Vicks Flu Action 200 + 30 mg 12 coated tablets

Vicks Flu Action 200 + 30 mg 12 coated tablets is an over-the-counter medicine designed to provide rapid and targeted relief from cold and flu symptoms . Thanks to its combined formulation, each tablet contains 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride , effectively acting on multiple disorders typical of flu and cold syndromes.

This product is particularly indicated for the symptomatic treatment of nasal and sinus congestion , blocked nose , headache and migraine , as well as to combat fever , osteoarticular pain and muscle pain associated with colds and flu. The coated tablets are easy to swallow and ensure effective release of the active ingredients, ensuring rapid relief from flu symptoms and colds .

Vicks Flu Action is the ideal solution for those looking for a complete treatment of flu and cold symptoms, allowing you to face the day with greater comfort and well-being. Thanks to its combined action, it helps to clear a stuffy nose, reduce congestion and relieve pain, promoting a faster recovery and a feeling of prolonged relief.

ACTIVE INGREDIENTS

Active ingredients contained in Vicks Flu Action 200 + 30 mg 12 coated tablets - What is the active ingredient in Vicks Flu Action 200 + 30 mg 12 coated tablets?

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

EXCIPIENTS

Composition of Vicks Flu Action 200 + 30 mg 12 coated tablets - What does Vicks Flu Action 200 + 30 mg 12 coated tablets contain?

Tablet core : Microcrystalline cellulose, Pregelatinised maize starch, Povidone K-30, Colloidal anhydrous silica, Stearic acid 95, Croscarmellose sodium, Sodium laurilsulfate. Film-coating : Polyvinyl alcohol - hydrolysed part, Talc (E553b), Macrogol 3350, Pearlescent pigment based on MICA (Potassium aluminium silicate mixture (E555)-[mica], titanium dioxide (E171)), Polysorbate 80 (E433), Hypromellose, Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Red iron oxide (E172), Black iron oxide (E172).

DIRECTIONS

Therapeutic indications Vicks Flu Action 200 + 30 mg 12 coated tablets - Why is Vicks Flu Action 200 + 30 mg 12 coated tablets used? What is it used for?

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 over.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Vicks Flu Action 200 + 30 mg 12 coated tablets - When should Vicks Flu Action 200 + 30 mg 12 coated tablets not be used?

- Hypersensitivity to ibuprofen, pseudoephedrine or to any of the excipients listed in section 6.1. - Patients under 15 years of age. - Pregnancy and breast-feeding (see section 4.6). - A history of hypersensitivity reactions (e.g. bronchospasm, asthma, nasal polyps, rhinitis or urticaria) associated with aspirin, other analgesics, antipyretics or other nonsteroidal anti-inflammatory drugs (NSAIDs). - Active peptic ulcer or history of recurrent ulcer/haemorrhage (two or more distinct episodes of proven ulcer or bleeding). - History of gastrointestinal bleeding or perforation, including cases associated with NSAIDs. - Cerebrovascular haemorrhage or other haemorrhage. - Unexplained haematopoietic abnormalities. - Severe renal insufficiency (eGFR <30 mL/minute/1.73 m²). - Severe hepatic impairment such as cirrhosis or end-stage liver disease - Severe cardiac failure (NYHA Class IV). - Severe cardiovascular disorders such as coronary artery disease (e.g. angina pectoris), severe or uncontrolled hypertension, tachycardia and other severe 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. - Angle-closure glaucoma. - Urinary retention related to urethroprostatic 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 greater than 75 mg, analgesics and selective COX-2 inhibitors (see section 4.5). - Concomitant or previous use of monoamine oxidase inhibitors (MAOIs) in the previous 2 weeks (see section 4.5). This medicinal product 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 greater than 20 mg/week)

DOSAGE

Quantity and method of taking Vicks Flu Action 200 + 30 mg 12 coated tablets - How to take Vicks Flu Action 200 + 30 mg 12 coated tablets?

Dosage Adults and adolescents aged 15 years and over: 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 4-6 hours as needed. For more severe symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg 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 duration 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 adults. Do not exceed 3 days of therapy for adolescents (15-18 years). This combination product should be used when both the decongestant action of pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen are needed. If one symptom is predominant (nasal congestion or headache and/or fever), therapy with a single active substance is preferable. In older patients, start therapy with the lowest possible dose because the risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing doses of NSAIDs. In these patients, or in patients taking other drugs that may increase the risk of gastrointestinal events (see below and section 4.5), 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 (liver inflammation or liver fibrosis) the dosage should be adjusted to the individual patient. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms (see section 4.4). Paediatric 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 with food. Do not break or crush the tablets.

CONSERVATION

Storage Vicks Flu Action 200 + 30 mg 12 coated tablets - How do you store Vicks Flu Action 200 + 30 mg 12 coated tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Vicks Flu Action 200 + 30 mg 12 coated tablets - About Vicks Flu Action 200 + 30 mg 12 coated tablets it is important to know that:

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 (liver inflammation or liver fibrosis) require dose adjustment on an individual basis (see section 4.2). Severe skin reactions Severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), may occur with medicinal products containing ibuprofen and pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules appearing on a widespread oedematous erythema and located mainly in 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 Vicks Flu Action should be discontinued and appropriate measures taken if necessary. Other skin manifestations potentially associated with this medicinal product 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 malaise, facial and acral oedema, multiple organ involvement, particularly the liver and kidneys, and haematological abnormalities. The first symptoms develop within hours/days up to two to six weeks, in the case of DRESS syndrome, after exposure. Masking of symptoms of underlying infections Vicks Flu Action may mask the symptoms of infection, which may delay the initiation of adequate 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 administered for the relief of fever or pain related to infection, monitoring for infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Special warnings relating to 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 advised to discontinue treatment if hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as onset or worsening of headache appear. Before using this product, patients should consult their doctor in case of: • Mild to moderate hypertension and heart disease well controlled (see section 4.3) • Psychosis • Concomitant administration of antimigraine drugs, in particular ergot alkaloid vasoconstrictors (due to the a-sympathomimetic activity of pseudoephedrine). Neurological symptoms such as convulsions, hallucinations, behavioural disturbances, agitation and insomnia have been described following the systemic administration of vasoconstrictors, especially during febrile episodes or in case of overdose. These symptoms have been commonly reported in the paediatric population. It is therefore advisable to: • avoid the administration of Vicks Flu Action both in association with medicinal products capable of lowering the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anaesthetics, and in cases of a history of convulsions; • strictly respect the recommended dosage in all cases and inform patients of the risk of overdose if Vicks Flu Action is taken in association with other medicinal products containing vasoconstrictors. Patients with urethral-prostatic disorders are more prone to the development of symptoms such as dysuria and urinary retention (see section 4.3). Elderly patients may be more sensitive to the 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 consulted. Precautions for use related to pseudoephedrine hydrochloride : • In patients undergoing elective surgery during which volatile halogenated anaesthetics are to be used, it is preferable to discontinue therapy with Vicks Flu Action several days before the operation because of the risk of acute hypertension (see section 4.5). • Athletes should be informed that treatment with pseudoephedrine hydrochloride may cause positive results in anti-doping tests. 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, such as scotoma, occurs. Interference with serological tests Pseudoephedrine may potentially reduce the reuptake of iobenguane I-131 in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings relating to ibuprofen : In patients with, or with a history of bronchial asthma or allergies, ibuprofen may trigger bronchospasm. The product should not be administered in cases of asthma without prior medical advice (see section 4.3). Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are at increased risk of allergic reactions with the intake of acetylsalicylic acid and/or NSAIDs. Administration of Vicks Flu Action may trigger an acute asthma attack, particularly in some patients allergic to acetylsalicylic acid or an NSAID (see section 4.3). There is a risk of renal failure in dehydrated adolescents. Gastrointestinal effects : With all NSAIDs, cases of gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported at any time during treatment, with or without warning signs or a previous history of gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation, which can be fatal, 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 patients over 60 years of age. These older patients should start treatment on the lowest available dose (see section 4.2). Combination therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for those taking concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and sections 4.3 and 4.5). Patients with a history of gastrointestinal disorders, particularly when elderly, may present with unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment. The administration of NSAIDs should be carefully considered in patients with coagulation disorders, since a reduction in clotting capacity is possible. Particular caution is advised in patients receiving concomitant therapy. Some drugs may increase the risk of ulceration or bleeding such as oral corticosteroids, anticoagulants such as warfarin, SSRIs or antiplatelet agents such as acetylsalicylic acid (see sections 4.3 and 4.5). Treatment with Vicks Flu Action should be stopped immediately if gastrointestinal bleeding or ulceration occurs. 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 (see section 4.8). Concomitant use of alcohol and NSAIDs may increase the adverse effects related to the active substance, in particular those relating to the gastrointestinal tract or the central nervous system. Cardiovascular and cerebrovascular effects : Clinical trials 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), proven ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen after careful consideration and high doses (2400 mg/day) 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 the adverse effects of 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 certain gastrointestinal diseases (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 renal or hepatic impairment, in patients treated with diuretics, in those hypovolaemic 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 should undergo a complete ophthalmological examination. If symptoms persist or worsen, the patient should consult a doctor. Vicks Flu Action contains 1.65 mg sodium per tablet.

INTERACTIONS

Interactions Vicks Flu Action 200 + 30 mg 12 coated tablets - Which medicines or foods can modify the effect of Vicks Flu Action 200 + 30 mg 12 coated tablets?

Association of pseudoephedrine with :	Possible reactions
Non-selective monoamine oxidase inhibitors (MAOIs)	Vicks Flu Action must not be taken by patients currently or in the past (last two weeks) on monoamine oxidase inhibitor (MAOI) therapy, as there is a risk of hypertensive episodes such as paroxysmal hypertension and hyperthermia, which may be fatal (see section 4.3).
Other sympathomimetics or indirectly acting vasoconstrictors, 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 inhibitors of monoamine oxidase A (RIMA), Linezolid, ergot alkaloids with dopaminergic action, vasoconstrictors ergot alkaloids	Risk of vasoconstriction and/or hypertensive crisis.
Volatile halogenated anesthetics	Acute perioperative hypertension. In scheduled surgical interventions, discontinue treatment with Vicks Flu Action several days before the intervention.
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	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 (maximum 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 (gastrointestinal ulceration or bleeding) (see section 4.3).
Antiplatelet	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). Concomitant administration of ibuprofen and acetylsalicylic acid (aspirin) is generally not recommended due to the potential for increased adverse effects. Experimental data indicate that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when they are administered concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional 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 may enhance the effect of anticoagulants (see sections 4.3 and 4.4)
Phenytoin	Concomitant use of Vicks Flu Action and phenytoin preparations may increase the serum levels of these medicinal products. With correct use (maximum 5 days), monitoring of phenytoin serum levels is usually not necessary.
Selective serotonin reuptake inhibitors (SSRIs)	Increased risk of gastrointestinal bleeding (see section 4.3).
Lithium	Concomitant use of Vicks Flu Action and lithium-based 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 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 concomitant administration of an ACE inhibitor, a beta-blocker or an angiotensin-II antagonist and drugs that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the administration of these drugs in combination should be undertaken 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 periodically 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 methotrexate administration may cause elevated methotrexate concentrations and an increase in its toxic effects (see section 4.3).
Cyclosporine	The risk of a renal damage due to ciclosporin increases with the concomitant administration of some nonsteroidal anti-inflammatory drugs. This effect cannot be excluded even for the combination of ciclosporin and ibuprofen.
Tacrolimus	The risk of nephrotoxicity increases if the two medicinal products are administered in combination.
Zidovudine	There have been reports of an increased risk of haemarthrosis and haematoma 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 between sulfonylureas and ibuprofen have been described, as a precaution during concomitant intake it is recommended to monitor blood glucose levels.
Quinolone antibiotics	Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients receiving NSAIDs and quinolones may be at increased risk of developing convulsions.
Heparin; Ginkgo biloba	Increased risk of bleeding (see section 4.3).

SIDE EFFECTS

Like all medicines, Vicks Flu Action 200 + 30 mg 12 coated tablets can cause side effects - What are the side effects of Vicks Flu Action 200 + 30 mg 12 coated tablets?

The most commonly observed adverse events related to ibuprofen are gastrointestinal in nature. In general, the risk of adverse events (particularly the risk of 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 dyspnoea; (c) Various skin disorders, including rashes 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 stiff neck, headache, nausea, vomiting, fever or disorientation have been reported during treatment with ibuprofen. Oedema, hypertension and cardiac failure have been reported in association with treatment with NSAIDs. Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400 mg/day) and in long-term therapy may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). The following list of adverse events relates to those experienced with ibuprofen and pseudoephedrine hydrochloride at normal over-the-counter doses, for short-term use. In the treatment of chronic diseases and in long-term treatment additional adverse events may occur. Patients should be advised to stop taking Vicks Flu Action immediately and consult their doctor if they experience a serious adverse drug reaction. 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 (cannot be estimated from the available data).

Infections and infestations	Ibuprofen	Very rare	Exacerbation of infectious inflammation (e.g. necrotizing fasciitis), Aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation in patients with pre-existing autoimmune diseases (SLE, mixed connective tissue disease)
Pathologies of the haemolymphopoietic system	Ibuprofen	Very rare	Hematopoietic disorders (anemia, 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, sudden drop in blood pressure, anaphylactic shock
Psychiatric pathologies	Ibuprofen	Very rare	Psychotic reactions, depression
	Pseudoephedrine hydrochloride	Frequency not known	Hallucinations, behavioral abnormalities
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, seizures, headache
Eye pathologies	Ibuprofen	Uncommon	Visual disturbances
	Pseudoephedrine hydrochloride	Not Known	Ischemic optic neuropathy
Ear and labyrinth pathologies	Ibuprofen	Rare	Tinnitus
Heart disease	Ibuprofen	Rare	Oedema, hypertension, palpitations, cardiac failure, myocardial infarction Clinical trials suggest that 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) (see section 4.4).
	Pseudoephedrine hydrochloride	Rare	Palpitations, tachycardia, chest pain, arrhythmia
Vascular pathologies	Ibuprofen	Rare	High blood pressure
	Pseudoephedrine hydrochloride	Frequency not known	Hypertension
Respiratory, thoracic and mediastinal pathologies	Pseudoephedrine hydrochloride	Rare	Asthma exacerbation or hypersensitivity reactions with bronchospasm
Gastrointestinal disorders	Ibuprofen	Uncommon	Gastrointestinal discomfort, dyspepsia, nausea, vomiting, diarrhea, anorexia
		Rare	Abdominal pain, flatulence, constipation
	Ibuprofen	Very rare	Peptic ulcer, perforation or gastrointestinal bleeding (with melaena or haematemesis, gastritis, ulcerative stomatitis). Exacerbation of colitis and Crohn's disease (see section 4.4)
	Ibuprofen	Very rare	Esophagitis, pancreatitis, intestinal stenosis with diaphragm
	Pseudoephedrine hydrochloride	Uncommon	Dry mouth, thirst, nausea, vomiting
	Pheudoephedrine hydrochloride	Frequency not known	Ischemic colitis
Hepatobiliary pathologies	Ibuprofen	Very rare	Liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis
Skin and subcutaneous tissue disorders	Ibuprofen	Rare	Various skin rashes
	Ibuprofen	Very rare	Severe forms of skin reactions such as exfoliative dermatitis or bullous exanthema 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	Rash, urticaria, pruritus, erythema, hyperhidrosis
	Ibuprofen	Not known	Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)
	Pseudoephedrine hydrochloride
	Ibuprofen	Not Known	Photosensitivity Reaction
Kidney and urinary disorders	Ibuprofen	Rare	Damage to kidney tissue (papillary necrosis) and elevated blood concentrations of uric acid
	Ibuprofen	Very rare	Increased serum creatinine, 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 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Vicks Flu Action 200 + 30 mg 12 coated tablets - What are the risks of Vicks Flu Action 200 + 30 mg 12 coated tablets in case of overdose?

Symptoms The most common manifestations of ibuprofen overdose are abdominal pain, nausea, vomiting, lethargy, thirst, muscle weakness, drowsiness, blurred vision and dizziness. Other undesirable effects may occur, including headache, tinnitus, CNS depression, convulsions, hypotension, bradycardia, tachycardia, supraventricular and ventricular arrhythmia and atrial fibrillation. Coma, acute renal failure, hyperkalemia, apnoea (especially in young children), respiratory depression and respiratory failure have been reported rarely. Worsening of asthma is possible in asthmatics. In severe poisoning, metabolic acidosis may occur . Signs and symptoms of pseudoephedrine overdose include irritability, insomnia, fever, sweating, anxiety, restlessness, tremors, convulsions, palpitations (sinus arrhythmia), hypertension, dry mouth, and difficulty urinating. Hallucinations have been reported (more likely in children). Treatment Treatment of overdose is supportive. Gastric lavage and activated charcoal may be beneficial within 1 hour of ingestion of a potentially toxic amount, and correction of serum electrolytes if necessary. Symptomatic and supportive treatment should be instituted, particularly with respect to the cardiovascular and respiratory systems. For example, severe hypertension may require treatment with an alpha-blocker, while a beta-blocker may be needed to control cardiac arrhythmias. Convulsions may be controlled with intravenous diazepam, while extreme excitability and hallucinations may be controlled with chlorpromazine.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Vicks Flu Action 200 + 30 mg 12 coated tablets.

Pregnancy : Vicks Flu Action is contraindicated in pregnancy (see section 4.3). Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryonic/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis following use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk for cardiovascular malformation 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 cause an increase in the rate of pre- and post-implantation miscarriage 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 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 oligohydramnios; They may expose the mother and 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 with consequent delay or prolongation of labor. There is a possibility of an association between the occurrence of fetal abnormalities and the use of pseudoephedrine during the first trimester of pregnancy. Breastfeeding Vicks Flu Action is contraindicated during breastfeeding (see section 4.3). Ibuprofen/pseudoephedrine have been identified in breast-fed neonates/infants of treated patients. Data on the effects of ibuprofen/pseudoephedrine on neonates/infants are limited. 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 attempting to conceive. Women with difficulties conceiving or undergoing fertility testing should consider stopping ibuprofen. There are no adequate reproductive toxicology studies on pseudoephedrine.

DRIVING AND USE OF MACHINERY

Take Vicks Flu Action 200 + 30 mg 12 coated tablets before driving or using machines - Does Vicks Flu Action 200 + 30 mg 12 coated tablets affect driving or using machines?

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