Calpol Infant 120mg/5ml Sugar Free Oral Suspension (Bottle & Sachets)
*Company:
KenvueStatus:
UpdatedLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 October 2024
File name
ie-leaflet-calpol-infant-sf-2364.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 18 October 2024
File name
ie-spc v19 calpol infant suspension sugar free-2364.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 25 April 2022
File name
ie-pl-calpol-infant-sf-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 sugar free-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-330-17-04-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 sugar free - 2082.pdf
Reasons for updating
- 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 sugar free - 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 sugar free - 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 sugar free infant - 1934.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 November 2019
File name
ie spc v14 calpol infant suspension sugar free 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
401538171_8395705_7714006_19_0178_LN505904_LEAFLET_CalpolInfantSuspensionSF_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 SUGAR FREE Infant Oral Suspension (Bottle)- 1808.pdf.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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 12 March 2019
File name
ie-spc v13 calpol infant suspension sugar free - 1808.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 04 January 2019
File name
LN505902-PIL CALPOL INFANT SF 60-140ML IEv11_10_v1_FVID488081 (1).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 04 January 2019
File name
ie-spc v12 Calpol Sugar Free Infant 1836.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
LN505902-PIL CALPOL INFANT SF 60-140ML IEv11_9.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 21 February 2018
File name
PIL_8605_831.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2018
Reasons for updating
- Correction of spelling/typing errors
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
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
This product contains the following excipients which have recognised effects:
- Carmoisine which may cause allergic reactions.
- Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ethyl parahydroxybenzoate (E214) which may cause allergic reactions (possibly delayed).
- The sorbitol (E420) and maltitol (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose.
Section 10 replaced date with "April 2016"
Updated on 09 April 2015
Reasons for updating
- Change to side-effects
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 - how to report a side effect
- 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
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.
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 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
Updated on 02 July 2013
Reasons for updating
- Change to packaging
- PIL retired pending re-submission
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 July 2008
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 29 July 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 28 August 2007
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Updated on 29 June 2007
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
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
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through general sale
Updated on 02 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 20 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale