BUPRENORPHINE 2 MG SUBLINGUAL TABLETS - patient leaflet, side effects, dosage

Buprenorphine 2mg, 8mg Sublingual tablets

Buprenorphine Hydrochloride

This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

What is in this leaflet

• 1. What Buprenorphine 2mg and 8mg Sublingual tablets are and what they are used for

• 2. What you need to know before you take Buprenorphine 2mg and 8mg Sublingual tablets

• 3. How to take the tablets

• 4. Possible side effects

• 5. How to store the tablets

• 6. Contents of the pack and other information

1. What Buprenorphine 2mg and 8mg Sublingual tablets are and what they are used for

This medicine has been prescribed for you for to treat dependence on opiate (narcotic) drugs, such as morphine and heroin in drug addicts who have agreed to be treated for their addiction. It contains buprenorphine which belongs to a class of medicines called opioids. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Buprenorphine sublingual tablets are used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support.

These tablets are described as ‘sublingual’. This means that the tablets should be placed under the tongue and kept there until fully dissolved which usually occurs within 5 to 10 minutes.

2. what you need to know before you take buprenorphine 2mg and 8mg sublingual tablets

Do not take Buprenorphine 2mg and 8mg Sublingual tablets:

• If you are a child under the age of 16 years
• If you are allergic (hypersensitive) to buprenorphine or to any of the other ingredients in this medicine (listed in section 6)
• If you have serious breathing problems
• If you have serious problems with your liver or if your doctor detects the development of such a problem during treatment
• If you are intoxicated due to alcohol or have trembling, sweating, anxiety, confusion or hallucinations caused by alcohol (delirium tremens).
• If you are breast-feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking Buprenorphine sublingual tablets if you have any of the following before treatment or develop them during treatment as your doctor may need to reduce your dose of this medicine or you may need extra treatment to control them:

• asthma or other breathing problems,
• any problems with your liver (inc. diseases such as hepatitis), gall bladder or bile ducts,
• low blood pressure,
• recently suffered head injury or brain disease,
• a urinary disorder (especially linked to enlarged prostate in men),
• any kidney disease,
• thyroid problems,
• adrenocortical disorder (e.g. Addison’s disease).
• if you suffer from seizures, fits or convulsions

Taking this medicine regularly, particularly for a long time, can lead to addiction

Addiction can cause withdrawal symptoms when you stop taking this medicine. 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 prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

The use of these medicines together with Buprenorphine 2mg and 8mg Sublingual tablets can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Buprenorphine 2mg and 8mg tablets”).

Important things to be aware of:

• - Misuse, abuse and diversion

Serious cases of infections with potential fatal outcome may occur in a context of misuse of this medicine when administered by the intravenous route. 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 this medicine or took it in combination with other central nervous system depressants, such as alcohol, benzodiazepines (tranquilisers), or other opioids.

• - Dependence

This product can cause dependence

• - Withdrawal symptoms

This product can cause withdrawal symptoms if you take it less than 6 hours after you use a short-acting opioid (e.g. morphine, heroin) or less than 24 hours after you use a long-acting opioid such as methadone. Buprenorphine can also cause withdrawal symptoms if you stop taking it abruptly.

• - Liver damage

Liver damage has been reported after taking buprenorphine, especially when the medicine is misused. This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4). 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 sublingual tablets.

• - Blood pressure

This product may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up too quickly from sitting or lying down.

• - Sleep-related breathing disorders

Buprenorphine sublingual tablets 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.

• - Elderly or debilitated patients

Additional caution should be taken if you are elderly or in a weakened state. It is important to take this medicine as your doctor or pharmacist has told you as you may require a reduced dose.

Other medicines and Buprenorphine 2mg and 8mg tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may increase the side effects of buprenorphine and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Buprenorphine tablets without first talking to your doctor, especially:

• anti-depressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Buprenorphine sublingual tablets 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.
• Benzodiazepines (used to treat anxiety or sleep disorders) such as diazepam, temazepam, alprazolam. 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 lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe this medicine 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.
• Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/se­izures, pain. These types of medicines will reduce your alertness levels making it difficult for you to drive and use machines. They may also cause central nervous system depression, which is very serious. Below is a list of examples of these types of medicines:

• – other opioid containing medicines such as methadone, certain pain killers and cough suppressants.

• – antidepressants (used to treat depression) such as monoamine oxidase inhibitors (inc. isocarboxazide, phenelzine, selegeline, tranylcypromine) and valproate may increase the effects of this medicine.

• – sedative antihistamines / H1 receptor antagonists (used to treat allergic reactions) such as diphenhydramine and chlorphenamine.

• – barbiturates (used to cause sleep or sedation) such as phenobarbital, secobarbital.

• – tranquilisers (used to cause sleep or sedation) such as chloral hydrate.

• Naltrexone may prevent Buprenorphine tablets from working. If you take naltrexone whilst you are taking Buprenorphine tablets you may experience a sudden onset of prolonged and intense withdrawal symptoms.
• Clonidine (used to treat high blood pressure or migraines) may extend the effects of this medicine.
• Anti-retrovirals (used to treat AIDS) such as ritonavir, nelfinavir, indinavir may increase the effects of this medicine
• Some antifungal agents (used to treat fungal infections) such as ketoconazole and itraconazole and certain antibiotics (macrolide) may extend the effects of this medicine.
• Some medicines may decrease the effect of Buprenorphine tablets. These include medicines used to treat epilepsy (such as carbamazepine and phenytoin) and medicines used to treat tuberculosis (rifampicin).

To get the greatest benefit from taking Buprenorphine tablets, you must tell your doctor about all the medicines you are taking, including alcohol, medicines containing alcohol, street drugs, and any prescription medicine you are taking that has not been prescribed for you by your doctor.

Buprenorphine tablets with food, drink and alcohol

Alcohol may increase drowsiness and may increase the risk of respiratory failure (inability to breathe) if taken with Buprenorphine Tablets. Do not drink alcohol or take medicines that contain alcohol whilst you are being treated with buprenorphine.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or intend to become pregnant. When taking during pregnancy, particularly late pregnancy, medicines like buprenorphine may cause drug withdrawal symptoms including problems with breathing in your new born baby. These symptoms may occur several days after birth. Do not breast-feed your baby whilst taking this medicine as Buprenorphine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine can cause drowsiness, which may be made worse if you also drink alcohol or take tranquillisers or anti-anxiety drugs. If you feel drowsy or dizzy while taking these tablets do not drive or operate machinery.

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

• ◦ The medicine has been prescribed to treat a medical or dental problem and

• ◦ You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

• ◦ It was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Important information about some of the ingredients of Buprenorphine tablets

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take buprenorphine 2mg and 8mg sublingual tablets

Your prescriber should discuss your treatment and whether you need to continue taking Buprenorphine

Sublingual tablets at regular intervals. If you and your prescriber decide to stop treatment, a plan will be put in place to gradually reduce the dose and stop taking the medicine to minimise the risk of withdrawal effects.

Always take this medicine as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not push the tablet our through the foil, this may damage the tablet.

Follow the diagram as indicated below.

The tablets are administered sublingually. This means that you must place the tablets under your tongue and allow it to dissolve which will take 5 to 10 minutes. This is the only effective and safe way the tablets should be taken. Do not chew or swallow them whole as this will make them ineffective.

Your doctor will tell you how many 2mg or 8mg Sublingual tablets to take and you should always follow this advice.

To avoid sudden withdrawal symptoms, treatment with Buprenorphine tablets should be given when there are already clear signs of withdrawal symptoms.The recommended dose is…

Adults and children over the age of 16 years: when beginning treatment the dose is between 0.8 to 4mg, taken once a day.

For drug addicts who have not had any withdrawal treatment: one dose of buprenorphine should be taken at least six hours after the last use of the opioid (narcotic such as morphine or heroin), or when the first signs of craving appear. If you take it less than six hours after you use a narcotic you may get withdrawal symptoms.

For patients receiving methadone: before beginning treatment your doctor should reduce your dose of methadone to not more than 30mg a day.

These tablets may cause withdrawal symptoms in patients who are dependent on methadone if used within 24 hours of the last dose of methadone.

During your treatment, your doctor may increase your dose to a maximum single daily dose of 32mg depending upon your response.

Once you have been stable for a while, your doctor may gradually reduce your dose. Depending on your condition your dose may continue to be reduced under careful medical supervision until it is stopped altogether. Do not suddenly stop taking these tablets as this may cause withdrawal symptoms.

If you take more Buprenorphine than you should

If you or someone else takes too much of this medicine, you must go or be taken immediately to an emergency centre or hospital as overdose with this product may cause serious and life-threatening breathing problems.

If you forget to take Buprenorphine

Tell your doctor as soon as possible if you miss a dose and follow his or her instructions. Do not take a double dose to make up for the forgotten dose.

If you stop taking Buprenorphine

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Pregnancy

Do not take Buprenorphine Sublingual tablets if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use buprenorphine during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Buprenorphine Sublingual tablets while you are breastfeeding as buprenorphine passes into breast milk and will affect your baby.

4. possible side effects

Like all medicines Buprenorphine tablets can cause side effects, although not everybody gets them.

Tell your doctor immediately or seek urgent medical attention if you experience side effects such as:-

• sudden wheezing, difficulty breathing, swelling of the eyelids, face, tongue, lips, throat or hands; rash or itching especially those covering your whole body. These may be signs of a life threatening allergic reaction
• if you start to breathe more slowly or weakly than expected (respiratory depression)
• if you start to feel faint, as this may be a sign of low blood pressure.

Also tell your doctor immediately if you experience side effects such as:

• severe fatigue (tiredness), have no appetite or if your skin or eyes look yellow. These may be symptoms of liver damage.

The frequency of possible side effects listed below is defined using the following convention:

• Very common (affects more than 1 user in 10)
• Common (affects 1 to 10 users in 100)
• Not known (frequency cannot be estimated from the available data).

Reporting of side effects

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:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store buprenorphine tablets

Keep out of the sight and reach of children.

Do not use after the expiry date which is stamped on the container.

Medicines should not be disposed of via wastewater or household waste. Return any unused tablets to your pharmacist. These measures will help protect the environment.

6. contents of the pack and other information

Each sublingual tablet contains buprenorphine hydrochloride equivalent to either 2mg or 8mg buprenorphine base as the active ingredient along with the following inactive ingredients: Lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate and magnesium stearate.

Buprenorphine tablets are white, uncoated tablets embossed with 2 or 8 on one side.

The sublingual tablets are available in cartons containing 7 tablets in a strip.

Marketing Authorisation Holder: Pharmacare (London) Limited, The Office, Heath View, Ray Lane, Blindley Heath Nr.Lingfield, Surrey, RH7 6LH, UK.

Manufacturer: Ascenders Consulting Services LTD, Basepoint 110 Butterfield, Great Marlings, Luton, LU2 8DL, UK.

PL numbers: 42311/0004 2mg, 42311/0005 8mg

This leaflet was last revised in February 2021