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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 (0)1 467 6500
Fax: +353 (0)1 467 6501
Medical Information Direct Line: +353 (0)1 467 6627
Summary of Product Characteristics last updated on medicines.ie: 05/12/2011
SPC Advil Cold and Flu

When a pharmaceutical company changes an SPC or PIL, 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 05/12/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   21-Nov-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
nervousness listed twice in overdose section 4.9.
Updated on 06/10/2011 and displayed until 05/12/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   29-Sep-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
6.1 List of Excipients

Tablet Core:
Maize starch
Starch, pregelinatised
Croscarmellose sodium
Colloidal anhydrous silica
Sodium laurilsulfate
Stearic acid

Tablet Coating:   
Sucrose
Microcrystalline cellulose
Carnauba wax (yellow)
Opalux Butterscotch AS-3739:
Sucrose
Titanium Dioxide (E 171)
Iron Oxide Yellow (E 172)
Iron Oxide Red (E 172)
Povidone


Methyl Parahydroxybenzoate (E 218)
Propyl Parahydroxybenzoate (E 216)
Opaglos GS-2-0310:
Industrial Methylated Spirit
Pharmaceutical shellac
Povidone
Acetylated monoglyceride

Opacode S-1-27794 black printing ink:
Shellac glaze
Iron Oxide black (E 172)
Propylene glycol
Or
Opacode S-1-17823 black printing ink:
Shellac glaze
Iron Oxide Black (E172)
Propylene glycol
Ammonium hydroxide

Note Removed Sodium Hydroxide from tablet coating, added industrial methylated spirits to Opaglos GS-2-0310, added new black ink and its ingredients, Opaglos S 1- 17823.  
Updated on 19/09/2011 and displayed until 06/10/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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
Date of revision of text on the SPC:   07-Sep-2011
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
4.3 Contraindications
• Hypersensitivity to the active substances or to any of the excipients.
• . Last trimester of pregnancy (see section 4.6).

4.4 Special Warnings and Precautions for Use
• If symptoms get worse or last more than 3 days or you experience any other symptoms not related to the original condition, treatment should be stopped unless directed otherwise by a doctor or healthcare professional.

• Patients suffering from liver cirrhosis, kidney disease, should consult their doctor before using this product.

4.6 Fertility, Pregnancy and Lactation

Pregnancy:

Ibuprofen:
Whilst no teratogenic effect has been demonstrated in animal experiments, use of ibuprofen during pregnancy should be avoided during the first 6 months of pregnancy.

During the third trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both mother and child (see Section 4.3).

Pseudoephedrine:
Data on pregnancy outcomes after maternal exposure to pseudoephedrine are limited. Two analyses of health maintenance organisation pharmacy data identified 9 malformed infants among 902 first-trimester pseudoephedrine exposures suggesting no specific association with birth defects overall. However the related compounds epinephrine, ephedrine and phenylephrine have been associated with haemorrhages and cardiovascular and limb malformations in animal models. The vasoconstrictive effects of these drugs may indicate that their use in early pregnancy might increases the risk of vascular disruption defects.

Lactation:

Ibuprofen:
In limited studies, ibuprofen appears in the breast milk in very low concentrations, and is unlikely to affect the breast fed infant adversely.

Pseudoephedrine:
Pseudoephedrine is excreted in breast milk in small quantities, but the effect of this on breast-fed infants is not known. It is estimated that 0.4% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in breast milk over 24 hours.

In summary, caution should be exercised by balancing the potential benefit of treatment against any possible risks.
 
4.8 Undesirable Effects

Effects added;  
abdominal distension, mouth ulcerations, angina pectoris haemolytic anaemia, leukopenia, agitation, irritability, nervousness, restlessness, tinnitus, vertigo, visual disturbances, tachycardia, psychomotor hyperactivity, meningitis and aseptic meningitis.

4.9 Overdose

Overdosage may result in nervousness, agitation, anxiety, irritability, nervousness, restlessness, dizziness, tremor, vertigo, insomnia, nausea, abdominal pain, vomiting, epigastric pain, diarrhoea, bradycardia, palpitation, tachycardia, tinnitus, headache and gastrointestinal bleeding. Hyperkalemia, metabolic acidosis, hypertension or hypotension are also possible signs of overdose. Toxicity may manifest as drowsiness, excitation, disorientation or coma. The patient may develop convulsions. Hepatic function may be abnormal. Metabolic acidosis may occur and the prothrombin time/INR may be prolonged. Acute renal failure and liver damage may occur. In asthmatics, exacerbation of asthma is possible.

5.1 Pharmacodynamic Properties

Ibuprofen
Pharmacotherapeutic group: Propionic acid derivatives.
ATC code: M01AE51

Pseudoephedrine Hydrochloride
Pharmacotherapeutic group: Nasal decongestants for systemic use, sympathomimetrics.
ATC code: R01BA52

10. DATE OF (PARTIAL) REVISION OF THE TEXT

May 2011.


Updated on 08/07/2010 and displayed until 19/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


7.         MARKETING AUTHORISATION HOLDER

 

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

 

 

(Note: MAH, Wyeth - DELETED) 
Updated on 29/06/2010 and displayed until 08/07/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
The last renewal date is the 08 Sept 2009, as part of the Section 6, the excipients were separated clearly out into tablet core, tablet coating and printing ink. No medical changes were made at renewal.  
Updated on 19/05/2009 and displayed until 29/06/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 4.5 Interactions with other medicinal products.
Now mentions that experimental data suggests that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However there are limitations to this data in relation to regular ibuprofen use. No clinically revelant effect is considered to be likely in occasional use. 

Section 5.1 Pharmacodynamic Properties
Now mentions that experimental data suggests that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 mins after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet agggregation occurred. 
However there are limitations to this data in relation to regular ibuprofen use. No clinically revelant effect is considered to be likely in occasional use. 
  
Updated on 26/11/2007 and displayed until 19/05/2009
Reasons for adding or 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
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   10/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
NSAIDs have been reviewed at EU level arising from which amendments to the product information was needed as follows; 
1. Disturbances to female fertility, 2. Cardiovascular, GI safety and serious skin reactions, 3. Thrombotic risks.     
SmPC Sections 4.3, 4.4, 4.5 & 4.8 have been updated accordingly for this product.
 
SmPC Section 4.5 and 4.8 were also updated in line with current company information.
 
SmPC Section 6.1 list of excipients was also updated to replace the printing ink used to S-1-27794 from S-1-8152-HV Black. 
Updated on 13/03/2006 and displayed until 26/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Updated on 20/12/2004 and displayed until 13/03/2006
Reasons for adding or 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Updated on 29/05/2003 and displayed until 20/12/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ibuprofen
  Pseudoephedrine Hydrochloride