NUROFEN 12CPR RIV 400MG PVC/AL

NUROFEN EXTERNAL REQUIREMENTS

active ingredients

Tablets coated 200 mg: each tablet contains 200 mg of ibuprofen Compressed 400 mg: each tablet contains 400 mg of excipient ibuprofen with known effects: Each 200 mg coated tablet contains: - 116,1 mg of sucrose, equivalent to approximately 0.34 mmol - 17,34 mg of sodium, equivalent to about 0.75 mmol Each 400 mg coated tablet contains: - 232,2 mg, equivalent to about 0,68 mmol - 34,69 mg sodium, equivalent to about 1.51 mmol. For the full list of excipients, see paragraph 6.1.

Excellent

Nurofen 200 mg coated tablets Sodium crusty, sodium laurilsolfato, sodium citrate, stearic acid, colloidal silica anidra, carmellosa soda, talc, dried nebulized arabic rubber, sucrose, titanium dioxide, macrogol 6000, ink (lack rubber, black iron oxide E172, propylene glycol E1520). Nurofen 400 mg coated tablets Cruscarmell soda, , sodium laurilsolfato, sodium citrate, stearic acid, colloidal silica anidra, carmellosa soda, talc, dried nebulized arabic rubber, sucrose, titanium dioxide, macrogol 6000, ink (laque rubber, red iron oxide (E 172), propylene glycol (E1520), hydroxide ammonium (E527), symeticons).

Therapeutic indications

Pain from various nature: headaches, toothaches, nerves, muscle pain and osteoarthritis, menstrual pain. Helpful in the symptomatic treatment of feverish and flu states. Nurofen is indicated in adults and adolescents over 12 years

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. Patients who have previously manifested hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or hives) resulting from the use of ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory products (NSAID). Patients with severe liver or kidney failure (see paragraph 4.4). Severe heart failure (IV class NYHA) Patients with history of hemorrhage or gastrointestinal perforation, related to previous therapies with NSAIDs. Patients with recurring peptic ulcers/hemorrhages in place or in advance (two or more distinct episodes of proven ulceration or bleeding). During the last trimester of pregnancy (see paragraph 4.6). Children under 12.

Dosage

Dosage Only for a short period of treatment. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible treatment duration needed to control symptoms (see paragraph 4.4). If symptomatology persists or worsens after a short period of treatment, consult your doctor. In case the use of the medicine is necessary for more than 3 days in adolescents, or in case of worsening of the symptomatology the doctor must be consulted. NUROFEN 200 mg coated tablets Pediatric population: Do not administer children under the age of 12.Adults and teenagers over 12 years: 1-2 tablets, 2-3 times a day. The interval between doses should not be less than 4 hours. Do not exceed the dose of 1200 mg (6 tablets) in 24 hours. Seniors: No modifications of the posological scheme are required. NUROFEN 400 mg coated tablets Pediatric population: Do not administer children under the age of 12.Adults and teenagers over 12 years One tablet 2- 3 times a day. The interval between doses should not be less than 4 hours Do not exceed the dose of 1200 mg (3 tablets) in 24 hours. Seniors: Changes in the posological scheme are not required. Method of administration Oral use It is recommended for patients with gastric sensitivity problems to take Nurofen on a full stomach.

Conservation

Nurofen 400 mg coated tablets: store at a temperature not exceeding 30°C.

Warnings

Precaution is required in patients with clotting defects. Undesirable effects can be minimized by the use of the minimum effective dose for the shortest possible duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risks below). Seniors: Older patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Pediatric population: in dehydrated adolescents there is a risk of alteration of kidney function. Respiratory diseases: In patients with bronchial asthma or allergic diseases in place or pregress may arise bronchospasm. Other NSAIDs: nurofen should be avoided in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors. (see paragraph 4.5) LES and Mixed Connective Disease Systemic erythematous lupus and with mixed connective disease for increased risk of aseptic meningitis (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 because in association with the treatment with the 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. Hepatic or renal functionality: • kidney failure, as kidney function can be compromised (see paragraphs 4.3 and 4.8). In general, the habitual use of analgesics, especially of the associations of different active analgesics, can lead to permanent kidney injuries with risk of kidney failure (nephropathy from analgesics). • hepatic dysfunction (see paragraphs 4.3 and 4.8). Particular caution should be taken in the treatment of patients with reduced liver or kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. Compromised female fertility: the administration of Nurofen should be avoided in women planning a pregnancy (see paragraph 4.6). Gastrointestinal safety: NSAIDs should be given with caution to patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). 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. The concomitant use of protective agents (e.g. 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 paragraph 4.5). Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Cautisus should be lent to patients taking concomitant medications that could increase the risk of ulceration or bleeding, 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 hemorrhage or gastrointestinal ulcer occurs in patients taking Nurofen, treatment must be suspended. 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 within the first month of treatment. Nurofen must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Other: during prolonged treatments with analgesic medicinal products at doses higher than those indicated, headache may arise which should not be treated with higher doses of the product. Important information about some excipients Nurofen contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Nurofen 200 mg coated tablets contains sodium: this medicine contains less than 1 mmol (23mg) of sodium per tablet (17.34 mg), i.e. essentially ‘without sodium’ and just over 1 mmol (23 mg) of sodium each 2 tablets (34.68 mg), equivalent to 1.73% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. Nurofen tablets covered by 400 mg contains sodium: this medicine contains 34.69 mg of sodium per tablet, equivalent to 1.73% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult.

Interactions

Hybuprofen should be avoided in association with: - Acetylsalicylic acid: concurrent administration of ibuprofen and acetylical 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 the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, it cannot be excluded 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 including selective cyclooxygenase-2 inhibitors: the concomitant use of two or more NSAIDs must be avoided as they can increase the risk of adverse reactions to the gastrointestinal tract (see paragraph 4.4). Ibuprofen (such as other NSAIDs) must be used with caution in association with: - Corticosteroids: increased risk of ulceration or gastrointestinal hemorrhage (see paragraph 4.4) - Anti-compulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4) - Anti-aggregating agents and selective seestiroin inhibitors of seestiroin. - Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: 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 should be considered in patients taking coxib (such as NUROFEN) in combination 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 consideration should be given to monitoring renal function after initiation of concomitant therapy and at regular intervals thereafter.Diuretics may increase the risk of nephrotoxicity of NSAIDs.- Cardiac glycosides: NSAIDs may worsen heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.- Lithium.There is evidence of the possibility of a potential increase in lithium levels in the blood, with the possibility of reaching the toxic threshold.If this combination is necessary, monitor the blood lithium levels in order to adapt the lithium dosage during concomitant treatment with ibuprofen.- Methotrexate.There is evidence of the possibility of an increase in plasma levels of methotrexate.- Ciclosporins: increase the risk of nephrotoxicity.- Mifepristone: NSAIDs should not be taken for 8-12 days after administration of Mifepristone as NSAIDs may reduce the effects of Mifepristone.- Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are administered with Tacrolimus.- Zidovudine: increased risk of haematological toxicity when NSAIDs are administered with Zidovudine.There is evidence of an increased risk of haemarthrosis and haematoma in HIV-seropositive haemophiliac patients when treated concomitantly with zidovudine and ibuprofen.- Quinolone antibiotics: data from animal studies indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Effects

The list of the following side effects includes the side effects that have been observed during treatment with ibuprofen to self-medication dosages (up to a maximum of 1200mg per day). In case of chronic conditions during a long-term treatment, further undesirable effects may occur. The side effects associated with the administration of ibuprofen 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.

Classification for systems and organs	Frequency	Reaction
Emolinfopoietic system pathologies	Very rare	Hematopoietic disorders1
Immune system disorders	Not common	Hypersensitivity reactions that include urticaria and itching 1
	Very rare	Severe hypersensitivity reactions that include swelling of the face, tongue and throat, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock) 2
Diseases of the nervous system	Not common	Headache, dizziness
	Very rare	Synthetic Meningitis 3
Pathologies of the eye	Very rare	Visual disturbances
Heart disease	Very rare	Heart failure and edema 4
Vascular diseases	Very rare	Hypertension 4
Respiratory, chest and mediastinic pathologies	Notable	Reactivity of the respiratory tract that includes asthma, worsening of asthma, bronchospasm or dispnea
Gastrointestinal diseases	Not common	Dispepsia, abdominal pain and nausea 5
	Rare	Diarrhea, flatulence, constipation and vomiting
	Very rare	Ulce peptiche, perforation or gastrointestinal hemorrhage, melena, ematemesi 6, ulcerative symptoms, gastritis
	Notable	Exacerbation of colitis and Crohn's disease 7
Hepatobiliary diseases	Very rare	Hepatic disorders, especially following long-term treatments
Pathologies of skin and subcutaneous tissue	Not common	Skin rashes2
	Very rare	multiform erythema, boiling reactions including Stevens-Johnson syndrome and epidermal toxic necrolysis. 2
	Notable	Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome)
Kidney and urinary pathologies	Very rare	Acute kidney failure 8
Diagnostic examinations	Very rare	Decrease in blood haemoglobin level

Description of some side effects ¹ Examples include anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first manifestations are: fever, throat, superficial ulcers of the oral cavity, simil symptoms - flu, severe fatigue, hematomas and unexplained bleeding. 2 Reactions of hypersensitivity: these reactions may 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, purple, angioedema and very seldomy dermatitis. 3 The pathogenesis of aseptic meningitis induced by drugs is not completely known. 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 The most commonly observed adverse reactions are gastrointestinal. ⁶ sometimes fatal, especially in the elderly ⁷ see paragraph 4.4 ⁸ particularly as a result of long-term treatments, associated with increased urea serious concentrations. decrease in the excretion of urea and edema. Includes also papillary necrosis 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: https://www.aifa.gov.it/ happy/signature-reaction-adverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus dizziness, seizures and loss of consciousness. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system, obnubilization of the sight. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs and an extension of the protrombine/INR time, probably caused by interference with the action of the factors of the coagulation present in the circle. Asthmatic subjects can be exacerbated. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is indicated and must include the maintenance of airway pervity and the monitoring of heart function and vital signs until the patient's stabilization. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity, the administration of activated carbon must be taken into account. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. If ibuprofen has already been absorbed, alkaline substances must be administered to promote excretion in the urine of acid ibuprofen. Administer bronchodilators in case of asthma. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy The inhibition of prostaglandin synthesis can negatively affect the pregnant and/or embryo/fetal development. Data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first period of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It is believed 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 first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If used by women in conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be the lowest and the shortest possible respectively. 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 that can progress to kidney failure with oligohydroamniosis; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Food The ibuprofen and its metabolites can pass in low concentrations in breast milk. No dangerous effect for infants is now known, so for short treatments with the recommended dose for pain and fever, breastfeeding is not generally necessary. Fertility There are demonstrations that medicinal products that inhibit the synthesis of cycloxygenase/prostaglandine can cause a weakening of female fertility due to ovulation. This effect is reversible after termination of treatment. The administration of Nurofen should be suspended in women who have fertility problems or who are subject to fertility surveys.

Source: Farmadati