You should not be given SUBLIMAZE if:
- you are hypersensitive (allergic) to fentanyl or any of the other ingredients of SUBLIMAZE (listed in section 6)
- you have previously had an allergic reaction to SUBLIMAZE or a similar painkiller, called opioid analgesics
- you are suffering from uncontrolled bronchial asthma or are in heart failure secondary to chronic lung disease
- you are suffering from respiratory depression, especially in the presence of cyanosis (blue-coloured skin caused by too little oxygen in your blood) and excessive bronchial secretion (mucus)
- you are in a coma (unconscious) due to a head injury or brain tumour, and conditions in which increased pressure in your skull/brain occurs
- you had an operation on your biliary tract
- you are taking monoamine oxidase inhibitors (medicine used to treat depression, panic or anxiety disorders, or Parkinson’s disease) or within 14 days of stopping such treatment (see Other medicines and SUBLIMAZE)
- you have a problem with or are dependent on the use of alcohol (alcoholism).
SUBLIMAZE should not be administered to children 2 years of age or younger.
Warnings and precautions
Take special care with SUBLIMAZE:
- SUBLIMAZE is a strong painkiller and should be given only by your doctor or health care provider.
- SUBLIMAZE may weaken breathing. This may also occur some time after the operation. Therefore, you will remain under supervision for a while after the operation. If you experience severe drowsiness or breathing problems, tell a doctor or health care provider immediately.
- If you have a lung disease or breathing problems, a brain disorder, impaired thyroid, liver or kidney function: always inform your doctor of this to ensure optimal care.
- If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
- If you feel you need to take more SUBLIMAZE to get the same level of pain relief. This may mean you are becoming tolerant to the effects of SUBLIMAZE or are becoming addicted to it. Consult your doctor who will discuss your treatment and may change your dose or prescribe an alternative pain reliever.
SUBLIMAZE should be kept in a safe and secure place, not accessible by others, due to the risks and fatal outcome associated with accidental ingestion, misuse and abuse of SUBLIMAZE. Receiving SUBLIMAZE regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely. Increasing the dose of SUBLIMAZE can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment. Addiction can cause withdrawal symptoms when you stop receiving SUBLIMAZE. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how your dose will be gradually reduced before stopping SUBLIMAZE. It is important that you do not stop receiving SUBLIMAZE suddenly, as you will be more likely to experience withdrawal symptoms. SUBLIMAZE should only be used by those they are prescribed for. Receiving higher doses or more frequent doses of an opioid may increase the risk of addiction. Opioid-induced hyperalgesia (OIH) occurs when an opioid, such as SUBLIMAZE, used for pain relief, causes an increase in pain (called hyperalgesia) or an increased sensitivity to pain (called allodynia). OIH is a condition that can occur at any dosage of SUBLIMAZE, but it may occur more often with higher doses and longer-term use. Talk to your doctor or health care provider if your pain increases, if you feel more sensitive to pain, or if you have new pain after receiving SUBLIMAZE. SUBLIMAZE may lead to increased pressure in your bile duct (the tubes that carry bile from your liver to your intestines), and spasms of the sphincter of Oddi (causing the small muscle not to open when it should) due to its anticholinergic effect. Tell your doctor or health care provider before receiving SUBLIMAZE if you have or have ever had:
- an underactive thyroid gland
- muscle weakness called myasthenia gravis
- low blood volume (excessive blood loss)
- a recent head injury.
If you are an elderly person or weak due to ill health, your doctor will carefully monitor the amount of SUBLIMAZE they give you. If you are not sure if any of the above applies to you, talk to your doctor or health care provider before receiving SUBLIMAZE.
Tell your doctor before receiving SUBLIMAZE if:
- 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.
Repeated use of opioid painkillers, as in SUBLIMAZE, may result in the medicine 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 are concerned that you may become dependent on SUBLIMAZE, it is important that you consult your doctor. If your SUBLIMAZE treatment is stopped, withdrawal symptoms may occur. Please tell your doctor or health care provider if you think this is happening to you (see section 4. Possible side effects).
Children and adolescents
SUBLIMAZE should not be given to children younger than 2 years of age.
Other medicines and SUBLIMAZE
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Occasionally, it is necessary to adapt the dose in the case of combined use. Your doctor will decide what dose is appropriate for you.
