Buprenorphine 2 mg sublingual tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)
• if you are a child under the age of 15 years
• if you have severe breathing problems
• if you have severe liver disease
• if you are an alcoholic or regularly drink large amounts of alcohol (more than two drinks per day for men and more than one drink per day for women (e.g. one drink = one 350 ml bottle of beer (4.5% alcohol) or one 150 ml glass of wine (12.9% alcohol))
• if you have delirium tremens (confusion and shaking after stopping drinking alcohol and hallucinations (seeing and hearing things that are not there))
• if you are breast-feeding a baby.

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:

• seizures, fits
• asthma or any other breathing problems
• any kidney problems
• any liver problems
• head injury or brain disease
• low blood pressure
• in men: urinary disorders (especially linked to enlarged prostate)
• thyroid problems
• adrenocortical disorder (e.g. Addison’s disease)
• depression or other conditions that are treated with antidepressants. The use of these medicines together with Buprenorphine can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Buprenorphine”).

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.

Breathing problems

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.

Dependence

This product can cause dependency.

Withdrawal symptoms

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.

Liver damage

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.

Blood pressure

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

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.

Tolerance, dependence, and addiction

This medicine contains buprenorphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Buprenorphine can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Buprenorphine 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.

If you notice any of the following signs whilst taking Buprenorphine, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Buprenorphine).

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:

• benzodiazepines (used for treatment of anxiety or sleep disorders) e.g. diazepam, temazepam, alprazolam: you should not take these medicines while you are taking Buprenorphine , unless prescribed by your doctor because this combination can be fatal if the correct dose is not carefully determined
• other opioid containing medicines, strong painkillers or cough medicines containing opioid-related medicines e.g. codeine, dihydrocodeine, methadone and morphine
• medicines used for the treatment of depression, including medicines known as monoamine oxidase inhibitors (MAOI; e.g. phenelzine)
• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Buprenorphine and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms
• antihistamine medicines (used for treatment of allergy and/or hay fever) e.g. promethazine and chlorphenamine
• barbiturates and other medicines used for the treatment of anxiety or sleep disorders
• medicines known as antipsychotics (used for the treatment of schizophrenia) e.g. chlorpromazine and haloperidol
• certain medicines for the treatment of high blood pressure (antihypertensives) e.g. clonidine.
• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• medicines to treat depression;
• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics);
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics);
• muscle relaxants;
• medicines to treat Parkinson’s disease;

Concomitant use of Buprenorphine 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 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:

• the antifungal medicine, ketoconazole (which can increase the levels of Buprenorphine in your blood if both are taken at the same time)
• medicines used to treat infections caused by viruses (antiviral agents) e.g. ritonavir, saquinavir and indinavir, used in the treatment of HIV infections
• oral contraceptive medicines containing gestodene
• certain medicines called ‘macrolide antibiotics’ (used for the treatment of infections), e.g troleandomycin.

If you are taking any of the following medicines, your doctor may need to prescribe a higher dose of Buprenorphine:

• anticoagulant medicine, phenprocoumon (to thin your blood).

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:

• medicines used for the treatment of epilepsy e.g. phenobarbital, carbamazepine and phenytoin
• the antibiotic medicine, rifampicin (used for the treatment of tuberculosis).

Use of Buprenorphine at the same time as the following medicines may cause withdrawal symptoms:

• methadone (used for treatment of opioid drug addiction)
• naltrexone (used to help you to remain free from your dependence on heroin, methadone and other similar opiate drugs of addiction).

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’.

For adults and adolescents aged 15 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 15 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 (respiratory depression).

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 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.

• The active substance is buprenorphine.
  Buprenorphine 2 mg: each tablet contains 2.16 mg buprenorphine hydrochloride equivalent to 2 mg buprenorphine.
  Buprenorphine 8 mg: each tablet contains 8.62 mg buprenorphine hydrochloride equivalent to 8 mg buprenorphine.
• The other ingredients are: lactose monohydrate, mannitol, citric acid anhydrous, sodium citrate dihydrate, povidone K30, butylhydroxyanisole (E320), maize starch, maize starch pregelatinised, magnesium stearate.

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

Manufacturer

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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 (Northern Ireland): Buprenorphine 2 mg sublingual tablets
Buprenorphine 8 mg sublingual tablets