PACKAGE LEAFLET: INFORMATION FOR THE USER

Buprenorphine 2 mg and 8 mg Sublingual Tablets

(Buprenorphine)

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 Sublingual Tablets are and what they are used for

2.    What you need to know before you take Buprenorphine Sublingual Tablets

3.    How to take Buprenorphine Sublingual Tablets

4.    Possible side effects

5.    How to store Buprenorphine Sublingual Tablets

6.    Contents of the pack and other information

1. What Buprenorphine Sublingual Tablets are and what they are used for

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 Sublingual Tablets are 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 Sublingual Tablets may form one aspect of a specialist support programme aimed at resolving opioid addiction.

The tablets are not to be used for pain relief purposes.

2. What you need to know before you take Buprenorphine Sublingual Tablets

Do not take Buprenorphine Sublingual Tablets

*    if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6)

*    if you have severe breathing problems

*    if you have severe liver disease

*    if you are an alcoholic or regularly drink large amounts of alcohol

*    if you have delirium tremens ('DTs', 'the shakes' and hallucinations)

*    if you are breast-feeding (see the section 'Pregnancy and breast-feeding' below for more information)

Buprenorphine Sublingual Tablets must not be used by children or adolescents under 16 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking Buprenorphine Sublingual Tablets:

*    if you have asthma or any other breathing problems

*    if you have any kidney problems

*    if you have any liver problems

Other medicines and Buprenorphine Sublingual Tablets

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

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 and temazepam: 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

*    barbiturates and other medicines used for the treatment of anxiety or sleep disorders

*    other medicines containing opioid-related medicines e.g. codeine, dihydrocodeine and morphine (used as strong painkillers and in some cough medicines)

*    medicines used for the treatment of depression, including medicines known as monoamine oxidase inhibitors (MAOIs) e.g. phenelzine

*    antihistamine medicines (used for treatment of allergy and/or hay fever) e.g. promethazine and chlorphenamine

*    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

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

*    the antifungal medicine, ketoconazole

*    medicines used to treat infections caused by viruses (antiviral agents) e.g. ritonavir, saquinavir and indinavir, which are used in the treatment of HIV infections

*    oral contraceptive medicines containing gestodene

*    certain medicines called 'macrolide antibiotics' (used for the treatment of infections)

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

*    medicines used for the treatment of epilepsy e.g. phenobarbital, carbamazepine and phenytoin

*    the antibiotic medicine, rifampicin (used for the treatment of tuberculosis)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Buprenorphine Sublingual Tablets with food and drink

These tablets should not be taken at the same time as food or drink. You should not drink alcohol or take any medicines that contain alcohol while taking Buprenorphine Sublingual Tablets.

Pregnancy and breast-feeding

Before taking these tablets, 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.

Since buprenorphine is passed into breast milk, you must not breast feed while taking this medicine.

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

Driving and using machines

If you feel drowsy while being treated with this medicine, you should not drive or operate machinery.

The 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.

Buprenorphine Sublingual Tablets contain lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Buprenorphine Sublingual Tablets

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

The tablets are described as 'sublingual'. This means that the tablet should be placed under the tongue and kept there until fully dissolved. Do not chew or swallow the tablets whole - the medicine will not work this way and you may get withdrawal symptoms. Do not take the tablets at the same time as food or drink.

Adults and adolescents aged 16 years and over:

The usual starting dose is 0.8 mg to 4 mg daily.

*    If you are still taking opioids, the dose of buprenorphine must be taken at least 6 hours after the last use of the opioid or when the first signs of craving appear

*    If you have been receiving methadone, your doctor should reduce the dose to no more than 30 mg per day before starting treatment with buprenorphine. This is because buprenorphine can cause withdrawal symptoms in patients who are dependent on methadone, if taken less than 24 hours after using methadone.

During your treatment, your doctor may increase your dose of buprenorphine to a maximum single daily dose of 32 mg, depending upon how you get on. After a period of successful treatment, your doctor may gradually reduce your dose. With careful medical supervision, your dose may continue to be reduced until it is stopped altogether.

Your doctor may wish to perform some tests to assess how well your liver is working before starting treatment with Buprenorphine Sublingual Tablets, and at regular intervals during treatment.

Buprenorphine Sublingual Tablets must not be used by children or adolescents under 16 years old.

If you take more Buprenorphine Sublingual Tablets than you should

Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take Buprenorphine Sublingual Tablets

You should tell your doctor and follow their instructions. Do not take a double dose to make up for the missed dose, unless your doctor tells you to.

If you stop taking Buprenorphine Sublingual Tablets

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.

4. Possible side effects

*    tearing (watery eyes) disorder

*    swollen glands (lymph nodes)

*    malaise

*    migraine

*    muscle spasms

*    muscle pain

*    dilation of pupil

*    neck pain

*    palpitations

*    paranoia

*    burning or tingling in hands and feet

*    swelling (hands and feet)

*    sore throat and painful swallowing

*    fever

*    rash

*    somnolence

*    syncope (fainting)

*    thinking abnormal

*    tooth disorder

*    tremor

*    flushing

*    yawning

*    dizziness

*    constipation

*    vomiting

Frequency not known:

*    drug dependence

*    drug withdrawal syndrome in new born

*    hallucinations (sensing things that are not real)

*    drop in blood pressure on changing position from sitting or lying down to standing

*    difficulty in urinating

Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Tell your doctor immediately or seek urgent medical attention

If you experience side effects such as:

*    sudden wheeziness, difficulty in breathing, swelling of the eyelids, face, lips, throat or hands; rash or itching especially those covering your whole body. These may be signs of life threatening allergic reaction.

*    if you start to breath 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), loss of appetite or if your skin or eyes look yellow. These may be symptoms of liver damage.

The following side effects have also been reported:

Very common, affects more than 1 per 10 users:

*    drug withdrawal symptoms

*    headache

*    hyperhidrosis (sweating)

*    insomnia (inability to sleep)

*    nausea (feeling sick)

*    pain

Common, affects 1 to 10 per 100 users:

*    abdominal pain

*    anxiety

*    agitation

*    joint pain

*    weakness

*    back pain

*    bone pain

*    bronchitis

*    chest pain

*    chills

*    cough

*    decreased appetite

*    depression

*    diarrhoea

*    dry mouth

*    painful period

*    indigestion

*    shortness of breath

*    flatulence

*    gastrointestinal disorder

*    hostility

*    increase in muscle tension

*    infection

*    influenza

*    nervousness

5. How to store Buprenorphine Sublingual Tablets

Keep this medicine out of the sight and reach of children.

Store your medicine in the original packaging to protect from moisture.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Buprenorphine Sublingual Tablets contain

*    The active substance is buprenorphine (as buprenorphine hydrochloride). Each tablet contains 2 mg or 8 mg of buprenorphine.

*    The other ingredients are lactose monohydrate, mannitol (E421), maize starch, citric acid (anhydrous), sodium citrate, povidone (plasdone K29/32), magnesium stearate, ascorbic acid and edetic acid (EDTA).

What Buprenorphine Sublingual Tablets look like and the contents of the pack

Buprenorphine 2 mg Sublingual Tablets are off-white to brownish, oval, biplane tablets marked with “B2” on one side.

Buprenorphine 8 mg Sublingual Tablets are off-white to brownish, oval, biplane tablets marked with “B8” on one side.

Your medicine is available in blisters containing 7, 14, or 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Limited 115 Narborough Road, Leicester LE3 0PA, United Kingdom

Manufacturer

SMB TECHNOLOGY S.A.

39 rue du Parc Industriel

6900 Marche en Famenne, Belgium

This leaflet was last revised in December 2015.