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Alliance Pharmaceuticals

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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: 04/03/2013
SPC Nu-Seals 300

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 04/03/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



6.1 Shelf Life


Changed from 2 years to 3 years

Updated on 12/07/2012 and displayed until 04/03/2013
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   07-Dec-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 11/01/2012 and displayed until 12/07/2012
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   31-Oct-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



The changes that have been made are in red.

6.1    List of excipients

 

Maize Starch Hypromellose Talc

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

Polyethylene Glycol 3350

Propylene Glycol Benzyl Alcohol Emulsion silicone

Edible Printing Ink – containing  shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone

Updated on 13/08/2010 and displayed until 11/01/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Aug-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes highlighted in red:


1.            
NAME OF THE MEDICINAL PRODUCT

 

Nu-Seals 300

Aspirin 300mg Gastro-resistant Tablets

1.             PHARMACEUTICAL FORM

 

White, gastro-resistant tablets, coded “300” in red or “GP” in black


4.1         Interaction with other medicinal products and other forms of interaction

 

Salicylates may enhance the effect of oral hypoglycaemic agents, phenytoin and sodium valproate.  They inhibit the uricosuric effect of probenecid and may increase the toxicity of sulphonamides. 

 

Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics.

 

Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may occur following withdrawal of the corticosteroids.  The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.

 

Concurrent use of aspirin and other NSAIDs should be avoided.  Use of two or more NSAID preparations increases the risk of serious gastrointestinal haemorrhage.

 

Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity.

 

In large doses, salicylates may also decrease insulin requirements.

 

Patients using gastro-resistant aspirin should be advised against ingesting antacids simultaneously to avoid premature drug release.

 

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).



5.1         Pharmacodynamic properties

 

Aspirin has analgesic, antipyretic and anti-inflammatory actions.

 

It also has antithrombotic action, which is mediated through inhibition of platelet activation.

 

Nu-Seals 300 tablets have a gastro-resistant coat sandwiched between a sealing coat and a top coat.  The gastro-resistant coat is intended to resist gastric fluid whilst allowing disintegration in the intestinal fluid.



1.             DATE OF REVISION OF THE TEXT

 

10th August 2010

Updated on 29/06/2009 and displayed until 13/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   19-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - The following red text has been added

Aspirin should be used with caution in patients with impaired renal or hepatic function (avoid if severe), or in patients who are dehydrated.

Updated on 22/12/2008 and displayed until 29/06/2009
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:   15-Dec-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.5 - the follwoing text has been added:

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- the following text has been added:

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 was taken within 8 hours before or within 30 minutes after immediate release aspirin (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 31/05/2006 and displayed until 22/12/2008
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   12/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 A new paragraph reading "Aspirin decreases platelet adhesiveness and increases bleeding time.  Haematological and haemorrhagic effects can occur, and may be severe.  Patients should report any unusual bleeding symptoms to their physician." has been added.
 
Section 4.5 The first sentence has been amended: "Salicylates may enhance the effect of anticoagulants, oral hypoglycaemic agents, phenytoin and sodium valproate."
The following text has been added:
"Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics.
Plasma salicylate concentrations may be reduced by concurrent use of corticosteroids, and salicylate toxicity may ocur following withdrawal of the corticosteroids.  The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.
Concurrent use of aspirin and other NSAIDs should be avoided.  Use of two or more NSAID preparations increases the risk of serious gastrointestinal haemorrhage.
Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity."
 
Section 4.6 Has been amended as follows (text in bold has been added):
Usage in pregnancy: Aspirin does not appear to have teratogenic effects.
Pregnancy: Although clinical and epidemiological evidence suggests the safety of aspirin for use in pregnancy, caution should be exercised when considering use in pregnant patients.  Aspirin has the ability to alter platelet function and there may be a risk of haemorrhage in infants whose mothers have consumed aspirin during pregnancy.
Prolonged pregnancy and labour, with increased bleeding before and after delivery, decreased birth weight and increased rate of stillbirth were have been reported with high blood salicylate levels.  With high doses there may be permanent closure of the ductus arteriosus and possible persistent pulmonary hypertension in the newborn.  Analgesic doses of aspirin should be avoided during the last trimester of pregnancy.
Lactation: As aspirin is excreted in breast milk, Nu-Seals should not be taken by patients who are breast-feeding,  as there is a risk of Reye's syndrome in the infant.  High maternal doses may impair platelet function in the infant.
 
Section 4.8 This section has been completely re-written.
 
Section 4.9 This section has been completely re-written.
Updated on 03/12/2003 and displayed until 31/05/2006
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
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/12/2003 and displayed until 03/12/2003
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
  • Change to section 10 (date of (partial) revision of the text
Updated on 06/01/2003 and displayed until 03/12/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 03/01/2003 and displayed until 06/01/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 02/01/2003 and displayed until 03/01/2003
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