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BUPRENORPHINE 1 MG SUBLINGUAL TABLETS

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PIL-407UK_BUP_V4.qxp

19/05/2010

12:30

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Buprenorphine 1 mg, 4 mg and 6 mg Sublingual Tablets
(Buprenorphine)
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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. BEFORE YOU TAKE BUPRENORPHINE SUBLINGUAL
TABLETS
Do not take Buprenorphine Sublingual Tablets:
• if you are allergic (hypersensitive) to buprenorphine
• if you are allergic to any of the other ingredients in the tablets
(these are listed in section 6, Further Information)
• 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.
Take special care with Buprenorphine Sublingual Tablets
Tell your doctor before taking these tablets:
• if you have asthma or any other breathing problems
• if you have any kidney problems
• if you have any liver problems.
Buprenorphine Sublingual Tablets contain buprenorphine which
can become addictive if used continually for a long period of time.
Drug dependence may occur as a result of taking this medicine.

Taking other medicines
Tell your doctor if you are taking or have recently taken any of the
following medicines as they may interact with Buprenorphine
Sublingual Tablets.
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.

Area available for 2 mm high edge code

In this leaflet:
1. What Buprenorphine Sublingual Tablets are and what they are used for
2. 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. Further information

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Taking Buprenorphine Sublingual Tablets with food and
4. POSSIBLE SIDE EFFECTS
drink
Like all medicines, Buprenorphine Sublingual Tablets can cause
These tablets should not be taken at the same time as food or drink. side effects, although not everyone gets them.
You should not drink alcohol or take any medicines that contain
All medicines can cause allergic reactions although
alcohol while taking buprenorphine sublingual tablets.
serious allergic reactions are very rare. If you get any of
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.
Important information about some of the ingredients of
Buprenorphine Sublingual Tablets
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.
3. HOW TO TAKE BUPRENORPHINE SUBLINGUAL
TABLETS

the following symptoms after taking these tablets, you
should contact your doctor immediately:
• Any sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or throat
• Peeling and blistering of the skin, mouth, eyes and genitals
• Rash affecting your whole body.
If you develop severe fatigue, loss of appetite or if your
skin or eyes look yellow, tell your doctor immediately.
The following side effects have also been reported:
The most common side effects are: constipation, headache,
difficulty in sleeping, weakness or lack of energy, drowsiness,
nausea and vomiting (feeling and being sick), fainting and
dizziness (especially when changing position from sitting or lying
down to standing) and sweating.
After your first dose, you may suffer from opioid withdrawal
symptoms. This is more likely if buprenorphine is taken less than
six hours after using an opioid (e.g. heroin).
Rare side effects: severe difficulty in breathing, hallucinations.

You must place the tablet under your tongue (sublingual) and
allow it to dissolve, which will take 5 to 10 minutes. This is the
only way to take the tablets. Do not chew or swallow them
whole, as they will not work.

• Athletes should be aware that this medicine may cause a
positive reaction to ‘anti-doping tests’
• Drug dependence can occur as a result of taking this medicine.

Your doctor will tell you how many tablets to take and you
should always follow this advice.

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

To avoid sudden withdrawal symptoms, treatment with
Buprenorphine Sublingual Tablets should be given when there
are already clear signs of withdrawal symptoms.

5. HOW TO STORE BUPRENORPHINE SUBLINGUAL
TABLETS

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

Keep out of the reach and sight of children

During your treatment, your doctor may increase your dose of
Buprenorphine Sublingual Tablets, to a maximum single daily
dose of 32mg, depending upon your response. Once you have
been stable for a while, your doctor will gradually reduce your
dose and it may be possible to stop it altogether. Do not
suddenly stop taking the tablets, as this may cause withdrawal
symptoms.

What Buprenorphine Sublingual Tablets contain:
• The active substance is buprenorphine (as buprenorphine
hydrochloride). Each tablet contains 1 mg, 4 mg or 6 mg of
buprenorphine.
• The other ingredients are lactose monohydrate, mannitol, maize
starch, citric acid (anhydrous), sodium citrate, povidone (K30),
magnesium stearate, talc and silica (colloidal anhydrous).

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.

What Buprenorphine Sublingual Tablets look like and the
contents of the pack
Buprenorphine 1 mg Sublingual Tablets are white, round tablets
marked with "1" on one side and with " " on the other side.
Buprenorphine 4 mg Sublingual Tablets are white, round tablets
marked with "4" on one side and with " " on the other side.
Buprenorphine 6 mg Sublingual Tablets are white, round tablets
marked with "6" on one side and with " " on the other side.

Store your medicine in the original packaging to protect from
light and moisture. The 1 mg strength of Buprenorphine
Sublingual Tablets should not be stored above 25°C. The 4 mg
For drug addicts who have not had any withdrawal
treatment: one dose of Buprenorphine Sublingual Tablets should and 6 mg strengths of Buprenorphine Sublingual Tablets do not
require any special temperature storage conditions.
be taken at least 6 hours after the last use of the opioid
(narcotic such as morphine or heroine), or when the first signs of Do not use Buprenorphine Sublingual Tablets after the expiry
craving appear. If you take it less than six hours after you use a
date, which is stated on the carton after EXP. The expiry date
narcotic you may get withdrawal symptoms.
refers to the last day of that month.
For patients taking methadone: before beginning treatment,
Medicines should not be disposed of via wastewater or household
your doctor should reduce your dose of methadone to not more
waste. Ask your pharmacist how to dispose of medicines no longer
than 30 mg a day. Buprenorphine Sublingual Tablets may cause
required. These measures will help to protect the environment.
withdrawal symptoms in patients who are dependent on
methadone if used within 24 hours of the last dose of methadone. 6. FURTHER INFORMATION

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

Marketing Authorisation Holder: Arrow Generics Limited,
Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ
Manufacturer: Ethypharm, Chemin de la Poudrière, 76120
Grand-Quevilly, France or Ethypharm, Z.I. de Saint-Arnoult,
28179 Châteauneuf-en-Thymerais, France
This leaflet was last approved in 05/2010.

Item code

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.

Your medicine is available in blisters containing 7 or 28 tablets.
Not all pack sizes may be marketed.

Pharmacode

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.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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