CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets
- Name:
CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets
- Company:
Johnson & Johnson (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/19
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Johnson & Johnson (Ireland) Ltd
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Company Products
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 3 April 2019 PIL
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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 3 April 2019 SmPC
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 5 February 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 5 February 2019 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Supply through general sale
Updated on 28 September 2018 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Updated on 28 June 2018 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 28 July 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 28 July 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 July 2015 SmPC
Reasons for updating
- 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
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.3 - QRD wording implemented
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 4.5 - the following text has been added
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
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 21 July 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through general sale
Updated on 19 January 2012 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
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 20 July 2010 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 12 May 2010 PIL
Reasons for updating
- Change to packaging
Updated on 25 August 2008 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 19 May 2008 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 19 September 2007 PIL
Reasons for updating
- Change of inactive ingredient
Updated on 19 September 2007 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 28 August 2007 SmPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 20 December 2006 PIL
Reasons for updating
- Change of active ingredient
- Change to date of revision
- Correction of spelling/typing errors
Updated on 20 December 2006 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category: Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 15 February 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale