Abstral sublingual tablets

Why am I taking ABSTRAL?
ABSTRAL contains the active ingredient fentanyl (as citrate). ABSTRAL is a strong pain medicine used to treat breakthrough cancer pain in adults who are already receiving an effective maintenance dose of opioid therapy for their underlying cancer pain. For more information, see Section 1. Why am I taking ABSTRAL? in the full CMI.

What should I know before I take ABSTRAL?
Do not take if you have ever had an allergic reaction to fentanyl or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take ABSTRAL? in the full CMI.

What if I am taking other medicines?
Some medicines may interfere with ABSTRAL and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I take ABSTRAL?
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. If needed, you can moisten your mouth by rinsing it with water before placing the tablet under your tongue.
More instructions can be found in Section 4. How do I take ABSTRAL? in the full CMI.

What should I know while taking ABSTRAL?


Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking ABSTRAL
Carefully follow your doctor's instructions on how much ABSTRAL to take for each breakthrough pain episode, especially when you first start taking ABSTRAL or change the dose
Talk to your doctor or pharmacist if your pain does not improve.

Things you should not do
Do not take ABSTRAL for other types of pain (e.g. post-operative pain, headache, migraine)
Do not take ABSTRAL unless you have already been receiving opioid maintenance therapy for cancer-related pain for at least one week, because it may increase the risk of experiencing severe breathing difficulties
Do not take ABSTRAL if you have any lung conditions or breathing difficulties unless your doctor tells you to.

Driving or using machines
Do not drive or operate machinery while taking ABSTRAL as it can cause dizziness, drowsiness or blurred vision.

Drinking alcohol
Do not consume alcohol while taking ABSTRAL, as dizziness and drowsiness may become worse.

Looking after your medicine
Keep your medicine in a cool dry place below 25°C
Keep your medicine where children cannot reach it.

For more information, see Section 5. What should I know while taking ABSTRAL? in the full CMI.

Are there any side effects?
The most common side effects of ABSTRAL are nausea, drowsiness and vomiting. Tell your doctor or pharmacist immediately or go to Emergency Department at your nearest hospital if you experience shortness of breath, wheezing or difficulty breathing, fast or slow heartbeat, dizziness or light-headedness, unusual or extreme mood swings, blurred vision, swelling of the face, lips, tongue or other parts of the body, or skin rashes.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.


WARNING:
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.
Hazardous and harmful use
ABSTRAL 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
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. Your doctor will monitor you and change the dose as appropriate.
Use of other medicines or alcohol while taking ABSTRAL
Taking ABSTRAL with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. 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 taking ABSTRAL.

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