Descrizione Clinica
Anti-inflammatory Eiren 12cpr riv 400mg
EIREN 400 MG COMPRESENT RIVES WITH FILM
active ingredients
EIREN 400 mg tablets coated with film: Each film-coated tablet contains 400 mg of ibuprofen. For the full list of excipients, see paragraph 6.1.Excellent
Compressed core: modified maize starch, sodium chrocharmellous, ipromellosa, stearic acid, anidra colloidal silica. Coating: ipromellose, macrogol 8000, titanium dioxide.Therapeutic indications
Short-term symptomatic treatment of: - mild to moderate painContraindications
EIREN 400 mg tablets coated with film is contraindicated in the following cases: - hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - known reactions of bronchospasm, asthma, rhinitis, angioedema or hives as a result of previous intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); - unspecified disorders of blood formation; - peptic ulcer/active bleeding or anamnesi of peptic ulcer/curring bleeding (two or more distinct episodes of proven ulceration or bleeding); - anamnesi of gastrointestinal hemorrhage or drilling related to previous treatments with NSAIDs; - cerebrovascular hemorrhage or other types of active hemorrhage; - severely impaired liver or kidney function; - severe heart failure (IV NYHA class; see also paragraph 4.4); - severe dehydration (caused by vomiting, diarrhea or insufficient intake of liquids); - last trimester of pregnancy (see paragraph 4.6). EIREN 400 mg tablets coated with film: The drug is contraindicated in children and adolescents under 12 years of age, since this dosage is not suitable due to the high amount of active ingredient.Population
Population: The minimum effective dose must be used for the minimum time necessary to relieve symptoms. The dose of ibuprofen is based on body weight and age. The intervals between administrations depend on the symptoms and the total daily maximum dose. A range of at least 6 hours must be applied. The recommended dose should not be exceeded. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). EIREN 400 mg tablets coated with film| Age | Single dose | Maximum daily dose |
| 12-15 years | 1⁄2 tablet (equivalent to 200 mg of ibuprofen) | 1 1⁄2 tablets (equivalent to 600 mg of ibuprofen) |
| over 15 years | 1⁄2-1 tablet (equivalent to 200-400 mg of ibuprofen) | 3 tablets (equivalent to 1200 mg of ibuprofen) |
Conservation
This medicine does not require special conditions for storage.Warnings
Undesirable effects can be minimized using the lowest effective dose for the minimum time needed to obtain control of symptoms (see paragraph 4.2 and the underlying chapters dedicated to gastrointestinal and cardiovascular risks). Gastrointestinal safety: Concurrent use of ibuprofen and NSAIDs, including selective cyclooxygenase-2 inhibitors should be avoided. Senior patients are subject to an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhage and gastrointestinal perforation, which can be fatal (see paragraph 4.2). Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration or perforation, which may be fatal. In patients with ulcer anamnesi, especially if complicated by hemorrhage or perforation (see paragraph 4.3), and in the elderly the risk of gastrointestinal hemorrhage, ulceration or perforation is greater with the increase of doses of NSAID. These patients must begin treatment with the lowest dose available. It is appropriate to consider the concomitant use of protective agents (e.g. misoprostol or protonic pump inhibitors) both for these patients and for patients taking low doses of acetylicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially if elderly, must report any unusual gastrointestinal nature (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caution is required in the treatment of patients taking concomitant medications that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as acetyl acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking ibuprofen, treatment must be suspended. NSAIDs should be administered with caution in patients with gastrointestinal disease anamnesis ( ulcerative colitis, Crohn's disease), since these conditions may be exacerbated (see paragraph 4.8). Cardiovascular and cerebrovascular effects: It requires special caution (disputing with the doctor or pharmacist) before starting treatment in patients with anamnesi of hypertension and/or heart failure, because in association with NSAID therapy were reported water retention, hypertension and edema. Clinical studies suggest that the use of ibuprofen, especially at a high dose (2400 mg/die) may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤ 1200 mg/die) are associated with increased risk of arterial thrombotic events. Patients suffering from uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful evaluation and should be avoided high doses (2400 mg/day). Precautionary analogy is also necessary before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses of ibuprofen are required (2400 mg/die). Strict skin reactions: Serious skin reactions have been reported, some of which are fatal, including exfoliative 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. Ibuprofen should be suspended at the first appearance of signs and symptoms of severe skin reactions, such as skin rash mucosa lesions or any other sign of hypersensitivity. Exceptionally, the chickenpox can be the origin of serious infectious complications of skin and soft tissues. So far, it has not been possible to exclude that the NSAIDs contribute to the worsening of these infections. It is therefore recommended not to use EIREN 400 mg tablets coated with film in case of chickenpox. Masking of symptoms of underlying infections: EIREN 400 mg tablets coated with film may mask the symptoms of infection, which may delay the initiation of adequate treatment and thus worsen the outcome of the infection.This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox.When EIREN 400 mg tablets coated with film is given for the relief of fever or pain related to infection, monitoring for infection is advised.In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Particular caution is required in patients with: - systemic lupus erythematosus (SLE) and mixed connective tissue disease (see section 4.8);- inborn errors of porphyrin metabolism (e.g. acute intermittent porphyria);- gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);- hypertension and/or heart failure;- impaired renal function (since acute deterioration of renal function may occur in patients with pre-existing renal disease);- dehydration;- impaired liver function;- hay fever, nasal polyps or chronic obstructive respiratory disease as there is an increased risk of allergic reactions for them.These may manifest as asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria;- allergies to other substances, as there is an increased risk of hypersensitivity reactions for them even with the use of EIREN 400mg tablets coated with film; - directly after major surgery. Additional Information: Ibuprofen, the active ingredient of EIREN 400 mg tablets coated with film may temporarily inhibit platelet function (platelet aggregation).Patients with coagulation disorders should therefore be carefully monitored.If the doctor considers prolonged therapy with ibuprofen to be necessary, regular checks of liver values, kidney function and blood cell counts should be performed.Adequate fluid intake should be ensured during treatment to prevent dehydration and possible increased kidney toxicity associated with the use of ibuprofen.Prolonged use of any painkiller for headache may worsen the headache.If this situation occurs or is suspected, the doctor should be consulted and the treatment should be discontinued.The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.In general, the habitual intake of analgesics, especially a combination of several analgesic substances, can cause permanent kidney damage with risk of renal failure (analgesic nephropathy).Following concomitant alcohol consumption, the undesirable effects related to the active substance, especially those affecting the gastrointestinal tract or the central nervous system, may increase during the use of NSAIDs.In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.Therapy must be suspended at the first signs of a hypersensitivity reaction after intake/administration of ibuprofen.Medical procedures appropriate to the symptomatology must be performed by specialized personnel. Pediatric population: There is a risk of renal impairment in dehydrated adolescents.Excipients: Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet coated with film, i.e. essentially “without sodium”.Interactions
Precaution is required if ibuprofen is taken simultaneously with the following medicines: - Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs/analgesics: increased risk of ulcer and gastrointestinal hemorrhage. - Digoxin, phenytoin, lithium: the concomitant use of EIREN 400 mg tablets coated with film and preparations based on digoxin, phenytoin or lithium can increase the serum levels of these medicines. The correct use of the mentioned drugs does not normally require control of the serum levels of lithium, digoxin and phenytoin. - Diuretics, ACE inhibitors, beta-blockers and antagonists of angiotensin II: 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, beta-blocker or an antagonist of angiotensin II and agents that inhibit the cyclooxygenase system, may result in further deterioration of kidney function, including acute reversal failure. Therefore, the association must be administered 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 with regular cadence. Concurrent administration of EIREN 400 mg tablets coated with film and potassium-saving diuretics can lead to hyperpotassium. - Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). - Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). - Anti-aggregating agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4). - Metotrexate: the administration of EIREN 400 mg tablets coated with film within 24 hours before or after the administration of metotrexate can lead to high concentrations of metotrexate and to increase its toxic effects. - Zidovudine: there are indications of an increase in the risk of hematoma and hematoma in positive HIV patients with hemophilia in concomitant treatment with zidovudine and ibuprofen. - Cyclosporin: There are indications of a possible interaction that involves an increase in the risk of kidney toxicity. - Sulfaniluree: clinical studies have shown interactions between nonsteroidal and anti-inflammatory drugs (sulfaniluree). Although interactions between ibuprofen and sulfanilurea have not yet been described, it is recommended to control blood glucose values as a precautionary measure during concurrent intake. - Tacrolimus: the risk of kidney toxicity increases if the two drugs are co-administrated. - Probenecid and sulfinpirazone: medicines containing probenecid or sulfinpirazone may delay the excretion of ibuprofene. - 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 strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole or fluconazole. - Acetylsalicylic acid: concurrent administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential increase in adverse effects. 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, the possibility that regular use, long-term of ibuprofen, may not be excluded to 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).Effects
The list of the following side effects includes all known side effects associated with treatment with ibuprofen, including those reported by patients with rheumatism in prolonged treatment at high doses. Frequency data, except for very rare reports, are based on the administration of the short-term drug with maximum daily doses of 1200 mg of ibuprofen for oral formulations, and maximum doses of 1800 mg for the supposed. The following frequencies have been used in assessing the side effects: Very common (≥1/10); Common (≥1/100, Infections and infestations: Very rarely has been described exacerbation of inflammations associated with infection (e.g. development of necrotizing bundles) in conjunction with the use of non-steroidal anti-inflammatory drugs. This is probably related to the mechanism of action of non-steroidal anti-inflammatory drugs. Therefore, if during treatment with EIREN 400 mg tablets coated with film signs of an infection appear or notice the worsening of an infection, it is recommended for the patient to address without delay to a doctor. It should therefore be evaluated if there is the need for anti-infective/antibiotic therapy. During treatment with ibuprofen, symptoms of aseptic meningitis were rarely observed, with neck stiffness, headache, nausea, vomiting, fever or discarding of consciousness. Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be predisposed. Emolinfopoietic system pathologies. Very rare: - hematopoietic disorders (anemia, leucopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first signs can be the following: fever, sore throat, superficial oral injury, flu-like symptoms, severe physical exhaustion, nasal bleeding and skin. In these cases, the patient must be advised to immediately stop taking the medicine, to avoid self-medication with analgesics or antipyretics and to contact a doctor. Immune system disorders. Not common: - hypersensitivity reactions, with rash and itching, or asthma attacks (possibly with decrease in blood pressure). The patient must be advised to inform a doctor immediately and not to hire, in this case, EIREN 400 mg tablets coated with film. Very rare: - severe reactions of general hypersensitivity. This may occur as edema of the face, swelling of the tongue, swelling of the internal larynx resulting in constriction of the respiratory tract, respiratory suffering, accelerated heartbeat, decrease in blood pressure until dangerous shock for patient survival. If one of these symptoms occurs, which may also occur when using the drug, immediate medical assistance is required. Psychiatric disorders. Very rare: - psychotic reactions, depression. Diseases of the nervous system. Not common: - central nervous system disorders such as headache, dizziness, insomnia, excitement, irritability or fatigue. Pathologies of the eye. Not common: - visual disturbances. In this case, the patient must be advised to inform the doctor immediately and to stop taking ibuprofen. Ear and labyrinth pathologies. Tinnitus. Heart disease. Very rare: - palpitations, heart failure, myocardial heart attack. Vascular disease. Very rare: - arterial hypertension, vasculite. Gastrointestinal diseases. City: - gastrointestinal disorders such as pyrosis, abdominal pain, nausea, vomiting, flatulence, diarrhea, stipsi and read gastrointestinal hematic leaks that can cause anemia in exceptional cases; Not common: - gastrointestinal ulcers, potentially with hemorrhage and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4), gastritis; Very rare: - esophagitis, pancreatis, formation of diaphragmatic intestinal stenosis. The patient must be advised to suspend the taking of the medicine and to go immediately to a doctor if there is relatively severe pain in the upper part of the abdomen or melena or ematemesis. Hepatobiliary diseases. Very rare: - liver 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: - Bollose reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (Lyell syndrome), - alopecia, - in isolated cases, severe skin infections with complications at the level of soft tissues may arise during a chickenpox infection (see also “Infections and infestations”); Not known: - reaction from drug with heosinophilia and systemic symptoms (DrESS syndrome), - generalized acute esantematic pustolosis (PEAG), - photosensitivity reactions. Kidney and urinary pathologies. Raro: - kidney tissue damage (paint necrosis), - increase in serum concentration of uric acid; Very rare: - formation of edemas, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that can be accompanied by acute kidney failure, - reduced urinary excretion and edema can be indicative signs of kidney disease, which can sometimes also include kidney failure. If such symptoms appear or worsen, the patient must be advised to stop taking ibuprofen and consult a doctor immediately. 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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.Overdosing
Synonyms After overdose, central nervous system disorders such as headaches, dizziness, dizziness and unconsciousness (even myoclonic convulsions in children), as well as abdominal pain, nausea and vomiting may occur. Gastrointestinal bleeding and liver and kidney function disorders are also possible. Hypotension, respiratory depression, and cyanosis may also appear. In cases of severe poisoning, it is possible to occur metabolic acidosis. Treatment There is no specific antidote. Treatment must be symptomatic.Pregnancy: The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. The data from epidemiological studies show an increased risk of abortion and heart disease and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has led to an increase in pre- and post-system loss and embryo-fetal mortality. In addition, in animals that had been given inhibitors of the synthesis of prostaglandin during the period of organgenesis, an increase in the incidence of various malformations, including cardiovascular disease was reported. During the first and second quarter of pregnancy, ibuprofen should not be administered, if not in strictly necessary cases. If ibuprofen is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose • fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligoidramnios; • the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Food: Only small amounts of ibuprofen and the products of its metabolism are excrete in breast milk. Since there are no known side effects, it is generally not necessary to stop breastfeeding during short-term use and recommended doses for mild to moderate pain treatment. However, in case of prescription of the drug for prolonged treatment or at high doses, an early weaning should be considered. Fertility: There are evidence that drugs that inhibit cyclooxygenase/synthesis of prostaglandins can cause impairment of female fertility as a result of an effect on ovulation. This event is however reversible with the suspension of treatment.
Source: Farmadati
