Subutex (buprenorphine)

Subutex sublingual tablets contain the active ingredient buprenorphine, which is a type of medicine called an opioid. Buprenorphine sublingual tablets are also available without a brand name, ie as the generic medicine.

What is it used for?

Buprenorphine substitution therapy for opioid addiction must be used in combination with other medical, social and psychological treatments.

How does it work?

Subutex sublingual tablets contain the active ingredient buprenorphine, which is a type of medicine called an opioid. Buprenorphine sublingual tablets are also available without a brand name, ie as the generic medicine.

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Opioids are painkillers such as codeine, morphine and diamorphine (heroin) that 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. However, opioids also act in the brain to cause feelings of euphoria and hallucinations. They can be addictive and people taking them long-term can become dependent on them.

Buprenorphine is an opioid that is used to wean people off their addiction to stronger opioids such as morphine, heroin and methadone. It is prescribed as a substitute for such drugs. By acting on the same opioid receptors as other opioids, buprenorphine prevents the physical withdrawal symptoms that occur when these drugs are stopped. This prevents physical cravings. Over time, the dose of buprenorphine is gradually reduced until it can be stopped completely.

Buprenorphine is only suitable as an opioid substitute in people who are moderately dependent on other opioids. This is because in addition to stimulating opioid receptors, buprenorphine also blocks them. In people who are dependent on high doses of opioids, this can cause withdrawal symptoms when the buprenorphine is started. For this reason, in people highly addicted to opioids, the daily opioid dose should be reduced gradually before therapy with buprenorphine is started.

For people taking methadone, the methadone dose should be reduced before this medicine is started. However, buprenorphine may still cause symptoms of withdrawal in people dependent upon methadone.

For drug addicts who have not undergone withdrawal, the first dose of this medicine should be taken at least 6 hours after the last use of the opioid, or when the first signs of craving appear. If it is taken earlier than this it can actually cause withdrawal symptoms.

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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.

Subutex sublingual tablets should placed under the tongue and allowed to dissolve. The buprenorphine will be absorbed into the bloodstream through the rich supply of blood vessels found in this area. The tablets dissolve in about five to ten minutes. They should not be sucked, chewed or swallowed, as this would make them less effective. 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.

Warning!

This medicine may cause drowsiness. If affected do not drive or operate machinery. Drowsiness will be made worse by alcohol, tranquilisers, sedatives and sleeping tablets such as benzodiazepines. Taking these in combination with buprenorphine can also cause potentially dangerous problems with breathing and so should be avoided while you are taking this medicine.

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.

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.

Your liver function should be regularly monitored while you are receiving treatment with this medicine.

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.

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Buprenorphine is not licensed for use during pregnancy. However, when it is prescribed as a substitute for illegal opioids such as heroin, it generally carries a lower risk to the mother and baby than if the mother continues to use illegal drugs. However, if the mother is dependent on buprenorphine during the third trimester of pregnancy, the baby may have withdrawal symptoms and breathing problems after birth and will need to be closely monitored. If you get pregnant while taking this medicine it is very important to get advice from your doctor. Withdrawal from buprenorphine (detox) is not generally recommended during the first or third trimesters of pregnancy. Pregnant women who are prescribed buprenorphine must be closely monitored by their doctor and midwife.

Small amounts of this medicine may pass into breast milk and it is not licensed for use during breastfeeding. 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. If the baby appears more sleepy than usual, becomes limp or floppy, or has any changes in its breathing, urgent medical advice is needed. It is important to get medical advice from your doctor and midwife before you start breastfeeding if you are taking buprenorphine.

Side effects

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.

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Constipation.

Headaches.

Difficulty sleeping (insomnia).

Feeling weak.

Drowsiness.

Nausea and vomiting.

Dizziness.

Fainting.

Sweating.

Slow, shallow breathing (respiratory depression).

Difficulty passing urine.

Inflammation of the liver (hepatitis).

Hallucinations.

Withdrawal symptoms in people addicted to high doses of opioids.

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 it's necessary they'll report it for you.

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, low blood pressure and slow, shallow breathing that can potentially be fatal, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following, which should be avoided while taking this medicine:

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alcohol

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 dependent on high doses of other opioids, eg morphine, diamorphine, methadone, this medicine may cause some withdrawal symptoms. This is because buprenorphine can block some of the effects of other opioids. People highly dependent on other opioids should have their daily opioid dose reduced before starting treatment with this medicine.

The following medicines may increase the blood level of buprenorphine and you may need a lower dose if you are taking one of these:

azole antifungals such as itraconazole, ketoconazole

macrolide antibiotics such as erythromycin, clarithromycin

protease inhibitors for HIV infection, such as ritonavir, indinavir, saquinavir.

The following medicines may decrease the blood level of buprenorphine and so could cause withdrawal symptoms if taken by someone dependent on buprenorphine:

carbamazepine

phenobarbital

phenytoin

rifampicin

the herbal remedy St John's wort (Hypericum perforatum).

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

Gabup sublingual tablets.

Prefibin sublingual tablets.

Buprenorphine sublingual tablets are also available without a brand name, ie as the generic medicine.

The following medicines also contain buprenorphine, but these are used for treating severe pain, not opioid addiction:

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