Subutex Sublingual Tablets (Buprenorphine Hydrochloride)

Subutex 0.4 mg, 2 mg and 8 mg Sublingual Tablets. Buprenorphine Hydrochloride

WHAT SUBUTEX IS AND WHAT IT IS USED FOR

Subutex Sublingual Tablets contain buprenorphine hydrochloride, which is a medicine called an ‘opioid analgesic’ (strong pain reliever). Subutex is used to help patients addicted to opiate (narcotic) drugs, such as morphine and heroin by acting as a substitute for these drugs. Over a period of time patients can withdraw from the narcotics that they were addicted to.

BEFORE YOU TAKE SUBUTEX SUBLINGUAL TABLETS

Do not take Subutex

• If you are a child under the age of 16 years.
• If you are allergic to buprenorphine or to any of the other ingredients in this medicine.
• If you have serious breathing problems.
• If you have serious problems with your liver.
• If you are intoxicated due to alcohol or have delirium tremens (confusion and shaking due to stopping drinking alcohol) and  hallucinations (seeing and hearing things that are not there).
• If you are breast feeding a baby.

Take special care with Subutex

If you have:

• asthma or other breathing problems.
• Problems with your kidneys

Tell your doctor before you taking Subutex.

Subutex contains buprenorphine which can become addictive if used continually for a long period of time. Drug dependance may occur as a result of taking this medicine.

Taking other medicines

You should not take benzodiazepines (medicines used to treat anxiety or sleep disorders) whilst you are taking Subutex, unless they are prescribed by your doctor.

Subutex may make you feel sleepy and taking any of the following medicines may make this worse. Tell your doctor if you are already taking:

• strong pain killers and cough medicines that contain opioid-related substances
• antidepressants, including monoamine oxidase inhibitors
• antihistamines that make you feel drowsy
• sedatives (to help you sleep)
• medicines for anxiety
• medicines for high blood pressure
• treatment for a mental problem.

You should tell your doctor if you are taking any of the following medicines as he may need to give you a lower dose of Subutex:

• Ketoconazole ( a medicine used to treat fungal infections which can increase the levels of Subutex in your blood if both are taken at the same time)
• gestodene (found in contraceptives)
• troleandomycin (an antibiotic)
• ritonavir, indinavir and saquinavir (the HIV protease inhibitors)

Also tell your doctor or pharmacist if you are taking any of the following medicines:

• phenobarbital, carbamazepine or phenytoin (used in treatment of epilepsy)
• rifampicin (used for infections)
• phenprocoumon (to thin your blood).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Subutex with food and drink

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

Pregnancy and breast-feeding

You should not take Subutex if you are pregnant unless your doctor has told you to. You must not breast-feed your baby if you are taking Subutex

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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.

Important information about some of the ingredients of Subutex

Subutex Sublingual Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

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

HOW TO TAKE SUBUTEX SUBLINGUAL TABLETS

You must place the tablet under your tongue (sublingual) and allow it to dissolve, which will take 5 to 10 minutes. This is the only way to take the tablets. Do not chew or swallow them whole, as they will not work.

Your doctor will tell you how many tablets to take and you should always follow this advice.

To avoid sudden withdrawal symptoms, treatment with Subutex should be given when there are already clear signs of withdrawal symptoms.

Adults and children over the age of 16 years: when beginning treatment the dose is between 0.8 to 4mg, taken once a day.

For drug addicts who have not had any withdrawal treatment: one dose of Subutex should be taken at least 6 hours after the last use of the opioid (narcotic such as morphine or heroin), or when the first signs of craving appear. If you take it less than six hours after you use a narcotic you may get withdrawal symptoms.

For patients taking methadone: before beginning treatment, your doctor should reduce your dose of methadone to not more than 30mg a day. Subutex may cause withdrawal symptoms in patients who are dependent on methadone if used within in 24hours of the last dose of methadone

During your treatment, your doctor may increase your dose of Subutex, to a maximum single daily dose of 32mg, depending upon your response. Once you have been stable for a while, your doctor will gradually reduce your dose and it may be possible to stop it altogether Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms.

If you take more Subutex than you should

Get medical help at once.

If you forget to take Subutex

You should tell your doctor and follow his or her instructions. Do not take a double dose to make up for the forgotten dose.

If you stop taking Subutex

Do not suddenly stop taking the tablets, as this may cause withdrawal symptoms.

POSSIBLE SIDE EFFECTS

Like all medicines, Subutex can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the folllowing symptoms after taking this medicine . Although they are rare, these symptoms can be serious

• sudden wheezing, difficulty breathing, swelling of the eyelids, fae, tongue, lips, throat or hands; rash or itching especially those covering your whole body. These may be signs of an allergic reaction.
• if you start to breath more slowly or weakly than expected (respiratory depression) -if you start to feel faint, as this may be a sign of low blood pressure.

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

Other side effects that may occur with Subutex are:

• constipation
• headaches
• feeling and or being sick
• sweating
• fainting and dizziness
• drowsiness or difficulty in sleeping
• lack of energy or feeling weak
• feeling faint or dizzy after standing up from a sitting or lying position
• hallucinations (sensing things that are not real)
• difficulty in urinating

It is possible that taking this medicine can lead to drug dependence .

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE SUBUTEX SUBLINGUAL TABLETS

As with all medicines, keep out of the reach and sight of children. The 0.4mg tablets should be stored below 25°C in the original package. The 2mg and 8mg tablets should be stored below 30 °C in the original package. Do not use after the date which is stamped on the pack.

FURTHER INFORMATION

What Subutex tablets contain

The active substances is buprenorphine hydrochloride

The other ingredients are monohydrated lactose, mannitol, maize starch, povidone K30, citric acid, magnesium stearate and sodium citrate

What Subutex tablets look like and contents of the pack

The sublingual tablets come in blister packs containing either 7 or 28 tablets.