Temgesic sublingual tablets (buprenorphine)
|Main use||Active ingredient||Manufacturer|
|Moderate to severe pain||Buprenorphine hydrochloride||Reckitt Benckiser Pharmaceuticals|
How does it work?
Temgesic sublingual tablets contain the active ingredient buprenorphine, which is a type of medicine called an opioid analgesic (painkiller). Buprenorphine is a strong painkiller related to morphine.
Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.
Buprenorphine mimicks the action of natural endorphins by stimulating the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.
Buprenorphine is used to relieve moderate to severe pain. However, it is used less frequently than other opioid painkillers because it can oppose the effects of other opioid painkillers that may be given at the same time. This is because as well as stimulating opioid receptors, buprenorphine can also block them and thus stop other opioids from acting on them. In people who are dependent on opioids, this can cause withdrawal symptoms and an increase in pain.
Temgesic sublingual tablets are designed to dissolve underneath the tongue. This allows the buprenorphine to be absorbed into the bloodstream through the rich supply of blood vessels found in this area. The tablets should not be chewed or swallowed, as this would make them less effective. The pain-relieving effect of these tablets lasts for about six to eight hours.
What is it used for?
- Relieving moderate to severe pain.
How do I take it?
- This medicine should only be taken as directed by your doctor. Follow the instructions given by your doctor or pharmacist. These will also be printed on the label your pharmacist has put on the medicine. If you are unclear about anything you should talk to your doctor or pharmacist.
- Temgesic sublingual tablets should placed under the tongue and allowed to dissolve. Do not chew, suck or swallow the tablets. The tablets don't dissolve as well in a dry mouth, so if your mouth is very dry you should have a drink of water before putting the tablet under your tongue.
- The tablets can be taken either before or after food and are usually taken every six to eight hours.
- This medicine may cause drowsiness and dizziness and can affect your ability to concentrate. This could affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure you can do so safely.
- You should avoid drinking alcohol while taking this medicine as it is likely to increase the chance of you feeling drowsy or dizzy.
- From March 2015 a new 'drug driving' law comes into force, which makes it an offence to drive with certain drugs or prescription medicines above specified limits in your body. Buprenorphine is in the same class of medicines as some of the medicines on the list, which means it may be an offence to drive while you are taking this medicine. The new law will allow police to use roadside drug tests to check for the presence of the prohibited drugs in a driver's saliva. There are very low limits for illegal drugs, but higher limits for prescribed medicines. This means most people taking buprenorphine as prescribed will not be breaking the law, provided they are not driving dangerously. If you test positive for one of the medicines there is a medical defence if you are taking it as prescribed, as long as your driving is not impaired. If you are taking a high dose of buprenorphine it may therefore be sensible to carry your prescription with you if you feel you are safe to drive, in case you are asked to take a test by the police. You should not drive if you think this medicine affects your ability to drive safely, for example if it makes you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision. If you are driving dangerously while taking this medicine you will be breaking the law.
- With prolonged use, the body may become dependent on this medicine. As a result, withdrawal symptoms such as feeling agitated, anxious, nervous or shaky, or having difficulty sleeping, may occur after you stop using the medicine. This is rare, but tell your doctor if you experience any of these symptoms after stopping this medicine. If they occur, these effects usually disappear within a few days.
- Buprenorphine is a controlled drug. If you are planning to travel abroad with it you should check its legal status in the countries you are travelling through and to. There are legal limits on how much of this medicine you can take abroad with you. If you need to take more than this limit you will have to apply to the Home Office for a licence before you travel. Even if you don't need a licence, if you are taking this medicine abroad it is always a good idea to carry a letter from your doctor that confirms your need for the medicine. You should always carry the medicine in correctly labelled packaging, as dispensed by the pharmacy.
Use with caution in
- Elderly, weak or debilitated people.
- People with decreased liver or kidney function.
- People with decreased lung function or breathing difficulties, for example asthma (see also below).
- People with low blood pressure (hypotension) or low circulating blood volume (hypovolaemia).
- People with reduced production of natural steroid hormones by the adrenal glands (adrenocortical insufficiency).
- People with an underactive thyroid gland (hypothyroidism).
- People with difficulty passing urine, for example men with an enlarged prostate gland.
- People with disorders of the bile ducts.
- People with chronic constipation, inflammatory or obstructive bowel disease.
- People with a history of convulsions (fits), eg epilepsy.
- A condition called myasthenia gravis, in which there is abnormal muscle weakness.
- People who have recently been treated with other opioid painkillers.
- People with a history of drug abuse.
Not to be used in
- Children under six years of age.
- People with very slow, shallow breathing (respiratory depression).
- People having an asthma attack.
- People who have or who are at risk of getting a blockage in the gut (paralytic ileus).
- People with a head injury or increased pressure in the brain (raised intracranial pressure).
- People dependent on opioids.
- Temgesic is not licensed for substitution therapy in people having treatment for opioid dependence. Other brands of buprenorphine are used for this - see end of page.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine is not recommended for use during pregnancy, particularly in the third trimester, unless the benefits to the mother outweigh any potential risks to the baby. If used during labour it may cause breathing difficulties in the baby after the birth. Babies born to mothers who have been taking this medicine for a long time may have withdrawal symptoms after the birth. Seek further medical advice from your doctor.
- Small amounts of this medicine may pass into breast milk. It should be used with caution in women who are breastfeeding because it can potentially cause problems in the nursing baby, such as breathing or feeding problems. If used during breastfeeding the nursing infant may need to be monitored. Seek further medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Nausea and vomiting.
- Drowsiness. See warnings above.
- Constricted pupils.
- Slow, shallow breathing.
- Low blood pressure (hypotension).
- Feeling confused or disorientated.
- Mood changes.
- Nervousness or restlessness.
- Seeing or hearing things that are not really there (hallucinations).
- Visual disturbances such as blurred or double vision.
- Changes in heart rate.
- Skin rashes or itching.
- Loss of appetite.
- Abdominal pain or diarrhoea.
- Difficulty passing urine (urinary retention).
- Inflammation of the liver (hepatitis).
- Mouth irritation.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think its necessary they'll report it for you.
You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
There may be an increased risk of side effects such as drowsiness, sedation and slow, shallow breathing, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following:
- antipsychotics, eg haloperidol, chlorpromazine
- barbiturates, eg phenobarbital, amobarbital
- benzodiazepines, eg diazepam, temazepam
- muscle relaxants, eg baclofen
- other opioids, eg codeine, tramadol, morphine
- sedating antihistamines, eg chlorphenamine, hydroxyzine
- sleeping tablets, eg zopiclone
- tricyclic antidepressants, eg amitriptyline.
In people who are highly dependent on other opioids, eg codeine, morphine, diamorphine, this medicine may cause some withdrawal symptoms. This is because buprenorphine can block some of the effects of other opioids.
The following medicines may increase the blood level of buprenorphine and you may need a lower dose if you are taking one of these:
- protease inhibitors for HIV infection, such as ritonavir, indinavir, saquinavir.
The following medicines may decrease the blood level of buprenorphine and could make it less effective:
The manufacturer states that this medicine should be used with caution in people who are taking a type of medicine called a monoamine oxidase inhibitor (MAOI), for example, the antidepressants isocarboxazid, phenelzine or tranylcypromine.
Other medicines containing the same active ingredient
- BuTrans patches.
- Hapoctasin patches.
- Temgesic injection.
- Tephine sublingual tablets.
- Transtec patches.
Subutex, Gabup, Prefibin and unbranded buprenorphine sublingual tablets also contain buprenorphine, but these are used to treat opioid dependence and are not for pain relief.
For background information about our medicine factsheets, including the references used to produce them, click here.