Advil Cold and Flu Coated Tablet

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/08/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 8/8/2019

Click on this link to Download PDF directly

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 9 August 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 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 8 August 2019 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 6.1 - List of excipients

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to section 4.2 Posology and method of administration: update to Paediatric population, and Renal and hepatic insufficiency.

Change to section 4.4 Special warnings and precautions for use: Addition of ischemic colitis warning.

Change to section 4.8  Undesirable effects: Addition of ischemic colitis warning.

Change to section 6.1  List of excipients: addition of E numbers.

Updated on 4 September 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 4 September 2018 SmPC

Reasons for updating

  • 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

Updated on 26 June 2018 SmPC

Reasons for updating

  • 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 pharmacy only

Updated on 18 February 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 18 February 2016 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 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2       Posology and Method of Administration

 

Adults, older people, and young persons over 12 years:


Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days.


4.3       Contraindications

 • Patients with severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4).


 

4.4     Special Warnings and Precautions for Use

Clinical studies trial and epidemiological data suggest that use of some NSAIDs (ibuprofen) (particularly at a high doses (2400 mg/day daily) and in long term treatment 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 daily) is associated with an increased risk of myocardial infarctionarterial 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. 


4.5       Interactions with other medicinal products and other forms of interactions

 

It is considered unsafe to take Ibuprofen in combination with warfarin or heparin unless under direct medical supervision.

 

Not recommended combinations:

 

Acetylsalicylic acid

Concomitant administration of ibuprofen and acetylsalicylic acid 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 acetylsalicylic acid 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 acetylsalicylic acid cannot be excluded.
                        No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).  

                        Refer to section 4.3 & 4.4 for more information on concomitant use of ibuprofen. with other drugs.  

4.8       Undesirable Effects

 

Clinical studies suggest that  use of ibuprofen, particularly at a high dose (2400 mg/day)may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Oedema, hypertension, angina pectoris and cardiac failure have been reported in association with NSAID treatment.

5.1       Pharmacodynamic Properties

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamicsIn one studies show thaty, when a single doses of ibuprofen 400 mg wereas taken within 8 h before or within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. Although However, the limitations of these data and there are uncertainties regarding extrapolation of these ex vivo data to the clinical situation, the possibility that regular, long term imply that no firm conclusions can be made for regular use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicyclic acid cannot be excluded. use, and nNo clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

10.       DATE OF REVISION OF THE TEXT

 

February  2016.

 

Updated on 17 February 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 February 2016 PIL

Reasons for updating

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

Updated on 30 March 2015 PIL

Reasons for updating

  • Change of manufacturer

Updated on 24 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 March 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

- In section 2, the active substances amount has been changed to per/tablet and mg has been added after quantitive numbers of active ingredients. Also, 'with known effects' has been addes to 'Excipients with known effect: Each tablet contains 174.6 mg sucrose, 0.003 mg methyl parahydroxybenzoate (E 218), and 0.002 mg propyl parahydroxybenzoate (E 216)'.


- In section 4.1 'Advil Cold & Flu' has been added before  is '...indicated in adults and adolescents over 12 years of age'.
-In section 4.2 Paediatric population 'Advil Cold and Flu is contraindicated in'  and '(see section 4.3) have been added, 'This product should not be given to' has been removed
-In section 4.3 Contraindication 'listed in Section 6.1' has been added in the second bullet point
-In section 4.4 Special Warnings and Precautions for Use, a word 'section' has been added at the end of the
sixth bullet point
In section 4.5 Interactions with other medicinal products and other forms of interactions:
 'Advil Cold and Flu' has been added 'invented name' has been removed in the fourth  and ninth, fourteenth, sixteenth, nineteenth, twentieth, square of possible reactions
 's' has been added in 'pseudoephedrine' word in the fifth and sixth square of possible reactions

-In section 4.6 Fertility, Pregnancy and Lactation 'Advil Cold & Flu' has been added, 'the use of this product' has been removed, and '(see section 4.3) has been added at the end of the sentence.
-In section 10 'partial' has been removed and date has been changed to March 2015

Updated on 10 March 2015 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 19 February 2015 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 11 September 2014 SmPC

Reasons for updating

  • Change due to harmonisation of SPC

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Multiple SmPC changes due to undergoing an MRP procedure in a number of European countries.

Includes changes to side effects, contraindications, interactions and date of revision.

Updated on 5 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change due to harmonisation of PIL

Updated on 1 September 2014 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 4.7 - Effects on ability to drive and use machines
  • Change to section 5.3 - Preclinical safety data

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration
Posology

Adults, the elderly and young persons over 12 years:
Take 1 or 2 tablets every 4-6 hours to a maximum of 6 tablets in 24 hours.

Not to be given to children under the age of 12.

Method of administration

For oral administration only. Tablets should be taken with a glass of water.

4.3 Contraindications

• Use in children under 12 years of age.
• Hypersensitivity to the active substances or to any of the excipients.
• Patients with allergy to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or with a history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria) in response to ibuprofen, aspirin or NSAIDs.
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
• Patients with active peptic ulceration/haemorrhage or a history of peptic ulceration/haemorrhage.
• Patients with phaeochromocytoma, closed angle glaucoma, diabetes or thyroid disease.
• Patients with kidney diseaserenal failure.
• Patients with severe liver disease.
• Patients suffering from heart disease, circulatory problems, prostatic hypertrophy, hypertension or coronary artery disease.
• Patients taking other NSAIDs, pain-relievers or decongestants.
• Patients receiving tricyclic antidepressants.
• Patients currently receiving, or who have within the last two weeks received, monoamine oxidase inhibitors.
• Patients with severe heart failure.
• Last trimester of pregnancy (see section 4.6).

4.4 Special Warnings and Precautions for Use

• The use of Advil Cold & Flu with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
• Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.
• If symptoms get worse or last more than 3 days or you patients experience any other symptoms not related to the original condition, treatment should be stopped unless directed otherwise by a doctor or healthcare professional.
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2)
• Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
• The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These pPatients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients requiring concomitant low dose aspirin or other drugs likely to increase gastrointestinal risk (see below and 4.5)
• Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
• Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).
• When GI bleeding or ulceration occurs in patients receiving Advil Cold & Flu, the treatment should be withdrawn.
• NSAIDs should be given with care to patients with a history of gastrointestinal disease (e.g. ulcerative colitis and, Crohn’s disease) as their condition may be exacerbated (see sections 4.8 – undesirable effects).
• In patients with cardiac or hepatic impairment, caution is required since the use of NSAIDs may result in deterioration in renal function.
• Advil Cold & Flu should be used with caution in patients with a history of peptic ulceration or inflammatory bowel disease.
• Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Undesirable effects may be minimised using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below)
• Cardiovascular and cerebrovascular effects:
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses (2400mg daily) and in long term treatment 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.  1200mg daily) is associated with an increased risk of myocardial infarction.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Advil Cold & Flu should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Systematic Lupus Erythematosus and mixed connective tissue disease – increase risk of aseptic meningitis (see section 4.8).
• As NSAIDs can interfere with platelet function, they should be used with caution in patients with intra-cranial haemorrhage and bleeding diathesis.
• Patients suffering from asthma, hypertension, heart disease, diabetes, liver cirrhosis, kidney diseaserenal impairment, thyroid disease or prostatic hypertrophy should consult their doctor before using this product.
• Bronchospasm may be precipitated in patients suffering from asthma or allergic disease.
• There is some evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
• The use of NSAIDs may impair female fertility (see section 4.6).
• and is not recommended in women attempting to conceive. In women who have difficulties conceiving and who are undergoing investigation of infertility, withdrawal of the product should be considered.
• Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
• This product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate which may cause allergic reaction (possibly delayed).


4.5 Interactions with other medicinal products and other forms of interactions

It is considered unsafe to take Ibuprofen in combination with warfarin or heparin unless under direct medical supervision.

Not recommended combinations:
Animal studies show that acetylsalicylic acid reduces the plasma concentrations of Ibuprofen. Ibuprofen should not be used with other pain relievers such as NSAIDs.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).

Combinations requiring precautions:

Care should be taken in patients treated with any of the following drugs as interactions have been reported.

Anticoagulants, antihypertensives or thiazide diuretics:
NSAIDs may enhance the effects of anticoagulants (e.g. warfarin, ticlopidine) and diminish the effects of antihypertensive or thiazide diuretics.

Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

Cardiac Glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels. Serum digitalis concentrations should therefore be monitored in patients with decreased renal function or congestive heart failure.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increase risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Phenytoin: Ibuprofen may increase the pharmacologically active free phenytoin. Patients taking Ibuprofen for long-term use should be monitored.

Lithium: Decreased elimination of lithium. This may result in clinically significant increases in lithium concentrations.

Methotrexate: Concomitant administration of Ibuprofen with moderate and high doses of methotrexate may lead to serious and fatal methotrexate toxicity. Patients with reduced renal function may be at additional risk of toxicity from the combination even when low doses of methotrexate (20 mg/week) are used.

Antacids: Certain antacids may increase the gastrointestinal absorption of Ibuprofen. This is considered to be of clinical relevance particularly during long-term use of Ibuprofen.

Cyclosporin: Increased risk of nephrotoxicity with NSAIDs.

Corticosteroids: Increased risk of gastro-intestinal bleeding or ulceration.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).

Aminoglycosides: Reduction in renal function in susceptible individuals decreased elimination of aminoglycosides and increased plasma concentrations.

Sulphonylureas: There is evidence of interactions between NSAID’s and sulfonylureas. No specific interactions between ibuprofen and sulfonylureas have been described.


Pseudoephedrine:

Pseudoephedrine may interact with:
The actions of other sympathomimetic drugs.
The antibacterial agent furazolidone.

Pseudoephedrine should not be given to patients receiving MAOI therapy or within 14 days of ceasing such treatment.

The action of Pseudoephedrine may be reduced by:
Guanethidine.
Reserpine.
Methyldopa.

The action of Pseudoephedrine may be reduced or enhanced by:
Tricyclic antidepressants.

Pseudoephedrine may reduce the action of:
Guanethidine.

Pseudoephedrine may increase the possibility of arrhythmias in patients taking:
Digitalis.
Quinidine.
Tricyclic antidepressants.

4.7 Effects on Ability to Drive and Use Machines

None knownPatients who experience dizziness, hallucinations, unusual headaches and visual or hearing disturbances should avoid driving or using machinery. Single administration or short-term use of this medicine does not usually warrant the adoption of any special precautions.


5.3 Preclinical Safety Data
Repeated dose toxicity studies on combinations of ibuprofen and pseudoephedrine have not been conducted. The combination was not mutagenic.

Sub-chronic and chronic toxicity studies have been conducted on ibuprofen alone with a 6 month NOAEL of 60 mg/kg in rats. Toxicity occurred in the form of lesions and ulcerations in the gastro-intestinal tract. Ibuprofen is not mutagenic nor was it carcinogenic in chronic rodent bioassays.

Sub-chronic or chronic toxicity studies have not been performed with pseudoephedrine alone. Combination ibuprofen and pseudoephedrine was not mutagenic. A human screening study of over 3,000 pseudoephedrine users showed no increase in cancer over 7.5 years
Reprotoxicity studies in animals with individual ingredients indicated that they were not teratogenic, however use of the product in pregnancy should if possible be avoided.
None stated.




Updated on 27 August 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 19 March 2013 SmPC

Reasons for updating

  • SPC re-instated

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Incorrect version used when legal entity changed therefore legal entity changed to correct versioin of SmPC and re-instated.   

Updated on 18 January 2013 SmPC

Reasons for updating

  • Change to marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

7.         MARKETING AUTHORISATION HOLDER

 

Pfizer Healthcare Ireland,

9 Riverwalk, National Digital Park,

Citywest Business Campus, Dublin 24.

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PA 822/164/1

 

Updated on 16 January 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 January 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 5 December 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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 6 October 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 6 October 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.1 - List of excipients

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 September 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - 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 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 19 September 2011 PIL

Reasons for updating

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

Updated on 8 July 2010 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 8 July 2010 SmPC

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

7.         MARKETING AUTHORISATION HOLDER

 

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

 

 

(Note: MAH, Wyeth - DELETED) 

Updated on 29 June 2010 SmPC

Reasons for 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

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 24 June 2010 PIL

Reasons for updating

  • Change to date of revision

Updated on 24 June 2009 PIL

Reasons for updating

  • Change of licence holder
  • Change to instructions about overdose
  • Change to date of revision

Updated on 19 May 2009 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

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 13 May 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 26 November 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 4.5 - 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

Legal category: Supply 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 26 November 2007 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions

Updated on 13 March 2006 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 20 December 2004 PIL

Reasons for updating

  • Change of active ingredient

Updated on 20 December 2004 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Updated on 24 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only