Nurofen Cold and Flu Film-Coated Tablets

Addition to Section 4.4:
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue infections complications. To date, the contributing role of NSAIDs in the worsening of these infections can not be ruled out. Thus, it is advisable to avoid use of Nurofen for Cold and Flu in case of varicella.


Addition to Section 4.8:
SYSTEM ORGAN CLASS: Infections and Infestations
FREQUENCY : Very rare
ADVERSE EVENT : Exacerbation of infections related inflammation (e.g. development of necrotising fasciitis), in exceptional cases, severe skin infections and soft tissue complications may occur during a varicella infection.

CCDS update sections highlighted updated.

Article 31 (ibuprofen)

Text highlighted in Blue has been added. 

 
4.                  CLINICAL PARTICULARS

 

4.1              Therapeutic Indications

 

For the symptomatic relief of head colds and influenza, including nasal congestion and to ease the pain of sore throats.

 

4.2              Posology and Method of Administration

 

Oral Administration

 

For short-term use only.

 

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.

 

The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 3 days.

 

 

Adults and children over 12 years of age:  Initial dose two tablets, then if necessary 1 – 2 tablets every four hours.  Do not exceed six tablets in any 24 hour period.

                        Paediatric population: 

Ibuprofen + pseudoephedrine combination solid dose strength products are contraindicated in children aged less than 12 years.

 

Elderly:  There is no indication that dosage needs to be modified in the elderly.  However, it may be advisable to monitor renal and hepatic function and, if there is serious impairment, caution should be exercised.

 

4.3              Contraindications

·         Hypersensitivity to ibuprofen,pseudoephedrine or any of the excipients in the product.

·         Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis,angioedema or urticaria) in response to ibuprofen, acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).

·         Active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) or other gastrointestinal

·         disorders.

·         History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

·         Severe heart failure, renal failure or

·         Last trimester of pregnancy. (See Section 4.6)

·         Cardiovascular disease including hypertension

·         Diabetes mellitus

·         Phaeochromocytoma

·         Hyperthyroidism

·         Closed angle glaucoma

·         Severe renal impairment

·         Sympathomimetic drugs

·         Tricyclic antidepressants

·         Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

·         Beta blockers (see section 4.5)

·         Prostatic enlargment

·        Use in children under 12 years.

 

4.4              Special Warnings and Special Precautions for Use

 

Ibuprofen:

Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms (See section 4.2, and GI and cardiovascular risks below).

 

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).  Prolonged use of NSAIDs in the elderly is not recommended.  Where prolonged therapy is required, patients should be reviewed regularly.

 

Gastrointestinal effects:  NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s Disease) as their condition may be exacerbated (see section 4.8 – undesirable effects.

 

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 any 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 patients 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 ibuprofen, the treatment should be withdrawn.

 

Respiratory

Bronchospasm may be precipitated in patients suffering from or with a history of bronchial asthma or allergic disease.

 

Other NSAIDs:  The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

 

SLE and mixed connective tissue disease:  Systemic lupus erythematosus and mixed connective tissue disease, due to increased risk of aseptic meningitis (see section 4.8).

 

Cardiovascular and cerebrovascular effects:  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.

 

 

Clinical trial and epidemiological data suggest that use of ibuprofen, 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.

                       

Renal:  Renal impairment as renal function may deteriorate (see section 4.3 and 4.8).

 

Hepatic:  Hepatic dysfunction (see section 4.3 and 4.8).

 

Dermatological effects:  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 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.  Nurofen Cold and Flu should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

 

 

Impaired female fertility:  There is limited 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.

 

Pseudoephedrine:

Keep out of the sight and reach of children.

Use with caution in occlusive vascular disease

If any of the following occur,

·        Hallucinations

·        Restlessness

·        Sleep disturbances

 

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, this product should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents, such as decongestants, appetite suppressants, and amphetamine-like psycho-stimulants. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be exercised in patients with elevated intraocular pressure and prostatic enlargement.

 

Caution in moderate to severe renal impairment.

 

4.5              Interaction with other medicinal products and other forms of interaction

 

Other NSAIDs: avoid concomitant use of two or more NSAIDs.

 

Ibuprofen should be avoided in combination with:

·        Acetylsalicylic acid (aspirin): unless low dose aspirin (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4)

 

·        Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4)

 

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).

 

Ibuprofen should be used with caution in combination with:

 

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin or heparin (see section 4.4).

 

Antihypertensives (ACE inhibitorsand Angiotensin II Antagonists) and diuretics: NSAIDs may diminish the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure,which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

 

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

 

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):

Increased risk of gastrointestinal bleeding (see section 4.4).

 

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

 

Lithium: There is evidence for potential increases in plasma levels of lithium.

 

Methotrexate: There is a potential for an increase in plasma levels of methotrexate.

 

Cyclosporin: increased risk of nephrotoxicity with NSAIDs.

 

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

 

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

 

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

 

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.

 

Aminoglycosides: reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.

 

Probenecid: reduction in metabolism and elimination of NSAID and metabolites.

 

Oral hypoglycaemic agents: inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.

 

Pseudoephedrine should not be used in combination with:

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of ceasing such treatment: increased risk of hypertensive crisis.

 

Moclobemide: risk of hypertensive crisis.

 

Antihypertensives (including adrenergic neurone blockers & betablockers): pseudoephedrine may block the hypotensive effects.

 

Cardiac glycosides: increased risk of dysrhythmias.

 

Ergot alkaloids (erotamine &methysergide): increased risk of ergotism. Sympathomimetic agents, such as decongestants and appetite suppressants and amphetamine-like psychostimulants: as it may potentiate their effects. Risk of hypertension.

 

Oxytocin: risk of hypertension.

 

Anticholinergics: Enhances effects of anticholinergic drugs (such as TCAs)

 

 

4.6              Fertility, Pregnancy and Lactation

 

Pregnancy

 

Ibuprofen:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.  During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.  During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

 

- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of the pregnancy, to:

- possible prolongation of bleeding time, an antiaggregating effect which

 

- inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

 

Pseudoephedrine:

Defective closure of the abdominal wall (gastroschisis) reported very rarely in newborns after first trimester exposure. The product should not be used in pregnancy unless considered essential by the physician.

 

Lactation and breast feeding

Ibuprofen:

In limited studies, ibuprofen appears in the breast milk in very low concentration and is

unlikely to affect the breast-fed infant adversely.

 

Pseudoephedrine:

Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast fed infants is not known. It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.

 

 

 

Fertility

 

Ibuprofen:

There is some evidence that medicinal products which inhibit cyclooxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. See section 4.4 regarding female fertility.

 

Pseudoephedrine:

Unknown

 

4.7              Effects on ability to Drive and Use Machines

 

Ibuprofen:

            No adverse effects known.

 

            Pseudoephedrine:

            None known

 

4.8              Undesirable Effects

 

The list of the following adverse effects relates to those experienced with the product at OTC doses (maximum 1200mg per day), in short-term use.  In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

 

Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. 

 

The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding which is dependent on the dosage range and duration of treatment.  The undesirable effects are less frequent when the maximum daily dose is 1200 mg. 

 

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke), (see section 4.4).

 

 

 

 

 

Adverse events observed with Ibuprofen:

System Organ Class	Frequency	Adverse Event
Blood and Lymphatic System Disorders	Very Rare	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis).   First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding and bruising.
Immune System Disorders		Hypersensitivity reactions consisting of 1:
	Uncommon	Urticaria and pruritus
	Very Rare	Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
	Not Known	Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.
Psychiatric disorders	Not known	Restlessness, insomnia, anxiety hallucination
Nervous System Disorders	Uncommon	Headache
	Very Rare	Aseptic meningitis2
	Not known	Dizziness, muscular weakness, tremor
Ear and labyrinth disorders	Not known	Hearing impaired
Cardiac Disorders	Not Known	Cardiac failure and oedema, palpitations
Vascular Disorders	Not Known	Hypertension
Gastrointestinal Disorders	Uncommon	Abdominal pain, nausea and dyspepsia
	Rare	Diarrhoea, flatulence, constipation and vomiting
	Very Rare	Peptic ulcers, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis
	Not Known	Exacerbation of colitis and Crohn's disease (section 4.4).
Hepatobiliary Disorders	Very Rare	Liver disorders
Skin and Subcutaneous Tissue Disorders	Uncommon	Various skin rashes
	Very Rare	Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
	Not known	Hyperhidrosis
Renal and Urinary Disorders	Very Rare	Acute renal failure, papillary necrosis especially in long-term use associated with increased serum urea and oedema.
	Not known	Dysuria
General disorders and administration site conditions	Not known	Chest pain, thirst
Investigations	Very Rare	Decreased haemoglobin levels

 

Adverse events observed with Pseudoephedrine:

System Organ Class	Frequency	Adverse Event
Psychiatric Disorders	Not known	Delusion, insomnia, anxiety, restlessness, excitability, hallucination (particularly in children)
Nervous System Disorders	Not Known	Headache
Cardiac Disorders	Not Known	Tachycardia, arrhythmia, palpitations
Vascular Disorders	Not Known	Hypertension
Gastrointestinal Disorders	Not known	Nausea and/or vomiting
Skin and Subcutaneous Tissue Disorders	Not known	Skin reaction including rash. Hypersensitivity - including crosssensitivity reaction with other sympathomimetics
Renal and Urinary Disorders	Not known	Urinary retention
General and Administration Site Conditions	Not known	Irritability

 

 

4.9              Overdose

 

Ibuprofen:

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut.  The half-life in overdose is 1.5-3 hours. 

 

Symptoms: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Other symptoms include

sweating, insomnia, dilated pupils, blurred vision, delusions and hallucinations, muscular weakness, drowsiness, thirst, and

anxiety. Tinnitus, headache and gastrointestinal bleeding are also possible.  In more serious poisoning, toxicity is seen in the central nervous system, manifesting as vertigo, drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning hyperkalaemia and metabolic

acidosis may occur and the prothrombin  to interference with the actions of circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur.

Exacerbation of asthma is possible in asthmatics.

 

Management: Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of

activated charcoal or gastric emptying if the patient presents within 1 hour of ingestion of a potentially toxic amount. If ibuprofen has

already been absorbed, alkaline substances may be administered to promote the excretion of acid ibuprofen in the urine. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

 

Pseudoephedrine:

Symptoms: Irritability, restlessness, tremor, palpitations, convulsions, urinary retention, hypertension, restless, difficulty in micturition nausea, vomiting, tachycardia and cardiac arrhythmias.

 

Management: Management of overdose generally involves supportive and symptomatic therapy, and in cases of severe overdose, aspiration followed by gastric lavage may be used to empty the stomach.

Treatment includes early gastric lavage and symptomatic and supportive measures.  Elimination can be accelerated by acid

diuresis or by dialysis. Hypertensive effects may be treated with an IV alpha- receptor blocking agent. Cardiac effects may require

the use of a beta-adrenergic blocking agent after alpha-adrenergic blockade.  Convulsions may be treated with an anticonvulsant.

time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure, liver damage, hypotension, respiratory depression and cyanosis may occur.  Exacerbation of asthma is possible in asthmatics.

 

Management: Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of

activated charcoal or gastric emptying if the patient presents within 1 hour of ingestion of a potentially toxic amount. If ibuprofen has

already been absorbed, alkaline substances may be administered to promote the excretion of acid ibuprofen in the urine. If frequent or prolonged, convulsions should be treated with intravenous diazepam or

lorazepam. Give bronchodilators for asthma.

 

Pseudoephedrine:

 

Symptoms: Irritability, restlessness, tremor, palpitations, convulsions, urinary retention, hypertension, restless, difficulty in micturition, nausea, vomiting, tachycardia and cardiac arrhythmias.

 

Management: Management of overdose generally involves supportive and symptomatic therapy, and in cases of severe overdose, aspiration followed by gastric lavage may be used to empty the stomach. Treatment includes early gastric lavage and symptomatic and supportive measures.  Elimination can be accelerated by acid

diuresis or by dialysis. Hypertensive effects may be treated with an IV alpha- receptor blocking agent. Cardiac effects may require the use of a beta-adrenergic blocking agent after alpha-adrenergic blockade.

Convulsions may be treated with an anticonvulsant.

 

5.                  PHARMACOLOGICAL PROPERTIES

 

5.1              Pharmacodynamic Properties

 

ATC Code:  M01AE01

 

      Ibuprofen:

Ibuprofen is a propionic acid derivative, having analgesic, anti-inflammatory and antipyretic activity. The therapeutic effects of ibuprofen as a NSAID are thought to result from its inhibitory activity on the enzyme prostaglandin synthetase.

 

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly.  In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. 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.

 

Pseduoephedrine:

The sympathomimetic effect of pseudoephredine produces vasoconstriction which in turn relieves nasal congestion.

It is a stereoisomer of ephedrine and has a similar action. Pseudoephedrine is a sympathommetic agent with direct and

indirect effects on adrenergic receptors. It has alpha and beta stimulant adrenergic activity and some stimulant effect on the central nervous system. It has a more prolonged, though less potent action than

adrenaline. However, pseudoephedrine has been stated to have less pressor activity and central nervous system effects than ephedrine.

 

5.2              Pharmacokinetic Properties

Ibuprofen:

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1 to 2 hours after administration.

 

Ibuprofen is extensively bound to plasma proteins

 

Ibuprofen is metabolised in the liver to two major inactive metabolites and these together with unchanged Ibuprofen are excreted by the kidney either as such or as conjugates.  The elimination half-life is approximately 2 hours.  Excretion by the kidney is both rapid and complete.

 

No significant differenences in pharmacokinetic profile are observed in the elderly.

 

In limited studies, ibuprofen appears in the breast milk in very low concentrations.

 

Pseudoephredrine:

Pseudoephredine is absorbed from the gastrointestinal tract and is largely excreted in the urine unchanged, together with small amounts of a hepatic metabolite.  It has an half-life of about 5 to 8 hours; elimination; is enhanced and half-life accordingly shorter in acid urine.  Small amounts are distributed into breast milk.

 

5.3              Preclinical Safety Data

 

No data is available which is of relevance to the consumer.

 

 

6.                  PHARMACEUTICAL PARTICULARS

 

 

6.1              List of Excipients

 

Core

                        Calcium phosphate

Microcrystalline cellulose

Povidone

Croscarmellose sodium

Magnesium stearate

 

Film Coating

Hypromellose

Talc

Opaspray Yellow M-1F-6168 or

Mastercote Yellow FA 0156 containing

Titanium dioxide

Sunset yellow (E110)

Quinilone Yellow

 

Printing Ink

Black printing ink containing:

Iron oxide black (E172)

Propylene Glycol

Shellac

 

6.2              Incompatibilities

 

Not applicable.

 

6.3              Shelf Life

 

3 years.

 

6.4              Special Precautions for Storage

                       

                        Do not store above 25°C.

Store in the original package in order to protect from moisture.

 

6.5              Nature and Contents of Containers

 

A strip pack consisting of a blister tray of white pigmented 250mm PVC/40 gsm PVDC laminate heat-sealed to lacquered 20mm aluminium foil containing 12 tablets.  One or two trays packed in a cardboard carton (12 or 24 tablets).

 

6.6              Instructions for Use/Handling

 

No special requirements.

 

7.                  NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER

 

Reckitt Benckiser Ireland Ltd

7 Riverwalk

Citywest Business Campus

Dublin 24

 

8.                  MARKETING AUTHORISATION NUMBER

 

PA 979/33/1

 

9.                  DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

Date of first authoristaion: 18 April 1994

 

Date of last renewal: 18 April 2009

 

10.              DATE OF (PARTIAL) REVISION OF THE TEXT

February 2013

 

Change in revision of text from June 2009 to January 2012.  No other changes made to the content of the SmPC

Section 10  - change in the revision date

Section 1  - product name has been updated to Nurofen Cold and Flu Film-Coated Tablets, Ibuprofen 200mg, Pseudoephedrine Hydrochloride 30mg

Section 2 - Quantity of sunset yellow per tablet has been included 

Section 4.5 - Addition of following information -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly.  However, the limitations of these data and the uncertainties regarding the 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 use (see section 5.1)

Section 5.1 - addition of the following text -
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelets aggregation when they are dosed concomitantly.  In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. 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. 

Section 6.1 - deletion of one of the printing inks

Section 6.4 - inclusion of the statement "Store in the original package in order to protect from moisture"

Section 9 - update date of renewal

Section 10 - update of revision date

Addition of NSAID warnings

Transfer of MA to Reckitt Benckiser Ireland Ltd. and change of PA number