(fentanyl citrate) solution for injection
Consumer Medicine Information
Limitations of Use
Fentanyl GH should only be used when your doctor decides that other treatment options are not able to effectively manage your pain, or you cannot tolerate them.
Hazardous and Harmful Use
Fentanyl GH poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.
Life Threatening Respiratory Depression
Fentanyl GH can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing), even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting Fentanyl GH and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate.
Use of Other Medicines While Using Fentanyl GH
Using Fentanyl GH with other medicines that can make you feel drowsy such as sleeping tablets (eg. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (eg. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Fentanyl GH.
What is in this leaflet
This leaflet answers some common questions about Fentanyl GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you receiving Fentanyl GH against the benefits this medicine is expected to have for you.
If you have any concerns about receiving Fentanyl GH, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What Fentanyl GH is used for
Fentanyl GH injection is a drug used to provide short-term pain relief and to help anaesthesia when you have an operation. It is a strong painkiller for use in hospitals.
Fentanyl GH injection contains a medicine called fentanyl. It belongs to a group of medicines known as opioid analgesics.
Fentanyl relieves pain by blocking the nerves in the brain that recognise pain messages from the body.
Your doctor may have prescribed Fentanyl GH for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Fentanyl GH may be addictive. Addiction is unlikely in patients who receive it under medical supervision.
You may be at more risk of addiction if:
- you or someone in your family have a history of drug and alcohol abuse or mental illness.
- you require repeated injections of Fentanyl GH.
- you need increasingly larger doses of Fentanyl GH to control your pain.
Before you are given Fentanyl GH
When you must not be given it
Fentanyl GH should not be used:
- if you have an allergy or known intolerance to fentanyl, other strong pain killers or any of the ingredients listed at the end of this leaflet.
- if you suffer from asthma or if you are particularly prone to breathing difficulties (for example, in the case of head injury, coma or brain tumour).
- if you have taken a type of medicine known as monoamine oxidase inhibitors (MAOIs) within the last 14 days. These include phenelzine, moclobemide and tranylcypromine (for depression) and selegiline (for Parkinson’s disease).
- if you suffer from a condition known as myasthenia gravis which causes constant weakness of muscles.
- in children less than two years old.
Fentanyl GH should not be used if the packaging is torn or shows signs of tampering. It should not be used beyond the expiry date (month and year) printed on the pack.
Before you are given it
You must tell your doctor if:
- you are pregnant or planning to become pregnant.
- you are breastfeeding or wish to breastfeed. Fentanyl is excreted in human milk.
- you have a lung disease or breathing problems such as severe asthma, severe bronchitis or emphysema.
- you have a brain disorder.
- you know you have a slow or irregular heartbeat or heart problems.
- you have or have ever had kidney or liver problems.
- you or someone in your family have a history of drug and alcohol abuse or mental illness.
- you have an underactive thyroid gland.
- you take any medicine that slows down your reactions (eg. CNS depressants), especially benzodiazepines or related drugs.
If you have not told your doctor or pharmacist about any of the above, tell them before you are given Fentanyl GH.
Your doctor will decide whether or not to treat you with Fentanyl GH or whether to adjust the dose or alter your treatment.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- medicines which make you feel drowsy or slow to react (eg. CNS depressants), such as benzodiazepines or related drugs, sleeping tablets, tranquillisers, alcohol, strong pain-killers or some illegal drugs. This also includes a group of medicines called neuroleptics, for example droperidol.
If you take any of these medicines, the dose of Fentanyl GH may have to be decreased. Also, if you receive a strong painkiller or other CNS depressant after receiving Fentanyl GH during surgery, the dose of the painkiller or other CNS depressants 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.
- medicines known as monoamine oxidase inhibitors (MAOIs). These include phenelzine, moclobemide and tranylcypromine (for depression) and selegiline (for Parkinson’s disease). They should be stopped for 14 days before Fentanyl GH is given.
- medicines for depression known as selective serotonin re-uptake inhibitors (SSRIs) or serotonin norepinephrine re-uptake inhibitors (SNRIs). These include fluoxetine, paroxetine, sertraline and venlafaxine.
- ritonavir (a protease inhibitor used to treat HIV).
- medicines for infections such as voriconazole or fluconazole.
These medicines may be affected by Fentanyl GH or may affect how well Fentanyl GH works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effect on driving and operating machinery
Fentanyl GH can have a negative effect on your alertness and ability to drive and operate machinery. Do not drive or operate machinery until your doctor says it is safe.
Effect of alcohol
Fentanyl GH can increase the effect of alcohol.
You can become addicted to Fentanyl GH even if you take it exactly as prescribed. Fentanyl GH may become habit forming causing mental and physical dependence. If abused, it may become less able to reduce pain.
As with all other opioid containing products, your body may become used to you taking Fentanyl GH. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Fentanyl GH suddenly, so it is important to take it exactly as directed by your doctor
Tolerance to Fentanyl 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.
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.
Fentanyl GH given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Prolonged use of Fentanyl GH during pregnancy may cause withdrawal syndrome in the newborn. Tell your doctor if you are pregnant or planning to become pregnant.
How Fentanyl GH is given
Fentanyl GH is given by your doctor as an injection into a muscle or a vein. Your doctor will decide how much Fentanyl GH you need. This will depend on your age, body weight, medical conditions and history.
The usual dose of Fentanyl GH ranges from 25 micrograms to 100 micrograms depending on what it is being used for. Repeat doses may be given in some cases.
If you are elderly or if have problem with your kidneys, you may be given a lower dose of Fentanyl GH.
Children 2 to 12 years old
The usual dose ranges from 20 micrograms to 30 micrograms per 10 kg of body weight.
Fentanyl GH is not recommended for use in children under 2 years of age.
If you are given too much (overdose)
The doctor or the anaesthetist giving you Fentanyl GH will be experienced in its use, so it is 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 Fentanyl GH, contact your doctor or nurse immediately or the Poisons Information Centre who will advise you what to do.
You can contact the Poisons Information Centre by dialling:
- Australia: 13 11 26.
While you are given Fentanyl GH
Things you must do
Tell your doctor or nurse if you do not feel well after being given Fentanyl GH (see ‘Side effects’).
Things you must not do
Do not drive or operate machinery until your doctor says it is safe to do so.
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 side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or nurse to answer any questions you may have.
Tell your doctor or nurse immediately if you notice any of the following as you may need urgent medical care:
- difficulty in breathing (abnormally slow and/or weak breathing or increased breathing rate or a temporary cessation of breathing);
- muscle stiffness or involuntary muscle movements, including slow, stiff or jerking movements;
- slow, fast or irregular heart beat or cardiac arrest;
- a feeling of choking which is caused by the spasm of the muscles around the voice box;
- allergic reactions such as skin rash, redness and swelling of the face, neck or throat;
- severe drowsiness;
- loss of consciousness.
Tell your doctor if you experience any of the following:
- low, high or variable blood pressure which may cause headache, weakness or dizziness;
- blurred vision;
- nausea, vomiting;
- excessive sweating;
- an unusual sense of wellbeing;
- post-operative confusion or agitation;
- neurological or airway complications of anaesthesia;
- vein pain or inflammation;
- chills or lowered body temperature;
- visual disturbance.
If you become dependent on Fentanyl GH and your injections are suddenly stopped or greatly reduced, you may experience withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety and shivering.
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
After using Fentanyl GH
Store unopened Fentanyl GH ampoules in the pack and in a cool dry place, where the temperature stays below 25°C. Protect from light.
Fentanyl GH will be kept in a locked cupboard in the hospital pharmacy or operating theatre.
Fentanyl GH should not be used after the use by date (month and year) printed after “EXP”. The anaesthetist will inspect Fentanyl GH before use to determine that it is still within its use by date.
The hospital staff looking after you will dispose of any remaining Fentanyl GH appropriately.
What it looks like
Fentanyl GH injection is a clear, colourless to almost colourless solution.
100 micrograms fentanyl in 2 mL Type 1 clear glass ampoules in cartons of 1, 5 or 10 ampoules.
500 micrograms fentanyl in 10 mL Type 1 clear glass ampoules in cartons of 1, 5 or 10 ampoules.
Not all pack sizes may be marketed.
The 2 mL ampoule contains 100 micrograms of fentanyl (as citrate).
The 10 mL ampoule contains 500 micrograms of fentanyl (as citrate).
- Sodium chloride.
- Sodium hydroxide.
- Water for injections.
Australian Registration Numbers
Fentanyl GH 100 micrograms/2 mL injection: AUST R 201872
Fentanyl GH 500 micrograms/10 mL injection: AUST R 201871
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Telephone: +61 3 9809 7900
This leaflet was prepared in October 2021.
Published by MIMS December 2021