Ibuprofen 200mg Soft Capsules
- Name:
Ibuprofen 200mg Soft Capsules
- Company:
GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/20

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd
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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 30 November 2020 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Supply through pharmacy only
Updated on 30 November 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 13 January 2020 PIL
Reasons for updating
- Change to product name
Updated on 13 January 2020 SPC
Reasons for updating
- Change to product name
Legal category: Supply through pharmacy only
Updated on 19 June 2019 SPC
Reasons for updating
- File format updated to PDF
Legal category: Supply through pharmacy only
Updated on 8 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 2 May 2018 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Supply through pharmacy only
Updated on 29 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 29 March 2018 PIL
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 13 May 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 9 December 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 9 December 2015 SPC
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 8 December 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 8 June 2015 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 4 November 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to improve clarity and readability
Updated on 2 September 2014 SPC
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 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 SPC
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 PIL
Reasons for updating
- Change of licence holder
Updated on 17 April 2012 SPC
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
Updated on 10 April 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 6 February 2012 SPC
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
Updated on 8 June 2011 SPC
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 6.4, the Storage conditions has been changed to Do not store above 25oC.
Updated on 8 June 2011 PIL
Reasons for updating
- Change to storage instructions
Updated on 2 June 2010 SPC
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 1 June 2010 PIL
Reasons for updating
- Change of licence holder
Updated on 8 January 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 18 December 2007 SPC
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
Updated on 23 August 2006 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 15 October 2005 PIL
Reasons for updating
- Change to date of revision
- Improved electronic presentation
- Change to storage instructions
Updated on 28 September 2005 SPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 19 September 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only