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Ibuprofen 200mg Soft Capsules

*
Pharmacy Only: Non-prescription

  • Company:

    Haleon Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Ibuprofen

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

Updated on 31 January 2024

File name

WORKING-ie-SmPC-Advil Liquid-PRAC-clean-240122SKDJ Ibuprofen PRAC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 31 January 2024

File name

WORKING-ie-text leaflet-Advil Liquid-PRAC-clean-240122SKDJ ibuprofen.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 25 April 2023

File name

ie-text leaflet-PRAC update-approved-Feb 2023.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Update to MAH name

Updated on 25 April 2023

File name

ie-SmPC-Ibuprofen 200mg soft capsules-MAH name change-approved April 2023.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to MAH name

Updated on 27 February 2023

File name

ie-SmPC-Ibuprofen 200mg soft capsules-PRAC update-pregnancy warning-approved-Feb 2023.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Supply through pharmacy only

Updated on 27 February 2023

File name

ie-text leaflet-PRAC update-approved-Feb 2023.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 19 March 2021

File name

1461_Ibuprofen200mg SmPC_20_323+20_366 clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 19 March 2021

File name

1461_PIL_Ibuprofen 200mg softcapsules_20_323 +20_366 clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 12 February 2021

File name

1461_PIL_Ibuprofen 200mg softcapsules_20_323 clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 12 February 2021

File name

1461_Ibuprofen200mg SmPC_20_323 clean.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 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 30 November 2020

File name

1631_Ibuprofen200mg SmPC_20_017_clean v1.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Updated on 30 November 2020

File name

1461_PIL_Ibuprofen 200 mgSC_IE_20_017_PAA151781_v01_v1_FVID977062.pdf

Reasons for updating

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

Updated on 13 January 2020

File name

1631_Ibuprofen 200mg soft capsules_IE_PIL_18 188_v2_crooped.pdf

Reasons for updating

  • Change to product name

Updated on 13 January 2020

File name

IE_SmPC_Ibuprofen 200mg Soft Capsules.doc.pdf

Reasons for updating

  • Change to product name

Legal category:Supply through pharmacy only

Updated on 19 June 2019

File name

1631_SmPC_17 135_v1.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Updated on 08 May 2018

File name

1631_SmPC_17 135_v1.docx

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 02 May 2018

File name

1631_SmPC_17 135_v1.docx

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Updated on 29 March 2018

File name

PIL_9031_952.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 13 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 09 December 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 09 December 2015

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

See new bold text;

Section 4.2 ....

For adults aged 18 years or older, the lowest effective dose should be used for the shortest duration necessary to relieve symptoms and minimise undesirable effect (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

Section 4.3.... updated Severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV).

Section 4.4 .....

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400mg/day)  may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.

Section 4.5 ....

Ibuprofen should be avoided in combination with:

Aspirin:

Concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects.

 

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these  data to the clinical situation, the possibility that regular, long-term use of ibuprofen, may reduce the cardioprotective effect of low-dose aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Section 4.8 under Cardiac disorders states  

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day)  may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

Section 5.1 states

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamic studies show that when single doses of ibuprofen 400mg were taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, (for) the possibility that regular, long-term use of ibuprofen may reduce cardioprotective effect of low-dose aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

Section 10, Date of revision is November 2015.

Updated on 08 December 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 08 June 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 04 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 02 September 2014

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 10, the date of revision has been changed from January 2013 to March 2014.

In section 4.8, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2. Tel: +353 1 6764971, Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie



In section 4.4, the following text has been added, and 'elderly' has been changed to 'older people':

There is a risk of renal impairment in dehydrated adolescents or young persons, between the age of 12 and 18 years.



In section 4.2, the following text has been added:

If in adolescents or young persons, between the age of 12 and 18 years, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.

 

For adults aged 18 years or older,

Updated on 22 January 2013

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

6.                  MARKETING AUTHORISATION HOLDER

 

Pfizer Healthcare Ireland,

9 Riverwalk, National Digital Park,

Citywest Business Campus, Dublin 24.

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 822/163/1

Updated on 18 January 2013

Reasons for updating

  • Change of licence holder

Updated on 17 April 2012

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of new excipients to Section 6.1 Lecithin, Triglycerides (medium chain), glycerol stearate, oleic acid and ascorbyl palmitate.

Updated on 10 April 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 06 February 2012

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

deletion of Markem printing technique. Corrections to terms.   

Updated on 08 June 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 6.3, the Shelf life has been changed from 2 to 3 years.
In section 6.4, the Storage conditions has been changed to Do not store above 25oC.    

Updated on 08 June 2011

Reasons for updating

  • Change to storage instructions

Updated on 02 June 2010

Reasons for updating

  • Change to marketing authorisation holder

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The MAH name and address has changed, Sse section 7.0  below. 
(previous MAH; Whitehall Labs Ltd T/A Wyeth Consumer Healthcare, Taplow, Berks, U.K.)   

7.         MARKETING AUTHORISATION HOLDER

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom





 

Updated on 01 June 2010

Reasons for updating

  • Change of licence holder

Updated on 08 January 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 18 December 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

To update Section 4.3, 4.4 and 4.8 of the SmPC in line with EU safety warnings for Ibuprofen products, in relation to cardiovascular events.  

Updated on 23 August 2006

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 15 October 2005

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation
  • Change to storage instructions

Updated on 28 September 2005

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through pharmacy only

Updated on 24 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 September 2003

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only