Abstral sublingual tablets (Fentanyl (As Citrate))
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Abstral sublingual tablets Used For?
Abstral is a strong pain medicine specifically designed to treat breakthrough cancer pain in adults who are already receiving effective opioid therapy for their underlying cancer pain.
Primary Uses
Abstral is used to treat breakthrough pain in adults with cancer who are already receiving an effective maintenance dose of opioid therapy to control their persistent cancer pain. Breakthrough pain is a short episode of sudden intense pain despite well controlled persistent cancer pain.
How It Works
Abstral belongs to a group of strong pain relieving medicines called opioid analgesics, and works by blocking the sensation of pain.
Limitations of use: ABSTRAL should only be taken when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them.
How to Take Abstral sublingual tablets
Abstral sublingual tablet is placed under your tongue until dissolved. Do not suck, chew or swallow the tablet. Do not eat or drink anything until the tablet is completely dissolved.
Dosage Instructions
You must start with 100 micrograms of ABSTRAL. If adequate pain relief is not achieved within 30 minutes, your doctor may recommend a supplemental (second) 100 microgram tablet. Do not use more than two (2) doses of ABSTRAL for each episode of breakthrough cancer pain. Wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL. You can take ABSTRAL whenever you have an episode of breakthrough cancer pain; up to four (4) doses per day.
Administration Steps
Step 1: Remove tablet from blister pack immediately before use by separating one blister square and peeling back the foil edge. Step 2: Place the tablet under your tongue as far back as you can, and let it dissolve completely. Step 3: Dispose of the empty blister square. If your mouth is dry, take a sip of water to moisten it before placing the tablet under your tongue.
Important: DO NOT TAKE MORE THAN THE DOSE YOUR DOCTOR HAS RECOMMENDED FOR EACH EPISODE OF BREAKTHROUGH CANCER PAIN. You must tell your doctor immediately if you are using ABSTRAL more than four times per day.
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Nausea
- Drowsiness
- Vomiting
- Headache
- Dizziness
- Tiredness
- Excessive sweating
- Dry mouth
- Sore mouth or mouth/gum/lip ulcers
- Blurred vision
- Low blood pressure
- Itchy skin rash
- Bruising
- Joint pain and stiffness
- Constipation
- Loss of appetite
- Stomach pain
- Indigestion
Seek immediate medical attention if you experience:
- Shortness of breath, wheezing or difficulty breathing
- Fast or slow heartbeat
- Unusual or extreme mood swings
- Swelling of the face, lips, tongue or other parts of the body
- Skin rashes
- Trouble breathing
- Pauses in breathing during sleep
- Extreme drowsiness with slowed breathing
- Slow shallow breathing
- Feeling faint
- Confusion or unconsciousness
- Inability to think, talk, or walk normally
- Hallucinations
- Tremors
- Difficulty swallowing
- Severe upper abdomen pain
Important Warnings
Abstral poses serious risks including addiction, misuse, and life-threatening breathing problems. Your doctor will monitor you regularly during treatment.
Who Should Not Take Abstral sublingual tablets
Do not take if you are allergic to fentanyl or any ingredients; allergic to other opioid analgesics; for other types of short-term or acute pain (e.g. post-operative pain, headache, migraine); if you are not already receiving opioid maintenance therapy for cancer-related pain; if you have any lung conditions or breathing difficulties.
Medical Conditions to Discuss
Check with your doctor if you have: difficulty breathing, wheezing, chronic cough, asthma or COPD; myasthenia gravis; brain tumour, increased pressure in skull, reduced alertness, coma, or head injury; heart problems; liver or kidney problems; low blood pressure; mouth wounds or mucositis.
Pregnancy and Breastfeeding
Prolonged treatment with fentanyl during pregnancy or use during labour can cause breathing problems, signs of withdrawal, severe harm or life-threatening damage in the newborn. Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. You should not start breastfeeding until at least 5 days after the last dose of ABSTRAL.
Life threatening respiratory depression: ABSTRAL can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when taken as recommended. These problems can occur at any time during use, but the risk is higher when first starting ABSTRAL and after a dose increase, if you are older, or have an existing problem with your lungs.
Addiction Risk: ABSTRAL poses risks of abuse, misuse and addiction which can lead to overdose and death. You may have a greater risk of becoming addicted if you or anyone in your family have a history of substance abuse or mental illness.
Drug Interactions
Some medicines may interfere with ABSTRAL and affect how it works. Tell your doctor about all medicines you are taking.
Dangerous combinations: Taking ABSTRAL with other medicines that can make you feel drowsy such as sleeping tablets, other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids, cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death.
- Antibiotics (erythromycin, rifampicin, rifabutin)
- Antifungal medicines (ketoconazole, itraconazole)
- HIV medicines (ritonavir)
- Seizure medicines (gabapentin, pregabalin, carbamazepine, phenobarbital, phenytoin)
- Other pain medicines and cough suppressants
- Anaesthetics and muscle relaxants
- Sedative antihistamines
- Sleep aids, anxiety medicines, antidepressants, antipsychotics (barbiturates, benzodiazepines, cannabis)
- Certain antidepressants (phenelzine, selegiline)
- Alcohol
- Strong pain killers (buprenorphine, nalbuphine, pentazocine)
- Anticholinergic medicines
Alcohol & Driving
Do not consume alcohol or drive while taking Abstral as it can cause dangerous side effects.
Alcohol
Do not consume alcohol while taking ABSTRAL, as dizziness and drowsiness may become worse. There is an increased risk of decreased awareness, breathing difficulties, coma and death if taken at the same time as alcohol.
Driving and Operating Machinery
Do not drive or operate machinery while taking ABSTRAL as it may cause dizziness, drowsiness or blurred vision in some people.
Storage
Keep your medicine where the temperature stays below 25°C. Keep your medicine in the original pack until it is time to take it. Store it in a cool dry place, away from moisture, heat or sunlight. Do not store in the bathroom, near a sink, in the car or on window sills. Keep this medicine in a safe and secure place where other people and young children cannot access it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Overdose Information
If you or someone else receives too much ABSTRAL, immediately call triple zero (000) for an ambulance. Overdose symptoms may include slow, unusual or difficult breathing; drowsiness, dizziness or unconsciousness; slow or weak heartbeat; nausea or vomiting; convulsions or fits. Keep the person awake by talking to them or gently shaking them. You should immediately phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital.
Frequently Asked Questions
Abstral dissolves rapidly under the tongue and is absorbed to provide pain relief. If adequate pain relief is not achieved within 30 minutes, your doctor may recommend a second 100 microgram tablet.
You should not drink or eat anything until the tablet has completely dissolved under your tongue. If your mouth is dry, you can take a sip of water to moisten it before placing the tablet under your tongue, but spit out or swallow the water before taking Abstral.
Yes, Abstral poses risks of abuse, misuse and addiction which can lead to overdose and death. It may become habit forming causing mental and physical dependence. You may have a greater risk of becoming addicted if you or anyone in your family have a history of substance abuse or mental illness.
Your body may become used to taking Abstral, and stopping suddenly may cause withdrawal symptoms including loss of appetite, nausea, vomiting, nervousness, restlessness, body aches, increased heart rate, watery eyes, runny nose, chills, and increased sweating. When you stop taking Abstral, you must continue to take your usual opioid pain relieving medicine as advised by your doctor.
No, you must not drink alcohol while taking Abstral. There is an increased risk of decreased awareness, breathing difficulties, coma and death if taken at the same time as alcohol. Dizziness and drowsiness may also become worse.
You can take Abstral up to four (4) doses per day for breakthrough cancer pain episodes. You must wait at least 2 hours before treating another episode of breakthrough pain with Abstral. You must tell your doctor immediately if you are using Abstral more than four times per day.
No, do not switch from ABSTRAL to other medicines that contain fentanyl without your doctor’s advice as it can result in a fatal overdose. ABSTRAL is NOT interchangeable with other fentanyl products. Your doctor will prescribe starting and maintenance doses of the new fentanyl medicine if you are switching.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.