go to medicines.ie homepage
  • Home  |  
  • About  |  
  • Links  |  
  • Help
Font Size
Search for:  
select
select
  • SPCs and PILs
  • SPCs Only
  • PILs Only
  Advanced Search
  • What's
    New
      
  • Browse
    Medicines
      
  • Browse
    Active Ingredients
      
  • Browse
    Companies
      
  • Codes
    of Practice
      
  • Adverse
    Reaction Reporting

GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd
Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 26/01/2012
SPC Amoxil Paediatric Suspension

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 26/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   25-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Update to excipients
Updated on 17/09/2008 and displayed until 26/01/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

old wording

new wording

 

Children under 40Kg#

 

 

 

Glomerular filtration rate

Oral treatment

< 30

No adjustment necessary

10-30 ml/min

15mg/kg given twice daily

 

< 10ml / min

15mg/kg given as as single daily dose

 

 

 

 

Children under 40Kg#

 

 

Glomerular filtration rate

Oral treatment

< 30

No adjustment necessary

10-30 ml/min

15mg/kg given twice daily

(maximum 500mg/twice daily)

< 10ml / min

15mg/kg given as as single daily dose (maximum 500mg)

Updated on 09/11/2006 and displayed until 17/09/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   10/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction

Probenecid decreases the renal tubular excretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives

4.8: Undesirable effects

Infections and Infestations

Very rare:Mucocutaneous candidiasis

Gastrointestinal disorders

#Common: Diarrhoea and nausea.

#Uncommon: Vomiting.

Very rare:Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). [44, 45]

Black hairy tongue

Updated on 27/06/2006 and displayed until 09/11/2006
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Dry Powder:
Do not Store above 25C. Keep bottle tightly closed in order to protect from moisture

Reconstituted Suspension:

Do not store above 25C

Updated on 21/02/2005 and displayed until 27/06/2006
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Updated on 12/05/2004 and displayed until 21/02/2005
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
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 03/07/2003 and displayed until 12/05/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 19/06/2003 and displayed until 03/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Amoxicillin trihydrate

Versions

 
26/01/2012 to Current
17/09/2008 to 26/01/2012
09/11/2006 to 17/09/2008
27/06/2006 to 09/11/2006
21/02/2005 to 27/06/2006
12/05/2004 to 21/02/2005
03/07/2003 to 12/05/2004
19/06/2003 to 03/07/2003
  • Terms & Conditions | 
  • Accessibility | 
  • Privacy Statement | 
  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

This website is certified by Health On the Net Foundation. Click to verify.

This site complies with the HONcode standard for trustworthy health information: verify here.

logo