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CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE 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

  • 77499 CALPOL® SixPlus 140ml.png

Updated on 25 April 2022

File name

ie-pl-calpol-six-plus-sf-cf-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 6 plus SF-CF 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 22 August 2021

File name

ie-leaflet-calpol six plus SF-CF 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 6 plus SF-CF 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 6 plus SF-CF 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 02 December 2019

File name

LEAFLET CalpolSixPlusSFCFSuspension.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 02 December 2019

File name

ie-spc-v13-proposed-tracked calpol 6 plus SF-CF suspension 1935.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 April 2019

File name

ie-pil-Calpol Six Plus SF CF Suspension - 1807.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 April 2019

File name

ie-spc-v12-calpol 6 plus sugar-free suspension bv 1807.pdf

Reasons for updating

  • 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 4.8 - 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 27 December 2018

File name

LN513701-PIL CALPOL 6PLUS SF 60ML IEv9_9_v1_FVID488082 (1).pdf

Reasons for updating

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

Updated on 26 December 2018

File name

ie-spc V13 Calpol 6+ SF-CF 1838.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

LN513701-PIL CALPOL 6PLUS SF 60ML IEv9_8.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 10 February 2015

File name

PIL_8650_40.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 February 2015

Reasons for updating

  • Change to side-effects

Updated on 04 February 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 04 February 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 27 March 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Change to format of section 4.8 and inclusion of additional side effect.

Updated on 22 March 2013

Reasons for updating

  • Change to side-effects

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 04 March 2011

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

added to Section 6.5:

Or

Amber glass bottle closed with a two-piece screw child resistant, tamper evident closure fitted with a polyethylene laminate faced wad

Updated on 15 February 2011

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 9 - Date of renewal of authorisation
  • 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

Renewal updates.

Update to Section 2 - list of excipients
Update to Section 4.4. - excipient warnings

Renewal date updated
Revision of text date updated

Updated on 11 February 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 20 July 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 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 19 May 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 28 August 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 1: Full name added. CALPOL SIX PLUS 250mg/5mlSUGAR/COLOUR FREE ORAL SUSPENSION
Section 3: Pharmaceutical form amened to read Oral Suspension. Description changed to "An off-white oral suspension with an odour of strawberries"
Section 4.4: Warning added. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Section 6.5: Added - A spoon with a 2.5ml and 5ml measure is supplied with all packs of the product

Updated on 14 November 2005

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through general sale

Updated on 14 November 2005

Reasons for updating

  • Change of inactive ingredient

Updated on 06 September 2004

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category:Supply through general sale

Updated on 06 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale