Vicks Flu Action 200 + 30 mg 12 coated tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 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.

CONTRAINDICATIONS

- 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)

WARNINGS AND PRECAUTIONS FOR USE

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

Association of pseudoephedrine with: | Possible reactions

Non-selective monoamine oxidase inhibitors (MAOIs) | Vicks Flu Action should 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 | 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 | Risk of vasoconstriction and/or hypertensive crisis.

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

Guanethidine, reserpine and methyldopa | The effect of pseudoephedrine may be reduced.

Tricyclic antidepressants | The effect of pseudoephedrine may be reduced or increased.

Digitalis, quinidine or tricyclic antidepressants | Increased frequency of arrhythmia.

Terpene derivatives, clobutinol, atropine-like substances and local anesthetics | Reduction of the epileptogenic threshold

Other NSAIDs, salicylates, analgesics, antipyretics and COX 2 inhibitors | The concomitant administration of several 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) | 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 | Corticosteroids may increase the risk of adverse reactions, particularly of the gastrointestinal tract (ulcer or gastrointestinal bleeding) (see section 4.3).

Antiplatelets | Increased risk of gastrointestinal bleeding (see section 4.3).

Acetylsalicylic acid (low dose) | 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) | Increased risk of gastrointestinal bleeding, because NSAIDs such as ibuprofen can increase the effect of anticoagulants (see sections 4.3 and 4.4)

Phenytoin | 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 serum phenytoin levels is usually not necessary.

Selective serotonin reuptake inhibitors (SSRIs) | Increased risk of gastrointestinal bleeding (see section 4.3).

Lithium | 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 | Medicinal products containing probenecid or sulfinpyrazone may delay the excretion of ibuprofen.

Diuretics, ACE inhibitors, beta blockers and angiotensin-II antagonists | 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 | Concomitant administration of Vicks Flu Action and potassium-sparing diuretics may cause hyperkalemia (monitoring of serum potassium levels is recommended).

Methotrexate | Administration of Vicks Flu Action within 24 hours before or after the administration of methotrexate may cause elevated concentrations of methotrexate and an increase in its toxic effects (see section 4.3).

Cyclosporine | 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 | The risk of nephrotoxicity increases if the two medicinal products are administered together.

Zidovudine | Cases of an increased risk of haemarthrosis and haematoma have been reported in HIV (+) haemophiliac patients receiving concomitant therapy with zidovudine and ibuprofen.

Sulfonylureas | 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 | 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 | 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)

Pathologies of the blood and lymphatic system | 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 pathologies | Ibuprofen | Very rare | Psychotic reactions, depression

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

Pseudoephedrine hydrochloride | Rare | Insomnia, nervousness, anxiety, agitation, restlessness, tremors

Frequency not known | Hemorrhagic stroke, ischemic stroke, convulsions, headache

Eye pathologies | Ibuprofen | Uncommon | Visual disturbances

Pseudoephedrine hydrochloride | Not Known | Ischemic optic neuropathy

Ear and labyrinth disorders | Ibuprofen | Rare | Tinnitus

Cardiac diseases | 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).

Pseudoephedrine hydrochloride | Rare | Palpitations, tachycardia, chest pain, arrhythmia

Vascular pathologies | Ibuprofen | Rare | Arterial hypertension

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, diarrhoea, anorexia

Rare | Abdominal pain, flatulence, constipation

Ibuprofen | Very rare | Peptic ulcer, perforation or gastrointestinal haemorrhage (with melena or haematemesis, gastritis, ulcerative stomatitis). Flare-up of colitis and Crohn's disease (see section 4.4)

Ibuprofen | Very rare | Esophagitis, pancreatitis, intestinal diaphragm stenosis

Pseudoephedrine hydrochloride | Uncommon | Dry mouth, thirst, nausea, vomiting

Peudoephedrine hydrochloride | Frequency not known | Ischemic colitis

Hepatobiliary disorders | Ibuprofen | Very rare | Liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis

Pathologies of the skin and subcutaneous tissue | Ibuprofen | Rare | Various skin rashes

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

Ibuprofen | Not known | Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Pseudoephedrine hydrochloride | Rare | Skin rash, urticaria, pruritus, erythema, hyperhidrosis

Ibuprofen | Not known | Severe skin reactions, including acute generalized exanthematous pustulosis (PEAG)

Pseudoephedrine hydrochloride

Ibuprofen | Not Known | Photosensitivity reaction

Renal and urinary disorders | Ibuprofen | Rare | Damage to kidney tissue (papillary necrosis) and high blood concentrations of uric acids

Ibuprofen | Very rare | Serum creatinine increased, edema (particularly in patients with arterial hypertension or renal insufficiency) edema, nephrotic syndrome, interstitial nephritis, acute renal failure

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.