VICKS FLU ACTION 12CPR200+30MG

VICKS FLU ACTION 200 MG/30 MG COMPRESSE RIVESTITE WITH FILM

active ingredients

One tablet contains 200 mg of ibuprofen and 30 mg of chloride pseudoephedrine equivalent to 24,6 mg of pseudoephedrine. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: Microcrystalline cellulose, Pregelatinized corn starch, Povidone K-30, Anidra colloidal silica, Stearic acid 95, Sodium chroscarmellosa, Sodium laurilsulfate. Coating Film: Polyvinyl Alcohol - Hydrolyzed Parz, Talco (E553b), Macrogol 3350, Perlescent Pigment based on MICA (Miscela di silicato dipotassium e alluminio (E555)-[mica], Titanium dioxide (E171)), Polysorbate 80 (E433), Ipromellose, Titanium dioxide (E 171), Macrogol 400, Yellow Iron oxide (E 172), Red Iron oxide (E 172), Black Iron oxide (E 172).

Therapeutic indications

Syntomatic relief of nasal/synus congestion with headache, fever and pain associated with cold and flu. Vicks Flu Action is indicated in adults and adolescents aged 15 or over.

Contraindications

- Hypersensitivity to ibuprofen, pseudoephedrine or any of the excipients listed in the paragraph 6.1. - Patients under the age of 15. - Pregnancy and nursing (see paragraph 4.6). - A history of hypersensitivity reactions (e.g. bronchospasm, asthma, nasal polyposi, rhinitis or hives) associated with aspirin, other analgesic, antipyretic or other non-steroidal anti-inflammatory drugs (NSAID). - Active peptic ulcer or anamnesi of ulcer/recurring bleeding (two or more distinct episodes of ulcer or proven bleeding). - Anamnesis of bleeding or gastrointestinal perforation, including cases associated with NSAIDs. - Cerebrovascular hemorrhage or other hemorrhage. - Unexplained hematopoietic abnormalities. - Severe kidney failure (eGFR (see paragraph 4.5). - Concurrent or previous use of monoaminoxydase inhibitors (IMAO) in the previous 2 weeks (see paragraph 4.5). This medicine should not generally be used in combination with: - oral anticoagulants, - corticosteroids, - eparine at curative doses or in the elderly, - anti-plastrine agents, - lithium, - selective serotonin reuptake inhibitors (SSRIs), - stressed (used at higher doses of 20 mg/week)

Population

Population Adults and teenagers aged 15 or older: 1 tablet (equivalent to 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride) every 4-6 hours in need. For the most serious symptoms, 2 tablets (equivalent to 400 mg of ibuprofen and 60 mg of pseudoephedrine hydrochloride) every 6-8 hours in need, up to the total daily maximum dose. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4) The total daily maximum dose of 6 tablets (equivalent to 1200 mg of ibuprofen and 180 mg of pseudoephedrine hydrochloride) should not be exceeded. Do not exceed 5 days of adult therapy. Do not exceed 3 days of therapy for teenagers (15-18 years). This association product must be used when both the decongesting action of the pseudoephedrine hydrochloride and the analgesic and/or anti-inflammatory action of ibuprofen. If a symptom is predominant ( nasal congestion or headache and/or fever), a therapy with a single active ingredient is preferred. In older patients start therapy with the minimum dose possible because the risk of hemorrhage, ulcer or gastrointestinal perforation is greater with increasing doses of NSAIDs. In these patients, or in patients taking other drugs that can increase the risk of gastrointestinal events (see below and paragraph 4.5), it should be considered the concomitant use of protective agents (misoprostol or protonic pump inhibitors). In patients with chronic kidney disease with eGFR >30 mL/min/1,73m2 Pediatric population Vicks Flu Action is contraindicated in children under 15 years (see paragraph 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 medicine does not require any special condition of conservation.

Warnings

The concomitant use of Vicks Flu Action and other NSAIDs containing COX-2 inhibitors must be avoided (see paragraph 4.3). Patients with chronic kidney disease or hepatocellular disease at stage 1 or 2 (hepatic inflammation or liver fibrosis) require an individual dose adjustment (see paragraph 4.2). Strict skin reactions Strict skin reactions, such as generalized acute acute exantelosis (PEAG), may occur with medicines containing ibuprofen and pseudoephedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous small pustulas, mostly not follicular, appearing on a widespread and localized edematous erythema mainly on the skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustulas are observed, the administration of Vicks Flu Action must be interrupted and appropriate measures must be taken if necessary. Other skin manifestations potentially associated with this medicine and requiring urgent medical care are: Stevens-Johnson syndrome, multiform erythema and toxic epidermal necrolysis (Lyell syndrome), Pharmaco reaction with Eosinophilia and Systemic Syntomas (DrESS syndrome). These serious conditions arise with an additional involvement of mucous membranes and skin erosion, or systemic reactions, such as lymphadenopathy, arthritis or general malaise, facial and acrale edema, involvement of several organs, in particular liver and kidneys and hematological abnormalities. The first symptoms develop within a few hours/days up to two-six weeks, in case of DRESS syndrome, after exposure. Masking the symptoms of underlying infections Vicks Flu Action can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When Vicks flu Action is soministrated for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Special warnings related to pseudoephedrine hydrochloride : • The dosage, the maximum recommended duration of treatment (see paragraph 4.2) and contraindications must be strictly respected (see paragraph 4.8). • Patients should be informed that treatment should be suspended if hypertension, tachycardia, palpitations, heart arrhythmias, nausea or any neurological sign such as the principle or worsening of cephalea. Before using this product, patients should consult the doctor in case of: • Mild to moderately controlled hypertension and cardiopathy (see paragraph 4.3) • Psychosis • Concurrent administration of anti- migraine drugs, in particular alkaloid vasoconstrictors of hergot (due to a-simpaticomimetic activity of pseudoephedrine). Neuronological symptoms such as seizures, hallucinations, behavior disorders, agitation and insomnia have been described as a result of the systemic overdose of vasoconstrictors, especially during feverish episodes or in case of overdose. These symptoms have been reported in the pediatric population. It is therefore advisable to avoid the administration of Vicks Flu Action in conjunction with medicines that can lower the epilepsy threshold, such as terpenic derivatives, chlobulin, atropine-similar substances and local anesthetics, whether there is an amnesi of seizures; • Strictly comply with the recommended dosage in all cases and inform patients about the risk of overdose if Vicks Flu Action is taken in association with other medicines containing vasoconstrictors. Patients with uretro-prostatic disorders are more likely to develop symptoms such as dysuria and urinary retention (see paragraph 4.3) Older patients may be more sensitive to the effects on the central nervous system (SNC). Ischetical Colite Some cases of ischemic colitis have been reported with pseudoephedrine. If sudden abdominal pain develops, rectal bleeding or other symptoms of ischemic colitis, pseudoephedrine should be suspended and consult a doctor. Precautions of use related to pseudoephedrine hydrochloride : • In patients subjected to election surgery during which volatile halogenated anaesthetics should be used, it is preferable to suspend therapy with Vicks Flu Action several days before surgery due to the risk of acute hypertension (see paragraph 4.5). • Athletes should be informed that the treatment with pseudoephedrine hydrochloride can cause positive results to antidoping tests. Ischemic Optical Neuropatia Cases of ischemic optical neuropathy have been reported with the pseudoephedrine. The pseudoephedrine should be interrupted if sudden loss of sight or reduction of visual acuity should occur, for example in case of scotoma. Interference with serological tests Pseudoephedrine can potentially reduce iobenguan I-131 recaptation in neuroendocrine tumors, thus interfering with scintigraphy. Special warnings related to ibuprofen : In patients with bronchial asthma or allergies, ibuprofen can trigger bronchospasm. The product should not be administered in case of asthma without prior medical consultation (see paragraph 4.3). Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polypoxes are more at risk of allergic reactions with the intake of acetyllic acid and/or FANS. The administration of Vicks Flu Action can trigger an acute attack of asthma, especially in some allergic patients with acetylicylic acid or an NSAID (see paragraph 4.3). In dehydrated adolescents there is a risk of kidney failure. Gastrointestinal effects: With all NSAIDs, at any time during treatment, with or without warnings or previous anamnes of gastrointestinal events, cases of bleeding, ulcer or gastrointestinal perforation have been reported, which may be fatal. The risk of bleeding, ulcer or gastrointestinal perforation, which can be fatal, is greater than the increase of the doses of NSAIDs, in patients with ulcer anamnesi (in particular if complicated by hemorrhage or perforation - see paragraph 4.3) and in patients aged 60 years. These older patients must start treatment at the minimum dose available (see paragraph 4.2). For these patients and for those taking a concurrent treatment with low dose acetylsalicylic acid or other drugs that may increase the gastrointestinal risk, it should be evaluated the association therapy with gastroprotectors (e.g. misoprostol or protonic pump inhibitors) (see below and paragraphs 4.3 and 4.5). Patients with a history of gastrointestinal disorders, especially if elderly, may have unusual abdominal symptoms (especially gastrointestinal bleeding) in the early stages of treatment. The administration of NSAIDs must be carefully evaluated in patients with clotting disorders, since a reduction in coagulative capacity is possible. Particular caution is recommended in patients in concomitant therapy. Some drugs may increase the risk of ulcer or bleeding such as oral corticosteroids, anticoagulants such as warfarin, SSRIs or antiplastrine such as acetyllic acid (see paragraphs 4.3 and 4.5). Treatment with Vicks Flu Action must be immediately suspended if bleeding or gastrointestinal ulcer occur. NSAIDs should be given carefully to patients with amnesia of gastrointestinal diseases ( ulcerative colitis, Crohn's disease) as these conditions may worsen (see paragraph 4.8). Concurrent use of alcohol and NSAIDs can increase unwanted effects related to the active ingredient, particularly those related to the gastrointestinal tract or central nervous system. Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a small increase in the risk of arterial thrombotic events (such as myocardial infarction or stroke). In general, epidemiological studies do not suggest that low-dose ibuprofen (e.g., ≤1200 mg/die) is associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), proven ischemic cardiopathy, peripheral arteriopathy and/or cerebrovascular disease should be treated with ibuprofen, after careful examination and at high doses (2400 mg/die) should be avoided. Precautions for use on ibuprofene • Senior Patients: The pharmacokinetics of ibuprofen is not modified by age, therefore in the elderly there is no need to adjust the dosage. However, elderly patients must be kept under strict medical control as they are more sensitive to unwanted effects from NSAIDs, and in particular to gastrointestinal bleeding and perforation, which can be fatal. • Particular caution and medical control is required during the administration of ibuprofen to patients with gastrointestinal pathologies. The use of Vicks Flu Action is contraindicated in some gastrointestinal diseases (see paragraph 4.3). • During the initial stages of treatment, careful monitoring of urinary excretion and kidney function is required in patients with heart failure, chronic impairment of kidney or liver function, in patients with diuretics, in hypovolemic ones due to important surgery and, in particular, in elderly patients. The kidney function of these patients can be adversely affected by treatment with NSAIDs. • In case of presentation of visual disturbances during treatment, the patient will need to be subjected to a complete ophthalmological examination. If symptoms persist or worsen, the patient should consult the doctor. Vicks Flu Action contains 1,65 mg sodium per tablet.

Interactions

Association of pseudophedrine with:	Possible reactions
Non-selective inhibitors of monoaminoxydase (IMAO)	Vicks Flu Action should not be taken by patients in current or past therapy (last two weeks) with monoaminoxydase inhibitors (IMAO), as there is the risk of hypertensive episodes such as paroxysmal hypertension and hyperthermia, which can be fatal (see paragraph 4.3).
Other sympathomimetic or vasoconstrictors with indirect action, administered by mouth or nasal, α-simpaticomimetic drugs, phenylpropanolamin, phenylphrine, ephedrine, methylfenidate	The pseudoephedrine can enhance the effect of other sympathomimetics (vasoconstrictors) and cause a risk of vasoconstriction and/or hypertensive crisis.
Reversible inhibitors of monoaminoxydase A (RIMA), Linezolid, alkaloids of hergot with dopaminergic action, alkaloid vasoconstrictors of hergot	Vasket risk and/or hypertensive crisis.
Halogenated volatile anesthetics	Acute perioperative hypertension. In planned surgery, suspend treatment with Vicks Flu Action several days before surgery.
Guanetidine, reserpine and methyldopa	The effect of pseudophedrine could be reduced.
Antidepressants	The effect of the pseudophedrine could be reduced or increased.
Digitalis, quinidine or tricyclic antidepressants	Increased frequency of arrhythmia.
Terpenic derivatives, clobutinol, atropino-similar substances and local anesthetics	Reduction of the epilepsy threshold
Other NSAIDs, salicylates, analgesics, antipyretics and COX inhibitors 2	Concurrent administration of various NSAIDs, analgesics, antipyretics and selective COX 2 inhibitors can 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 must therefore be avoided (see paragraph 4.3 and 4.4).
Heart glycosides (such as digoxin)	Concurrent use with digoxin-based preparations can increase the serum levels of cardiac glycosides (digoxin). With the correct use (maximum 5 days), it is usually not necessary to control the serum levels of digoxin.
Courtesy	Corticosteroids may increase the risk of adverse reactions, particularly gastrointestinal tract (ulcer or gastrointestinal bleeding) (see paragraph 4.3).
Antiplatelet	Increase in the risk of gastrointestinal bleeding (see paragraph 4.3).
Acetylsalicylic acid (low dosage)	Concurrent administration of acetylsalicylic acid must be avoided (see paragraph 4.3). Concurrent administration of ibuprofen and acetylsalicylic acid (aspirin) is not generally recommended due to the potential increase in adverse effects. Experimental data indicate that ibuprofen can competitively inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation when administered simultaneously. Although there are uncertainties regarding the extrapolation of these data from the clinical situation, the possibility that the regular and long-term use of ibuprofen may reduce the cardioprotective effect of low doses of acetylsalicylic acid. It is believed that no clinically relevant effect is likely to be found for occasional use of ibuprofen (see paragraph 5.1).
Anticoagulanti (e.g.: warfarin, ticlopidine, clopidogrel, thyrofiban, eptifibatide, abciximab, iloprost)	Increase in the risk of gastrointestinal bleeding, because NSAIDs such as ibuprofen can increase the effect of anticoagulants (see paragraph 4.3 and 4.4)
Fenitoin	The concomitant use of Vicks Flu Action and preparations based on phenytoin could increase the serum levels of these medicinal products. With the correct use (maximum 5 days), it is usually not necessary to control the serum levels of phenytoin.
Selective serotonin reuptake inhibitors (SSRI)	Increase in the risk of gastrointestinal bleeding (see paragraph 4.3).
Litio	Concurrent use of Vicks Flu Action and lithium-based preparations can increase the serum levels of these medicinal products (see paragraph 4.3)
Probenecid and the Finpirazone	Medicinal products containing probenecid or sulfinpirazone may delay the excretion of ibuprofene.
Diuretics, ACE inhibitors, beta blockers and antagonists of angiotensin-II	NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated or elderly patients with impaired kidney function) the concomitant administration of an inhibitor ACE, a betabloccant or angiotensin angiotensin- II and drugs that inhibit cycle-oxygenase can cause further deterioration of kidney function, including possible acute kidney failure, usually reversible. Therefore, the administration of these drugs in association must be carried out with caution, especially in elderly patients. Patients should be properly hydrated and renal function monitoring should be taken into consideration after the start of treatment and subsequently on a periodic basis.
Diuretic potassium savers	Concurrent administration of Vicks Flu Action and potassium-saving diuretics can cause hyperkaliemia (it is recommended to control potassium serum levels).
Methodology	The administration of Vicks Flu Action within 24 hours before or after the administration of metotrexate can cause high metotrexate concentrations and an increase in its toxic effects (see paragraph 4.3).
Ciclosporin	The risk of a harmful effect for kidneys due to cyclosporin increases with the concomitant administration of some non-steroidal anti-inflammatory drugs. This effect cannot be excluded even for the association between cyclosporin and ibuprofene.
Tacrolimo	The risk of nephrotoxicity increases if the two medicinal products are administered in association.
Zidovudina	Cases of an increase in the risk of hematoma and hematoma in HIV hemophiliac patients (+) in concomitant therapy with zidovudine and ibuprofen have been reported.
Sulfaniluree	Clinical studies have shown interactions between non-steroidal and anti-diabetic anti-inflammatory drugs (sulfaniluree). Although interactions between sulfaniluree and ibuprofen have not been described, as precaution during concurrent intake, it is recommended to check blood glucose values.
Chinolonic Antibiotics	Animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients in therapy with NSAIDs and Chinolones may have an increase in the risk of developing seizures.
Eparine; Gingko biloba	Increase in the risk of bleeding (see paragraph 4.3).

Effects

The most commonly observed adverse events related to ibuprofen are gastrointestinal. In general, the risk of presenting adverse events (especially the risk of presenting gastrointestinal complications) increases with increased dose and duration of treatment. Following treatment with ibuprofen, cases of hypersensitivity reactions were reported. These can consist of: (a) Specific allergic reactions and anaphylaxis; (b) Reactivity of the respiratory tract, including asthma, worsening of asthma, bronchospasm or dispnea; (c) Skin disorders of various kinds, including skin rash of various types, itching, hives, porpora, angioedema and, more rarely, exfoliative dermatitis and bollous dermatitis (including epidermal necrolysis and multiform erythema). In patients with pre-existing autoimmune pathology (such as systemic lupus erythematosis, mixed connective tissue disease) during treatment with ibuprofen, individual cases of symptoms from aseptic meningitis were reported, such as nucal stiffness, headache, nausea, vomiting, fever or disorientation. In association with the treatment with NSAIDs were reported edema, hypertension and heart failure. Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg/die) and in long-term therapies, may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke), (see paragraph 4.4). The following list of adverse events is related to those presented with ibuprofen and pseudoephedrine hydrochloride at normal counter doses, for short-term use. In the treatment of chronic diseases and in long-term treatment, further adverse events may occur. Patients should be informed about the need to immediately stop taking Vicks Flu Action and consult the doctor if a serious adverse drug reaction occurs. The frequency of adverse reactions is defined by the following convention: Very common (≥1/10); common (from ≥1/100 to Infections and infestations Ibuprofen Very rare Exacerbation of infectious inflammation (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) Emolinfopoietic system pathologies Ibuprofen Very rare Hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis, neutropenia). Immune system pathologies Ibuprofen and pseudoephedrine hydrochloride Very rare Severe generalized reactions of hypersensitivity: signs can be facial edema, angioedema, dispnea, bronchospasm, tachycardia, sudden decrease in blood pressure, anaphylactic shock Psychological pathologies Ibuprofen Very rare Psychic reactions, depression Pseudoefedrine Hydrochloride Frequency not known Hallucinations, abnormalities of behavior Diseases of the nervous system Ibuprofen Not common Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue Pseudoefedrine Hydrochloride Rare Insomnia, nervousness, anxiety, agitation, restlessness, tremors Frequency not known Hemorrhagic stroke, ischemic stroke, seizures, headache Pathologies of the eye Ibuprofen Not common Visual disturbances Pseudoefedrine Hydrochloride Note Ischemic Optical Neuropatia Ear and labyrinth pathologies Ibuprofen Rare Tinnitus Heart disease Ibuprofen Rare Edema, hypertension, palpitations, heart failure, myocardial infarction Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/die), may be associated with a small increase in the risk of arterial thrombotic events (such as myocardial infarction or stroke) (see paragraph 4.4). Pseudoefedrine Hydrochloride Rare Palpitations, tachycardia, chest pain, arrhythmia Vascular diseases Ibuprofen Rare Arterial hypertension Pseudoefedrine Hydrochloride Frequency not known Hypertension Respiratory, chest and mediastinic pathologies Pseudoefedrine Hydrochloride Rare Riacutization of asthma or hypersensitivity reactions with bronchospasm Gastrointestinal diseases Ibuprofen Not common Gastrointestinal discomfort, dyspepsia, nausea, vomiting, diarrhea, anorexia Rare Abdominal pain, flatulence, stipsi 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 Pseudoefedrine Hydrochloride Not common Dry mouth, thirst, nausea, vomiting Pseudoephedrine hydrochloride Frequency not known Ischetical Colite Hepatobiliary pathologies Ibuprofen Very rare Liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis Pathologies of skin and subcutaneous tissue Ibuprofen Rare Various rashes Ibuprofen Very rare Severe forms of skin reactions such as exfoliative dermatitis or bollous exantema such as Stevens-Johnson syndrome, multiform erythema and toxic epidermal necrolysis ( Lyell syndrome), alopecia, severe skin infections, soft tissue complications in a chickenpox infection Ibuprofen Notable Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome) Pseudoefedrine Hydrochloride Rare Rash, urticaria, pruritus, erythema, hyperhidrosis Ibuprofen Notable Severe skin reactions, including generalized acute exantelosis (PEAG) Pseudoefedrine Hydrochloride Ibuprofen Note Photosensitivity reaction Kidney and urinary disorders Ibuprofen Rare Damage to renal tissue (paint necrosis) and high blood concentrations of uric acids Ibuprofen Very rare Increased serum creatinine, edema (especially in patients with arterial hypertension or kidney failure) edema, nephrosic syndrome, interstitial nephritis, acute kidney failure Pseudoefedrine Hydrochloride Frequency not known Urinary retention in men with prostate hypertrophy Reporting of suspected adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Synonyms The most frequent manifestations of overdose from ibuprofen are abdominal pain, nausea, vomiting, lethargy, thirst, muscle weakness, numbness, sight blur and dizziness. Other side effects, including cephalea, tinnitus, SNC depression, convulsions, hypotension, bradycardia, tachycardia, supraventricular arrhythmia, and ventricular fibrillation may occur. Rarely they were reported coma, acute kidney failure, hyperkaliemia, apnea (especially in small children), respiratory depression and respiratory failure. Asthmatics make it possible to worsen asthma. In case of severe poisoning, it is possible that metabolic acidosis occurs. Signs and symptoms of overdose from pseudoephedrine include irritability, insomnia, fever, sweating, anxiety, restlessness, tremors, convulsions, palpitations (synus arrhythmia), hypertension, dry mouth and difficulty urinating. Hallucinations were reported (more likely in children). Treatment The treatment of overdose is supportive. Within 1 hour of ingestion of a potentially toxic quantity, it can benefit from gastric lavender and activated carbon and, if necessary, correction of serum electrolytes. Symptomatic and supportive treatment should be undertaken, particularly with regard to cardiovascular and respiratory systems. For example, severe hypertension may have to be treated with an alpha-blocking drug, while to control cardiac arrhythmias it may be necessary to use a betabloccant. Convulsions can be controlled by intravenous diazepam, while for extreme excitability and hallucinations the chlorromazine can be used.

Pregnancy

: Vicks Flu Action is contraindicated in pregnancy (see paragraph 4.3). Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Data from epidemiological studies suggest an increase in the risk of miscarriage, heart malformation and gastroschisis following the use of an inhibitor of prostaglandin synthesis during the first months of pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals it has been shown that the administration of an inhibitor of the synthesis of prostaglandine causes an increase in the rate of miscarriage pre- and post-system and embryo-fetal lethal. In addition, increased incidences of various malformations were reported, including cardiovascular ones, in animals to which during the organogenic period an inhibitor of prostaglandin synthesis was given. During the third trimester of pregnancy all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress to kidney failure with oligoidramnios; They can expose mother and newborn, at the end of pregnancy, to:- possible prolongation of bleeding time, an anti-aggregating effect that may occur even at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. There is the possibility of an association between the appearance of fetal abnormalities and the taking of pseudoephedrine during the first trimester of pregnancy.

Breastfeeding

Vicks Flu Action is contraindicated during breastfeeding (see paragraph 4.3). Ibuprofen/pseudoefedrine have been identified in infants/children breast-feeding treated patients. The data on the effects of ibuprofen/pseudoephedrine on infants/children are limited.

Fertility

The effects of this drug on fertility have not been studied. The use of ibuprofen can compromise fertility and is not recommended in women who are trying to conceive. Women with difficulty in conceiving or subject to fertility analysis should consider the suspension of ibuprofen. There are no adequate studies of reproductive toxicology on pseudoephedrine.

Source: Farmadati