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Calpol 120mg/5ml Infant Oral Suspension

*
General Sale: Non-prescription

  • Company:

    Kenvue

  • Status:

    No Recent Update

  • Legal Category:

    Supply through general sale

  • Active Ingredient(s):

    Paracetamol

    *Additional information is available within the SPC or upon request to the company

  • 83921 CALPOL® Infant 140ml.png

Updated on 25 April 2022

File name

ie-pl-calpol-infant-2110.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 April 2022

File name

ie-spc v17-calpol infant suspension-2210.pdf

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 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 14 March 2022

File name

ie-spc-clean-pa-330-17-01-bv2218.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Updated on 22 August 2021

File name

ie-leaflet-calpol infant suspension - 2082.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 August 2021

File name

ie-spc v16 calpol infant suspension - 2082.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 12 December 2019

File name

ie-spc v15 calpol infant suspension - 2004.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 26 November 2019

File name

ie-pl-calpol infant - 1934.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 26 November 2019

File name

ie spc v14 calpol infant suspension 1934.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 05 November 2019

File name

401538173_8392105_7714106_19_0177_LN505804_LEAFLET_CalpolInfantSuspension_60ml_140ml_IE_r0.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 12 March 2019

File name

ie-leaflet Calpol Infant Oral Suspension - 1808.pdf.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 March 2019

File name

ie-spc v12 calpol infant suspension - 1808.pdf

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 10 December 2018

File name

ie-leaflet (proposed) - 1835.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 10 December 2018

File name

ie-spc v13 Calpol Infant 1835.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 28 June 2018

File name

LN505802-PIL CALPOL INFANT 60-140ML IEv12_6.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 12 April 2017

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:Supply through general sale

Free text change information supplied by the pharmaceutical company

The sentence 'unless your doctor or nurse has been advised otherwise' was added to section 4.2 and the date of revision was updated accordingly.

Updated on 04 April 2017

File name

PIL_8607_757.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 April 2017

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 6 - date of revision

Updated on 31 May 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4 added text

This product contains the following excipients which have recognised effects:

 

-            Sucrose and sorbitol.  Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose iso-maltase insufficiency should not take this medicine,

-            Carmoisine which may cause allergic reactions.

-            Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216),                 Ethyl parahydroxybenzoate (E214) which may cause allergic reactions (possibly delayed).


Section 10 replaced date with "April 2016"

Updated on 05 March 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.4 - the following warning has been added:

Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Section 4.6 has been updated as follows:

There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women. Epidemiological studies indicate that paracetamol, when taken as directed, does not adversely affect the pregnant mother or fetus.

 

Pregnancy

When given to the mother in labeled doses, paracetamol crosses the placenta into fetal circulation as early as 30 minutes after ingestion and is effectively metabolized by fetal sulfate conjugation. When taken as directed, paracetamol

does not adversely affect the pregnant mother or fetus

 

Breastfeeding

Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal ingestion of paracetamol in labeled doses does not present a risk to the nursing infant.



Section 4.8 & 4.9 have been updated with new information - please see revised SPC for details. Section 4.8 has also been updated with Adverse events reporting information

Section 5.1 - the following paragraph has been added

ATC Code: N02BE01 – Other analgesics and antipyretics

Paracetamol is a centrally acting, non-opiate, non-salicylate analgesic. Paracetamol is a clinically proven analgesic/antipyretic, and it is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating centre.  Single-dose studies (12.5 mg/kg) of paracetamol in febrile children showed an onset of fever reduction within 15 to 30 minutes. 

Updated on 05 March 2015

Reasons for updating

  • Change to side-effects

Updated on 04 July 2013

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Inclusion of syringe dosing device.

Updated on 02 July 2013

Reasons for updating

  • Change to packaging

Updated on 19 January 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Implementation of change(s) requested by the National Competent Authority following the assessment of the paracetamol pediatric dosing schedule (section 4.2) with subsequent changes to section 4.4 warnings and precautions.

Updated on 17 January 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 11 August 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 12 May 2010

Reasons for updating

  • Change to packaging

Updated on 29 January 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Post renewal commitments to include preclinical safety data.Inclusion of anaphylaxis warning, frutose intolerance warning. Inclusion of pharmacokinetic data in nursing mothers.Details on risk factors associated with paracetamol. Inclusion of ATC codes.

Updated on 03 November 2008

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Renewal change - list of excipients updated to include E-numbers, sachet presentation removed from the SPC and the renewal date updateed to 01/04/08.

Updated on 03 November 2008

Reasons for updating

  • Change of inactive ingredient
  • Change to packaging

Updated on 25 August 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.

Updated on 25 August 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 May 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 August 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 4.2 Dosage information on infants 3 months to 1 year added
Section 4.4 Warning - "If your child is taking any other medicine, consult your doctor or pharmacist before taking this product" added.

Updated on 22 May 2006

Reasons for updating

  • Change to dosage and administration

Updated on 16 March 2006

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through general sale

Updated on 08 December 2004

Reasons for updating

  • Change of manufacturer

Updated on 03 September 2004

Reasons for updating

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

Legal category:Supply through general sale

Updated on 02 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale