Amoxil Paediatric Suspension

  • Name:

    Amoxil Paediatric Suspension

  • Company:
    info
  • Active Ingredients:

    Amoxicillin trihydrate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/01/18

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Summary of Product Characteristics last updated on medicines.ie: 17/1/2018
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 136 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 17 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 January 2018 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

GDS No: 29, Update 1: TSC 3:
• Addition of the agreed wording from a PRAC recommendation on Drug Reaction with eosinophilia and systemic symptoms (DRESS) syndrome to:
-SmPC Sections 4.4 Special warnings and precautions for use
-SmPC 4.8 Undesirable effects

-PIL Section 4. Possible side effects
• Addition of ‘contains penicillin’ to Labelling Section 7. Other special warning(s) - for IE only, as this warning was already present on UK cartons
• Addition of ‘EXP’ abbreviation to PIL Section 5. (How to store Amoxil)
• Update of MHRA adverse event reporting details in Section 4.8 of SmPC and Section 4 of PIL (UK only - all except for the combined PIL for Amoxil Vials for Injection 500 mg and 1 g)

Workshare variation Procedure Number: FR/H/XXXX/WS/101

Updated on 16 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 January 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 October 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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 17 October 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 April 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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 April 2016 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 21 April 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change of special precautions for disposal
  • Change due to harmonisation of PIL
  • Addition of information on reporting a side effect.

Updated on 17 July 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to address of the MA Holder

Updated on 16 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 5 December 2014 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 4 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 June 2013 PIL

Reasons for updating

  • Change of active ingredient
  • Change to packaging
  • Change of manufacturer
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to appearance of the medicine

Updated on 11 June 2013 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 June 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

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 19 June 2012 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 26 January 2012 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to excipients

Updated on 18 February 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 17 September 2008 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 9 November 2006 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

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 June 2006 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

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 18 November 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 August 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 8 July 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 February 2005 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 May 2004 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)