BUPRENORPHINE 2MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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Assessed against UK PIL dated March 2004
By keddies at 2:45 pm, 5/9/06

PATIENT INFORMATION LEAFLET

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BUPRENORPHINE 2mg SUBLINGUAL TABLETS
BUPRENORPHINE 8mg SUBLINGUAL TABLETS
(buprenorphine hydrochloride)
Your medicine is known by either of the above names but will be referred to as
Buprenorphine Tablets throughout the following patient information leaflet.
Please read this information leaflet about Buprenorphine Tablets carefully before you start
using your medicine. It contains all the information you should need to know. If you have
any further questions or are not sure about anything, ask your doctor or pharmacist.
Please keep this leaflet in a safe place, you may wish to refer to it again.
Your medicine is called Buprenorphine Tablets. Each Buprenorphine 2mg Sublingual
Tablet contains 2.16mg buprenorphine hydrochloride equivalent to 2mg buprenorphine.
The oval white tablets are marked ‘B2’ on one side with a sword logo on the other.
Each Buprenorphine 8mg Sublingual Tablet contains 8.64mg buprenorphine hydrochloride
equivalent to 8mg buprenorphine. The oval white tablets are marked ‘B8’ on one side with
a sword logo on the other.
Buprenorphine Tablets also contain the following inactive ingredients: lactose
monohydrate, mannitol (E421), maize starch, povidone K30, citric acid, sodium citrate and
magnesium stearate.
Warnings and precautions:
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.
Buprenorphine Tablets are available as blister packs of 7 tablets.
Buprenorphine hydrochloride belongs to a group of medicines called ‘opioid analgesics’.
This means that it is a strong pain reliever. However, when it is used for the treatment of
patients addicted to opiate (narcotic) drugs, such as morphine and heroin, it acts as a
substitute for these drugs and therefore aids the patient in withdrawing from them over a
period of time. If treatment is stopped abruptly, withdrawal symptoms can occur.
These 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.
POM

PL No. 19488/0514
PL No. 19488/0515

Buprenorphine 2mg Sublingual Tablets
Buprenorphine 8mg Sublingual Tablets

These products are manufactured by Reckitt Benckiser Healthcare (UK) Ltd, Dansom
Lane, Hull, HU8 7DS. They are procured from within the EU and repackaged by the
Parallel Import Product Licence holder: S & M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, Middlesex, HA0 1DX.
Why you need to take this medicine:
Buprenorphine Tablets are used as part of a medical, social and psychological treatment
programme for patients addicted to opiate (narcotic) drugs.
Before you take your medicine:
Buprenorphine Tablets should not be used:
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In children under the age of 16 years
If you are allergic to buprenorphine or to any of the other ingredients of this medicine
If you have serious breathing problems
If you have serious problems with your liver, of if your doctor detects the development of
such a problem during treatment
• If you are intoxicated due to alcohol or have delirium tremens (the ‘shakes’ and
hallucinations)
• If you are breast feeding a baby
• If you are pregnant (unless your doctor tells you to take it)
Tell your doctor if you have any of the following illnesses 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
• Kidney disease
Buprenorphine Tablets should be used exactly as prescribed by your doctor. Some people
have died from respiratory failure (inability to breathe) whilst using benzodiazepines
(medicines used to treat anxiety or sleep disorders) in combination with Buprenorphine
Tablets. Therefore whilst you are being treated with this medicine, do not use
benzodiazepines unless they have been prescribed by your doctor.
Some cases of severe liver problems have occurred during treatment, although they may
not necessarily have been caused by Buprenorphine Tablets. If you develop severe
fatigue, have no appetite or if your skin or eyes look yellow, tell your doctor immediately.
This medicine can cause withdrawal symptoms if you take it less than four hours after you
use a narcotic (morphine, heroin or other related products).
This medicine can cause drowsiness, which may be made worse if you also drink alcohol
or take tranquilisers or anti-anxiety drugs. If you are drowsy, do not drive or operate
machinery.
Buprenorphine Tablets may cause your blood pressure to drop suddenly, causing you to
feel dizzy if you get up too quickly from sitting or lying down.
Drug dependencies may occur as a result of taking this medicine.
Athletes should be aware that this medicine may cause a positive reaction to ‘anti-doping’
tests.
Are there any medicines which should not be taken at the same time as
Buprenorphine Tablets?
You should not use benzodiazepines (medicines used to treat anxiety or sleep disorders)
whilst you are taking Buprenorphine Tablets unless they are prescribed by your doctor.
Strong pain killers and cough medicines (containing opioid-related substances), certain
antidepressants (including monoamine oxidase inhibitors), sedating antihistamines,
sedatives, anti-anxiety drugs, certain drugs for high blood pressure and antipsychotic
drugs may increase the effects of Buprenorphine Tablets.

Ketoconazole, a medicine used for the treatment of fungal infections, can increase the
effects of Buprenorphine Tablets if both are taken at the same time. If you are taking
ketoconazole, or any of the following medicines: gestodene, troleandomycin, the HIV
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protease inhibitors ritonavir, indinavir and saquinavir, you should tell your doctor or
pharmacist as they may need to reduce your dose of Buprenorphine Tablets.
Also tell your doctor or pharmacist if you are taking any of the following medicines:
phenobarbital, carbamazepine, phenytoin, rifampicin. You will be closely monitored whilst
you are taking these medicines at the same time as Buprenorphine Tablets.
Be sure to tell your doctor if you are taking a blood thinning drug called phenprocoumon.
If you are taking any other medicines, you should tell your doctor or pharmacist before you
begin treatment with Buprenorphine Tablets.
Do not drink alcohol or take medicines that contain alcohol whilst you are being treated
with Buprenorphine Tablets. Alcohol and certain other medicines (as listed above)
increase the sedative effects of buprenorphine, which can make driving and operating
machinery hazardous.
How to take your medicine:
The tablets are administered sublingually. This means that you must place the tablet under
your tongue and allow it to dissolve, which will take 5 to 10 minutes. This is the only 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 much Buprenorphine Tablets to take and you should always
follow this advice.
Adults and children over the age of 16 years: the initial dose is from 0.8 to 4mg,
administered once a day.
For drug addicts who have not undergone withdrawal: one dose of Buprenorphine
Tablets at least 4 hours after the last use of opioid (narcotic) or when the first signs of
craving appear.
For patients receiving methadone: before beginning treatment your doctor should
reduce your dose of methadone to a maximum of 30mg a day. Buprenorphine Tablets may
cause withdrawal symptoms in patients who are dependent on methadone.
During your treatment your doctor may increase your dose of Buprenorphine Tablets to a
maximum single daily dose of 32mg, depending upon your response. After a period of
successful treatment 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 the tablets as this may cause
withdrawal symptoms.
What to do if an overdose is taken:
You should contact your doctor immediately.
What to do if you miss a dose:
You should tell your doctor and follow his or her instructions.
Side Effects:
Like all drugs Buprenorphine Tablets may cause side effects. After your first dose you may
suffer from some opiate withdrawal symptoms. Other side effects which may occur are:
constipation, headaches, difficulty in sleeping, lack of energy or weakness, drowsiness,
nausea and vomiting, fainting and dizziness, drop in blood pressure on changing position
from sitting or lying down to standing, sweating.

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Rarely, the following have occurred: severe difficulty in breathing, liver problems,
hallucinations.
If you think you are suffering from these or any other side effects you should tell your
doctor.
Hypersensitivity (allergic) reactions have been reported. Symptoms may include skin rash,
hives and itching. If you develop symptoms of a severe allergic reactions (such as difficulty
in breathing, wheezing, swelling of the eyes, lips, tongue, throat or hands), seek urgent
medical help.
Drug dependence can occur as a result of taking this medicine.
Expiry Date:
Do not use after the expiry date printed on the carton label or blister strip.
Storage:
Buprenorphine Tablets should not be stored above 30°C. They should be stored in the
original package.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop using the medicine, please take it back to the pharmacist for
safe disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.
IMPORTANT:
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to
anyone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have
any questions, or are not sure about anything, ask your doctor or pharmacist, who has
access to additional information.
Leaflet revision date: 4 April 2006.

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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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