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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: 09/01/2008
SPC Metoclopramide Hydrochloride 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 09/01/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Name re-arrangement as per current guidance
Section 4.4: To include the precaution of use in patients with a history of atopy (including asthma) or porphyria.
Section 4.8: Addition of hypersensitivity, including anaphylaxis.
Updated on 11/07/2007 and displayed until 09/01/2008
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 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: Added contraindication: should not be used during 1st 3-4 days following GI operations.
Section 4.4: Updated with: neurlopetic malignant syndrome, excipient warnings (sorbitol, parahydroxybenzoates), porphyria
Section 4.5: Absorption of orally adminstered drugs may be affected, info on extrapyramidal reactions causing drugs, drugs acting central dopamine receptors, atovaquone.
Section 4.8: Neuroleptic malignant syndrome, depression, raised serum prolactin levels, red cell disorders, allergice reactions (inc. anaphylaxis) added.
 
Updated on 21/09/2006 and displayed until 11/07/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 (Undesirable effects): " A small number of skin reactions such as urticaria, pruritus and oedema (including face oedema)." added
Section 9 (Renewal of authorisation): "15 June 2006" added
Section 10 (Date of revision of text): Updated to 15-Jun-06
Updated on 31/07/2002 and displayed until 21/09/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 14/12/2001 and displayed until 31/07/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  metoclopramide hydrochloride