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GlaxoSmithKline (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 495 5000
Fax: +353 1 4955225
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5225
Summary of Product Characteristics last updated on medicines.ie: 18/10/2017
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 18/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Oct-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Updates to SPC:
Section 6.5 - Update to description of cap and dosing syringe
Section 10 - update to Date of revision of the text
Updated on 20/04/2017 and displayed until 18/10/2017
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Apr-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



Section 4.2 SmPC:
• The current dosing recommendations for adults undergoing haemodialysis in the EU SmPC are incorrect. What is currently recommended in the EU SmPC is actually dosing recommendations for children ≤ 40 kg. Therefore, Section 4.2 of the SmPC has been amended to reflect the correct dosing recommendations for oral amoxicillin in adults and children ≥ 40 kg undergoing haemodialysis.  There are no updates to the PIL or Labelling components as a result of this change. This update is also in line with GDS 28 which was updated in parallel.

 

Updated on 21/04/2016 and displayed until 20/04/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   29-Feb-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



·         Section 2 – addition of excipients

·         Section 3 – editorial changes

·         Section 4.1 – harmonisation of indications across the EU

·         Section 4.2 – harmonisation of the recommendations on how to use Amoxil.

·         Section 4.3 – editorial changes

·         Section 4.4 – harmonisation of warnings across the EU including excipient warnings

·         Section 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 – harmonisation of information across the EU

·         Section 4.8 - addition of reporting of suspected adverse reactions
Sections 6.1, 6.2 – harmonisation of pharmaceutical information across the EU

·         Section 6.3, 6.4 – addition of reconstituted storage and shelf life

·         Section 6.5 - harmonisation of pharmaceutical information

·         Section 6.6 – editorial changes

·         Section 9 – editorial changes

·         Section 11 – legal status removed

Updated on 17/07/2015 and displayed until 21/04/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to address of the MA Holder
Updated on 05/12/2014 and displayed until 17/07/2015
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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-Nov-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.4- Administrative changes

Section 4.5- Administrative changes

Section 4.6- Additional information about use in pregnancy.

Section 4.8- Removal of ‘for suspension and chewable tablets only’. Administrative changes, and the addition of reporting side effects.

Updated on 11/06/2013 and displayed until 05/12/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   31-May-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Summary of track changes for the SPC:

Amoxil Paediatric 125mg/1.25ml Powder for Oral Suspension

 

 

Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

125mg amoxicillin per 1.25ml as amoxicillin trihydrate

For excipients see section 6.1.

 

List of excipients with known effects:

Aaspartame (E951)                              4 mg/1.25 ml

Sodium benzoate (E211)         2.125 mg/1.25 ml

Sulphur dioxide (E220)                      0.11 µg/1.25 ml

Maltodextrin (contains glucose)          7 mg/1.25 ml

 

Section 3. PHARMACEUTICAL FORM

 

Powder for oral suspension

White free flowing powderWhite powder with yellowish grains

 

Section 4.4 Special warnings and precautions for use

 

Addition of the following warnings:

 

‘Amoxil’ Paediatric Suspension contains sodium benzoate which is a mild irritant to the skin, eyes and mucous membrane. It may increase the risk of jaundice in newborn babies.

 

Amoxil contains Aspartame (E951) which is a source of Phenylalanine. This may be harmful for people with phenylketonuria.

 

The lemon-peach-strawberry flavour contains sulphur dioxide (E220) which may rarely cause severe allergic reaction (called hypersensitivity reaction) and tightness in your chest (called “bronchospasm”). 

 

This medicinal product contains maltodextrin (contains glucose). Patients with rare glucose-galactose malabsorption should not take this medicine.

 

Deletion of the following warning:

 

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

 

Section 6.1.List of excipients

 

            Sodium benzoate (E211)

Sodium carboxymethyl cellulosecarmellose sodium (E466)

Crospovidone

Xanthan gum

Silica hydrophobic colloidal

Magnesium stearate

Lemon-peach-strawberry flavour (containing sulphur dioxide (E220) & maltodextrin (contains glucose).

)

Aspartame (E951)

peach dry flavour

strawberry dry flavour

lemon dry flavour

sucrose.

 

 

Section 6.5. Nature and contents of container

 

A clear 45ml glass bottle moulded from type III Ph. Eur. glass. The bottles are fitted with an aluminium roll-on pilfer-proof (ROPP), internally lacquered, externally enamelled closure containing a flowed-in PVC liner or polyolefin liner. These primary packs are placed in a carton with a 6mL syringe.

 

 

Section 6.6. Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

At time of dispensing, the dry powder should be reconstituted to form a citrus flavoured, colourless an oral suspension, as detailed below:

         Check cap seal is intact before use.

         Invert and shake bottle to loosen powder.

         Fill the bottle with water to just below the mark on bottle label.

         Invert and shake well, then top up with water to the mark. Invert and shake again.

         Shake well before taking each dose.

 

 

Volume of water to be added to reconstitute                           13ml                           

Nominal bottle size                                                                  4530ml                                   

Final volume of reconstituted oral suspension                         20ml

 

 

Updated on 20/06/2012 and displayed until 11/06/2013
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   15-Jun-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.2        Posology and Method of Administration

 

Children up to 10 years of age Children weighing < 40 kg:

The usual total daily dosage is 375mg in divided doses (i.e. 125mg three times daily by the oral route).

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).

*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

 

In severe or recurrent acute otitis media, especially where compliance may be a problem, 750mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Children weighing more than 40 kg should be given the usual adult dosage.

 

Special dosage recommendation

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.

Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.

 

Prophylaxis of Endocarditis

 

Children weighing < 40 kg     Under 10:        half the adult dose. 

Under 5:          quarter the adult dose.

50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.

 

Renal impairment: In renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage. The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2).

 

Children under 40kg

 

Glomerular filtration rate

Dose

Oral treatmentInterval between administration

> 30 ml / min

Usual dose*

No adjustment necessary

10-30 ml/min

Usual dose*

12 h

(corresponding to 2/3 of the dose)15 mg/kg given b.i.d.

(maximum 500mg/twice daily)

< 10ml / min

Usual dose*

24 h

(corresponding to 1/3 of the dose) 15 mg/kg given as a single daily dose

(maximum 500mg)

 

 

4.4              Special warnings and precautions for use

 

 

Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

 

5.2       Pharmacokinetic properties

           

In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.

 

 

 

 

Updated on 26/01/2012 and displayed until 20/06/2012
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

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Active Ingredients

 
   Amoxicillin trihydrate