Subutex 0.4mg, 2mg and 8mg Sublingual Tablets

  • Name:

    Subutex 0.4mg, 2mg and 8mg Sublingual Tablets

  • Company:
    info
  • Active Ingredients:

    Buprenorphine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Summary of Product Characteristics last updated on medicines.ie: 17/10/2017
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Indivior UK Limited

Indivior UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Suboxone 2mg/0.5mg Sublingual Tablets Active Ingredients Buprenorphine hydrochloride, Naloxone Hydrochloride dihydrate
Medicine Name Suboxone 8mg/2mg Sublingual Tablets Active Ingredients Buprenorphine hydrochloride, Naloxone Hydrochloride dihydrate
Medicine Name Subutex 0.4mg, 2mg and 8mg Sublingual Tablets Active Ingredients Buprenorphine hydrochloride
Medicine Name Subutex Sublingual Tablets Active Ingredients Buprenorphine hydrochloride
1 - 0 of 4 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 October 2017 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

·         Change to section 7 - Marketing authorisation holder

·         Change to section 10 - Date of revision of the text

·         Changes to Sections 4.2

·         Changes to section 5.2

·         Changes to section 4.8

Updated on 17 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 October 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

·         Change to section 7 - Marketing authorisation holder

·         Change to section 10 - Date of revision of the text

·         Changes to Sections 4.2

·         Changes to section 5.2

·         Changes to section 4.8

Updated on 16 April 2013 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.3, shelf-life has been increased
In section 6.4, storage temperature has been changed from 25ºC to 30ºC for the 0.4mg strength
In section 6.5, the nature of the container has been changed from PVC/PVdC/Aluminium to nylon/aluminium/uPVC
In section 10, the revision date has been changed

Updated on 16 April 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.3, shelf-life has been increased
In section 6.4, storage temperature has been changed from 25ºC to 30ºC for the 0.4mg strength
In section 6.5, the nature of the container has been changed from PVC/PVdC/Aluminium to nylon/aluminium/uPVC
In section 10, the revision date has been changed

Updated on 19 July 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



 

In section 3, Added tablet(s) physical appearance

In section 7, RB Pharmaceuticals Ltd and company address added, Schering-Plough Ltd details removed

In section 8, Marketing Authorisation Numbers updated

In section 9, Last date of authorisation added

In section 10, date of text revision updated   

 

Updated on 19 July 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company



 

In section 3, Added tablet(s) physical appearance

In section 7, RB Pharmaceuticals Ltd and company address added, Schering-Plough Ltd details removed

In section 8, Marketing Authorisation Numbers updated

In section 9, Last date of authorisation added

In section 10, date of text revision updated   

 

Updated on 10 August 2007 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 2 - The following has been added:

 

Excipients: Lactose monohydrate 29.262mg/tablet (0.4 mg), 47.94mg/tablet (2 mg) or 191.76mg/tablet (8 mg).

 

            For full list of excipients, see section 6.1

Section 4.2 - the following sentence has been deleted:

 

When initiating SUBUTEX treatment, the physician should be aware of the partial agonist profile of the buprenorphine molecule. Buprenorphine binds to the m and k opiate receptors, and may precipitate withdrawal symptoms in opioid-dependent patients.

 

and the following has been added:

 

            Adults

Initiation therapy:

Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.  Patients who are positive for viral hepatitis, on concomitant medication (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.  Regular monitoring of liver function is recommended (see section 4.4).

Induction:

Prior to treatment induction, consideration should be given to the type of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence.  To avoid precipitating withdrawal, induction with Subutex should be undertaken when objective and clear signs of withdrawal are evident.

 

Within the bullet point starting: "for opioid-dependent drug addicts who have not undergone withdrawal:" 4 hours has now been changed to 6 hours

 

Section 4.4

 

After the frist sentence, the following has been added:

 

It is also recommended that the treatment is prescribed by a physician who ensure comprehensive management of the drug addicted patient(s).

 

The following has also been added:

 

Diversion:

Diversion refers to the introduction of Subutex into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies.  This diversion may lead to new addicts using Subutex as the primary drug of abuse with the risk of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.

 

Precipitated Withdrawal

When initiating treatment with buprenorphine the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients particularly if administered less than 6 hours after the last use of heroin or other short-acting opioids, or if administered less than 24 hours after the last dose of methadone.  Conversely, withdrawal symptoms may also be associated with suboptimal dosing.

The risk of serious adverse events such as overdose or treatment dropout is greater if a patient is under treated with Subutex and continues to self medicate withdrawal symptoms with opioids, alcohol or other sedative-hypnotics in particular benzodiazepines.

 

Dependence

Buprenorphine is a partial; agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type.  Discontinuation of treatment may result in a withdrawal that may be delayed.

 

In the sub-section entitled Hepatitis, hepatic events, the following has been deleted:

 

hepatic necrosis and hepatitis with jaundice, which generally have resolved favourably, have been reported in patients who use buprenorphine. Causality has not been clearly established.

 

And replaced with the following:

 

Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post-marketing adverse event reports.  The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure.  In many cases the presence of pre-existing liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant use of other potentially hepatotoxic drugs and ongoing injecting drug use may have a causative or contributory role.  These underlying factors must be taken into consideration before prescribing Subutex and during treatment. 

 

The following sentence has been deleted:

 

This product can cause opioid withdrawal symptoms if administered to an addicted patient less than 4 hours after the last use of the drug. (See 4.2 Posology and method of administration.)

 

Under “Precautions for use” the following has been added:

 

Patients with lactose intolerance: This product contains lactose (see section 6.1).  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Section 6.1, the following has been changed from:

 

            Monohydrated lactose

 

To:

 

Monohydrated lactose, approx. 28 mg (0.4 mg), approx. 45 mg (2 mg), approx. 182 mg (8 mg)

 

Section 10 – date of revision of text has been updated

 

Updated on 10 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 - The following has been added:

 

Excipients: Lactose monohydrate 29.262mg/tablet (0.4 mg), 47.94mg/tablet (2 mg) or 191.76mg/tablet (8 mg).

 

            For full list of excipients, see section 6.1

Section 4.2 - the following sentence has been deleted:

 

When initiating SUBUTEX treatment, the physician should be aware of the partial agonist profile of the buprenorphine molecule. Buprenorphine binds to the m and k opiate receptors, and may precipitate withdrawal symptoms in opioid-dependent patients.

 

and the following has been added:

 

            Adults

Initiation therapy:

Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.  Patients who are positive for viral hepatitis, on concomitant medication (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury.  Regular monitoring of liver function is recommended (see section 4.4).

Induction:

Prior to treatment induction, consideration should be given to the type of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence.  To avoid precipitating withdrawal, induction with Subutex should be undertaken when objective and clear signs of withdrawal are evident.

 

Within the bullet point starting: "for opioid-dependent drug addicts who have not undergone withdrawal:" 4 hours has now been changed to 6 hours

 

Section 4.4

 

After the frist sentence, the following has been added:

 

It is also recommended that the treatment is prescribed by a physician who ensure comprehensive management of the drug addicted patient(s).

 

The following has also been added:

 

Diversion:

Diversion refers to the introduction of Subutex into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies.  This diversion may lead to new addicts using Subutex as the primary drug of abuse with the risk of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.

 

Precipitated Withdrawal

When initiating treatment with buprenorphine the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients particularly if administered less than 6 hours after the last use of heroin or other short-acting opioids, or if administered less than 24 hours after the last dose of methadone.  Conversely, withdrawal symptoms may also be associated with suboptimal dosing.

The risk of serious adverse events such as overdose or treatment dropout is greater if a patient is under treated with Subutex and continues to self medicate withdrawal symptoms with opioids, alcohol or other sedative-hypnotics in particular benzodiazepines.

 

Dependence

Buprenorphine is a partial; agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type.  Discontinuation of treatment may result in a withdrawal that may be delayed.

 

In the sub-section entitled Hepatitis, hepatic events, the following has been deleted:

 

hepatic necrosis and hepatitis with jaundice, which generally have resolved favourably, have been reported in patients who use buprenorphine. Causality has not been clearly established.

 

And replaced with the following:

 

Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post-marketing adverse event reports.  The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure.  In many cases the presence of pre-existing liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant use of other potentially hepatotoxic drugs and ongoing injecting drug use may have a causative or contributory role.  These underlying factors must be taken into consideration before prescribing Subutex and during treatment. 

 

The following sentence has been deleted:

 

This product can cause opioid withdrawal symptoms if administered to an addicted patient less than 4 hours after the last use of the drug. (See 4.2 Posology and method of administration.)

 

Under “Precautions for use” the following has been added:

 

Patients with lactose intolerance: This product contains lactose (see section 6.1).  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Section 6.1, the following has been changed from:

 

            Monohydrated lactose

 

To:

 

Monohydrated lactose, approx. 28 mg (0.4 mg), approx. 45 mg (2 mg), approx. 182 mg (8 mg)

 

Section 10 – date of revision of text has been updated

 

Updated on 29 November 2005 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Updated on 29 November 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 July 2005 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Updated on 19 July 2005 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 May 2003 PIL

Reasons for updating

  • New SPC for medicines.ie

Updated on 30 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)