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Rosemont Pharmaceuticals Limited
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312
Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/05/2012
SPC Methadone Hydrochloride Sugar Free 1mg/1ml Oral Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 23/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.3 (Contraindications) The following contraindications have been added:  raised intracranial pressure or head injury, phaeochromocytoma and risk of paralytic ileus.

 

In section 4.4 (Special warnings and precautions for use) A heading for ‘Biliary tract disorders’ has been added.

 

In section 4.5 (Interaction with other medicinal products and other forms of interaction) CNS depressants now gives examples of the hypnotics. The section now also lists anxiolytics. There is reference to antipsychotics enhancing the sedative effects and hypotensive effects of methadone. Methadone may increase desipiramide levels. This section is also updated with reference to alcohol enhancing the sedative and hypotensive effects of methadone and how it may increase respiratory depression.

 

A heading for antibacterials has been added. This section now lists erythromycin and fluconazole and ketoconazole.  The ciprofloxacin  paragraph has additional text regarding plasma levels of methadone increasing with concurrent use, due to inhibition of CYP1A2 and CYP 3A4.

 

In section 4.6 (Fertility, pregnancy and lactation) The advice for lactation has been updated. This no longer reads breast feeding is not recommended during methadone treatment. Specialist care and dosing advice is given. Reference to physical dependence and withdrawal symptoms in breast-fed infants is provided.

 

In section 4.8 (Undesirable Effects) The presentation of the undesirable effects has been changed to SOC format also including frequencies. The adverse events have been updated with blurred vision under eye disorders. The listed rare cardiac disorders have been noted with high doses of methadone. GI disorders now include xerostomia and glossitis. Skin and subcutaneous disorders has been updated to include pruritis, urticaria and in uncommon cases bleeding in urticaria. Renal and urinary disorders include urinary retention and antidiuretic effect. Reduced potency is now listed in reproductive system and breast disorders. The general disorders and admin. Site conditions lists oedema of the lower extremities.


In section 10 (Date of (partial) revision of the text) the date has been updated to 23-Apr-2012
Updated on 15/03/2012 and displayed until 23/05/2012
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.3 (Shelf life) This has been increased from 12 months to 24 months in the HDPE bottle.
In section 10 (Date of (partial) revision of the text) the date has been updated to 08-Mar-2012
Updated on 09/02/2011 and displayed until 15/03/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   13-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following Brand name has been added:

Metharose Sugar Free Green 1mg/1ml Oral Solution
Updated on 26/05/2009 and displayed until 09/02/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3: Addition of shelf life of plastic pack
Section 6.5: Addition of plastic pack and 40ml pack size
Updated on 29/10/2008 and displayed until 26/05/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1: Re-arranged product name as per current guidance
Section 4.3: Removed contraindication of concurrent us of CNS depressants
Section 4.4: Added warning of of concurrent us of CNS depressants

Updated on 09/01/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: Added hypersensitivity to methadone, concurrent use of CNS depressants
Section 4.4: Added sections on addiction, tolerance. dependence, withdrawal, respiratory depression, hepatic disorders, noenates/childredn, further warnings
Section 4.5: More info on MAOIs, CNS depressants, H2 antagonists, rifampicin, anticonvulsants, pH of urine, opioid antagonists, added effact on gastro-intestinal motility, pregnancy tests, St John's Wort.
Section 4.6: Further information
Section 4.7: Added 'may cause drowsiness and reduced alertness'.
Section 4.8: Re-written into body system: CNS effects, autonomic nervous system, CV effects, other.
Section 6.5: Added 'Not all pack sizes may be marketed'.
 
Updated on 25/07/2005 and displayed until 09/01/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 26/09/2002 and displayed until 25/07/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  methadone hydrochloride