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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

SUBOXONE

Buprenorphine Hydrochloride + Naloxone Hydrochloride

What is in this leaflet?

This leaflet answers some common questions about SUBOXONE. It does not contain all the available information.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking SUBOXONE against the benefits you may gain and he/she believes it will help in your treatment.

If you have any concerns about taking SUBOXONE, ask your doctor.

Keep this leaflet. You may want to read it again.

What is SUBOXONE used for?

SUBOXONE is used as part of a medical, social and psychological treatment program for patients addicted to opiate drugs like heroin. SUBOXONE is used to help such patients to kick the habit.

SUBOXONE tablets contain the active ingredients buprenorphine hydrochloride and naloxone hydrochloride. Buprenorphine acts as a substitute for opiate drugs like heroin and it helps withdrawal from opiate drugs over a period of time. When taken sublingually (under the tongue) as prescribed, naloxone has no effect, as it is very poorly absorbed. However, if SUBOXONE is injected, naloxone will act to block the effects of other opiates like heroin, methadone or morphine, leading to bad withdrawal symptoms. Therefore, naloxone is included in SUBOXONE to discourage misuse by injection, as it can cause very bad withdrawal symptoms.

SUBOXONE should be used exactly as prescribed by your doctor.

Ask your doctor if you have any questions about why SUBOXONE has been prescribed for you.

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 2 to 10 minutes.

Before you take SUBOXONE.

SUBOXONE is not suitable for everyone.

When you must not take SUBOXONE.

Do not take SUBOXONE if you are pregnant. If you become pregnant while taking SUBOXONE tell your doctor.

Do not take SUBOXONE if you are breastfeeding a baby.

Do not take SUBOXONE if the package is torn, shows signs of tampering or the tablets do not look quite right.

Before you start to use SUBOXONE.

Tell your doctor if you have any of the following before treatment, or develop them during treatment, as your doctor may need to adjust your dose of SUBOXONE.

Some people have died from respiratory failure (inability to breathe) when using benzodiazepines (medicines used to treat anxiety or sleeping problems ) at the same time as SUBOXONE. Whilst you are being treated with SUBOXONE, do not use benzodiazepines unless they have been prescribed by your doctor.

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

As SUBOXONE contains naloxone, it is highly likely to produce strong opiate withdrawal symptoms if misused as an injection while you are still experiencing the effects of other opiates.

When taken sublingually SUBOXONE can cause withdrawal symptoms if you take it less than six hours after you use a short acting opioid such as(morphine, heroin or other related products) or less than 24hrs after a long acting opioid such as methadone.

SUBOXONE can cause drug dependence. This means that you can get withdrawal symptoms if you stop using the medicine too quickly. Withdrawal symptoms may be delayed in some cases.

SUBOXONE is not intended for occasional use and should be taken only as prescribed.

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

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

Athletes should be aware that this medicine may cause a positive reaction to "anti-doping" tests.

Taking Other Medicines.

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop, before you begin treatment with SUBOXONE.

You should not use benzodiazepines (medicines used to treat anxiety or sleeping problems) whilst you are taking SUBOXONE unless they are prescribed by your doctor.

A number of medicines may alter the effects of SUBOXONE. These include:

Tell your doctor if you are scheduled to have surgery using a general anaesthetic.

Do not drink alcohol or take medicines that contain alcohol whilst you are being treated with SUBOXONE.

Alcohol and certain other medicines (as listed above) may increase the sedative effects of buprenorphine, which can make driving and operating machinery hazardous.

Some people have died when using sedatives (benzodiazepines) or other depressants or alcohol or other opioids at the same time as SUBOXONE

How To Take SUBOXONE.

Do not take SUBOXONE to treat any condition other than the one prescribed for by your doctor.

Do not give SUBOXONE to anyone else, even if their symptoms seem the same as yours. It may harm them.

The tablets are taken sublingually. This means that you place the tablet under your tongue and allow it to dissolve, which may take 2 to 10 minutes. This is the only way the tablets should be taken. You may take the tablets all at once or in two lots, the second after the first lot has dissolved.

The tablets will not work if you chew or swallow them whole.

Do not inject SUBOXONE, patients have died from injecting SUBOXONE when also taking benzodiazepines (medicines used to treat anxiety or sleeping problems).

How much to take.

SUBOXONE is only for adults and children over the age of 16 years. Your doctor will tell you how much SUBOXONE to take and you should always follow medical advice.

Each SUBOXONE sublingual tablet contains buprenorphine and naloxone. SUBOXONE containing 2mg buprenorphine and 0.5mg naloxone is referred to as the '2mg' tablets and SUBOXONE containing 8mg buprenorphine and 2mg naloxone is referred to as the '8mg' tablets.

On the first day the recommended starting dose is 4 mg SUBOXONE but the dose will be determined by your treating doctor.

SUBOXONE may cause withdrawal symptoms if taken too soon after methadone or an illicit opioid.

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

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.

If you miss a dose of SUBOXONE

If you miss a dose of SUBOXONE take it as soon as you remember. If you are unsure consult your doctor.

In an emergency

Have family members or friends tell hospital or ambulance staff that you are dependent on opioids (narcotics) and are being treated with SUBOXONE.

If you take too much of SUBOXONE (overdose).

If you think that you or anyone else may have taken too much SUBOXONE, immediately telephone your doctor or National Poison Centre (telephone Australia on 13 11 26 (Australia); New Zealand 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

Side effects.

Like all medications, SUBOXONE may have unwanted side effects which may need medical treatment.
Ask your doctor or pharmacist to answer any questions you may have.

Many of the common side effects reported with the use of SUBOXONE were related to opiate withdrawal symptoms, such as difficulty sleeping, anxiety, nervousness, malaise, fatigue, pain in the abdomen, back, joints and muscles, leg cramps, muscle weakness, flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery eyes and sweating, upset stomach and diarrhoea.
These usually resolve with continued daily use of SUBOXONE.

Other side effects which have occurred are: headache, migraine, sleepiness, dizziness, abnormal vision, depression, abnormal thinking, reduced sex drive, chest pain, nausea, vomiting, constipation, wind, indigestion, decreased weight, increased blood pressure, hives, flushing, swelling of the legs and arms, abnormal liver function, difficulty urinating, rash and itching.

Rarely, the following have occurred: loss of memory, fits, blood in vomit, fatigue, jaundice, anorexia, swollen joints, reduced feeling, miscarriage, shortness of breath and suicidal thinking.

There have been rare cases of life-threatening severe hypersensitivity reactions with symptoms of severe difficulty in breathing, swelling of the face, lips, mouth or throat.

If you think you are suffering from any of the above side effects, or any other side effects, you should tell your doctor immediately.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

After Using SUBOXONE.

If you stop taking SUBOXONE and restart your heroin habit, you are at risk of being more sensitive to opiates, which could be dangerous. You should talk to your doctor if you start taking heroin again.

Storage.

Suboxone contains a narcotic that can be a target for people who abuse prescription medicines or street drugs. Therefore, keep your tablets in a safe place to protect them from theft. Never give them to anyone else.

The tablets should be stored below 30°C in the original package. SUBOXONE should be protected from moisture and prolonged exposure to light. As with all medicines, keep out of the reach of children. Do not use SUBOXONE after the expiry date that is stamped on the pack.

Product Description

What SUBOXONE Looks Like.

SUBOXONE are white, hexagon shaped tablets. Each tablet has a sword logo on one side, with the 2mg having 'N2' on the reverse, and the 8mg having 'N8' on the reverse.

Ingredients:
Each SUBOXONE 2mg sublingual tablet contains 2mg buprenorphine (as the hydrochloride) + 0.5mg naloxone (as the hydrochloride) as active ingredients. Each SUBOXONE 8mg sublingual tablet contains 8mg buprenorphine (as the hydrochloride) + 2mg naloxone (as the hydrochloride) as active ingredients. SUBOXONE 2mg and 8mg tablets also contain the following inactive ingredients: lactose; mannitol; starch-maize; povidine; citric acid; sodium citrate, magnesium stearate, acesulfame potassium, and a lemon and lime flavour.

Each pack of SUBOXONE 2mg/0.5mg tablets is labelled with AUST R 120159

Each pack of SUBOXONE 8mg/2mg tablets is labelled with AUST R 120160

Sponsor:
Reckitt Benckiser
289 Lincoln Rd
Henderson
Auckland

Date of Preparation:

21 March 2006

© Reckitt Benckiser 2005