NUROFEN INFLUENCE RAFFR 24CPR

NUROFEN INFLUENCE AND FURNITURE 200 MG + 30 MG

active ingredients

One tablet contains: Ibuprofen 200 mg, Pseudoefedrine Hydrochloride 30 mg. Excipients with known effects: sodium, yellow coloring FCF (E 110). For the full list of excipients, see paragraph 6.1.

Excellent

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

Therapeutic indications

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

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Patients with peptic ulcer. History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage / recurrent peptic ulcer (two or more distinct episodes of proven ulceration or bleeding). Subjects that have previously shown hypersensitivity reactions (such as nasal polypoxes, asthma, rhinitis, angioedema or urticaria) resulting from the use of ibuprofen, acetylsalicylic acid or other analgesics, antipyretics, other non-steroidal anti-inflammatory drugs (FANS). Severe kidney or liver failure. Severe heart failure (IV class NYHA) Patients with cardiovascular disease series, tachycardia, hypertension, angina pectoris, hyperthyroidism, diabetes, feocromocytoma, glaucoma, prostate syndrome. Pregnancy. Nursing (see paragraph 4.6). Children under 12. Patients who hire or hire in the previous 14 days monoamino-oxidase inhibitors (IMAO) (see paragraph 4.5).

Population

Posology. Only for a short period of treatment. • 5 days maximum therapy for adult population; • 3 days maximum therapy for the pediatric population (12-18 years). Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.4). In case the use of the medicine is necessary for more than 5 days in adults and for more than 3 days in adolescents, or in case of worsening of symptomatology should be consulted by the doctor. Pediatric population: Do not administer children under the age of 12.Adults and teenagers over 12 years: The initial dose is 1-2 tablets daily, then, if necessary, 1-2 tablets every 4 hours. Do not exceed the dose of 6 tablets in 24 hours. Seniors: In the elderly, no modifications of the recommended dosage are required except in patients with kidney or liver alterations for which it is necessary to individually adapt posology. Method of administration: Oral use.

Conservation

This medicine does not require any special condition for conservation.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and the paragraphs below on gastrointestinal and cardiovascular risk). Other NSAIDs: the use of NUROFEN INFLUENCE AND RAFFREDDORE must be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. Avoid the contemporary use of two or more analgesic, antipyretic, non-steroid anti-inflammatory drugs, as this leads to an increase in the risk of unwanted effects. The use of NSAIDs must be carefully evaluated in patients with clotting disorders as it is possible to reduce coagulability. The same applies to patients in treatment with oral anticoagulants, for the possibility of strengthening the anticoagulant effect (see also paragraph 4.5). Gastrointestinal safety: as for all anti-inflammatory drugs, the drug should not be taken if the patient is suffering from ulcers or gastric disorders. Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of acetyllic acid or other drugs that may increase the risk of gastrointestinal events (see subparagraph 4.5). Patients with a history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking concomitant medications that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as acetilsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking NUROFEN INFLUENCE AND FURNITURE The treatment must be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Cardiovascular and cerebrovascular effects: caution is required (discussed with your physician or pharmacist) before starting treatment in patients with positive anamnesis for hypertension and/or heart failure since in association with the treatment with NSAIDs, fluid retention, hypertension and edema were found. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with an increase in the risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. Skin reactions: severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and Epidermal Toxic Necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases in the early stages of treatment. NUROFEN INFLUENCE AND RAFFREDDORE must be interrupted by the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Severe skin reactions Severe skin reactions such as acute and generalized exantematic pustolosis (AGEP) can occur with products containing pseudophedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from 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 Nurofen Influenza and Raffreddore must be interrupted and appropriate measures must be taken if necessary. Respiratory pathologies: in patients with bronchial asthma or allergic diseases in place or pregress may arise bronchospasm. Do not take the product in cases of asthma and allergy to acetylsalicylic acid if not after consulting the doctor (see paragraph 4.3). LES and mixed connective disease: in case of systemic erythematous lupus and mixed connective disease may lead to an increased risk of aseptic meningitis (see paragraph 4.8). Renal functionality: kidney failure, as kidney function can be compromised (see paragraphs 4.3 and 4.8). Hepatic functionality: liver dysfunction (see paragraphs 4.3 and 4.8). Promoted female fertility: see paragraph 4.6. To be used with caution in combination with antihypertensives including adrenergic neuronal blockers and beta blockers (see paragraph 4.5). To be used with caution with other sympathomimetic agents such as decongestants, appetite suppressants and psycho-stimulants amphetamines (see paragraph 4.5). To be used with caution in case of hyperexcitation. If hallucinations occur; restlessness or sleep disorders during the administration of the medicinal product, the use of the medicinal product must be stopped. Senior patients have a higher frequency of adverse reactions to NSAIDs, especially hemorrhage and gastrointestinal perforation that can be fatal (see paragraph 4.2). Pediatric population: in dehydrated adolescents there is a risk of alteration of kidney function. This medicine contains: • less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “without sodium”; • yellow coloring FCF sunset (E 110), which can cause allergic reactions.

Interactions

Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). The product should not be taken by patients in treatment with monoaminoxydase inhibitors and for 14 days after 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 guanetidine, reserpine and methyldopa, and could be influenced by tricyclic antidepressants. In turn pseudoephedrine can reduce the effect of guanetidine and may increase the possibility of arrhythmias in digitized patients, or in patients taking anticholinergics (including antidepressants triciclici) or chinidine. Diuretics, ACE inhibitors and Angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system can lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking NUROFEN INFLUENCE AND FURNITURE in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. Acetylsalicylic acid: the concomitant administration of ibuprofen and acetylylethyl acid is not generally recommended due to the potential increase in unwanted effects (see paragraph 4.4). Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be ruled out the possibility that regular long-term use of ibuprofen can reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). Other NSAIDs included selective cyclooxygenase-2 inhibitors: the concomitant use of two or more NSAIDs must be avoided as it could increase the risk of adverse events (see paragraph 4.4). Heart glucosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration speed) and plasma glucoside levels. Litio. There are demonstrations of the possibility of a potential increase in lithium levels in the blood. Metotrexato. There are demonstrations of the possibility of an increase in plasma levels of metotrexate. Ciclosporins: increase the risk of nephrotoxicity. Mifepristone: NSAIDs cannot be administered for the 8-12 days following mifepristone administration as NSAIDs can reduce the effect of mifepristone. Tacrolimus: possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus. Zidovudine: increased risk of hematological toxicity when NSAIDs are used in conjunction with Zidovudine. There are evidence of increased risk of hematoma and hematoma in HIV seropositive hemophilic patients if treated simultaneously with zidovudine and ibuprofen. Chinolonic antibiotics: data from animal studies indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones may have an increased risk of developing seizures. Alkaloids of the horned rye (ergotamine and methylrgid): increased risk of ergotism. Appetite inhibitors (anoressizers) and psychostimulating amphetamines: risk of hypertension. Oxytocin: risk of hypertension

Effects

The list of the following side effects includes those that were observed during treatment with ibuprofens to self-medication doses (up to a maximum of 1200mg per day) and with sympathomimetics including pseudo-ephedrine for short periods of administration. The undesirable effects associated with the administration of ibuprofen and sympathomimetics such as pseudophedrine are listed to follow according to the classification for systems and organs and frequency. For the frequency of the occurrence of unwanted effects, the following expressions are used: Very common (≥ 1/10); City (≥ 1/100, Not common (≥ 1/1000, Rare≥ 1/10.000, Very rare ( Within each frequency class, unwanted effects are presented in decreasing order of gravity. Table of side effects.

Classification for systems and organs	Frequency	Reaction
Emolinfopoietic system pathologies	Not common	Reactions of hypersensitivity characterized by hives and itching2
	Very rare	Hematopoietic disorders1. Severe hypersensitivity reactions. The symptoms may be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). 2
Psychiatric disorders	Not known	Insomnia, anxiety, restlessness, agitation, hallucinations.
Diseases of the nervous system	Not common	Headache, tremors
	Very rare	Synthetic Meningitis3
Heart disease	Not known	Heart failure and edema4, tachycardia, chest pain, arrhythmia, palpitations.
Vascular diseases	Not known	Hypertension4
Respiratory pathologies, chests and mediastinics	Not known	Reactivity of the respiratory system including asthma, bronchospasmo or dispnea2
Gastrointestinal diseases	Not common	Abdominal pain, nausea and dyspepsia5
	Rare	Diarrhea, flatulence, constipation and vomiting
	Very rare	Peptic ulcer, perforation or gastrointestinal hemorrhage, melena, ematemesis, sometimes fatal, especially in the elderly (see paragraph 4.4). Ulcerative symptoms, mouth ulceration, gastritis.
	Not known	Dry mouth. Exacerbation of colitis and Crohn's disease (see paragraph 4.4).
Hepatobiliary diseases	Very rare	Hepatitis disorders
Pathologies of skin and subcutaneous tissue	Not known	Hyperhidrosis
	Not common	Skin rashes 2
	Very rare	Bollose reactions include Stevens-Johnson syndrome, multiform erythema and Epidermal Toxic Necrolysis.
	Not known	Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome)
	Not known	Severe skin reactions, including generalized acute exantelosis (AGEP)
Diseases of musculoskeletal system and connective tissue	Not known	Muscle weakness
Kidney and urinary pathologies	Very rare	Severe kidney failure 6
	Not known	Urinary retention
Synthetic pathologies and conditions for the administration	Not known	Irritability, thirst
Diagnostic examinations	Very rare	Decrease of blood haemoglobin level

Description of some side effects. 1) Examples of hematopoietic disorders include anemia, leucopenia, thrombocytopenia, pancitopenia and agranulocytosis. The first symptoms are fever, sore throat, superficial ulcers of the mouth, flu-like symptoms, severe feeling of fatigue, inexplicable bleeding and ecchimosis. 2)Reactions of hypersensitivity: these reactions include a) non-specific allergic reactions and anaphylaxis, b) reactivity of the respiratory tract that includes asthma, worsening of asthma, bronchospasm or dispnea or c) different skin diseases such as various rashes, itching, hives, porpora, angioedema and very rarely dermatitis bollose and esfolider. However, the data available on aseptic meningitis related to the administration of NSAIDs induce to think of an immune reaction of hypersensitivity (due to a temporary relationship with the intake of the drug and the disappearance of symptoms after the suspension of treatment). Note, individual cases of symptoms of aseptic meningitis (such as torcicollo, headache, nausea, vomiting, fever and disorientation) were observed during treatment with ibuprofen in patients with autoimmune disorders (such as systemic lupus erythematosus, mixed connective disease). 4) Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4) 5) Gastrointestinal: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). 6) Especially in the course of long treatments, associated with an increase in serum edema and edema. It also includes papillary necrosis. Gastrointestinal intolerance, bleeding, sweating, dizziness, precordial pain, difficulty in urination and insomnia can be manifested. Reporting of suspicious 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 via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Synonyms Nausea, vomiting, abdominal pain and more rarely diarrhea can occur. Tinnitus, headaches and gastrointestinal bleeding can also be manifested. In cases of more severe poisoning, toxicity is observed at the expense of the central nervous system that is manifested with dizziness, drowsiness, occasionally excitement and disorientation or coma. Occasionally patients develop seizures. In cases of severe poisoning, metabolic acidosis and protrobinin/INR time may occur, probably caused by interference with the action of the coagulation factors present in the circle. Acute kidney failure, liver damage and respiratory depression can also be presented. Asthmatic subjects can be exacerbated. As with other sympathomimetics, an excessive dose of pseudo-ephedrine can cause symptomatic disorders of the central nervous system and cardiovascular stimulation, including: irritability, restlessness, tremors, thirst, blurred vision, anxiety, insomnia, fever, sweat, esoftalm, hallucinations, muscle weakness, palpitations, seizures, urinary retention, hypertension, difficulty in urination, nausea, vomiting, tachycardia and heart arrhythmias. Treatment The treatment must be symptomatic and supportive, in particular against the cardiovascular and respiratory system and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. Oral administration of activated carbon should be taken into account if the patient is present within 1 hour of ingestion of a potentially toxic quantity. If necessary, corrective intervention of serum electrolytes should be required. Convulsions must be treated with benzodiazepines intravenously if they are frequent or prolonged. Administer bronchodilators in case of asthma. The elimination of pseudoephedrine can be accelerated by acid diuresis or dialysis. Hypertensive phenomena can be treated with blocking drugs of alpha IV receptors. Heart arrhythmias may require the use of beta-adrenergic blockers after the administration of alpha-adrenergic blockers. Hypereccitability and hallucinations can be treated with chlorromazine.

The product should not be used during pregnancy and nursing. Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose Fetus a: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction that can progress to kidney failure with oligo-idroamnios; The mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. There is the possibility of an association between the occurrence of fetal abnormalities and the assumption of pseudo-ephedrine in the first trimester of pregnancy. Nursing: Despite ibuprofen is present in breast milk in very low concentrations, pseudo-phedrine is secreted in milk in significant quantities; for this the product should not be used during breastfeeding. Fertility: As with other NSAIDs, the use of NUROFEN INFLUENCE AND FURNITURE may alter female fertility due to ovulation. Therefore it is not recommended in women who wish to conceive.

Source: Farmadati