Subutex

Buprenorphine hydrochloride
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Subutex. It does not contain all the information that is known about Subutex. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What SUBUTEX is used for

SUBUTEX is used as part of a medical, social and psychological treatment program for patients addicted to opiate drugs like heroin, morphine, oxycodone or codeine. SUBUTEX is used to help patients overcome this medical condition.
SUBUTEX tablets contain the active ingredient buprenorphine hydrochloride. It acts as a substitute for opiate drugs like heroin, morphine, oxycodone or codeine and it helps withdrawal from opiate drugs over a period of time.
SUBUTEX should be used exactly as prescribed by your doctor.
Ask your doctor if you have any questions about why SUBUTEX 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 SUBUTEX

SUBUTEX is not suitable for everyone.

When you must not take SUBUTEX

If you are under the age of 16 years.
If you are allergic to buprenorphine or to any of the other ingredients in this medicine (see Product Description).
If you have serious breathing problems.
If you have serious problems with your liver, or if your doctor detects the development of such a problem during treatment.
If you are intoxicated due to CNS depressant medicines (e.g. sedative/hypnotics, narcotic pain killers, anti-anxiety or antipsychotic medicines), alcohol or have delirium tremens (the 'shakes' and hallucinations).
If you are pregnant. If you become pregnant while taking SUBUTEX tell your doctor.
If you are breast-feeding.
Do not take SUBUTEX if the package is torn, shows signs of tampering or if the tablets do not look quite right.

Before you start to use SUBUTEX

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 SUBUTEX:
asthma or other breathing problems;
thyroid problems;
prostate problems;
problems with excess alcohol use;
problems with your central nervous system;
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 you have increased pressure within your head;
if you have problems related to the biliary tract, or
if you have a history of seizures.
Some people have died from respiratory failure (inability to breathe) when using benzodiazepines (medicines used to treat anxiety or sleeping problems), or other depressants such as alcohol or other opioids at the same time as SUBUTEX. For further information please discuss with your doctor.
SUBUTEX may cause fatal respiratory failure in children who accidentally ingest it.
Keep this medicine out of reach and sight of children.
Some cases of severe liver problems have occurred during treatment. If you develop severe fatigue, have no appetite or if your skin or eyes look yellow, you have light coloured bowel motions or dark coloured urine, tell your doctor immediately.
SUBUTEX can cause withdrawal symptoms if you take it less than six hours after you use heroin or morphine.
Also, if treatment is stopped abruptly, withdrawal symptoms may occur, which may be delayed in some cases.
SUBUTEX 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.
SUBUTEX 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.
The safety and effectiveness in patients over 65 years of age have not been established.
Your doctor may ask you to have additional blood tests to see if this medication is right for you.

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 SUBUTEX.
You should not use benzodiazepines (medicines used to treat anxiety or sleep disorders) whilst you are taking SUBUTEX unless they are prescribed by your doctor.
A number of medicines may alter the effects of SUBUTEX. These include:
certain medicines for treating HIV/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;
medicines used to treat alcohol dependence;
certain medicines for high blood pressure;
antipsychotic medicines;
other opioid medicines, and
naltrexone.
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 SUBUTEX.
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, alcohol or other opioids at the same time as SUBUTEX.

How to take SUBUTEX

Do not take SUBUTEX to treat any condition other than the one prescribed for by your doctor.
Do not give SUBUTEX 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. Do not swallow or consume food or drink until the tablet is completely dissolved.
The tablets will not work if you chew or swallow them whole.
Do not inject SUBUTEX, patients have died from injecting SUBUTEX. Additionally, when injecting SUBUTEX and also taking benzodiazepines (medicines used to treat anxiety or sleeping problems), people were even more likely to die.

How much to take

SUBUTEX is only for adults and children over the age of 16 years. Your doctor will tell you how much SUBUTEX to take and you should always follow medical advice.
On the first day the recommended starting dose is 4 mg SUBUTEX with an additional 4 mg depending on your needs as determined by your treating doctor.
For patients who are still using short acting opioids such as heroin, morphine, oxycodone or codeine: when starting treatment the dose of SUBUTEX should be taken at least 6 hours after your last use of opioids or when the first signs of craving appear.
For patients receiving methadone: before beginning treatment with SUBUTEX, your doctor will probably reduce your dose of methadone to a maximum of 30 mg/day. The first dose of SUBUTEX should be taken at least 24 hours after your last dose of methadone or when the first signs of craving appear.
SUBUTEX may cause withdrawal symptoms if taken while still under the influence of another opioid.
During your treatment, your doctor may increase your dose of SUBUTEX 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 SUBUTEX

If you forget to take a dose of SUBUTEX take it as soon as you remember. If you are unsure consult your doctor.

If you take too much of SUBUTEX (overdose)

Immediately telephone your doctor or Poisons Information Centre (Australia - telephone 13 11 26; New Zealand - telephone 0800 764 766 or 0800 POISON) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much SUBUTEX. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much SUBUTEX, some of the symptoms which may or may not occur are listed in the Side effects section of this leaflet.

Side effects

Like all medicines, SUBUTEX 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 SUBUTEX were related to opioid 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 SUBUTEX.
Other side effects which have occurred are: dry mouth, tooth disorders, headache, migraine, sleepiness, dizziness, fainting, abnormal vision, depression, abnormal thinking, hostility, agitation, paranoid reactions, chest pain, neck pain, palpitations, difficulty in breathing, yawning, nausea, vomiting, constipation, flatulence or wind, poor appetite, decreased weight, swelling of the legs and arms, numbness, tremors, lymph node problems, abnormal liver function, hives, rash and itching, painful periods.
Rarely, the following have occurred: severe difficulty in breathing, hallucinations, coma, convulsions, confusion, asphyxia (lack of oxygen intake), airway function problems, heart rate and rhythm problems and death.
There have been rare cases of life-threatening severe hypersensitive 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 occur in some patients.
Tell your doctor if you notice anything else that is making you feel unwell.

After using SUBUTEX

If you stop taking SUBUTEX and start using opioids again, you are at risk of being more sensitive to opioids, which could be dangerous. You should talk to your doctor if you start using opioids again.

Presentation and storage

SUBUTEX is packed in child resistant blisters. Below are instructions on how to open these blisters.

1. Remove just one section from the blister pack, tearing it along the perforated line.

2. Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet.

SUBUTEX 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. Keep out of reach and sight of children. Never give them to anyone else.
The tablets should be stored below 30°C in the original package.
As with all medicines, keep out of the reach of children.
Do not use SUBUTEX after the expiry date that is stamped on the pack.

Product description

What SUBUTEX looks like

SUBUTEX are white, flat oval shaped tablets. Each tablet has a sword logo on one side, with the 0.4 mg having '04' on the reverse, the 2 mg having 'B2' on the reverse, and the 8 mg having 'B8' on the reverse.

Ingredients

Each SUBUTEX sublingual tablet contains 0.4 mg, 2 mg or 8 mg buprenorphine (as the hydrochloride) as the active ingredient, along with the following inactive ingredients:
lactose
mannitol
starch-maize
povidone
citric acid
sodium citrate
magnesium stearate
SUBUTEX:
0.4 mg - AUST R 76661
2 mg - AUST R 76662
8 mg - AUST R 76663

Sponsor

Reckitt Benckiser
44 Wharf Rd
West Ryde NSW 2114
Australia
 
Date of most recent amendment: June 2014.