NUROFEN * 12CPR RIV 200MG

  • Reckitt Benckiser Healthcare (Italia)
  • 025634015

Pain of various kinds: headache, toothache, neuralgia, muscle and bone and joint pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and flu. Nurofen is indicated in adults and adolescents over 12 years of age

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NUROFEN * 12CPR RIV 200MG

Therapeutic indications

Pain of various kinds: headache, toothache, neuralgia, muscle and bone and joint pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and flu. Nurofen is indicated in adults and adolescents over 12 years of age

Dosage and method of use

Dosage Only for a short period of treatment.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 symptoms persist or worsen after a short period of treatment, consult your doctor. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. NUROFEN 200 mg coated tablets Pediatric population:Do not give to children under the age of 12.Adults and adolescents 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.Elderly people: No modification of the dosage regimen is required. NUROFEN 400 mg coated tablets Pediatric population:Do not give to children under the age of 12.Adults and adolescents over 12 yearsOne tablet 2-3 times a day. The interval between doses must not be less than 4 hours. Do not exceed the dose of 1200 mg (3 tablets) in 24 hours.Elderly people:No changes to the dosing schedule are required.Method of administrationOral use Patients with gastric sensitivity problems are advised to take Nurofen on a full stomach.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Patients who have previously experienced hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of ibuprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory products (NSAIDs). Patients with severe hepatic or renal insufficiency (see section 4.4). Severe heart failure (NYHA class IV) Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy. Patients with recurrent peptic ulcers / haemorrhages in place or in the past (two or more distinct episodes of proven ulceration or bleeding). During the last trimester of pregnancy (see section 4.6). Children under 12 years old.

Side effects

The list of side effects below includes side effects that have been observed during treatment with ibuprofen at self-medication doses (up to a maximum of 1200mg per day). In case of chronic conditions during long-term treatment additional side effects may occur. Undesirable effects associated with ibuprofen administration 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.

System and organ classification Frequency Adverse Reaction
Disorders of the blood and lymphatic system Very rare Hematopoietic disorders¹
Disorders of the immune system Uncommon Hypersensitivity reactions including urticaria and pruritus ¹
Very rare Severe hypersensitivity reactions including swelling of the face, tongue and throat, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock) ²
Nervous system disorders Uncommon Headache, dizziness
Very rare Aseptic meningitis ³
Eye disorders Very rare Visual disturbances
Cardiac pathologies Very rare Heart failure and edema4
Vascular pathologies Very rare Hypertension4
Respiratory, thoracic and mediastinal disorders Not known Respiratory tract reactivity including asthma, worsening of asthma, bronchospasm or dyspnoea
Gastrointestinal disorders Uncommon Dyspepsia, abdominal pain and nausea5
Rare Diarrhea, flatulence, constipation and vomiting
Very rare Peptic ulcers, gastrointestinal perforation or haemorrhage, melaena, haematemesis6, Ulcerative stomatitis, gastritis
Not known Exacerbation of colitis and Crohn's disease7
Hepatobiliary disorders Very rare Liver disorders, especially following long-term treatments
Skin and subcutaneous tissue disorders Uncommon Skin rashes²
Very rare erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis. ²
Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Renal and urinary disorders Very rare Acute renal failure8
Diagnostic tests Very rare Decrease in the level of hemoglobin in the blood

Description of some side effects1

Examples include anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bruising and bleeding. ² Hypersensitivity reactions: These reactions may include a) non-specific allergic reactions and anaphylaxis, b) respiratory tract reactivity 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. 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) .4Clinical 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).5The most commonly observed adverse reactions are gastrointestinal in nature.6sometimes fatal, particularly in the elderly7see section 4.48particularly following long-term treatments, associated with an increase in serum urea concentrations. decreased urea excretion and edema. It also includes papillary necrosisReporting of suspected adverse reactionsReporting 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:https://www.aifa.gov.it/ content / reports-adverse-reactions.

Special warnings

Caution is needed in patients with coagulation defects Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see gastrointestinal and cardiovascular risks below).Elderly people:Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).Pediatric populationThere is a risk of impaired renal function in dehydrated adolescents.Respiratory disorders:Bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases.Other NSAIDs:the use of Nurofen should be avoided in conjunction with other NSAIDs, including selective cyclooxygenase-2 inhibitors. (see section 4.5)SLE and mixed connective tissue diseaseSystemic lupus erythematosus and with mixed connective tissue disease due to an increased risk of aseptic meningitis (see section 4.8);Cardiovascular and cerebrovascular effects:caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as 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 (e.g. myocardial infarction or stroke). 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 (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg) are required. / day) of ibuprofen.Liver or kidney function:• renal insufficiency, as renal function may be impaired (see sections 4.3 and 4.8). In general, the habitual use of analgesics, especially combinations of different analgesic active substances, can lead to permanent renal lesions with the risk of developing renal failure (analgesic nephropathy). • liver dysfunction (see sections 4.3 and 4.8). Particular caution should be exercised in the treatment of patients with impaired hepatic or renal function. In such patients, periodic monitoring of clinical and laboratory parameters should be resorted to, especially in the case of prolonged treatment.Impaired female fertility:administration of Nurofen should be avoided in women planning pregnancy (see section 4.6).Gastrointestinal safety: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). 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 (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (e.g. 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 (see section 4.5). . 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 (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Nurofen, the treatment should be discontinued.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 (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Nurofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.Other:during prolonged treatments with analgesic medicinal products at doses higher than those indicated, headaches may arise which should not be treated with higher doses of the product.Important information about some of the ingredients Nurofencontains 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 tabletscontains sodium: this medicine contains less than 1 mmol (23 mg) sodium per tablet (17.34 mg), i.e. essentially 'sodium-free' and just over 1 mmol (23 mg) sodium per 2 tablets (34.68 mg) ), equivalent to 1.73% of the WHO recommended maximum daily intake which corresponds to 2 g of sodium for an adult.Nurofen 400 mg coated tablets contain sodium:this medicine contains 34.69 mg of sodium per tablet, equivalent to 1.73% of the WHO recommended maximum daily intake of 2 g of sodium for an adult.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis can adversely affect the pregnant woman and / or the embryo / fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk is believed 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 first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. When used by women about to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. 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 oligohydroamniosis; 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. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for infants are known to date, so for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. Fertility There is evidence that medicinal products that inhibit cyclooxygenase / prostaglandin synthesis can cause a weakening of female fertility by effect on ovulation. This effect is reversible after discontinuation of treatment. Nurofen administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Expiration and retention

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

Interactions with other drugs

Ibuprofen should be avoided in combination with: - 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 the two drugs are administered simultaneously. 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 they may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). Ibuprofen (like other NSAIDs) should be used with caution in combination with: - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4) - Anticoagulants: NSAIDs may increase 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). - 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 renal function (e.g. dehydrated patients or elderly patients with impaired renal function) 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 a coxib (such as NUROFEN) 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 and at regular intervals thereafter. Diuretics may increase the risk of NSAID nephrotoxicity. - Cardiac glycosides: NSAIDs can worsen heart failure, reduce VGF (glomerular filtration rate) and increase plasma levels of glycosides. - Lithium. There is evidence of the possibility of a potential increase in blood lithium levels, with the possibility of reaching the toxic threshold. If this combination is necessary, monitor lithemia in order to adjust the lithium dosage during concomitant treatment with ibuprofen. - Methotrexate. There is evidence of the possibility of increased plasma methotrexate levels. - Ciclosporins: increase the risk of nephrotoxicity. - Mifepristone: NSAIDs should not be taken for 8-12 days after administration of Mifepristone as NSAIDs can reduce the effects of Mifepristone. - Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with Tacrolimus. - Zidovudine: increased risk of haematological toxicity when NSAIDs are administered 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.

Overdose

ToxicitySigns and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater.SymptomsMost patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression, visual impairment have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis and prolongation of prothrombin time / INR may occur, possibly caused by interference with the action of circulating clotting factors. Exacerbation of asthma can occur in asthmatics.TreatmentThere is no specific antidote to ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore indicated and should include maintenance of a patent airway and monitoring of cardiac function and vital signs until the patient is stabilized. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage should be considered within one hour of ingesting a potentially life-threatening overdose in adults. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. If ibuprofen has already been absorbed, alkaline substances should be administered to promote the excretion of the acid ibuprofen in the urine. Administer bronchodilators in case of asthma. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.

Active principles

200 mg coated tablets: each tablet contains 200 mg of ibuprofen 400 mg coated tablets: each tablet contains 400 mg of ibuprofen Excipients with known effect: Each 200 mg coated tablet contains: - 116.1 mg of sucrose, equivalent to approximately 0, 34 mmol - 17.34 mg sodium, equivalent to approximately 0.75 mmol Each 400 mg coated tablet contains: - 232.2 mg, equivalent to approximately 0.68 mmol - 34.69 mg sodium, equivalent to approximately 1 , 51 mmol. For the full list of excipients, see section 6.1.

Excipients

Nurofen 200 mg coated tabletsCroscarmellose sodium,sodiumlauryl sulfate,sodiumcitrate, stearic acid, anhydrous colloidal silica, carmellosesodium, talc, dried nebulized gum arabic,sucrose, titanium dioxide, macrogol 6000, ink (shellac, black iron oxide E172, propylene glycol E1520).Nurofen 400 mg coated tabletsCroscarmellosasodium,sodiumlauryl sulfate,sodiumcitrate, stearic acid, anhydrous colloidal silica, carmellosesodium, talc, dried nebulized gum arabic,sucrose, titanium dioxide, macrogol 6000, ink (shellac, red iron oxide (E 172), propylene glycol (E1520), ammonium hydroxide (E527), simethicone).

025634015

Data sheet

Packaging
200 mg 12 coated tablets
Product Type
HUMAN DRUG
ATC code
M01AE01
ATC description
Ibuprofen
Therapeutic Group
NSAID analgesics
Active principle
ibuprofen (DC.IT) (FU)
Class
C.
Pharmaceutical form
coated tablet
coated tablets
Type of Administration
oral
Container
blister
Quantity
12 coated tablets
Quantity of the Active Ingredient
200MG
Recipe required
OTC - self-medication medicine
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