Nurofen Flu and Cold 12 tablets

WARNINGS
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Other NSAIDs: Use of the medicinal product should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Avoid the simultaneous use of two or more analgesics, antipyretics, non-steroidal anti-inflammatory drugs, as this involves an increased risk of undesirable effects. The use of NSAIDs must be carefully evaluated in patients with coagulation disorders as a reduction in coagulability is possible. The same applies to patients being treated with oral anticoagulants, due to the possibility of an enhancement of the anticoagulant effect. Gastrointestinal safety: the drug should not be taken if the patient is suffering from ulcer or gastric disorders. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs in patients taking the drug discontinue treatment. Administer NSAIDs with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Cardiovascular and cerebrovascular effects: caution is required before starting treatment in patients with a history of hypertension and / or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. 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. In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. <= 1200 mg / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment for patients with risk factors for cardiovascular events, especially if high doses (2400 mg / day) of ibuprofen are required. Skin reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases in the early stages of treatment. Discontinue the drug at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Respiratory disorders: bronchospasm may arise in patients with bronchial asthma or current or previous allergic diseases. Do not take the product in cases of asthma and allergy to acetylsalicylic acid unless after consulting your doctor. SLE and mixed connective tissue disease: in the case of systemic lupus erythematosus and mixed connective tissue disease it can lead to an increased risk of aseptic meningitis. Renal function: renal failure, as renal function may be compromised. Hepatic function: hepatic dysfunction. To be used with caution in combination with antihypertensives including neuronal adrenergic blockers and beta blockers. To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine psycho-stimulants. To be used with caution in case of hyperexcitation. If hallucinations occur; restlessness or sleep disturbances during administration of the medicinal product, use of the medicinal product should be discontinued Elderly: Elderly patients have a higher frequency of adverse reactions to NSAIDs, in particular gastrointestinal bleeding and perforation which can be fatal. Pediatric population: in dehydrated adolescents there is a risk of alteration of renal function.
PHARMACOTHERAPEUTIC CATEGORY
Nasal decongestants for systemic use.
STORAGE
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the listed excipients; 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 diseases, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, pheochromocytoma, glaucoma, prostate syndrome; pregnancy; feeding time; Children under 12 years old; patients who are taking or have taken within the previous 14 days monoamine oxidase inhibitors (MAOIs).
NAME
NUROFEN INFLUENZA AND COOLING 200 MG + 30 MG COATED TABLETS
EXCIPIENTS
Tricalcium phosphate, sodium carboxymethylcellulose, microcrystalline cellulose, povidone, methylhydroxypropylcellulose, magnesium stearate, talc, dyes: E 104, E 110, E 171.
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. 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, <1/10); uncommon (> = 1/1000, <1/100); rare (> = 1 / 10,000, <1/1000); very rare (<1 / 10,000), not known. Disorders of the blood and lymphatic system. Uncommon: hypersensitivity reactions' characterized by urticaria and pruritus; very rare: haematopoietic disorders; severe hypersensitivity reactions. Symptoms can be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Psychiatric disorders. Not known: insomnia, anxiety, restlessness, agitation, hallucinations. Nervous system disorders. Uncommon: headache, tremors; very rare: aseptic meningitis. Cardiac pathologies. Not known: heart failure and edema, tachycardia, chest pain, arrhythmia, palpitations. Vascular pathologies. Not known: hypertension. Respiratory, thoracic and mediastinal disorders. Not known: respiratory system reactivity including asthma, bronchospasm or dyspnoea. Gastrointestinal disorders. Uncommon: abdominal pain, nausea and dyspepsia; rare: diarrhea, flatulence, constipation and vomiting; very rare: peptic ulcer, gastrointestinal perforation or haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly; ulcerative stomatitis, mouth ulcerations, gastritis; not known: dry mouth; exacerbation of colitis of crohn's disease. Hepatobiliary disorders. Very Rare: hepatic disorders. Skin and subcutaneous tissue disorders. Not known: hyperhidrosis; uncommon: skin rash; very rare: Bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis may occur. Musculoskeletal and connective tissue disorders. Not known: muscle weakness. Renal and urinary disorders. Very rare: severe renal failure; not known: urinary retention. General disorders and administration site conditions. Not known: irritability, thirst. Diagnostic tests. Very rare: decrease in the level of hemoglobin in the blood. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
The product should not be used during pregnancy and lactation. Inhibition of prostaglandin synthesis can negatively 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 risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered 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 may 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 that 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 the intake of pseudoephedrine in the first trimester of pregnancy. 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. The use of the drug can alter female fertility by effect on ovulation. Therefore it is not recommended in women who wish to conceive.
INDICATIONS
The medicine 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.
INTERACTIONS
Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. The product should not be taken by patients being treated with monoamine oxidase inhibitors and for 14 days following the cessation of such treatment. The product can 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 influenced by tricyclic antidepressants. In turn, pseudoephedrin can reduce the effect of guanethidine and can 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 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 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 the drug 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: co-administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. 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 the 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 effect is considered likely following occasional use of ibuprofen 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 . 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 an increase in plasma levels of methotrexate.Ciclosporins: increase the risk of nephrotoxicity. Mifepristone: NSAIDs cannot be administered for 8-12 days following the administration of mifepristone as NSAIDs may reduce the effect of mifepristone. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudine: increased risk of haematological toxicity when NSAIDs are used concomitantly with Zidovudine. There are demonstrations of an increased risk of haemarthrosis and hematoma in HIV-positive haemophilic 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.
DOSAGE
Only for a short period of treatment: maximum 5 days 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. In case the use of the medicine is necessary for more 'than 5 days in adults and for more' 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Pediatric population: do not administer to children under the age of 12 years. Adults and adolescents over 12 years: the initial dose is 1-2 tablets per day, then, if necessary, 1-2 tablets every 4 hours. Do not exceed the dose of 6 tablets in 24 hours. Elderly: in the elderly no modifications of the recommended dosage are required except in patients with renal or hepatic alterations for which it is necessary to individually adjust the dosage. Method of administration: oral use.
ACTIVE PRINCIPLES
Ibuprofen 200 mg, pseudoephedrine hydrochloride 30 mg.