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Alliance Pharmaceuticals Ireland
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 44 (0)1249 466966
Fax: +44 (0)1249 466 977
Medical Information e-mail: medinfo@alliancepharma.co.uk
Summary of Product Characteristics last updated on medicines.ie: 05/12/2011
SPC Nu-Seals 75

When a pharmaceutical company changes an SPC or PIL, 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 05/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   25-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Changes/amendments highlighted in red text below:



2 Qualitative and Quantitative Composition





Each tablet contains:





Acetylsalicylic Acid Ph.Eur. (Aspirin) 300mg.



Excipients: also includes trace amounts of Ponceau 4R (E124)



For a full list of excipients see section 6.1.











6.1 List of Excipients







Maize Starch

Polyethlene Glycol 3350

Talc

Emulsion silicone

Hypromellose

Propylene Glycol

Benzyl alcohol

Methacrylic acid – ethyl acrylate (1:1) copolymer dispersion 30 per cent



Polyethylene glycol 3350

Propylene glycol

Benzyl alcohol

Emulsion silicone



Edible pPrinting ink containing Ponceau 4R (E124) shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone
Updated on 23/04/2009 and displayed until 05/12/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   04/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.5 Now includes the following text

Ibuprofen: Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

 
 
Section 5.1 Now inlcudes the following text

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg vas taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
Updated on 08/11/2007 and displayed until 23/04/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change to section 1 - trade name,
Change to section 2 - qualitative and quantitative composition,
Change to section 4.2 - Posology and Method of Administration,
Change to section 4.3 - Contra-indications,
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 4.6 - Pregnancy and Lactation,
Change to section 4.8 - Undesirable Effects,
Change to section 4.9 - Overdose,
Change to section 5.1 - Pharmacodynamic Properties,
Change to section 6.1 - List of Excipients
Updated on 05/09/2007 and displayed until 08/11/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1: Now reads, Nu-Seals 75 mg gastro-resistant tablets.
 
Section 2: Now reads

Each tablet contains:

            Aspirin (Acetylsalicylic Acid) 75mg.

 

            Excipients: also includes trace amounts of Ponceau 4R (E124)

            For a full list of excipients, see 6.1.

 

Section 6.1: Now reads

Edible printing ink containing ponceau 4R, E124.

 
Section 6.4: Now reads,

Do not store above 25ºC. Store in the original package. 

 
Section 6.6: Now reads

No special requirements

 
Section 7: Now reads

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK
Updated on 28/11/2005 and displayed until 05/09/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 06/08/2004 and displayed until 28/11/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 22/07/2004 and displayed until 06/08/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 23/06/2003 and displayed until 22/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Aspirin