they may interact with your REMIFENTANIL B. BRAUN:

• medicine for blood pressure or heart problems (known as beta-blockers or calcium channel blockers). These medicines may increase the effect of REMIFENTANIL B. BRAUN on your heart (lowering of your blood pressure and your heart beat).
• Other sedative medicine, such as benzodiazepines. These medicines increase the risk of drowsiness, difficulties in breathing, coma and may be life-threatening. Your doctor or pharmacist will alter the dose of these medicines when you are being given REMIFENTANIL B. BRAUN.
• Other opioids.
• Certain antidepressants.
• Medicines to treat migraine (triptans) or to treat vomiting.
• Medicines for the treatment of depression such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) and Monoamine Oxidase Inhibitors (MAOIs). It is not recommended to use these medicines at the same time as REMIFENTANIL B.BRAUN as they may increase the risk of serotonin syndrome, a potentially life-threatening condition.
• The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening.
• It may still be all right for you to receive REMIFENTANIL B. BRAUN and your doctor will be able to decide what is suitable for you.

REMIFENTANIL B. BRAUN with alcohol

After having received REMIFENTANIL B. BRAUN you should not drink alcohol until fully recovered.

Pregnancy and breastfeeding

REMIFENTANIL B. BRAUN should not be given to pregnant women. REMIFENTANIL B. BRAUN is not recommended during labour or a Caesarian section. If you are given this medicine during labour or close to childbirth, it can affect your baby’s breathing. You and your baby will be monitored for signs of excessive sleepiness and difficulty breathing. It is recommended that you stop breastfeeding for 24 hours after REMIFENTANIL B. BRAUN has been given to you. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before this medicine is given to you.

Driving and using machines

This medicine is only used in hospitalized patients. If you are discharged early, after you have been given REMIFENTANIL B. BRAUN, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone.

This medicine must only be given under carefully controlled conditions and emergency equipment has to be available. This medicine will be given by or under the supervision of an experienced doctor who is familiar with the use and action of the type of medicine. You will never be expected to give yourself this medicine. It will be given to you by a person who is qualified to do so.

The usual dosing and the duration of your infusion will be worked out by the doctor and can vary according to factors as your body weight, age, physical fitness, other medicines you are given and the type of operation you have.

REMIFENTANIL B. BRAUN can be given:

• as a single injection into your vein (intravenous bolus injection)
• as a continuous infusion (normally through a pump) into your vein. This is where the medicine is given to you over a period of time

If you receive more REMIFENTANIL B. BRAUN than you should or if you miss a dose of REMIFENTANIL B. BRAUN. Since a health care provider will administer REMIFENTANIL B. BRAUN, he/she will control the dosage, it is unlikely that you will be given too much or that you will miss a dose. However, in the event of overdosage your doctor will manage the overdosage. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

REMIFENTANIL B. BRAUN can have side effects. Not all side effects reported for REMIFENTANIL B. BRAUN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving REMIFENTANIL B. BRAUN, please consult your health care provider for advice.

The following side effects may be serious and demand immediate treatment:

Frequent

• breathing stops (apnoea)

Less frequent

• severe allergic reactions including shock, circulatory failure and heart attack in patients receiving REMIFENTANIL B. BRAUN with one or more anaesthetic medicines
• slow heart beat followed by heart block in patients receiving REMIFENTANIL B. BRAUN with one or more anaesthetic medicine

Frequency not known

• conculsions (seizures)
• heart block

Other side effects

Frequent

• muscle stiffness
• feeling nausea
• vomiting
• low blood pressure (hypotension)
• slow heart beat (bradycardia)
• shallow breathing (respiratory depression)
• itching
• shivering after the operation
• high blood pressure (hypertension) after the operation
• cough

Less frequent

• constipation
• pain after the operation
• oxygen deficiency (hypoxia)
• sleepiness (during recovering from the operation)

Frequency not known

• medicine tolerance
• irregular heartbeat (arrhythmia)

Discontinuation of treatment Symptoms following withdrawal of REMIFENTANIL B. BRAUN including fast heart rate, high blood pressure and extreme arousal have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days. Long-term use of REMIFENTANIL B. BRAUN can lead to dependence. 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 doctor or pharmacist. 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 REMIFENTANIL B. BRAUN.

• Keep this medicine out of reach of children.
• This medicine will be stored in the hospital pharmacy and the pharmacist will ensure:
• This medicine is not used after the expiry date which is stated on the carton and label after "EXP". The expiry date refers to the last day of that month.
• Is stored at or below 25 ˚C.
• Is not refrigerated or frozen.
• The solution is clear and free of particles and the container is not damaged.
• It is not disposed of in drains or sewerage systems (e.g. toilets).