Nurofenteen 200 mg - anti-inflammatory analgesic 12 lemon orodispersible tablets

Product Description

Lemon Orodispersible Tablets

Composition:

Each orodispersible tablet contains 200 mg of ibuprofen. Excipients: 15.0 mg of aspartame/tablet.

Excipients

Ethylcellulose, precipitated silicon dioxide, hypromellose, mannitol, aspartame (E951), croscarmellose sodium, magnesium stearate, flavouring (lemon).

Therapeutic indications

Mild or moderate painful symptoms such as headache, toothache, menstrual cramps. Fever.

Contraindications

Patients with hypersensitivity to ibuprofen or to other excipients. Patients who have previously shown hypersensitivity reactions (bronchospasm, asthma, rhinitis, angioedema, or urticaria) following the use of acetylsalicylic acid, ibuprofen, or other nonsteroidal anti-inflammatory drugs. Patients with severe hepatic, renal, or cardiac insufficiency. Patients with a history of gastrointestinal bleeding or perforation related to previous therapy with NSAIDs (nonsteroidal anti-inflammatory drugs). Patients with recurrent peptic ulcers/haemorrhages, active or in history (two or more distinct episodes of proven ulceration or bleeding). Patients with cerebrovascular haemorrhage or other types of active haemorrhage. Patients with unexplained haematopoietic disorders. Patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake). During the last trimester of pregnancy.

Dosage

Oral administration: Place one tablet on the tongue, allow it to dissolve, then swallow. No water is necessary. Do not administer to children under 12 years of age.

Adults and children over 12 years of age: Initial dose of 200 to 400 mg of ibuprofen, then, if necessary, 200 to 400 mg of ibuprofen every 4–6 hours. Do not exceed a dose of 1200 mg of ibuprofen in 24 hours.

Elderly: No changes to the dosage regimen are required.

Patients with gastric sensitivity problems are advised to take the tablet with food. For short-term treatment only. If this medicine is needed in adolescents for a treatment period longer than 3 days or if symptoms worsen, consult a doctor. If the product is needed for more than 3 days in case of fever or for more than 4 days in the treatment of pain, or if symptoms worsen, the patient should be advised to consult a doctor. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Warnings and precautions

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Gastrointestinal and cardiovascular risks below). Elderly: Elderly patients have a higher frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal. Elderly patients are at greater risk of adverse reactions. Caution is required in patients with: systemic lupus erythematosus or mixed connective tissue disease, due to an increased risk of aseptic meningitis, congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria), gastrointestinal disorders and chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), history of hypertension and/or heart failure, as fluid retention and edema have been reported in association with NSAID therapy, renal insufficiency, as renal function may be impaired; liver dysfunction, immediately following major surgery. In patients suffering from hay fever, nasal polyps, chronic obstructive pulmonary disease, or who have a history of allergic diseases, as these patients are at increased risk of developing allergic reactions. These may manifest themselves in the form of asthma attacks (so-called "analgesic asthma"), Quincke's edema, or urticaria. In patients who have allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using Nurosolv. Other NSAIDs: The use of Nurosolv should be avoided in conjunction with other NSAIDs, including cyclooxygenase-2 selective inhibitors. 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 NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arteriothrombotic events (for example, myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low doses of ibuprofen (for example, 1200 mg/day) are associated with an increased risk of myocardial infarction. Gastrointestinal safety: Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of gastrointestinal bleeding, ulceration or perforation is greater in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation. High blood pressure may be increased with increased doses of NSAIDs. These patients should start treatment on 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-dose aspirin or other drugs likely to increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment. Caution should be advised in patients taking concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or anti-platelet agents such as acetylsalicylic acid. If gastrointestinal bleeding or ulceration occurs in patients taking Nurosolv, 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 may be exacerbated. 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. Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Nurosolv should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Chickenpox may exceptionally cause serious infectious complications of the skin and soft tissues. To date, no treatment can be recommended. It is important to exclude the contribution of NSAIDs in the worsening of these infections, therefore it is advisable to avoid the use of Nurosolv in case of chickenpox. Respiratory disorders: bronchospasm may occur in patients with bronchial asthma or current or previous allergic diseases. Other considerations: Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. At the first signs of a hypersensitivity reaction after administration/intake of Nurosolv, therapy must be discontinued. Medical measures required based on symptoms must be undertaken by specialized personnel. Ibuprofen, the active ingredient in Nurosolv, can temporarily inhibit platelet function (thrombocyte aggregation), therefore it is recommended to carefully monitor patients with coagulation disorders. In case of prolonged administration of Nurosolv, regular monitoring of liver values, renal function and blood counts is required. Prolonged use of any type of painkiller for headache may worsen symptoms. If this situation occurs or is suspected, a doctor should be consulted and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite or because of the regular use of headache medications. Side effects related to the active substance, particularly those affecting the gastrointestinal tract or the central nervous system, may be increased when NSAIDs are taken in combination with alcohol. NSAIDs may mask the symptoms of infections and fever. Kidney disorders: In general, the habitual use of painkillers, especially combinations of different painkillers, can lead to permanent kidney damage with the risk of developing renal failure (analgesic nephropathy). Paediatric population: There is a risk of impaired renal function in dehydrated adolescents. Specific warnings for this medicinal product: This medicinal product contains aspartame, a source of phenylalanine, which may cause renal impairment. be dangerous for people with phenylketonuria.

Interactions

Ibuprofen should not be used in combination with: Acetylsalicylic acid (aspirin), Corticosteroids, Anticoagulants, Phenytoin, Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), Antihypertensives (ACE inhibitors, beta-blockers and angiotensin II antagonists) and diuretics, Cardiac glycosides (Dioxin), Lithium, Probenecid and sulfinpyrazone, Potassium-sparing diuretics, Methotrexate, Zidovudine, Sulfonylureas, Tacrolimus, Quinolone antibiotics, CYP2C9 inhibitors.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnant woman and/or embryonic/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor during early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk may increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. Animal studies have shown reproductive toxicity. During the first and second trimesters of pregnancy, ibuprofen should not be administered unless clearly necessary. If used by women attempting to conceive or during the first and second trimesters 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 may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may lead to renal failure. progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of bleeding time, an antiaggregant 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.

Breastfeeding Ibuprofen and its metabolites can pass into breast milk in low concentrations. No dangerous effects for newborns are known to date, therefore, for short-term 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 may cause impairment of female fertility by affecting ovulation. This effect is reversible after discontinuation of treatment.

Undesirable effects

The list of the following undesirable effects includes all the undesirable effects that have been recognized during treatment with ibuprofen, including those observed during prolonged high-dose therapy in patients with rheumatism. The reported frequencies, which extend beyond reports of very rare undesirable effects, refer to short periods of treatment for daily doses of up to a maximum of 1200 mg of ibuprofen for oral dosage forms and up to a maximum of 1800 mg for suppositories. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. The adverse reactions associated with the administration of ibuprofen are listed below according to 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 (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness. The most frequently observed adverse reactions are gastrointestinal in nature. Adverse reactions are in most cases dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following ibuprofen administration. Gastritis has been observed less frequently. Edema, hypertension, and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example, myocardial infarction or stroke). Worsening of infection-related inflammation (for example, necrotizing fasciitis) has been described in association with the use of nonsteroidal anti-inflammatory drugs. This is likely due to the mechanism of action of nonsteroidal anti-inflammatory drugs. If signs of infection develop or worsen while using Nurosolv, the patient should be advised to contact a doctor immediately to assess whether anti-infective/antibiotic therapy is necessary. For prolonged treatment, blood counts should be monitored regularly. If any symptoms of hypersensitivity reactions occur, the patient should be instructed to inform the doctor immediately and stop taking Nurosolv; this can also happen on the first use, in which case immediate medical attention is required. The patient should be instructed to stop taking the medicine and consult a doctor immediately if severe upper abdominal pain or melaena or haematemesis occurs.

Description of selected adverse reactions Hypersensitivity reactions have been reported following treatment with ibuprofen. These reactions include: non-specific allergic reactions and anaphylaxis; Respiratory tract reactivity, including asthma, worsening asthma, bronchospasm, or dyspnea; various skin conditions, including various rashes, pruritus, urticaria, purpura, angioedema, and very rarely, bullous and exfoliative dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme). The pathogenesis of drug-induced aseptic meningitis is not fully understood. However, available data on aseptic meningitis related to NSAID administration suggest an immune reaction (due to a temporary relationship with drug intake 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 erythromatosus, mixed connective tissue disease).

Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.