What is in this leaflet
This leaflet answers some of the common questions people ask about Alfentanil GH.
It does not contain all the information that is known about Alfentanil GH.
It does not take the place of talking to your doctor, anaesthetist or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given Alfentanil GH against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor, anaesthetist or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Alfentanil GH is used for
Alfentanil GH is a drug used to relieve pain and produce anaesthesia.
It can be used as a premedication before an operation, or with a general anaesthetic during an operation.
Alfentanil GH belongs to a group of medicines called opioid analgesics.
Alfentanil GH works by changing the messages that are sent to the brain about pain.
Your doctor will have explained why you are being given Alfentanil GH.
Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
Alfentanil GH can be addictive, but when it is used only to relieve or prevent pain it is unlikely to become habit forming.
Before you are given Alfentanil GH
When you must not use it
Alfentanil GH should not be used for pain relief after surgery has taken place.
Alfentanil GH should not be used if you have an allergy, intolerance or hypersensitivity to:
- alfentanil;
- any ingredients listed at the end of this leaflet;
- other opioid analgesics (pain killers), eg. morphine or pethidine.
Symptoms of an allergic or hypersensitivity reaction may include:
- rash, itching or hives on the skin;
- shortness of breath, wheezing or difficulty breathing;
- swelling of the face, lips, tongue or other parts of the body.
Alfentanil GH is not generally given to children under 12 years of age.
Alfentanil GH injection will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not passed.
Before you are given it
You must tell your doctor if:
- you are pregnant or planning to become pregnant. Your doctor will decide if you can take Alfentanil GH. It may affect your baby if it is given early in pregnancy or in the last weeks before your baby is due.
- you are breastfeeding or wish to breastfeed. Alfentanil GH may be excreted in breast milk. Breastfeeding is not advisable for 24 hours after Alfentanil GH has been given.
- You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
- You are a smoker.
- You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
This medicine contains alfentanil which is an opioid medicine. Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on Alfentanil GH, it is important that you consult your doctor.
Tell your doctor if you have any of the following medical conditions:
- problems with your breathing such as severe asthma, severe bronchitis or emphysema;
- a history of fits or head injury;
- under-active thyroid;
- myasthenia gravis (muscle weakness);
- heart problems;
- liver or kidney problems;
- overweight or obese.
Tell your doctor if you take any medicine that slows down your reactions (CNS depressants), especially benzodiazepines or related drugs or have problems with alcohol. It may not be safe for you to be given Alfentanil GH or you may be given a reduced dose if you have any of these conditions.
If you have not told your doctor about any of the above, tell them before you are given Alfentanil GH.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food store.
Tell your doctor immediately and do not take Alfentanil GH if you are taking:
- medicines for depression called Monoamine Oxidase (MAO) Inhibitors. These medicines must not be taken in the 14 days before Alfentanil GH is given.
Also tell your doctor if you are taking:
- any anaesthetic agents such as propofol.
- any medicine that slows down your reactions (CNS depressants) such as benzodiazepines or related drugs, sleeping pills, tranquillizers, medicines for mental disorders, alcohol, some illegal drugs.
If you receive a strong pain killer or other CNS depressant after receiving Alfentanil GH during surgery, the dose of the pain killer or other CNS depressant may need to be lowered to reduce the risk of potentially serious side effects such as breathing difficulties, with slow or shallow breathing, severe drowsiness and decreased awareness, coma and death. 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. - an antibiotic called erythromycin.
- an antifungal called fluconazole, voriconazole, ketoconazole or itraconazole.
- a medicine for the stomach called cimetidine.
- an antiviral called ritonavir.
- a heart medicine called diltiazem.
- medicines for depression known as selective serotonin re-uptake inhibitors (SSRIs) or serotonin norepinephrine re-uptake inhibitors (SNRIs).
Alfentanil GH can increase the effects of alcohol. Tell your doctor about your consumption of alcohol and follow the doctor's advice.
If you have not told your doctor about any of these things, tell them before you are given Alfentanil GH.
These medicines may be affected by Alfentanil GH or may affect how well Alfentanil GH works. Your doctor can tell you what to do if you are taking any of these medicines.
Addiction
You can become addicted to Alfentanil GH even if you take it exactly as prescribed. Alfentanil GH may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking Alfentanil GH. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Alfentanil GH suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to Alfentanil GH may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:
- nervousness, restlessness, agitation, trouble sleeping or anxiety;
- body aches, weakness or stomach cramps;
- loss of appetite, nausea, vomiting or diarrhoea;
- increased heart rate, breathing rate or pupil size;
- watery eyes, runny nose, chills or yawning;
- increased sweating.
Alfentanil GH given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Also, if women receive this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
How Alfentanil GH is given
Alfentanil GH will be given to you by injection by a specially trained anaesthetist.
The injection is given into the vein (intravenous use).
Your doctor will decide how much Alfentanil GH you will need.
Elderly people may be given a smaller dose.
If you take too much (overdose)
The doctor or nurse giving you Alfentanil GH will be experienced in its use, so it is extremely unlikely that you will be given too much.
In the unlikely event that an overdose occurs, your doctor or the anaesthetist will take the necessary actions. The symptoms of overdose could include:
- slow, unusual or difficult breathing;
- drowsiness, dizziness or unconsciousness;
- slow or weak heartbeat;
- nausea or vomiting;
- convulsions or fits;
- muscle stiffness;
- lowering of blood pressure;
- lowering of heart rate.
If these symptoms occur, you may be administered another medicine (eg. naloxone) to help reverse the effects.
If you think you or anybody else has been given too much Alfentanil GH, immediately contact your doctor or nurse, or phone the Poisons Information Centre (telephone 13 11 26).
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well after you have been given Alfentanil GH.
Alfentanil GH helps most people suffering severe pain, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
After you have been given Alfentanil GH you will probably feel light-headed, dizzy, sleepy and you may feel quite strange, especially if you are not lying down.
Tell your doctor or nurse if you notice any of the following side effects and they worry you:
- nausea and vomiting;
- dizziness;
- drowsiness or sleepiness;
- injection site pain or pain during the procedure.
Tell your doctor or nurse as soon as possible if you have any of the following as you may need medical attention:
- feeling of extreme happiness (euphoric mood);
- visual disturbance such as blurred vision;
- chills;
- rash.
Tell your doctor or nurse immediately if you experience:
- breathing difficulties, which can last longer than its pain-killing effect;
- slow, fast or irregular heartbeat;
- tightening of the chest or heart attack;
- low or high blood pressure;
- muscle stiffness or involuntary muscle movements, including slow, stiff or jerking movements;
- spasm of the larynx (voice box).
Alfentanil GH may affect your alertness and ability to drive. Therefore you should not drive or operate machinery until your doctor advises that you can.
Some people may get other side effects after being given Alfentanil GH.
Tell your doctor or nurse if you notice anything else that is making you feel unwell.
After using Alfentanil GH
Storage
Store unopened Alfentanil GH ampoules in a cool dry place, where the temperature stays below 25°C. Do not freeze. Protect from light.
Alfentanil GH will be kept in a locked cupboard in the hospital pharmacy or operating theatre.
Alfentanil GH should not be used after the date printed on the label has passed. The anaesthetist will inspect Alfentanil GH before use to determine that it is still within its expiry date.
Disposal
The hospital staff looking after you will dispose of any remaining Alfentanil GH appropriately.
Product description
What it looks like
Alfentanil GH is a clear, colourless solution.
Alfentanil GH is available in 2 mL or 10 mL glass ampoules in cartons of 1, 5 or 10 ampoules*.
* Not all pack sizes may be marketed.
Ingredients
Active ingredient
Alfentanil GH is available as a sterile solution in an ampoule containing 1 mg/2 mL or 5 mg/10 mL of alfentanil (as hydrochloride).
Other ingredients
- Sodium chloride
- Hydrochloric acid
- Water for injections
Australian Registration Numbers
Alfentanil GH 1 mg/2 mL: AUST R 200007
Alfentanil GH 5 mg/10 mL: AUST R 199999
Sponsor
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
E-mail: ghinfo@generichealth.com.au
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au
This leaflet was prepared in December 2023.
Published by MIMS February 2024