NUROFEN FLU AND COLD

200 MG + 30 MG IBUPROFEN 12 COATED TABLETS

Nurofen Cold and Flu is a treatment indicated for adults and adolescents over 12 years of age, for the symptoms of colds and flu.
It helps reduce nasal and sinus congestion, pain, fever, sore throat and headache.

ACTIVE INGREDIENTS
One tablet contains: ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg.

DOSAGE
Dosage.
Only for a short period of treatment.
5 days maximum of therapy for the adult population; 3 days maximum of therapy for the pediatric population (12-18 years).
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
If the use of the medicine is necessary for more than 5 days in adults and for more than 3 days in adolescents, or in case of worsening of the symptoms, the doctor must be consulted.
Paediatric population: Do not administer to children under 12 years of age.
Adults and adolescents over 12 years: the initial dose is 1-2 tablets per day, then, if necessary, 1-2 tablets every 4 hours.
Do not exceed the dose of 6 tablets in 24 hours.
Elderly: no changes to the recommended dosage are required in the elderly except in patients with renal or hepatic impairment for whom it is necessary to individually adapt the dosage.
Method of administration: oral use.

CONSERVATION
This medicinal product does not require any special storage conditions.

WARNINGS:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Other NSAIDs: The use of this medicine should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs, as this increases the risk of adverse effects.
The use of NSAIDs should be carefully evaluated in patients with coagulation disorders since a reduction in coagulability is possible.
The same applies to patients undergoing treatment with oral anticoagulants, due to the possibility of an enhancement of the anticoagulant effect.
Gastrointestinal safety: as with all anti-inflammatory drugs, the drug should not be taken if the patient suffers from ulcers or gastric disorders.
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
In the elderly and in patients with a history of ulcer, particularly if complicated by haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs.
These patients should start treatment on the lowest available dose.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose acetylsalicylic acid or other drugs likely to increase the risk of gastrointestinal events.
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal 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 acetylsalicylic acid.
If gastrointestinal bleeding or ulceration occurs in patients receiving this drug, the treatment should be withdrawn.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
Cardiovascular and cerebrovascular effects: Caution is advised (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and edema have been reported in association with NSAID treatment.
Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (e.g., coronary artery disease).
(myocardial infarction or stroke).
Overall, epidemiological studies do not suggest that low doses of ibuprofen (e.g.
<= 1200 mg/day) are associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g.
hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/day) of ibuprofen are required.
Skin reactions: 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.
Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases in the early stages of treatment.
This medicinal product should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Severe skin reactions Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine.
This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules, arising from a widespread edematous eruption and located mainly on the skin folds, trunk and upper limbs.
Patients should be carefully monitored.
If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, administration of this medicinal product should be discontinued and appropriate measures taken if necessary.
Respiratory disorders: bronchospasm may occur in patients with current or previous bronchial asthma or allergic diseases.
Do not take the product in cases of asthma and allergy to cetylsalicylic acid unless after consulting your doctor.
SLE and mixed connective tissue disease: In case of systemic lupus erythematosus and mixed connective tissue disease it may lead to an increased risk of aseptic meningitis.
Renal function: renal insufficiency, as renal function may be impaired.
Liver function: liver dysfunction.
Use with caution in combination with antihypertensives including adrenergic neuronal blockers and beta blockers.
Use with caution with other sympathomimetic agents such as decongestants, appetite suppressants, and amphetamine psychostimulants.
Use with caution in case of hyperexcitement.
If lucidity, restlessness or sleep disturbances occur during administration of the medicinal product, the use of the medicinal product should be discontinued.
Elderly: Elderly patients have a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation which may be fatal.
Paediatric population: There is a risk of impaired renal function in dehydrated adolescents.
This medicinal product contains: less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'; sunset yellow FCF colour (E 110), which may cause allergic reactions.

CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to the active substances or to any of the excipients.
Patients with peptic ulcer.
History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Subjects who have previously shown hypersensitivity reactions (such as nasal polyposis, edema, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, other non-steroidal anti-inflammatory drugs (NSAIDs).
Severe renal or hepatic insufficiency.
Severe heart failure (NYHA class IV) Patients with serious cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostate syndrome.
Pregnancy.
Breastfeeding.
Children under 12 years old.
Patients who are taking or have taken in the previous 14 days monoamine oxidase inhibitors (MAOIs).

INTERACTIONS:
Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4).
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding.
The product must not be taken by patients undergoing treatment with monoamine oxidase inhibitors and for 14 days following cessation of such treatment.
The product may enhance the effect of other sympathomimetic agents, such as decongestants.
The effect of pseudoephedrine may be reduced by guanethidine, reserpine and methyldopa and may be influenced by tricyclic antidepressants.
In turn, pseudoephedrine may reduce the effect of guanethidine and may increase the possibility of arrhythmias in digitalized patients, or in patients taking anticholinergics (including tricyclic antidepressants) or quinidine.
Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive 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 an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to a further deterioration of renal function, including possible acute renal failure, which is usually reversible.
These interactions should be considered in patients taking this drug concomitantly with ACE inhibitors or angiotensin II antagonists.
Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy.
Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly.
Although there are uncertainties regarding the 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 effects are considered likely following occasional use of ibuprofen.
Other NSAIDs including cyclooxygenase-2 selective inhibitors: Concomitant use of two or more NSAIDs should be avoided as it may increase the risk of adverse events.
Cardiac glycosides: NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate) and plasma glycoside levels.
Lithium: There is evidence of the possibility of a potential increase in lithium levels in the blood.
Methotrexate: There is evidence of the possibility of an increase in plasma levels of methotrexate.
Cyclosporins: increase the risk of nephrotoxicity.
Mifepristone: NSAIDs should not be administered for 8-12 days following mifepristone administration as NSAIDs may reduce the effect of mifepristone.
Tacrolimus: possible increased risk of nephrotoxicity when NSAIDS are administered with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are used concomitantly with Zidovudine.
There is evidence of increased risk of haemarthrosis and haematoma in HIV-seropositive haemophilic patients treated concomitantly with zidovudine and ibuprofen.
Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.
Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Seed sorghum alkaloids (ergotamine and methysergide): increased risk of ergotism.
Appetite suppressants (anorexigents) and mphetamine-like psychostimulants: risk of hypertension.
Oxytocin: risk of hypertension and

SIDE EFFECTS:
The list of adverse reactions below includes those that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200 mg per day) and with sympathomimetics including pseudoephedrine for short periods of administration.
Undesirable effects associated with the administration of ibuprofen and sympathomimetics such as pseudoephedrine are listed below according to system organ class and frequency.
For the frequency of occurrence of adverse reactions, the following expressions are used: Very common (>= 1/10); Common (>= 1/100, <1/10); Uncommon (>= 1/1000, <1/100); Rare (>= 1/10,000, <1/1000); Very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
Summary of adverse reactions.
Pathologies of the haemolymphopoietic system.
Uncommon: hypersensitivity reactions characterized by urticaria and pruritus; very rare: haematopoietic disorders.
Severe hypersensitivity reactions.
Symptoms may include swelling of the face, tongue and larynx, dyspnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
Psychiatric disorders.
Not known: insomnia, anxiety, restlessness, agitation, hallucinations.
Pathologies of the nervous system.
Uncommon: headache, tremors; very rare: aseptic meningitis.
Heart disease.
Not known: cardiac failure and edema, tachycardia, chest pain, arrhythmia, palpation.
Vascular pathologies.
Not known: hypertension.
Respiratory, thoracic and mediastinal disorders.
Not known: respiratory system reactivity including asthma, bronchospasm or dyspnoea.
Gastrointestinal pathologies.
Uncommon: abdominal pain, nausea and dyspepsia; rare: diarrhoea, flatulence, constipation and vomiting; very rare: peptic ulcer, gastrointestinal perforation or haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly.
Ulcerative stomatitis, mouth ulceration, gastritis; not known: dry mouth.
Exacerbation of colitis and Crohn's disease.
Hepatobiliary pathologies.
Very rare: liver disorders.
Skin and subcutaneous tissue disorders.
Not known: hyperhidrosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe skin reactions, including pustulosis and acute generalized rash (AGEP); uncommon: skin rashes; very rare: bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur.
Musculoskeletal and connective tissue disorders.
Not known: muscle weakness.
Renal and urinary disorders.
Very rare: severe renal failure; not known: urinary retention.
Systemic pathologies and conditions related to the administration site.
Not known: irritability, thirst.
Diagnostic tests.
Very rare: decrease in the level of haemoglobin in the blood.
Gastrointestinal intolerance, bleeding, sweating, dizziness, chest pain, difficulty urinating and insomnia may occur.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur 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 the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp etta-reazione-avversa.

PREGNANCY AND BREASTFEEDING:
The product should not be used during pregnancy and breastfeeding.
Pregnancy: Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryo/fetal development.
Results of 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 of heart defects increased from less than 1% to approximately 1.5%.
The risk has been thought to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus 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 pregnancy, to: possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.
There is a possibility of an association between the onset of fetal anomalies and the intake of pseudoephedrine in the first trimester of pregnancy.
Breastfeeding: Although ibuprofen is present in breast milk in very low concentrations, pseudoephedrine is secreted into the milk in significant quantities; for this reason the product should not be used during breastfeeding.
Fertility: As with other NSAIDs, the use of this medicine may alter female fertility by affecting ovulation.
Therefore it is not recommended in women wishing to conceive.