NUROFEN INFLUENZA COOLING * 12CPR

  • Reckitt Benckiser Healthcare (Italia)
  • 034246013

Nurofen flu and cold what is it for?

Therapeutic properties

NUROFEN INFLUENZA AND COLD 200 mg + 30 mg Coated Tablets, is indicated in adults and adolescents over 12 years. Treatment of cold and flu symptoms such as nasal and sinus congestion, pain, fever, sore throat, headache.

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NUROFEN INFLUENZA COOLING * 12CPR

Therapeutic indications

NUROFEN INFLUENZA AND COLD 200 mg + 30 mg Coated Tablets, is indicated in adults and adolescents over 12 years. Treatment of cold and flu symptoms such as nasal and sinus congestion, pain, fever, sore throat, headache.

Dosage and method of use

Dosage.Only for a short period of treatment. • 5 days maximum of therapy for the adult population; • 3 days maximum of therapy for the pediatric population (12-18 years). Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4). If the use of the medicine is necessary for more than 5 days in adults and for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted.Pediatric population:Do not give to children under the age of 12.Adults and adolescents over 12 years:The starting dose is 1-2 tablets a day, then 1-2 tablets every 4 hours if necessary. Do not exceed the dose of 6 tablets in 24 hours.Elderly people:In the elderly, no modification of the recommended posology is required except in patients with renal or hepatic disorders for which it is necessary to individually adjust the posology.Method of administration:Oral use.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with peptic ulcer. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Subjects who have previously shown hypersensitivity reactions (such as nasal polyposis, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, other non-steroidal anti-inflammatory drugs (NSAIDs). Severe renal or hepatic insufficiency. Severe heart failure (NYHA class IV) Patients with serious cardiovascular disease, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostatic syndrome. Pregnancy. Breastfeeding (see section 4.6). Children under 12 years old. Patients taking or have taken within the previous 14 days monoamine oxidase inhibitors (MAOIs) (see section 4.5).

Side effects

The list of the following undesirable effects includes those which have been observed during treatment with ibuprofen at self-medication dosages (up to a maximum of 1200mg per day) and with sympathomimetics including pseudoephedrine for short periods of administration. Undesirable effects associated with the administration of ibuprofen and sympathomimetics such as pseudoephedrine are listed below by system organ class and frequency.For the frequency of occurrence of undesirable effects, the following expressions are used:Very common (1/10); Common (1/100,Uncommon (1/1000,Rare (1 / 10,000,Very rare (Within each frequency class, undesirable effects are presented in descending order of severity. Table of undesirable effects.

System and organ classification Frequency Adverse Reaction
Disorders of the blood and lymphatic system Uncommon Hypersensitivity reactions characterized by hives and itching²
Very rare Hematopoietic disorders¹. Severe hypersensitivity reactions. Symptoms can be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
Psychiatric disorders You don't notice Insomnia, anxiety, restlessness, agitation, hallucinations.
Nervous system disorders Uncommon Headache, tremors
Very rare Aseptic meningitis³
Cardiac pathologies Not known Heart failure and edema4, tachycardia, chest pain, arrhythmia, palpitations.
Vascular pathologies Not known Hypertension4
Respiratory, thoracic and mediastinal disorders Not known Respiratory system reactivity including asthma, bronchospasm or dyspnoea²
Gastrointestinal disorders Uncommon Abdominal pain, nausea and dyspepsia5
Rare Diarrhea, flatulence, constipation and vomiting
Very rare Peptic ulcer, gastrointestinal perforation or haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly (see section 4.4). Ulcerative stomatitis, mouth ulcerations, gastritis.
Not known Dry mouth Exacerbation of colitis and Crohn's disease (see section 4.4).
Hepatobiliary disorders Very rare Liver disorders
Skin and subcutaneous tissue disorders Not known Hyperhidrosis
Uncommon Skin rashes ²
Very rare Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur.
Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Not known Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)
Musculoskeletal and connective tissue disorders Not known Muscle weakness
Renal and urinary disorders Very rare Severe renal insufficiency6
Not known Urinary retention
Systemic disorders and administration site conditions Not known Irritability, thirst
Diagnostic tests Very rare Decrease in the level of hemoglobin in the blood

Description of some side effects

. 1) Examples of haematopoietic disorders include anemia, leukopenia, thrombocytopenia, pancytopenia and agranulocytosis. The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe tiredness, unexplained bleeding and bruising. 2) Hypersensitivity reactions: These reactions include a) non-specific allergic reactions and anaphylaxis, b) reactivity of the respiratory tract including asthma, worsening of asthma, bronchospasm or dyspnoea or c) various skin conditions such as various skin rashes, itching, hives, purpura, angioedema and very rarely bullous and exfoliative dermatitis including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, d) cross reactivity reactions with pseudoephedrine 3) The pathogenesis of drug-induced aseptic meningitis is not fully understood. However, the available data on aseptic meningitis related to the administration of NSAIDs suggest an immune hypersensitivity reaction (due to a temporary relationship with taking the drug and the disappearance of symptoms after discontinuation of treatment). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever and disorientation) have been observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) . 4) Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4) 5 ) Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). 6) Especially during long treatments, associated with an increase in serum urea and edema. It also includes papillary necrosis. Gastrointestinal intolerance, bleeding, sweating, dizziness, precordial pain, difficulty urinating and insomnia may occur. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Gli effetti indesiderati possono essere minimizzati con l’uso della più bassa dose efficace per la più breve durata possibile di trattamento che occorre per controllare i sintomi (vedere paragrafo 4.2 e i paragrafi sottostanti sui Rischi gastrointestinali e cardiovascolari). Altri FANS: l’uso di NUROFEN INFLUENZA E RAFFREDDORE deve essere evitato in concomitanza di FANS, inclusi gli inibitori selettivi della COX-2. Evitare l’uso contemporaneo di due o più analgesici, antipiretici, antinfiammatori non-steroidei, in quanto ciò comporta un aumento del rischio di effetti indesiderati. L’impiego di FANS deve essere attentamente valutato nei pazienti affetti da disturbi della coagulazione in quanto è possibile una riduzione della coagulabilità. Lo stesso dicasi per i pazienti in trattamento con anticoagulanti orali, per la possibilità di un potenziamento dell’effetto anticoagulante (vedere anche paragrafo 4.5). Sicurezza gastrointestinale: come per tutti gli antinfiammatori, il farmaco non va assunto se il paziente è affetto da ulcera o disturbi gastrici. Emorragia gastrointestinale, ulcerazione e perforazione: durante il trattamento con tutti i FANS, in qualsiasi momento, con o senza sintomi di preavviso o precedente storia di gravi eventi gastrointestinali, sono state riportate emorragia gastrointestinale, ulcerazione e perforazione, che possono essere fatali. Negli anziani e in pazienti con storia di ulcera, soprattutto se complicata da emorragia o perforazione (vedere paragrafo 4.3), il rischio di emorragia gastrointestinale, ulcerazione o perforazione è più alto con dosi aumentate di FANS. Questi pazienti devono iniziare il trattamento con la più bassa dose disponibile. L’uso concomitante di agenti protettori (misoprostolo o inibitori di pompa protonica) deve essere considerato per questi pazienti e anche per pazienti che assumono basse dosi di acido acetilsalicilico o altri farmaci che possono aumentare il rischio di eventi gastrointestinali (vedere sotto paragrafo 4.5). Pazienti con una storia di tossicità gastrointestinale, in particolare anziani, devono riferire qualsiasi sintomo gastrointestinale inusuale (soprattutto emorragia gastrointestinale) in particolare nelle fasi iniziali del trattamento. Cautela deve essere prestata ai pazienti che assumono farmaci concomitanti che potrebbero aumentare il rischio di ulcerazione o emorragia, come corticosteroidi orali, anticoagulanti come warfarin, inibitori selettivi del reuptake della serotonina o agenti antiaggreganti come l’ acido acetilsalicilico (vedere paragrafo 4.5). Quando si verifica emorragia o ulcerazione gastrointestinale in pazienti che assumono NUROFEN INFLUENZA E RAFFREDDORE il trattamento deve essere sospeso. I FANS devono essere somministrati con cautela nei pazienti con una storia di malattia gastrointestinale (colite ulcerosa, morbo di Crohn) poiché tali condizioni possono essere esacerbate (vedere paragrafo 4.8). Effetti cardiovascolari e cerebrovascolari: cautela è richiesta (discutere con il proprio medico o farmacista) prima di iniziare il trattamento nei pazienti con anamnesi positiva per ipertensione e/o insufficienza cardiaca poiché in associazione al trattamento con i FANS sono stati riscontrati ritenzione di liquidi, ipertensione ed edema. Studi clinici suggeriscono che l’uso di ibuprofene, specialmente ad alte dosi (2400 mg/die), può essere associato a un modesto aumento del rischio di eventi trombotici arteriosi (es. infarto del miocardio o ictus). In generale, studi epidemiologici non suggeriscono che basse dosi di ibuprofene (es. ≤ 1200 mg/die) siano associate ad un aumento del rischio di eventi trombotici arteriosi. I pazienti con ipertensione non controllata, insufficienza cardiaca congestizia (II-III classe NYHA), cardiopatia ischemica accertata, malattia arteriosa periferica e/o malattia cerebrovascolare devono essere trattati con ibuprofene soltanto dopo attenta considerazione e si devono evitare dosi elevate (2400 mg/die). Attenta considerazione deve essere esercitata anche prima di iniziare il trattamento a lungo termine per i pazienti con fattori di rischio per eventi cardiovascolari (es. ipertensione, iperlipidemia, diabete mellito, abitudine al fumo di sigaretta), soprattutto se sono necessarie dosi elevate (2400 mg/die) di ibuprofene. Reazioni cutanee: gravi reazioni cutanee alcune delle quali fatali, includenti dermatite esfoliativa, sindrome di Stevens-Johnson e Necrolisi Tossica Epidermica, sono state riportate molto raramente in associazione con l’uso dei FANS (vedere paragrafo 4.8). Nelle prime fasi della terapia i pazienti sembrano essere a più alto rischio: l’insorgenza della reazione si verifica nella maggior parte dei casi nelle prime fasi del trattamento. NUROFEN INFLUENZA E RAFFREDDORE deve essere interrotto alla prima comparsa di rash cutaneo, lesioni della mucosa o qualsiasi altro segno di ipersensibilità. Gravi reazioni cutanee Reazioni cutanee gravi come la pustolosi esantematica acuta e generalizzata (AGEP) possono verificarsi con prodotti contenenti pseudoefedrina. Questa eruzione pustolosa acuta può verificarsi entro i primi 2 giorni di trattamento, con febbre e numerose, piccole pustole, per lo più non follicolari, derivanti da un eritema edematoso molto diffuso e localizzate principalmente sulle pieghe cutanee, sul tronco e sugli arti superiori. I pazienti devono essere attentamente monitorati. Se si osservano segni e sintomi come piressia, eritema o numerose piccole pustole, la somministrazione di Nurofen Influenza e Raffreddore deve essere interrotta e se necessario devono essere prese misure appropriate. Patologie respiratorie: in pazienti con asma bronchiale o malattie allergiche in atto o pregresse può insorgere broncospasmo. Non assumere il prodotto nei casi di asma e allergia all' acido acetilsalicilico se non dopo aver consultato il medico (vedere paragrafo 4.3). LES e malattia mista del connettivo: in caso di lupus eritematoso sistemico e di malattia mista del connettivo può portare ad un aumentato rischio di meningite asettica (vedere paragrafo 4.8). Funzionalità renale: insufficienza renale, in quanto la funzionalità renale può essere compromessa (vedere paragrafi 4.3 e 4.8). Funzionalità epatica: disfunzioni epatiche (vedere paragrafi 4.3 e 4.8). Fertilità femminile compromessa: vedere paragrafo 4.6 riguardante la fertilità femminile. Da usare con cautela in combinazione con antiipertensivi inclusi i bloccanti neuronali adrenergici e i beta bloccanti (vedere paragrafo 4.5). Da usare con cautela con altri agenti simpaticomimetici come decongestionanti, soppressori dell'appetito e psico-stimolanti anfetaminici (vedere paragrafo 4.5). Da usare con cautela in caso di ipereccitazione. Se si manifestano allucinazioni; irrequietezza o disturbi del sonno durante la somministrazione del medicinale, l’utilizzo del medicinale deve essere interrotto. Anziani: i pazienti anziani presentano una maggiore frequenza di reazioni avverse ai FANS, in particolare emorragia e perforazione gastrointestinale che possono essere fatali (vedere paragrafo 4.2). Popolazione pediatrica: negli adolescenti disidratati esiste il rischio di alterazione della funzionalità renale. Questo medicinale contiene: • meno di 1 mmol (23 mg) di sodiumper tablet, ie essentially “sodium-free”; •sunset yellow color FCF (E 110), which can cause allergic reactions.

Pregnancy and breastfeeding

The product should not be used during pregnancy and lactation.Pregnancy:Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors 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 arterial duct and pulmonary hypertension); - renal dysfunction which can progress to renal failure with oligo-hydroamnios; The mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. There is a possibility of an association between the onset of fetal abnormalities and taking pseudoephedrine in the first trimester of pregnancy.Feeding time:Although ibuprofen is present in breast milk in very low concentrations, pseudoephedrine is secreted in milk in significant quantities; for this reason the product should not be used during breastfeeding.Fertility:As with other NSAIDs, the use of NUROFEN INFLUENZA E COLFFREDORE can alter female fertility by effecting ovulation. Therefore it is not recommended in women who wish to conceive.

Expiration and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4). Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). The product should not be taken by patients being treated with monoamine oxidase inhibitors and for 14 days following cessation of such treatment. The product may enhance the effect of other sympathomimetic agents, such as decongestants. The effect of pseudoephedrine could be reduced by guanethidine, reserpine and methyldopa and could be affected by tricyclic antidepressants. In turn, pseudoephedrine may reduce the effect of guanethidine and may increase the possibility of arrhythmias in digitized patients, or in patients taking anticholinergics (including tricyclic antidepressants) or quinidine. Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking NUROFEN FLU AND COLD concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased undesirable effects (see section 4.4). Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concurrently. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including selective cyclooxygenase-2 inhibitors: concomitant use of two or more NSAIDs should be avoided as it may increase the risk of adverse events (see section 4.4). Cardiac glucosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and plasma glucoside levels. Lithium. There is evidence of the possibility of a potential increase in blood lithium levels. Methotrexate. There is evidence of the possibility of increased plasma methotrexate levels. Ciclosporins: increase the risk of nephrotoxicity. Mifepristone: NSAIDs cannot be administered for 8-12 days following mifepristone administration as NSAIDs may reduce the effect of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. Zidovudine: increased risk of haematological toxicity when NSAIDs are used concomitantly with Zidovudine. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophilia patients when treated concomitantly with zidovudine and ibuprofen. Quinolone antibiotics: Data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Ergot alkaloids (ergotamine and methysergide): increased risk of ergotism. Appetite inhibitors (anorectics) and amphetamine-like psychostimulants: risk of hypertension. Oxytocin: risk of hypertension

Overdose

SymptomsNausea, vomiting, abdominal pain and more rarely diarrhea may occur. Tinnitus, headache and gastrointestinal bleeding can also occur. In more severe cases of poisoning, central nervous system toxicity is observed, manifesting as dizziness, somnolence, occasionally arousal and disorientation or coma. Occasionally, patients develop seizures. In cases of severe poisoning, metabolic acidosis and prolongation of prothrombin time / INR may occur, possibly caused by interference with the action of circulating coagulation factors. Acute renal failure, liver damage and respiratory depression may also occur. Exacerbation of asthma can occur in asthmatics. As with other sympathomimetics, an overdose of pseudoephedrine can cause symptoms related to central nervous system disorders and cardiovascular stimulation, including:irritability, restlessness, tremors, thirst, blurred vision, anxiety anxiety, insomnia, fever, sweat, exophthalmos, hallucinations, muscle weakness,palpitations, convulsions, urinary retention, hypertension, difficulty urinating, nausea, vomiting, tachycardia and cardiac arrhythmias.TreatmentTreatment should be symptomatic and supportive, particularly of the cardiovascular and respiratory systems, and should include maintaining a patent airway and monitoring cardiac function and vital signs until the patient is stabilized. Oral administration of activated charcoal should be considered if the patient presents within 1 hour of ingesting a potentially toxic amount. If necessary, corrective action of serum electrolytes should be used. Seizures should be treated with intravenous benzodiazepines if they are frequent or prolonged. Administer bronchodilators in case of asthma. Elimination of pseudoephedrine can be accelerated by acid diuresis or dialysis. Hypertensive phenomena can be treated with alpha IV receptor blocking drugs. Cardiac arrhythmias may require the use of beta-adrenergic blocking agents after administration of alpha-adrenergic blockers. Hyperexcitability and hallucinations can be treated with chlorpromazine.

Active principles

One tablet contains: Ibuprofen 200 mg, Pseudoephedrine hydrochloride 30 mg. Excipients with known effects: sodium, FCF sunset yellow dye (E 110). For the full list of excipients, see section 6.1.

Excipients

Tricalcium phosphate, sodium carboxymethylcellulose, microcrystalline cellulose, povidone, methylhydroxypropylcellulose, magnesium stearate, talc, dyes: E 104, E 110, E 171.

034246013

Data sheet

Packaging
200 mg + 30 mg 12 coated tablets
Product Type
HUMAN DRUG
ATC code
M01AE51
ATC description
Ibuprofen, associations
Ibuprofen - associations
Therapeutic Group
NSAID analgesics + decongestants
Active principle
ibuprofen + pseudoephedrine
Class
C.
Pharmaceutical form
coated tablets
Type of Administration
oral
Container
cpr / cps / pills / confetti in blister packs
Quantity
12 tablet
Quantity of the Active Ingredient
200MG (ibuprofen) + 30MG (pseudoephedrine hydrochloride)
Recipe required
OTC - self-medication medicine
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