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Author: RB Pharmaceuticals Ltd.


Long information

What is it?

Suboxone is a medicine that contains two active substances, buprenorphine and naloxone. It is available aswhite, hexagonal, sublingual tabletscontainingeither 2mg buprenorphine and 0.5mg naloxone, or 8mg buprenorphine and 2mg naloxone.?Sublingual?means that the tablet isplaced under the tongue where itdissolves.

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Suboxone is used to treat dependenceon opioid(narcotic) drugssuch as heroin or morphineindrug addicts who have agreed to be treated for their addiction.Suboxone is used in adults and children over 15years of age, who are also receiving medical, social and psychological support.

The medicine can only be obtained by?special?prescription.This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.

How is it used?

Suboxone must be used under the supervision of a doctor who has experience in the management of opioid addiction. It is recommended that the patient?s liver be checked before starting treatment withSuboxoneandshould also be monitoredregularly during treatment. The way Suboxone is used depends on the patient?s status: type of addiction, state of withdrawal, and whether the patient is already using another substitution treatment such as methadone before starting Suboxone.

The tablets must never be swallowed but shouldbe placed under the tongue and allowed to dissolve, whichusuallytakesfiveto 10 minutes.The recommended starting dose is one or two tablets of Suboxone 2mg/0.5mg. The doctor may increasethe dose depending on the patient?s responsebut thedaily dose should not be higher than 24mg buprenorphine. Once the patient has been stabilised, themaintenancedose may be reduced gradually and eventually treatment may be stopped.

The effectiveness of Suboxonetreatment depends on the patientalso receiving other medical, social and psychological support. For full details, see the summary of product characteristics (also part of the EPAR).

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How does it work?

Suboxone contains two active substances:buprenorphine, a partial opioid agonist (it acts like an opioid drug), and naloxone, an opioid antagonists (it counteracts the effects of opioid drugs).

Sublingual tabletscontaining Buprenorphinealonehavebeen available in the EUsince the mid-1990?s for thetreatment ofopioid addiction. However, Buprenorphine tablets have beenmisusedby drug addicts whodissolvethe tabletsandinjectthemselves withthe resulting solution. The addition of naloxone helps prevent the misuse of the medicine. This is because, when injected, naloxone counteracts the effects of opioids,causingthe patient to experience acute withdrawal symptoms.

How has it been studied?

Onemain study compared Suboxone withbuprenorphine on its own or withplacebo (a dummy treatment) in 326 heroin-dependent patientsfor fourweeks, and measured the percentage of patients who had no trace of opioids in their urine at the end of the study. Patients also used a specially designed questionnaire to record their cravings, and the change in the questionnaire score before and at the end ofthe study was measured.

What benefits has it shown during the studies?

Suboxone was as effective as buprenorphine on its own and more effective than placebo: 17.8% of the patients who received Suboxone had a urine sample that tested negative at the end of the study, compared with5.8% of thepatients receiving placebo. The craving score, which was between 62.4 and 65.6 before treatment, decreasedat the end of the study to 29.8 with Suboxone,compared with 55.1 with placebo.

What is the risk associated?

The most common sideeffects with Suboxone (seen in more than 1 patient in 10) are insomnia (difficulty sleeping), constipation, nausea (feeling sick), sweating, headache and withdrawal syndrome. For the full list of all side effects reported with Suboxone, see the package leaflet.

Suboxone should not be used in people who may be hypersensitive (allergic) to buprenorphine or naloxone, or to any of the other ingredients. It mustnot be used in patients with severe respiratoryinsufficiency(difficulty breathing) orsevere liverproblems. It must also not be used in patients with acute alcohol intoxication (excessive alcohol consumption)or delirium tremens(a condition causedby alcohol withdrawal).

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Why has it been approved?

The CHMP notedthat the combination of an opioid analogue with an opioid antagonist is an established strategy for reducing the potential misuseof the medicine. The Committee decided that Suboxone?s benefits are greater than its risks and recommended that itbe given marketing authorisation.

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