Vicks Flu Action 200 + 30 mg 12 coated tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Symptomatic relief of nasal/sinus congestion with headache, fever and pain associated with colds and flu. Vicks Flu Action is indicated in adults and adolescents aged 15 years and older.

ACTIVE INGREDIENTS

One tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride equivalent to 24.6 mg of pseudoephedrine. For the full list of excipients, see section 6.1.

EXCIPIENTS

Tablet core: Microcrystalline cellulose, Pregelatinized corn starch, Povidone K-30, Colloidal anhydrous silica, Stearic acid 95, Croscarmellose sodium, Sodium lauryl sulfate. Coating film: Polyvinyl alcohol - Parz. hydrolysate, Talc (E553b), Macrogol 3350, Pearlescent pigment based on MICA (Mixture of potassium aluminum silicate (E555)-[mica], titanium dioxide (E171)), Polysorbate 80 (E433), Hypromellose, Titanium dioxide (E 171), Macrogol 400, Yellow iron oxide (E 172), Red iron oxide (E 172), Black iron oxide (E 172).

CONTRAINDICATIONS AND SIDE EFFECTS

- Hypersensitivity to ibuprofen, pseudoephedrine or to any of the excipients listed in section 6.1. - Patients under the age of 15. - Pregnancy and breastfeeding (see section 4.6). - A history of hypersensitivity reactions (e.g. bronchospasm, asthma, nasal polyposis, rhinitis or urticaria) associated with aspirin, other analgesics, antipyretics or other non-steroidal anti-inflammatory drugs (NSAIDs). - Active peptic ulcer or history of recurrent ulcer/hemorrhage (two or more distinct episodes of proven ulcer or bleeding). - History of gastrointestinal bleeding or perforation, including cases associated with NSAIDs. - Cerebrovascular hemorrhage or other type of hemorrhage. - Unexplained hematopoietic abnormalities. - Severe renal insufficiency (eGFR <30 mL/minute/1.73 m²). - Severe hepatic impairment such as cirrhosis or end-stage liver disease - Severe heart failure (NYHA Class IV). - Severe cardiovascular disorders such as coronary artery disease (e.g. angina pectoris), severe or uncontrolled hypertension, tachycardia and other serious cardiac and/or vascular disorders. - History of myocardial infarction. - History of stroke or presence of risk factors for stroke (due to the α-sympathomimetic activity of pseudoephedrine hydrochloride). - Hyperthyroidism, diabetes, pheochromocytoma. - Closed-angle glaucoma. - Urinary retention related to urethro-prostatic disorders. - History of seizures. - Disseminated systemic lupus erythematosus and mixed connective tissue disease (increased risk of aseptic meningitis, see section 4.8). - Concomitant use of other vasoconstrictor drugs used as nasal decongestants, administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine), and methylphenidate (see section 4.5). - Concomitant use of NSAIDs or aspirin with a daily dose exceeding 75 mg, analgesics and selective COX 2 inhibitors (see paragraph 4.5). - Concomitant or previous use of monoamine oxidase inhibitors (MAOIs) in the previous 2 weeks (see section 4.5). This medicine should generally not be used in combination with: - oral anticoagulants, - corticosteroids, - heparins at curative doses or in the elderly, - anti-platelet agents, - lithium, - selective serotonin reuptake inhibitors (SSRIs), - methotrexate (used at doses higher than 20 mg/week)

DOSAGE

Dosage Adults and adolescents aged 15 years and older: 1 tablet (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 4-6 hours as needed. For more severe symptoms, 2 tablets (equivalent to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6-8 hours as needed, up to the maximum total daily dose. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see section 4.4). The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) should not be exceeded. Do not exceed 5 days of therapy for the adult population. Do not exceed 3 days of therapy for adolescents (15-18 years). This combination product must be used when both the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are necessary. If one symptom is predominant (nasal congestion or headache and/or fever), therapy with a single active ingredient is preferable. In older patients, start therapy with the lowest possible dose because the risk of gastrointestinal bleeding, ulcer or perforation is greater with increasing doses of NSAIDs. In these patients, or in patients taking other drugs capable of increasing the risk of gastrointestinal events (see below and in section 4.5), the concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered. In patients with chronic kidney disease with eGFR >30 mL/min/1.73m² < 90 mL/min/1.73m² or stage 1 or 2 hepatocellular disease (hepatic inflammation or liver fibrosis) it is necessary to adapt the dosage to the individual patient. Undesirable effects can be reduced by using the lowest effective dose for the minimum duration needed to relieve symptoms (see section 4.4). Pediatric population Vicks Flu Action is contraindicated in children under 15 years of age (see section 4.3). Method of administration For oral use. The tablets should be swallowed with water, preferably on a full stomach. Do not break or crush the tablets.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

The concomitant use of Vicks Flu Action and other NSAIDs containing COX-2 inhibitors should be avoided (see section 4.3). Patients with chronic kidney disease or stage 1 or 2 hepatocellular disease (hepatic inflammation or hepatic fibrosis) require dose adjustment on an individual basis (see section 4.2). Severe skin reactions Severe skin reactions, such as acute generalized exanthematous pustulosis (PEAG), may occur with medicines containing ibuprofen and pseudoephedrine. This acute pustular eruption can occur within the first 2 days of treatment, with fever and numerous small pustules, mostly non-follicular, appearing on a very widespread edematous erythema and localized 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, the administration of Vicks Flu Action should be stopped and appropriate measures taken if necessary. Other skin manifestations potentially associated with this medicine and requiring urgent medical attention are: Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis (Lyell's syndrome), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome). These serious conditions present with additional involvement of mucous membranes and skin erosion, or systemic reactions, such as lymphadenopathy, arthritis or general malaise, facial and acral edema, involvement of multiple organs, particularly liver and kidneys, and hematological abnormalities. The first symptoms develop within a few hours/days up to two to six weeks, in case of DRESS syndrome, after exposure. Masking of symptoms of underlying infections Vicks Flu Action can mask the symptoms of infection, which could delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Vicks flu Action is given for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Special warnings regarding pseudoephedrine hydrochloride : • The dosage, maximum recommended duration of treatment (see section 4.2) and contraindications must be strictly respected (see section 4.8). • Patients should be informed that treatment should be discontinued if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as onset or worsening headache appear. Before using this product, patients should consult their doctor in case of: • Well-controlled mild to moderate hypertension and heart disease (see section 4.3) • Psychosis • Concomitant administration of anti-migraine drugs, in particular ergot alkaloid vasoconstrictors (due to the a-sympathomimetic activity of pseudoephedrine). Neurological symptoms such as convulsions, hallucinations, behavioral disturbances, agitation and insomnia have been described following the systemic administration of vasoconstrictors, especially during feverish episodes or in case of overdose. These symptoms have been commonly reported in the pediatric population. The following is therefore advisable: • avoid the administration of Vicks Flu Action both in association with medicines capable of lowering the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anaesthetics, and where there is a history of convulsions; • strictly respect the recommended dosage in all cases and inform patients about the risk of overdose if Vicks Flu Action is taken in combination with other medicinal products containing vasoconstrictors. Patients with urethro-prostatic disorders are more susceptible to the development of symptoms such as dysuria and urinary retention (see section 4.3). Elderly patients may be more sensitive to effects on the central nervous system (CNS). Ischemic colitis Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis develop, pseudoephedrine should be discontinued and a physician should be consulted. Precautions for use relating to pseudoephedrine hydrochloride : • In patients undergoing elective surgery during which volatile halogenated anesthetics will be used, it is preferable to suspend therapy with Vicks Flu Action several days before surgery due to the risk of acute hypertension (see section 4.5). • Athletes should be informed that treatment with pseudoephedrine hydrochloride may cause positive doping test results. Ischemic optic neuropathy Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma. Interference with serological tests Pseudoephedrine may potentially reduce iobenguane I-131 reuptake in neuroendocrine tumors, thereby interfering with scintigraphy. Special warnings regarding ibuprofen : In patients suffering from, or with a history of bronchial asthma or allergies, ibuprofen may trigger bronchospasm. The product must not be administered in case of asthma without prior medical consultation (see section 4.3). Patients suffering from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are at greater risk of allergic reactions when taking acetylsalicylic acid and/or NSAIDs. The administration of Vicks Flu Action can trigger an acute asthma attack, particularly in some patients allergic to acetylsalicylic acid or an NSAID (see section 4.3). In dehydrated adolescents there is a risk of kidney failure. Gastrointestinal effects: With all NSAIDs, cases of gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported at any time during treatment, with or without warnings or previous history of gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal, is greater with increasing doses of NSAIDs, in patients with a history of ulcer (particularly if complicated by haemorrhage or perforation - see section 4.3) and in patients over 60 years of age. These older patients should start treatment at the lowest available dose (see section 4.2). For these patients and for those taking concomitant treatment with low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, combination therapy with gastroprotectors (e.g. misoprostol or proton pump inhibitors) should be considered (see below and sections 4.3 and 4.5). Patients with a history of gastrointestinal disorders, particularly if elderly, may experience unusual abdominal symptoms (particularly gastrointestinal bleeding) in the initial stages of treatment. The administration of NSAIDs must be carefully evaluated in patients with coagulation disorders, since a reduction in coagulation capacity is possible. Particular caution is advised in patients receiving concomitant therapy. Some drugs may increase the risk of ulcer or bleeding such as oral corticosteroids, anticoagulants such as warfarin, SSRIs or antiplatelets such as acetylsalicylic acid (see sections 4.3 and 4.5). Treatment with Vicks Flu Action must be stopped immediately if bleeding or gastrointestinal ulceration occurs. NSAIDs should be administered with caution to patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn's disease) as these conditions may worsen (see section 4.8). The concomitant use of alcohol and NSAIDs may increase side effects related to the active ingredient, in particular those relating to the gastrointestinal tract or central nervous system. Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (such as myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low-dose ibuprofen (e.g., ≤1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), demonstrated ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen, after careful examination and at high doses (2400 mg/day) its administration should be avoided. Precautions for use relating to ibuprofen : • Elderly patients: The pharmacokinetics of ibuprofen are not modified by age, therefore dosage adjustments are not necessary in the elderly. However, elderly patients must be kept under close medical supervision as they are more sensitive to side effects from NSAIDs, and in particular to gastrointestinal bleeding and perforation, which can be fatal. • Particular caution and medical supervision are required when administering ibuprofen to patients with a history of gastrointestinal disease. The use of Vicks Flu Action is contraindicated in some gastrointestinal pathologies (see section 4.3). • During the initial phases of treatment, careful monitoring of urinary excretion and renal function is required in patients with heart failure, chronic impairment of renal or hepatic function, in patients on diuretic therapy, in those hypovolemic due to major surgery and, in particular, in elderly patients. The renal function of these patients may be adversely affected by treatment with NSAIDs. • If visual disturbances occur during treatment, the patient will need to undergo a complete ophthalmological examination. If symptoms persist or worsen, the patient should consult his doctor. Vicks Flu Action contains 1.65 mg sodium per tablet.

INTERACTIONS

Non-selective monoamine oxidase inhibitors (MAOIs) - Possible reactions: Vicks Flu Action must not be taken by patients on current or past (last two weeks) therapy with monoamine oxidase inhibitors (MAOIs), as there is a risk of hypertensive episodes such as paroxysmal hypertension and hyperthermia, which can be fatal (see section 4.3).

Other sympathomimetics or vasoconstrictors with indirect action, administered orally or nasally, α-sympathomimetic drugs, phenylpropanolamine, phenylephrine, ephedrine, methylphenidate - Possible reactions: Pseudoephedrine may potentiate the effect of other sympathomimetics (vasoconstrictors) and cause a risk of vasoconstriction and/or hypertensive crisis.

Reversible monoamine oxidase A inhibitors (RIMA), Linezolid, ergot alkaloids with dopaminergic action, ergot alkaloid vasoconstrictors - Possible reactions: Risk of vasoconstriction and/or hypertensive crisis.

Halogenated volatile anesthetics - Possible reactions: Acute perioperative hypertension. In scheduled surgical interventions, suspend treatment with Vicks Flu Action several days before the operation.

Guanethidine, reserpine and methyldopa - Possible reactions: The effect of pseudoephedrine may be reduced.

Tricyclic antidepressants - Possible reactions: The effect of pseudoephedrine may be reduced or increased.

Digitalis, quinidine or tricyclic antidepressants - Possible reactions: Increased frequency of arrhythmia.

Terpene derivatives, clobutinol, atropine-like substances and local anesthetics - Possible reactions: Reduction of the epileptogenic threshold.

Other NSAIDs, salicylates, analgesics, antipyretics and COX 2 inhibitors - Possible reactions: The concomitant administration of various NSAIDs, analgesics, antipyretics and selective COX 2 inhibitors may increase the risk of adverse reactions such as ulcers and gastrointestinal bleeding due to a synergistic effect. The concomitant use of Vicks Flu Action with these drugs should therefore be avoided (see sections 4.3 and 4.4).

Cardiac glycosides (such as digoxin) - Possible reactions: Concomitant use with digoxin preparations may increase serum levels of cardiac glycosides (digoxin). With correct use (a maximum of 5 days), monitoring of serum digoxin levels is usually not necessary.

Corticosteroids - Possible reactions: Corticosteroids may increase the risk of adverse reactions, particularly of the gastrointestinal tract (ulcer or gastrointestinal bleeding) (see section 4.3).

Antiplatelets - Possible reactions: Increased risk of gastrointestinal bleeding (see section 4.3).

Acetylsalicylic acid (low dose) - Possible reactions: Concomitant administration of acetylsalicylic acid should be avoided (see section 4.3). Coadministration of ibuprofen and acetylsalicylic acid (aspirin) is generally not recommended due to the potential for increased adverse effects. Experimental data indicate that ibuprofen can competitively inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation, when they are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data from the clinical situation, the possibility cannot be excluded that regular and long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid. No clinically relevant effect is considered likely for occasional use of ibuprofen (see section 5.1).

Anticoagulants (e.g. warfarin, ticlopidine, clopidogrel, Tirofiban, eptifibatide, abciximab, iloprost) - Possible reactions: Increased risk of gastrointestinal bleeding, because NSAIDs such as ibuprofen can increase the effect of anticoagulants (see sections 4.3 and 4.4).

Phenytoin - Possible reactions: The concomitant use of Vicks Flu Action and phenytoin preparations could increase the serum levels of these medicinal products. With correct use (a maximum of 5 days), monitoring of phenytoin serum levels is usually not necessary.

Selective serotonin reuptake inhibitors (SSRIs) - Possible reactions: Increased risk of gastrointestinal bleeding (see section 4.3).

Lithium - Possible reactions: The concomitant use of Vicks Flu Action and lithium preparations may increase the serum levels of these medicinal products (see section 4.3).

Probenecid and sulfinpyrazone - Possible reactions: Medicinal products containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen.

Diuretics, ACE inhibitors, beta blockers and angiotensin-II antagonists - Possible reactions: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the concomitant administration of an ACE inhibitor, a beta blocker or an angiotensin-II antagonist and drugs that inhibit cyclo-oxygenase may cause further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the administration of these drugs in combination must be carried out with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of treatment and on a periodic basis thereafter.

Potassium-sparing diuretics - Possible reactions: Concomitant administration of Vicks Flu Action and potassium-sparing diuretics may cause hyperkalemia (monitoring of serum potassium levels is recommended).

Methotrexate - Possible reactions: Administration of Vicks Flu Action within 24 hours before or after administration of methotrexate may cause high concentrations of methotrexate and an increase in its toxic effects (see section 4.3).

Ciclosporin - Possible reactions: The risk of a harmful effect on the kidneys due to ciclosporin increases with concomitant administration of some non-steroidal anti-inflammatory drugs. This effect cannot be excluded even for the association between ciclosporin and ibuprofen.

Tacrolimus - Possible reactions: The risk of nephrotoxicity increases if the two medicinal products are administered in combination.

Zidovudine - Possible reactions: Cases of an increased risk of hemarthrosis and hematoma have been reported in HIV (+) hemophiliac patients receiving concomitant therapy with zidovudine and ibuprofen.

Sulfonylureas - Possible reactions: Clinical studies have demonstrated interactions between nonsteroidal anti-inflammatory drugs and antidiabetics (sulfonylureas). Although no interactions have been described between sulphonylureas and ibuprofen, as a precaution during concomitant use it is recommended to monitor blood glucose values.

Quinolone antibiotics - Possible reactions: Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients treated with NSAIDs and quinolones may have an increased risk of developing seizures.

Heparins; Gingko biloba - Possible reactions: Increased risk of bleeding (see section 4.3).

SIDE EFFECTS

The most commonly observed adverse events related to ibuprofen are gastrointestinal in nature. In general, the risk of presenting adverse events (in particular the risk of presenting serious gastrointestinal complications) increases with increasing dose and duration of treatment. Cases of hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of: (a) Nonspecific allergic reactions and anaphylaxis; (b) Respiratory tract reactivity, including asthma, worsening of asthma, bronchospasm, or dyspnea; (c) Skin disorders of various nature, including rash of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative dermatitis and bullous dermatitis (including epidermal necrolysis and erythema multiforme). In patients with pre-existing autoimmune disease (such as systemic lupus erythematosus, mixed connective tissue disease), single cases of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever or disorientation have been reported during treatment with ibuprofen. Edema, hypertension and heart failure have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of ibuprofen (particularly at high doses 2400 mg/day) and in long-term therapy may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke), (see section 4.4). The following list of adverse events relates to those occurring with ibuprofen and pseudoephedrine hydrochloride at normal over-the-counter doses, for short-term use. In the treatment of chronic pathologies and long-term treatment, further adverse events may occur. Patients should be informed of the need to immediately stop taking Vicks Flu Action and consult their doctor if a serious adverse drug reaction occurs. The frequency of adverse reactions is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), frequency not known (frequency cannot be estimated from the available data).

Infections and infestations: Ibuprofen Very rare Exacerbation of infectious inflammations (e.g. necrotizing fasciitis), Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever or disorientation in patients with pre-existing autoimmune diseases (SLE, mixed connective tissue disease).

Blood and lymphatic system disorders: Ibuprofen Very rare Hematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia).

Immune system disorders: Ibuprofen and pseudoephedrine hydrochloride Very rare Severe generalized hypersensitivity reactions: signs may be facial edema, angioedema, dyspnoea, bronchospasm, tachycardia, sharp drop in blood pressure, anaphylactic shock.

Psychiatric disorders: Ibuprofen Very rare Psychotic reactions, depression.

Psychiatric disorders: Pseudoephedrine hydrochloride Frequency not known Hallucinations, behavioral anomalies.

Nervous system disorders: Ibuprofen Uncommon Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or tiredness.

Nervous system disorders: Pseudoephedrine hydrochloride Rare Insomnia, nervousness, anxiety, agitation, restlessness, tremors.

Nervous system disorders: Pseudoephedrine hydrochloride Frequency not known Haemorrhagic stroke, ischemic stroke, convulsions, headache.

Eye disorders: Ibuprofen Uncommon Visual disturbances.

Eye disorders: Pseudoephedrine hydrochloride Not Known Ischemic optic neuropathy.

Ear and labyrinth disorders: Ibuprofen Rare Tinnitus.

Cardiac disorders: Ibuprofen Rare Edema, hypertension, palpitations, heart failure, myocardial infarction Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increase in the risk of arterial thrombotic events (such as myocardial infarction or stroke) (see section 4.4).

Cardiac disorders: Pseudoephedrine hydrochloride Rare Palpitations, tachycardia, chest pain, arrhythmia.

Vascular disorders: Ibuprofen Rare Arterial hypertension.

Vascular disorders: Pseudoephedrine hydrochloride Frequency not known Hypertension.

Respiratory, thoracic and mediastinal disorders: Pseudoephedrine hydrochloride Rare Asthma exacerbation or hypersensitivity reactions with bronchospasm.

Gastrointestinal disorders: Ibuprofen Uncommon Gastrointestinal discomfort, dyspepsia, nausea, vomiting, diarrhea, anorexia.

Gastrointestinal disorders: Ibuprofen Rare Abdominal pain, flatulence, constipation.

Gastrointestinal disorders: Ibuprofen Very rare Peptic ulcer, perforation or gastrointestinal haemorrhage (with melena or haematemesis, gastritis, ulcerative stomatitis). Exacerbation of colitis and Crohn's disease (see section 4.4).

Gastrointestinal disorders: Ibuprofen Very rare Esophagitis, pancreatitis, intestinal diaphragm stenosis.

Gastrointestinal disorders: Pseudoephedrine hydrochloride Uncommon Dry mouth, thirst, nausea, vomiting.

Gastrointestinal disorders: Peudoephedrine hydrochloride Frequency not known Ischemic colitis.

Hepatobiliary disorders: Ibuprofen Very rare Liver dysfunction, liver damage, particularly in long-term therapy, liver failure, acute hepatitis.

Skin and subcutaneous tissue disorders: Ibuprofen Rare Various skin rashes.

Skin and subcutaneous tissue disorders: Ibuprofen Very rare Severe forms of skin reactions such as exfoliative dermatitis or bullous rash such as Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis (Lyell's syndrome), alopecia, severe skin infections, soft tissue complications in a chickenpox infection.

Skin and subcutaneous tissue disorders: Ibuprofen Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Skin and subcutaneous tissue disorders: Pseudoephedrine hydrochloride Rare Skin rash, urticaria, pruritus, erythema, hyperhidrosis.

Skin and subcutaneous tissue disorders: Ibuprofen Not known Serious skin reactions, including acute generalized exanthematous pustulosis (PEAG).

Skin and subcutaneous tissue disorders: Pseudoephedrine hydrochloride Not known Serious skin reactions, including acute generalized exanthematous pustulosis (PEAG).

Skin and subcutaneous tissue disorders: Ibuprofen Not Known Photosensitivity Reaction

Renal and urinary disorders: Ibuprofen Rare Damage to renal tissue (papillary necrosis) and high blood concentrations of uric acids.

Renal and urinary disorders: Ibuprofen Very rare Increased serum creatinine, edema (particularly in patients with arterial hypertension or renal failure) edema, nephrotic syndrome, interstitial nephritis, acute renal failure.

Renal and urinary disorders: Pseudoephedrine hydrochloride Frequency not known Urinary retention in men with prostatic hypertrophy.

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Symptoms The most frequent manifestations of ibuprofen overdose are abdominal pain, nausea, vomiting, lethargy, thirst, muscle weakness, drowsiness, blurred vision and dizziness. Other side effects may occur, including headache, tinnitus, CNS depression, seizures, hypotension, bradycardia, tachycardia, supraventricular and ventricular arrhythmia, and atrial fibrillation. Coma, acute renal failure, hyperkalemia, apnea (especially in young children), respiratory depression and respiratory failure have been reported rarely. In asthmatics, worsening of asthma is possible. In cases of severe poisoning, metabolic acidosis may occur. Signs and symptoms of pseudoephedrine overdose include irritability, insomnia, fever, sweating, anxiety, restlessness, tremors, seizures, palpitations (sinus arrhythmia), high blood pressure, dry mouth, and difficulty urinating. Hallucinations (more likely in children) have been reported. Treatment Treatment of overdose is supportive. Within 1 hour of ingesting a potentially toxic amount you may benefit from gastric lavage and activated charcoal and, if necessary, correction of serum electrolytes. Symptomatic and supportive treatment should be undertaken, particularly regarding the cardiovascular and respiratory systems. For example, severe hypertension may need to be treated with an alpha-blocker drug, while the use of a beta blocker may be necessary to control cardiac arrhythmias. Seizures can be controlled with intravenous diazepam, while for extreme excitability and hallucinations chlorpromazine can be used.

PREGNANCY AND BREASTFEEDING

Pregnancy: Vicks Flu Action is contraindicated during pregnancy (see paragraph 4.3). Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformation and gastroschisis following the use of a prostaglandin synthesis inhibitor during the first months of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk is thought to increase with the dose and duration of therapy. In animals it has been demonstrated that the administration of a prostaglandin synthesis inhibitor causes an increase in the rate of pre- and post-implantation spontaneous abortion and embryo-foetal lethality. Furthermore, increased incidences of various malformations, including cardiovascular ones, have been reported in animals to which an inhibitor of prostaglandin synthesis was administered during the organogenetic period. During the third trimester of pregnancy all prostaglandin synthesis inhibitors can 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 oligohydramnios; They can expose mother and newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delay or prolongation of labor. There is the possibility of an association between the appearance of fetal anomalies and the intake of pseudoephedrine during the first trimester of pregnancy. Breastfeeding Vicks Flu Action is contraindicated during breastfeeding (see paragraph 4.3). Ibuprofen/pseudoephedrine has been identified in breastfed newborns/infants of treated patients. There is limited data on the effects of ibuprofen/pseudoephedrine on infants/children. Fertility The effects of this drug on fertility have not been studied. The use of ibuprofen may impair fertility and is not recommended in women who are trying to conceive. Women with difficulty conceiving or undergoing fertility tests should consider discontinuing ibuprofen. There are no adequate reproductive toxicology studies on pseudoephedrine.

EFFECTS ON DRIVING ABILITY

Vicks Flu Action has no known effects on the ability to drive or use machinery. However, given that dizziness or hallucinations may occur due to the presence of pseudoephedrine, this possibility must be taken into account if you intend to drive a vehicle or use machinery.