eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

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: 11/01/2010
SPC Orphenadrine Hydrochloride 50mg/5ml 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 11/01/2010 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.3 (contraindications), hypersensitivity to orphenadrine or to any of the excipients has been added and prostatic hypertrophy added.
In section 4.4 (Special warnings and special precautions for use), use in caution with the elderly has been added. Caution in patient with pre-existing tachycardia has also been added. A note recommending against use in tardive dyskinesia has been included.
In section 4.5 (Interaction with other Medicinal Products and other forms of Interaction) medications with anti-muscarinic properties such as antihistamines, antispasmodics, tricyclic antidepressants, phenothiazines, dopaminergic anti parkinsonian drugs including amantadine, and anti-arrhythmics such as disopyramide have been  added with a potential for enhanced anti-muscuranic effects of orphenadrine.
In section 4.8 Undesirable Effects has been edited for better presentation of data by system organ class and frequency.
In section 4.9 (overdose) the text has been edited to include toxicity information for adults and children and a break down of features under common and uncommon. A more detailed description of treatment has also been added
Section 10 Date of (Partial) Revision of the Text has been updated to the 23rd Nov 2009.
Updated on 21/06/2007 and displayed until 11/01/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Amended from orphenadrine oral solution 50mg/5ml to Orphenadrine Hydrochloride 50mg/5ml Oral Solution to meet current guidance
Updated on 07/06/2007 and displayed until 21/06/2007
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arranged to bring in to line with current legislation. From ORphenadrine Oral Solution 50mg/5ml to Orphenadrine Hydrochloride 50mg/5ml Oral Solution
Updated on 05/04/2007 and displayed until 07/06/2007
Reasons for adding or updating:
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4: Addition of statement regarding caution should be exercised in patients with micturition difficulties, pregnancy and breast-feeding. Avoid abrupt discontinuatio. Excipient warnings updated.
Section 4.5: May affect the absorption of orally administered drugs
Section 4.6: Caution in breast-feeding and pregnancy
Section 4.7: Added 'blurred vision'
Section 4.8: added: tachycardia, hypersensitivity, nervousness, hallucination, insomnia, confusion, co-ordination disturbance
 
Updated on 26/09/2002 and displayed until 05/04/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  orphenadrine hydrochloride