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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: 26/05/2009
SPC Methadone Hydrochloride DTF 1mg/1ml Oral Solution (Rosemont Pharmaceuticals Ltd)

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 26/05/2009 and displayed until Current
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: Extended shelf life in plastic pack to 12 months
Section 6.5: Added 40ml pack size
Updated on 26/01/2009 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 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 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arrangement as per guidance.
Section 4.3: Added: Patients dependent on non-opioid drugs, hypersensitivity to methadone, use during an asthma attack.
Section 4.4: Added that caution should be used in hepatic/renal dysfunction. Added sections on: Addiction/tolerance/dependence, withdrawal, respiratory depression, hepatic disorders, constipation, neonates/children. Added caution for patients with acute alocholism, convulsive disroders, head injuries, raised intracranial pressure, hypothyroidism, adrenocortical insufficiency, prostatic hyperplasia, hypotension, shock, inflammatory or obstructive bowel disorders, myasthenia gravis, taking concurrent CNS depressants. Updated excipient warnings for sucrose.
Section 4.5: Added: SSRIs, histamine H2 antagonist, drugs causing reduced GI motility, pregnancy tests, St John's Wort. Expanded on: Rifampicin, anticonvulsants, MAOIs, pH or urine, antiretroviral agents.
Section 4.6: has been expanded.
Section 4.8: Added the following system organ classes: Cardiac, Nervous system, eye, ear and labyrinth, respiratory, gastrointestinal, renal and urinary, skin, endocrine, vascular, general, reproductive system and psychiatric.
Section 6.3: Added shelf life of HDPE pack
Section 6.5: Added container for HDPE pack
Section 9: Date of renewal added
Updated on 26/07/2005 and displayed until 26/01/2009
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 05/03/2003 and displayed until 26/07/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
  • Improved Electronic Presentation
Updated on 26/09/2002 and displayed until 05/03/2003
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  methadone hydrochloride