NEW 12CPR OROD 200MG M

NUROFENTEEN 200 MG COMPRESSE ORODISPERSIBILITY

active ingredients

Each available gold tablet contains 200 mg of excipient ibuprofen with known effects: 25.0 mg aspartame/compressed orodispersible 0.072 mg sorbitol/compress orodispersible 2,37 mg sodium/compress orodispersible For the full list of excipients, see the paragraph 6.1.

Excellent

Etilcellulose, precipitated silicon dioxide, ipromellose, mannitol, aspartame (E951), sodium chrostatic, magnesium stearate, aroma (while - contains sorbitol).

Therapeutic indications

Mild or moderate painful symptoms such as headaches, toothache, menstrual pain. Fever. NUROFENTEEN is indicated for adults and adolescents over 12 years

Contraindications

Patients with hypersensitivity to the active ingredient or any of the excipients, see paragraph 6.1. Patients who have previously shown hypersensitivity reactions (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) following the use of acetylsalicylic acid, ibuprofen or other non-steroidal anti-inflammatory drugs. Patients with severe hepatic impairment, severe renal impairment, or severe heart failure (NYHA class IV). Patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID (nonsteroidal anti-inflammatory drugs) therapies. Patients with current or past peptic ulcers/hemorrhages (two or more distinct episodes of proven ulceration or bleeding). Patients with cerebrovascular hemorrhage or other types of current hemorrhage Patients with unclarified disorders of hematopoiesis. Patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake). During the last trimester of pregnancy (see section 4.6).

Population

Population Do not administer children under the age of 12.Adults and teenagers over 12 years: initial dose from 200 to 400 mg of ibuprofen, therefore, if necessary, from 200 to 400 mg of ibuprofen every 4-6 hours. Do not exceed 1200 mg of ibuprofen in 24 hours. Seniors: no modifications of the posological scheme are required. Only for a short period of treatment. In case the use of the medicine is necessary for more than 3 days in adolescents or in case of worsening of symptomatology, the doctor must be consulted. In case the use of the medicine in adults is necessary for more than 3 days in case of fever or for more than 4 days in the treatment of pain, or in case of worsening of symptoms it is recommended to the patient to consult a doctor. 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). Method of administration Oral use Place a tablet on the tongue, let it dissolve, then swallow. Water is not required. It is recommended for patients with gastric sensitivity problems to take NUROFENTEEN on a full stomach.

Conservation

Store at a temperature below 25°C.

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 Gastrointestinal and cardiovascular risk below). Seniors: elderly patients have a greater frequency of adverse reactions to NSAIDs, particularly hemorrhage and gastrointestinal perforation that can be fatal (see paragraph 4.2). Older patients have greater risk of adverse reactions. Caution is necessary in patients with: - systemic erythematosetic lupus or with mixed connective disease, due to increased risk of aseptic meningitis (see paragraph 4.8); - congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria); - gastrointestinal pathologies and chronic intestinal inflammatory disease ( ulcerative colitis, Crohn's disease) (see paragraph 4.8); - history of hypertension and/or heart failure since, in association with NSAID therapy, water retention and edema were reported; - renal impairment, as kidney function can deteriorate (see paragraphs 4.3 and 4.8); - liver dysfunction (see paragraphs 4.3 and 4.8); - immediately after a major surgery; - hay fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of developing allergic reactions for these patients. These can be manifested in the form of asthma attacks (called “analgesic asthma”), edema of Quincke or hives. - in patients who have already experienced allergic reactions to other substances, as they are at higher risk of developing hypersensitivity reactions even when using NUROFENTEEN. Other: the use of NUROFENTEEN must be avoided in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors. Masking of symptoms of underlying infections NUROFENTEEN can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When NUROFENTEEN is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Cardiovascular and cerebrovascular effects: Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg per day), 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 (for example, ≤ 1200 mg per day) 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, smoking), especially if high doses are needed (2400 mg/die) of ibuprofen. Gastrointestinal effects: gastrointestinal bleeding, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal bleeding, 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 when the doses of NSAID increase. These patients must begin treatment with the lowest dose available. Concurrent 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 acetylsalicylic 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 bleeding) 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 bleeding or gastrointestinal ulceration occurs in patients taking NUROFENTEEN, treatment must be suspended. 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). Severe skin reactions: Severely serious skin reactions have been reported, some of which fatal, including exfoliatory dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis in association with the use of NSAIDs (see paragraph 4.8). Patients seem to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. NUROFENTEEN must be suspended at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosa lesions or any other sign of hypersensitivity. The chickenpox can exceptionally be the origin of serious infectious complications to the skin and soft tissues. It is recommended to avoid using NUROFENTEEN in case of chickenpox. Respiratory diseases: in patients with bronchial asthma or allergic diseases in place or in pregress, bronchospasm may arise. Other considerations Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are rarely observed. To the first signs of reaction of hypersensitivity after administration/take of NUROFENTEEN the therapy must be interrupted. Medical relief measures required according to symptoms must be undertaken by specialized personnel. Ibuprofen, the active ingredient of NUROFENTEEN, can temporarily inhibit the functionality of platelets (thrombocytic aggregation), so it is recommended to carefully monitor patients with clotting disorders. In case of prolonged administration of NUROFENTEEN, regular control of hepatic values, kidney function and blood count is required. Prolonged use of any type of analgesic for cephalea can make its symptoms worse. If this situation occurs or is suspected, the doctor must be consulted and the treatment must be suspended. Diagnosis of drug abuse headache (medication overuse headache -MOH) must be suspected in patients who manifest frequent or daily headaches despite or due to regular use of headache medication. Undesirable effects related to the active ingredient, especially those related to the gastrointestinal tract or the central nervous system, can be increased by taking NSAIDs in association with alcohol. Renal diseases: 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). Pediatric population: in dehydrated adolescents there is a risk of alteration of kidney function. Promoted female fertility: see paragraph 4.6. Specific warnings for this medicine: this medicine contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicine contains aspartame, a source of phenylalanine, which can be dangerous for people with phenylchetonuria.

Interactions

Ibuprofen should be avoided in association with: Acetylsalicylic acid (ASA): concurrent administration of ibuprofen and acetylicylic acid is not generally recommended due to the potential increase in unwanted effects. Other NSAIDs included selective cycloxygenase-2 inhibitors: avoid the concomitant use of two or more NSAIDs, as this may increase the risk of adverse events (see paragraph 4.4). Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when 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). Ibuprofen (such as other NSAIDs) should be used with caution in association with: - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4) - Antiagulants: the NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4) - Fenitoin: the concomitant use of ibuprofenin with preparations based. The correct use of drugs (administrated for a maximum period of 4 days) usually does not require control of serum levels of phenytoin. - Serotonin reuptake selective agents and inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). - Antihypertensives (ACE inhibitors, beta-blockers and antagonists of angiotensin II) and diuretics: NSAIDs can decrease the effects of these 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, beta-blocker or an antagonist of angiotensin II and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, including a possible acute reversible failure, generally reversible. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently at regular intervals. Diuretics can increase the risk of NSAID nephrotoxicity. - cardiac glycosides (Digoxin): NSAIDs can worsen heart failure, reduce GFR and plasma levels of glycosides. Concurrent use of NUROFENTEEN with digoxin based preparations can increase the serum levels of these medicines. The correct use of drugs (administrated for a maximum period of 4 days) usually does not require control of the serum levels of digoxin. - Ciclosporin: increased risk of nephrotoxicity. - Litio. There are demonstrations of the possibility of a potential increase in lithium levels in the blood. The correct use of drugs (administrated for a maximum period of 4 days) usually does not require control of the serum levels of lithium. - Probenecid and sulfinpirazone: Medicines containing probenecid or sulfinpirazone may delay the excretion of ibuprofen. - Diuretic potassium savers: Concurrent administration of NUROFENTEEN and potassium-saving diuretics can lead to hyperpotassiemia (should be sieric potassium control). - Metotrexato. There are demonstrations of the possibility of an increase in plasma levels of metotrexate. The administration of NUROFENTEEN in the previous 24 hours and after the administration of metotrexate can lead to an increase in plasma levels of metotrexate and to an increase in its toxic effects. - Zidovudina. There are evidence of increased risk of hematoma and hematoma in HIV seropositive hemophilic patients if treated simultaneously with zidovudine and ibuprofen. - Sulfaniluree: clinical studies have shown interactions between non-steroidal and anti-diabetic anti-inflammatory drugs (sulfoniluree). Although interactions between ibuprofen and sulfaniluree have not been described so far, it is recommended to control blood glucose values as a precautionary measure during concurrent intake. - Tacrolimus: possible increase in the risk of nephrotoxicity when NSAIDs are administered with tacrolimus. - 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. - CYP2C9 inhibitors: Concurrent administration of ibuprofen and CYP2C9 inhibitors can increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 80% to 100% was observed. You should consider reducing the dose of ibuprofen when concurrently administering powerful CYP2C9 inhibitors, especially when high doses of ibuprofen are administered with voriconazole or fluconazole.

Effects

The list of the following side effects includes all the side effects that have been recognized during treatment with ibuprofen, even those observed during prolonged high-dose therapy in patients with rheumatism. The frequencies reported, which extend beyond the indications of very rare unwanted effects, refer to short periods of treatment for daily doses up to a maximum of 1200 mg of ibuprofen for oral pharmaceutical forms and up to a maximum of 1800 mg for the supposed. It should be taken into account that the following adverse reactions are predominantly dose-dependent and vary from individual to individual. Adverse reactions associated with the administration of ibuprofen are listed to follow according to the classification for systems and organs and according to the frequency. The frequencies are defined as: Very common (≥1/10); Common (≥1/100, Classification for systems and organs Frequency Adverse reaction Infections and infestations Very rare The worsening of infections related to infections has been described (e.g. development of necrotizing fascites). In exceptional cases severe skin infections and complications to soft tissues were found during a chickenpox infection. Emolinfopoietic system pathologies Very rare Hematopoiesi disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first manifestations are: fever, throat, superficial ulcers of the oral cavity, simil symptoms - flu, severe fatigue, nasal bleeding and cutaneous, contusions. In these cases, the patient should immediately stop the medicine, avoid any self-medication medicine containing analgesics or antipyretics and consult the doctor. Psychiatric disorders Very rare Psychic reactions, depression Immune system disorders   Reactions of hypersensitivity that manifest with1: Not common Orticaria and itching Very rare severe hypersensitivity reactions. The symptoms may be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Exacerbation of asthma Not known Reactivity of the respiratory tract that includes asthma, bronchospasm and dispnea. Diseases of the nervous system Not common Central nervous system disorders such as headache, dizziness, insomnia, agitation, irritability or fatigue. Very rare Meningitis aseptica2 Pathologies of the eye Not common View disturbances Ear and labyrinth pathologies Rare Tinnitus Heart disease Very rare heart failure, palpitations and edema, myocardial infarction Vascular diseases Very rare Hypertension, vasculitis Gastrointestinal diseases Town gastrointestinal problems, such as abdominal pain, nausea and dysspepsia. Diarrhea, flatulence, constipation, heartburn, vomiting and slight blood loss in the stomach and/or in the intestine that in exceptional cases may cause anemia. Not common Gastrointestinal ulcers, gastrointestinal perforation or bleeding, ulcerative stomatitis, colitis worsening or Crohn's disease (see paragraph 4.4), gastritis. Very rare Esophagitis and formation of membranous shrinkages in the intestine (symyldiaphragmic intestinal tightenings), pancreatitis. Hepatobiliary diseases Very rare hepatic dysfunction, liver damage, especially in long-term therapy, liver failure, acute hepatitis. Pathologies of skin and subcutaneous tissue Not common Various skin rashes Very rare severe forms of skin reactions such as stamping reactions including Stevens-Johnson syndrome, multiform erythema and toxic epidermal necrolysis, alopecia. Not known Reaction to the drug with heosinophilia and systemic symptoms ( DRESS syndrome), generalized acute hexantholysis (PEAG). Photosensitivity reactions. Kidney and urinary pathologies Rare Rarely there may be damage to kidney tissues (paint necrosis) and high concentrations of uric acid in the blood. Very rare Edema formation, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that can be accompanied by kidney failure. Diagnostic examinations Rare Decrease of hemoglobin levels Description of some adverse reactions ¹ Hypersensitivity reactions were reported following treatment with ibuprofen. These reactions include a) non-specific and anaphylaxis allergic reactions., b) respiratory tract reactivity that includes asthma, aggravated asthma, bronchospasm or dispnea or c) different skin pathologies that include various rashes, itching, hives, porpora, angioedema and very rarely bollose and esfoliative (which include Stevensonitis epidermis. However, the data available on aseptic meningitis related to the administration of NSAIDs induce to think of an immune reaction (due to a temporal 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 torque neck numb, headache, nausea, vomiting, fever and disorientation) were observed during treatment with ibuprofen in patients with autoimmune diseases (such as systemic erythromatic lupus, mixed connective disease). 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In children taking more than 400 mg/kg can cause symptoms. In adults the dose response effect is not clearly defined in overdose. The half-life in overdose is 1.5-3 hours. Synonyms Most patients who have ingested clinically relevant amounts of NSAIDs have exclusively nausea, vomiting, abdominal pain and more rarely diarrhea. It is also possible to manifest nistagm, blurred vision, tinnitus, headache and gastrointestinal hemorrhage. In cases of more severe poisoning, toxicity is observed at the expense of the central nervous system that manifests itself with dizziness, dizziness, drowsiness, occasionally excitement and disorientation, loss of consciousness or coma. Occasionally patients develop seizures. In cases of severe poisoning it is possible that metabolic acidosis occurs. Hyperkaliemia, hypothermia and an extension of the protrombine/INR time, probably caused by interference with the action of the coagulation factors present in the circle. Acute kidney failure, liver damage, hypotension, respiratory depression and cyanosis can also be found. Asthmatic subjects can be exacerbated. Treatment A specific antidote is not available. The treatment must be symptomatic and supportive 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 charcoal emptiness should be taken into account if the patient occurs within 1 hour from ingestion of a potentially toxic quantity. If ibuprofen has already been absorbed, alkaline substances must be administered to promote excretion in the urine of acid ibuprofen. Convulsions must be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators in case of asthma. For more information contact the local poison 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 use of a prostaglandine synthesis inhibitor during the first period of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. The risk could increase 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, there was an increase in the incidence of various malformations, including cardiovascular disease, in animals that had been administered prostaglandin synthesis inhibitors during the organogenetic period. Animal studies showed toxicity on the reproductive apparatus (see paragraph 5.3). During the first and second quarter of pregnancy, ibuprofen should not be administered if not clearly necessary. 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

Hybuprofen 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 medicines that inhibit cycloxygenase/prostaglandin synthesis can cause a female fertility composure due to ovulation. This effect is reversible after termination of treatment.

Source: Farmadati