Nurofen 24 Coated tablets 200 mg

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025634041
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WARNINGS
Caution is required in patients with: systemic lupus erythematosus or mixed connective tissue disease; history of hypertension and / or heart failure since fluid retention and edema have been reported in association with NSAID therapy; kidney changes; liver dysfunction; coagulation defects. Concomitant use should be avoided with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see gastrointestinal and cardiovascular risks below). 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 and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and for long-term treatments, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction. or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (for example, L. 1200 mg per day) are associated with an increased risk of myocardial infarction. Particular caution should be adopted in the treatment of patients with impaired hepatic or renal function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. 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 (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. 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 could 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 product, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions can be exacerbated. 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 within the first month of treatment. Discontinue at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. Bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. Older people are at increased risk of consequences from adverse reactions. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible time. 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. In general, the habitual use of analgesics, especially the combinations of different analgesic active ingredients, can lead to permanent renal lesions with the risk of onset of renal failure (analgesic nephropathy).
PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory and antirheumatic agents, derivatives of proprionic acid.
STORAGE
Store the 400 mg coated tablets at a temperature not exceeding 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Patients with hypersensitivity to the active substance or to any of the excipients. Patients who have experienced bronchospasm, asthma, rhinitis or urticaria following the use of acetylsalicylic acid or other non-steroidal anti-inflammatory products. Patients with severe hepatic, renal or cardiac insufficiency. Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy (non-steroidal anti-inflammatory drugs). Patients with recurrent peptic ulcers / bleeding in progress or in the past (two or more distinct episodes of proven ulceration or bleeding). It is contraindicated during the last trimester of pregnancy and in children under 12 years of age. Contains sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
NAME
NUROFEN TABLETS
EXCIPIENTS
Coated tablets 200 mg: croscarmellose sodium, sodium laurilsulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, black iron oxide (E 172). 400 mg coated tablets: croscarmellose sodium, sodium laurilsulfate, sodium citrate, stearic acid, colloidal anhydrous silica, carmellose sodium, talc, dried nebulized gum arabic, sucrose, titanium dioxide, macrogol 6000, red iron oxide (E 172).
SIDE EFFECTS
Uncommon (> = 1/1000 <= 1/100), rare (> = 1/10000 <= 1/1000), very rare (<= 1/10000). Alterations of the blood and lymphatic system. Very rare: haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first manifestations are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nasal and skin bleeding. Alterations of the immune system. Very rare: in patients with pre-existing autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) isolated cases of aseptic meningitis symptoms such as neck rigidity, headache, nausea, vomiting, fever or disorientation have been observed during treatment with ibuprofen. . Alterations of the nervous system. Uncommon: headache and dizziness. Eye disorders. Very rare: some rare cases of ocular alteration with consequent visual disturbances. Cardiac alterations. Uncommon: edema, hypertension and heart failure have been reported in association with NSAID treatments. Alterations of the gastro-intestinal system. Uncommon: gastrointestinal disorders such as dyspepsia, abdominal pain and nausea. Rare: diarrhea, flatulence, constipation and vomiting. Very rare: peptic ulcers, gastrointestinal perforation or haemorrhage (sometimes fatal, particularly in the elderly) melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease gastritis has been observed less frequently. Alterations of the hepatobiliary system. Very rare: liver disorders, especially following long-term treatments. Alterations of the skin and subcutaneous tissue. Very rare: severe forms of skin reactions such as erythema multiforme bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis may occur. Renal and urinary disorders. Very rare: decreased urea excretion and edema may occur, as well as acute renal failure papillary necrosis, particularly following long-term treatment, increased serum urea concentrations. General disorders and changes in the administration site. Uncommon: hypersensitivity reactions' with urticaria and itching. Very rare: severe hypersensitivity reactions'. Symptoms can be: swelling of the face, tongue and larynx, dyspnoea, tachycardia, hypotension or severe shock. Exacerbation of asthma. Clinical studies and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg per day) and for long-term treatment, may be associated with a slightly increased risk of arterial thrombotic events (e.g. myocardial infarction. or stroke).
PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively 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 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 first and second trimester of pregnancy, ibuprofen should not be administered except in strictly necessary cases. When used by women in the process of conception or during the first and second trimester of pregnancy, the dose and duration of treatment should be respectively the lowest and the shortest possible. 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 oligohydroamniosis. They can also expose 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. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Ibuprofen and its metabolites can pass in low concentrations into breast milk. No dangerous effects for newborns are known to date, so for short treatments with the recommended dose for pain and fever, interruption of breastfeeding is generally not necessary. 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. The administration of the drug should be suspended in women who have fertility problems 'or who are undergoing investigation of fertility'.
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.
INTERACTIONS
Ibuprofen (like other NSAIDs) should be used with caution in combination with: corticosteroids (increased risk of gastrointestinal ulceration or bleeding), anticoagulants (NSAIDs may increase the effects of anticoagulants, such as warfarin), antiplatelet agents and selective inhibitors of serotonin reuptake, i.e. with SSRIs (increased risk of gastrointestinal bleeding). Acetylsalicylic acid and other NSAIDs may increase the risk of adverse reactions affecting the gastrointestinal tract. NSAIDs may reduce the effect of diuretics, ACE inhibitors and angiotensin II antagonists. 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 medicinal product 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. There are demonstrations 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. There is evidence of the possibility of an increase in plasma methotrexate levels. There is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophilia patients when treated concurrently with zidovudine and ibuprofen. NSAIDs can enhance the hypoglycemic effect of sulfonylureas by displacing them from plasma protein binding sites. Experimental data indicate that ibuprofen can inhibit the effects of low dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. However, the limited data and the uncertainties relating to their application to the clinical situation do not allow definitive conclusions to be drawn for the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.
DOSAGE
>> Oral administration: do not administer to children under the age of 12 years. Patients with gastric sensitivity problems are advised to take the drug on a full stomach. If symptoms persist or worsen after a short period of treatment, consult your doctor. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. >> 200 mg coated tablets. Adults and children over 12 years: 1-2 tablets, 2-3 times a day. Do not exceed the dose of 1200 mg (6 tablets) in 24 hours. For the elderly, no modification of the dosage regimen is required. >> 400 mg coated tablets. Adults and children over 12 years: one tablet 2-3 times a day. Do not exceed the dose of 1200 mg (3 tablets) in 24 hours. No changes to the dosing schedule are required for the elderly.
ACTIVE PRINCIPLES
Ibuprofen.

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Nurofen 24 Coated tablets...

€11.40