BUPRENORPHINE 0.4MG SUBLINGUAL TABLETS

Active substance: BUPRENORPHINE HYDROCHLORIDE

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M553-360957_M553-360957 16/06/2010 15:50 Page 1

Are there any medicines that should not be taken at the same time as Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets?

Buprenorphine 0.4mg, 2mg, 8mg

You should not use benzodiazepines (medicines used to treat anxiety and sleep disorders) whilst you are taking this medicine unless they are
prescribed by your doctor.
Strong pain killers and cough medicines containing opioid-related substances, certain anti-depressants 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.

Sublingual tablets

Ketoconazole a medicine used for the treatment of fungal infections can increase the effects of Buprenorphine if both are taken at the same time.
If you are taking ketoconazole or any of the following medicines: gestodene, troleandomycin, the HIV protease inhibitors ritonavir, indinavir and
saquinavir you should tell your doctor or pharmacist as they may need to reduce your dose of buprenorphine.

Patient information

Also tell your doctor or pharmacist if you are taking any of the following medicines: phenobarbital, carbamazapine, phenytoin, rifampicin.
You will be closely monitored whilst you are taking these medicines at the same time as buprenorphine.
Be sure to tell your doctor if you are taking a blood thinning agent called phenprocoumon.

Please read this leaflet carefully before you start taking this medicine.

If you are taking any other medicines you should tell your doctor or pharmacist before you begin treatment with buprenorphine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your doctor or pharmacist.

Do not drink alcohol or take medicines that contain alcohol whilst you are being treated with buprenorphine. Alcohol and certain other medicines (as
listed above) increases the sedative effects of buprenorphine which can make driving or operating machinery hazardous.

• This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them even if their
symptoms are the same as yours.

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.

• If any of the side effects become serious or you notice any side effects not listed in the leaflet please tell your doctor or pharmacist.

3. How to take the tablets

This leaflet informs you about:

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 effective and safe way the tablets should be taken. Do not chew or swallow them whole as this will make them ineffective.

1. What Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets are and what they are used for
2. Before you take Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets

Your doctor will tell you how many 0.4mg, 2mg or 8mg Sublingual tablets to take and you should always follow his advice.

3. How to take the tablets

Adults and children over the age of 16 years: the initial dose is from 0.8 to 4mg administered once a day.

4. Possible side effects

For drug addicts who have not undergone withdrawal: one dose of 0.4mg, 2mg or 8mg Sublingual tablets at least four hours after the last use
of the opioid (narcotic) or when the first signs of craving appear.

5. How to store the tablets

For patients receiving methadone: before beginning treatment your doctor should reduce your dose of methadone to a maximum of 30mg a day.

6. Further information

These tablets may cause withdrawal symptoms in patients who are dependent on methadone.
1. What Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets are and what they are used for

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

Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets contain buprenorphine hydrochloride equivalent to 0.4mg, 2mg or 8mg buprenorphine.
Buprenorphine is one of a group of medicines used in opioid dependence. 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.

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 these tablets as this may cause withdrawal symptoms.
What to do in the case of overdose
You should contact your doctor immediately.

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.

What to do if you forget to take your tablets

2. Before you take Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets

You should tell your doctor and follow his or her instructions.

Buprenorphine 0.4mg, 2mg and 8mg Sublingual tablets should not be used:

4. Possible side effects

• in children under the age of 16 years

Like all drugs, these 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.

• if you are allergic to buprenorphine or any of the other ingredients in this medicine
• if you have serious breathing problems

Rarely the following have occurred: severe difficulty in breathing, liver problems, hallucinations.

• if you have serious problems with your liver or if your doctor detects the development of such a problem during treatment

If you think you are suffering from these or any other side effects you should tell your doctor.

• if you are intoxicated due to alcohol or have delirium tremens (the shakes and hallucinations)

Hypersensitivity (allergic) reactions have been reported. Symptoms may include skin rash, hives and itching. If you develop symptoms of a severe
allergic reaction (such as difficulty in breathing, wheezing, swelling of the eyes, lips, tongue, throat or hands) seek urgent medical help.

• if you are breast-feeding
• if you are pregnant (unless your doctor tells you to take it)

Drug dependence can occur as a result of taking this medicine.

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:

5. How to store the tablets
Keep out of the reach and sight of children.

• asthma or other breathing problems

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

• kidney disease
The 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 and sleep disorders) in combination with Buprenorphine and also when Buprenorphine
was not used according to doctor's instructions.

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.

Therefore whilst you are being treated with this medicine do not use benzodiazepines unless they have been prescribed by your doctor.

6. Further Information

Some cases of severe liver problems have occurred during treatment although they may not necessarily have been caused by these tablets.
If you develop severe fatigue, have no appetite or if your skin or eyes look yellow tell your doctor immediately.

Each sublingual tablet contains buprenorphine hydrochloride equivalent to either 0.4mg, 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 0.4mg Sublingual tablets also contain talc and silica colloidal anhydrous.

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).

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

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

Marketing Authorisation Holder: The marketing authorisation holder is Thornton & Ross Ltd
Manufacturer: The manufacturer is Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

The 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.

PL numbers: 00240/0347 0.4mg, 00240/0354 2mg, 00240/0355 8mg
Date of revision: June 2010

Drug dependence 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.

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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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