Consumer medicine information

ALFENTANIL GH

ALFENTANIL GH

(alfentanil hydrochloride) solution for injection


Consumer Medicine Information

WARNING
Limitations of use
Alfentanil 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
Alfentanil 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
Alfentanil 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 Alfentanil 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 Alfentanil GH
Using Alfentanil 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 Alfentanil GH.

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.

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.
  • 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.

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 September 2020.

Published by MIMS November 2020