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

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

Name:
CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION
Company:
Johnson & Johnson (Ireland) Ltd
Active Ingredients:
Paracetamol
Legal Category:
Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/04/19

Company Products

Medicine Name	Active Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup	Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets	Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules	Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs	Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs	Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup	Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets	Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup	Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup	Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets	Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs	Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup	Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup	Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup	Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension	Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle)	Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets)	Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension	Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION	Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets	Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream	Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder	Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel	Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules	Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets	Active Ingredients Loperamide Hydrochloride

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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 5 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 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 5 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 27 December 2018 PIL

Reasons for updating

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

Updated on 26 December 2018 SmPC

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 PIL

Reasons for updating

Improved presentation of PIL

Updated on 10 February 2015 PIL

Reasons for updating

New PIL for new product

Updated on 10 February 2015 PIL

Reasons for updating

Change to side-effects

Updated on 4 February 2015 SmPC

Reasons for updating

New SmPC for new product

Legal category: Supply through general sale

Updated on 4 February 2015 SmPC

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 SmPC

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 PIL

Reasons for updating

Change to side-effects

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 4 March 2011 SmPC

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 SmPC

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 PIL

Reasons for updating

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

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 SmPC

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 PIL

Reasons for updating

Change to marketing authorisation holder

Updated on 28 August 2007 SmPC

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 PIL

Reasons for updating

Change of inactive ingredient

Updated on 14 November 2005 SmPC

Reasons for updating

Change to section 6.1 - List of excipients

Legal category: Supply through general sale

Updated on 6 September 2004 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form

Legal category: Supply through general sale

Updated on 6 September 2004 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