Advil Liquigels, 200mg Capsules

  • Name:

    Advil Liquigels, 200mg Capsules

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/03/18

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Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

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Pfizer Consumer Healthcare

Pfizer Consumer Healthcare

Company Products

Medicine NameActive Ingredients
Medicine Name Advil Cold and Flu Coated Tablet Active Ingredients Ibuprofen, Pseudoephedrine Hydrochloride
Medicine Name Advil Liquigels, 200mg Capsules Active Ingredients Ibuprofen
Medicine Name Anadin Analgesic Tablets Active Ingredients Acetylsalicylic Acid, Caffeine
Medicine Name Anadin Maximum Strength Capsules Active Ingredients Acetylsalicylic acid (Aspirin), Caffeine
Medicine Name Caltrate 500 mg / 1000 IU, chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Caltrate 600mg/400IU Film-coated Tablets Active Ingredients Calcium Carbonate, Vitamin D3
Medicine Name Nexium Control 20 mg gastro-resistant tablets Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Nexium Control Capsules 20mg Esomeprazole Active Ingredients Esomeprazole magnesium trihydrate
Medicine Name Paracetamol 500 mg Film Coated Tablets Active Ingredients Paracetamol
Medicine Name PARAEXTRA Hard Capsules Active Ingredients Caffeine, Paracetamol
Medicine Name Paraeze Hard Capsules Active Ingredients Caffeine, Paracetamol
Medicine Name Robitussin Chesty Cough Active Ingredients Guaifenesin
Medicine Name Robitussin Dry Cough Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Robitussin Plus Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
1 - 0 of 14 items.Total: Infinity pages

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 19 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 8 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 2 May 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 9 December 2015 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 4.8 - 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 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
  • 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 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 6 February 2012 SmPC

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 8 June 2011 SmPC

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 8 June 2011 PIL

Reasons for updating

  • Change to storage instructions

Updated on 2 June 2010 SmPC

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 SmPC

Reasons for updating

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

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only