The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0043 .
Buprenorphine 2 mg and 8 mg sublingual tablets
Buprenorphine 2 mg sublingual tablets
Buprenorphine 8 mg sublingual tablets
1. What Buprenorphine is and what it is used for
2. What you need to know before you take Buprenorphine
3. How to take Buprenorphine
4. Possible side effects
5. How to store Buprenorphine
6. Contents of the pack and other information
Buprenorphine belongs to a group of medicines called opioid analgesics (also known as ‘opiates’ or ‘narcotics’). Opioid analgesics, such as morphine or diamorphine (heroin), are often subject to abuse, which can lead to dependence (addiction). If you are addicted to these drugs, you need a regular dose to feel ‘normal’, otherwise you will develop withdrawal symptoms within a day or so of the last dose. Withdrawal symptoms include sweating, feeling hot and cold, runny eyes and nose, feeling or being sick, diarrhoea, stomach cramps, poor sleep and just feeling awful.
Buprenorphine is used as a substitution (replacement) treatment in patients who are addicted to opioid drugs such as heroin and morphine. The tablets prevent or reduce the unpleasant withdrawal symptoms experienced when addicts stop using opioid drugs.
Treatment with Buprenorphine may form one aspect of a specialist support programme aimed at resolving opioid addiction.
Treatment with Buprenorphine is intended for use in adults and adolescents aged 16 years or older who have agreed to be treated for addiction.
Talk to your doctor or pharmacist before taking Buprenorphine if you have any of the following illnesses before treatment or if you develop them during treatment, as your doctor may need to reduce your dose of Buprenorphine or you may need extra treatment to control them:
Misuse, abuse and diversion
This medicine can be a target for people who abuse prescription medicines, and should be kept in a safe place to protect it from theft. Do not give this medicine to anyone else. It can cause death or otherwise harm them.
Some people have died from respiratory failure (inability to breathe) because they misused buprenorphine or took it in combination with other central nervous system depressants such as alcohol, benzodiazepines (medicines used to treat anxiety or sleep disorders) or other opioids.
This product can cause dependency.
This medicine can cause withdrawal symptoms if you take it less than 4-6 hours after you use a narcotic such as morphine or heroin or less than 24 hours after you use methadone.
Buprenorphine can cause withdrawal symptoms if you stop taking it abruptly.
Cases of severe liver injury have been reported following misuse, especially by intravenous route and at a high dose. These injuries may be worsened by viral infections (chronic hepatitis C), alcohol abuse, anorexia or some medicines with the ability to harm your liver (e.g. antiretroviral medicines, acetylsalicylic acid (aspirin), amiodarone, isoniazid, valproate). If you have symptoms of severe fatigue, no appetite, itching, or if your skin or eyes look yellow, tell your doctor immediately so that you can receive the proper treatment. Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Buprenorphine.
This medicine may cause sudden drop in blood pressure, causing you to feel dizzy if you get up too quickly from sitting or lying down.
Diagnosis of unrelated medical conditions
This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you take this medicine.
Sleepiness which may be worse if you also drink alcohol or take tranquillisers or anti-anxiety medicines. If you are drowsy, do not drive or operate machinery.
Sleep-related breathing disorders
Buprenorphine can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
Due to lack of data in adolescents (age 16-18), patients in this age group should be more closely monitored during treatment.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking or have recently taken any of the medicines listed below as they may interact with Buprenorphine.
The following medicines have sedative effects (make you feel sleepy/drowsy). These effects are increased if these medicines are taken while you are being treated with Buprenorphine:
Concomitant use of Buprenorphine SUN and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Buprenorphine SUN together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
If you are taking any of the following medicines, your doctor may need to prescribe a lower dose of Buprenorphine:
If you are taking any of the following medicines, your doctor may need to prescribe a higher dose of Buprenorphine:
If you are taking any of the following medicines, your doctor may need to prescribe either higher dose of Buprenorphine or lower dose of the following medicines:
Use of Buprenorphine at the same time as the following medicines may cause withdrawal symptoms:
You should not drink alcohol or take any medicines that contain alcohol while taking Buprenorphine. Alcohol increases the sedative effects of buprenorphine, which can make driving and operating machinery hazardous.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Buprenorphine should only be used during pregnancy in case the potential benefits outweigh the risks. Tell your doctor if you are pregnant or trying to become pregnant. If you become pregnant during treatment with buprenorphine, tell your doctor straight away. He will decide if your treatment should be continued with an alternative medication.
Since Buprenorphine is passed into breast milk, you must not breast-feed while taking this medicine.
Buprenorphine may cause drowsiness, particularly when taken together with alcohol or certain antidepressants. If you feel drowsy while being treated with this medicine, you should not drive or operate machinery.
Buprenorphine sublingual tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Buprenorphine sublingual tablets contain butylhydroxyanisole (E320), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Buprenorphine contains less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor may wish to perform some tests to see how well your liver is working before starting treatment with Buprenorphine, and at regular intervals during treatment.
To avoid sudden withdrawal symptoms, treatment with Buprenorphine should be given when there are already clear signs of withdrawal symptoms.
For adults and adolescents aged 16 years or older
The usual starting dose is between 0.8 mg to 4 mg, taken once a day. 0.4 mg dose strength of Buprenorphine is not available. If a lower dose is required, you should use tablets (0.4 mg) from another manufacturer.
For drug addicts who have not had any withdrawal treatment
One dose of Buprenorphine should be taken at least 4-6 hours after the last use of the opioid (narcotic such as morphine or heroin), or when the first signs of craving withdrawal appear. If you take it less than 4-6 hours after you use a narcotic you may get craving withdrawal symptoms.
For patients taking methadone
Your doctor should reduce the dose of methadone to no more than 30 mg per day before starting treatment with Buprenorphine. Buprenorphine may cause withdrawal symptoms in patients who are dependent on methadone if used within 24 hours of the last dose of methadone.
There are no clinical data on efficacy and safety for the use of Buprenorphine in children and adolescents. Therefore, Buprenorphine should not be used by children or adolescents under 16 years old.
Do not take the tablets at the same time as food or drink.
The tablets are described as ‘sublingual’. This means that the tablet should be placed under the tongue and kept there until fully dissolved, which usually occurs within 5 to 10 minutes. Do not chew or swallow the tablets whole - the medicine will not work this way and you may get withdrawal symptoms.
During your treatment, your doctor may increase your dose of Buprenorphine up to a dose of 24 mg per day, depending upon how you get on. Once you have been stable for a while, your doctor will gradually reduce your dose. With careful medical supervision, your dose may continue to be reduced until it is stopped altogether.
The effectiveness of this treatment depends on the dose and a combination of the associated medicinal, psychological and social treatment.
If you have the impression that the effect of Buprenorphine is too strong or too weak, talk to your doctor or pharmacist.
Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets with you as overdose with Buprenorphine may cause serious and life-threatening breathing problems.
You should tell your doctor and follow their instructions. Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to.
Do not suddenly stop taking the tablets unless told to do so by your doctor, as this may cause withdrawal symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Tell your doctor immediately or seek urgent medical attention if you experience side effects such as:
Also tell your doctor immediately if you experience side effects such as:
The following side effects have also been reported:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Frequency not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or house hold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Buprenorphine 2 mg sublingual tablet: white to off-white, round, biconvex uncoated sublingual tablet debossed with “2” on one side and plain on the other side.
Buprenorphine 8 mg sublingual tablet: white to off-white, round, biconvex uncoated sublingual tablet debossed with “8” on one side and plain on the other side.
The tablets are marketed in blisters of 7 and 28 sublingual tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Italy: Buprenorfina SUN 2 mg compresse sublinguale
Buprenorfina SUN 8 mg compresse sublinguale
The Netherlands: Buprenorphine SUN 2 mg tabletten voor sublinguaal gebruik
Buprenorphine SUN 8 mg tabletten voor sublinguaal gebruik
United Kingdom: Buprenorphine 2 mg sublingual tablets
Buprenorphine 8 mg sublingual tablets
This leaflet was last revised in 06/2021