SUBOXONE
SUBLINGUAL FILM

Buprenorphine hydrochloride and Naloxone hydrochloride

Consumer Medicine Information

What is in this leaflet

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

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

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

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

What SUBOXONE SUBLINGUAL FILM is used for

SUBOXONE SUBLINGUAL FILM is used as part of a medical, social and psychological treatment program for patients addicted to opiate drugs like heroin, morphine or oxycodone. SUBOXONE SUBLINGUAL FILM is used to help such patients to regain control over their lives.

SUBOXONE SUBLINGUAL FILMS contain the active ingredients buprenorphine hydrochloride and naloxone hydrochloride. Buprenorphine acts as a substitute for opiate drugs like heroin, morphine or oxycodone 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 SUBLINGUAL FILM is injected, naloxone will act to block the effects of other opiates like heroin, morphine and oxycodone, leading to bad withdrawal symptoms. Therefore, naloxone is included in SUBOXONE SUBLINGUAL FILM to discourage misuse by injection, as it can cause very bad withdrawal symptoms.

SUBOXONE SUBLINGUAL FILM should be used exactly as prescribed by your doctor.

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

These films are described as 'sublingual'. This means that the film should be placed under the tongue and kept there until fully dissolved, which usually occurs within 4 to 8 minutes.

Before you are given SUBOXONE SUBLINGUAL FILM

SUBOXONE SUBLINGUAL FILM is not suitable for everyone.

When you must not use it

You should not take SUBOXONE SUBLINGUAL FILM if:

• you are under the age of 16 years
• you are allergic to buprenorphine, naloxone or any of the other ingredients in this medicine (see Product Description)
• you have serious breathing problems
• you have serious problems with your liver, or if your doctor detects the development of such a problem during treatment
• you are intoxicated due to Central nervous system (CNS) depressant medicines (e.g. tranquillisers, sedative/hypnotics, narcotic analgesics, anti-anxiety medicines, antipsychotics), alcohol or have delirium tremens (the 'shakes' and hallucinations)
• you are pregnant
  If you become pregnant while taking SUBOXONE SUBLINGUAL FILM tell your doctor.
• you are breastfeeding
• the package is torn, shows signs of tampering or the films do not look quite right.

Do not take SUBOXONE SUBLINGUAL FILM after the Expiry Date printed on the pack.

If you take this medicine after the Expiry Date has passed it may not work as well.

Before you start to use SUBOXONE SUBLINGUAL FILM

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 SUBLINGUAL FILM:

• asthma or other breathing problems
• thyroid problems
• prostate problems
• problems with excess alcohol use
• problems with your central nervous system
• adrenal gland problems (e.g. Addison's disease)
• kyphoscoliosis (hunchback disease)
• low blood pressure problems
• urination problems
• kidney problems
• liver problems
• if you are pregnant
• if you have head injuries or have a condition where there is increased pressure within your head
• if you have problems related to the biliary tract
• if you have severe mental problems or hallucinations (seeing or hearing things that are not really there)

Whilst you are being treated with SUBOXONE SUBLINGUAL FILM, do not use benzodiazepines unless they have been prescribed by your doctor.

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 SUBLINGUAL FILM.

If you develop severe fatigue, have no appetite or if your skin or eyes look yellow, tell your doctor immediately.

Some serious cases of severe liver problems have occurred during treatment, although they may not necessarily have been caused by SUBOXONE SUBLINGUAL FILM.

As SUBOXONE SUBLINGUAL FILM 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 SUBLINGUAL FILM can cause withdrawal symptoms if you take it less than six hours after you use a short acting opioid (such as morphine or heroin) or less than 24 hours after a long acting opioid (such as methadone).

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

SUBOXONE SUBLINGUAL FILM can cause drowsiness, which may be made worse if you also drink alcohol or take sedatives or anti-anxiety medicines.

If you experience drowsiness, do not drive or operate machinery.

SUBOXONE SUBLINGUAL FILM 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 SUBLINGUAL FILM.

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

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

• certain medicines for treating AIDS
• certain medicines for treating fungal and bacterial infections
• strong pain killers
• cough medicines containing opioid-related substances
• certain antidepressants including monoamine oxidase inhibitors
• certain medicines used to treat fits or epilepsy (anti-convulsants)
• sedating antihistamines
• sedatives
• anti-anxiety medicines
• certain medicines for high blood pressure
• antipsychotic medicines

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 SUBLINGUAL FILM.

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), other depressants, alcohol or other opioids at the same time as SUBOXONE SUBLINGUAL FILM.

How to take SUBOXONE SUBLINGUAL FILM

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

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

The films are taken sublingually. This means that you place the film under your tongue and allow it to dissolve, which may take between 4 and 8 minutes. This is the only way the films should be taken. If you are prescribed more than two films, you should take the films in two or three lots, with no more than two films in each lot. Each lot should only be taken after the previous lot has dissolved.

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

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

How much to take

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

Each SUBOXONE SUBLINGUAL FILM contains buprenorphine and naloxone.

SUBOXONE SUBLINGUAL FILM 2/0.5, containing 2mg buprenorphine and 0.5mg naloxone, is referred to as 'the 2mg film'.

SUBOXONE SUBLINGUAL FILM 8/2, containing 8mg buprenorphine and 2mg naloxone, is referred to as 'the 8mg film'.

On the first day the usual starting dose is 4 mg of SUBOXONE SUBLINGUAL FILM, but the dose will be ultimately determined by your treating doctor.

• For patients who are still using illicit opioids: When starting treatment the dose of SUBOXONE SUBLINGUAL FILM should be taken when the first signs of craving appear or at least 6 hours after your last use of heroin (or another opiate drug).
• For patients receiving methadone: Before beginning treatment with SUBOXONE SUBLINGUAL FILM, your doctor will probably reduce your dose of methadone to a maximum of 30 mg/day. The first dose of SUBOXONE SUBLINGUAL FILM should preferably be taken when the first signs of craving appear and at least 24 hours after your last dose of methadone.

SUBOXONE SUBLINGUAL FILM 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 SUBLINGUAL FILM up 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 films, as this may cause withdrawal symptoms.

If you miss a dose of SUBOXONE SUBLINGUAL FILM

If you miss a dose of SUBOXONE SUBLINGUAL FILM, 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 SUBLINGUAL FILM.

If you take too much of SUBOXONE SUBLINGUAL FILM (overdose)

If you think that you or anyone else may have taken too much SUBOXONE SUBLINGUAL FILM, immediately telephone your doctor or National Poison Centre (in Australia telephone 13 11 26 or in New Zealand telephone 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 medicines, SUBOXONE SUBLINGUAL FILM 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 SUBLINGUAL FILM 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 SUBLINGUAL FILM.

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 experiencing 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 SUBLINGUAL FILM

If you stop taking SUBOXONE SUBLINGUAL FILM and restart your opiate use, you are at risk of being more sensitive to opiates, which could be dangerous.

You should talk to your doctor if you commence using opiates again.

Storage

SUBOXONE SUBLINGUAL FILM contains a narcotic that can be a target for people who abuse prescription medicines or street drugs.

Therefore, keep your medications in a safe place to protect them from theft. Never give them to anyone else.

SUBOXONE SUBLINGUAL FILM should be stored below 25°C in the original package. The films 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 SUBLINGUAL FILM after the expiry date that is stamped on the pack.

Disposal

If your doctor tells you to stop taking SUBOXONE SUBLINGUAL FILM or the films have passed their Expiry Date, ask your pharmacist what to do with any that are left over.

Product Description

What SUBOXONE SUBLINGUAL FILM Looks Like

SUBOXONE SUBLINGUAL FILM is an orange, rectangular soluble film. A logo is printed on each film to indicate the dosage strength:

• "N2" for the 2mg and "N8" for the 8mg.

Ingredients:

• Each SUBOXONE SUBLINGUAL FILM 2/0.5 contains 2mg buprenorphine (as the hydrochloride) + 0.5mg naloxone (as the hydrochloride) as active ingredients.
• Each SUBOXONE SUBLINGUAL FILM 8/2 contains 8mg buprenorphine (as the hydrochloride) + 2mg naloxone (as the hydrochloride) as active ingredients.

SUBOXONE SUBLINGUAL FILM also contains the following inactive ingredients: acesulfame potassium, citric acid anhydrous, maltitol solution, hypromellose, polyethylene oxide, sodium citrate anhydrous, lime flavour, Sunset Yellow FCF and a white printing ink.

• Each pack of SUBOXONE SUBLINGUAL FILM 2/0.5 is labelled with AUST R 163443
• Each pack of SUBOXONE SUBLINGUAL FILM 8/2 is labelled with AUST R 163444

Sponsor

Reckitt Benckiser
44 Wharf Rd
West Ryde NSW 2114
Australia

Date of Preparation
March 2010

Published by MIMS/myDr July 2011

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