Descrizione Clinica
Anti-inflammatory Abidol 12cpr riv200mg
IBUPROFENE PHARMENTIS 200 MG COMPRESSE RIVESTITES WITH FILM
active ingredients
IBUPROFENE PHARMENTIS 200 mg tablets coated with film Each tablet coated with film contains 200 mg of ibuprofen. For the full list of excipients, see paragraph 6.1.Excellent
Compressed core modified corn starch croscarmellosa sodium ipromellosa silica silica colloidal anidra Coating ipromellosa macrogol 8000 titanium oxideTherapeutic indications
Short-term symptomatic treatment of: - mild to moderate painContraindications
IBUPROFENE PHARMENTIS 200 mg tablets coated with film is contraindicated in the following cases: - hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - reprocession of bronchospasm, asthma, rhinitis, angioedema or urticaria following previous intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAID) - unspecified disorders of blood formation - active peptic ulcer/hemorrhage. IBUPROFENE PHARMENTIS 200 mg tablets coated with filmThe drug is contraindicated in children 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 the body weight and age of the patient. The intervals between administrations depend on the symptoms and the total daily maximum dose. A minimum interval 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). IBUPROFENE PHARMENTIS 200 mg tablets coated with film| Age | Single dose | Maximum daily dose |
| 12-15 years | 1 tablet (equivalent to 200 mg of ibuprofen) | 3 tablets (equivalent to 600 mg of ibuprofen) |
| over 15 years | 1-2 tablets (equivalent to 200-400 mg of ibuprofen) | 6 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 below chapters dedicated to gastrointestinal and cardiovascular risks). Gastrointestinal safety Concurrent use of ibuprofen and other NSAIDs, including selective cyclooxygenase-2 inhibitors should be avoided. Seniors: 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 acetylsalicylic 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 high doses (2400 mg/die) 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 (e.g. ≤ 1200 mg/die) are associated with an increase in the 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 consideration and should avoid high doses (2400 mg/day). Careful consideration is also necessary before starting long-term treatment 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 Severely serious skin reactions have been reported, some of which 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 severe skin signs and symptoms such as 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 IBUPROFENE PHARMENTIS 200 mg tablets coated with film in case of chickenpox. Masking the symptoms of underlying infections IBUPROFENE PHARMENTIS 200 mg tablets coated with film may 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 IBUPROFENE PHARMENTIS 200 mg tablets coated with film 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. Special caution is required in patients with: - systemic erythematosis lupus (LES) and mixed disease of connective tissue (see paragraph 4.8) - congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria) - gastrointestinal disorders or chronic inflammatory bowel disease ( ulcerative colitis, Crohn disease) - hypertension and/or heart failure. These can occur as an asthma attacks (called analgesic asthma), Quincke edema or hives - allergies to other substances, since there is an increase in the risk of hypersensitivity reactions even with the use of IBUPROFENE PHARMENTIS 200 mg tablets coated with film - directly after major surgery Additional information: Ibuprofen, the active ingredient of IBUPROFENE PHARMENTIS 200 mg tablets coated with film can temporarily inhibit the function of platelets (plastrine aggregation). Patients with clotting disorders must therefore be carefully monitored. If your doctor considers prolonged therapy with ibuprofen necessary, regular checks of hepatitis, kidney function and blood cell count should be performed. A proper water supply must be ensured during treatment to prevent dehydration and the possible increase in kidney toxicity associated with the use of ibuprofen. Prolonged use of any headache painkiller can make it worse. If this situation is manifested or suspected, you should ask for advice to the doctor and treatment must be stopped. Diagnosis of drug abuse headache (MOH) must be suspected in patients who have frequent or daily headache despite (or due to) regular use of headache medications. In general, the habitual intake of analgesics, in particular an association of different analgesic substances, can cause permanent kidney damage with risk of kidney failure (nephropathy from analgesics). Following concurrent consumption of alcohol, the side effects related to the active ingredient, especially those concerning the gastrointestinal tract or the central nervous system, can increase during use of NSAIDs. In rare cases severe acute reactions of hypersensitivity were observed (e.g. anaphylactic shock). The therapy must be suspended at the first signs of a hypersensitivity reaction after taking/ administering ibuprofen. Syntomatology-appropriate medical procedures must be performed by specialized personnel. Pediatric population In dehydrated adolescents there is a risk of renal impairment. Excipient 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 IBUPROFENE PHARMENTIS 200 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 IBUPROFENE PHARMENTIS 200 mg tablets coated with film and potassium-saving diuretics can lead to hyperpotassium. - Corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (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 IBUPROFENE PHARMENTIS 200 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 (sulphonluree). 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 not generally recommended due to the potential increase in unwanted 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, it cannot be ruled out 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).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 IBUPROFENE PHARMENTIS 200 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, IBUPROFENE PHARMENTIS 200 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 infarction. Vascular diseases 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 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 can arise during a chickenpox infection (see also “Infections and infestations”). Notable: - reaction from drug with eosinophilia and systemic symptoms (DrESS syndrome). - generalized acute exantematic pulstolosis (PEAG). Kidney and urinary pathologies Raro: - kidney tissue damage (paint necrosis) - increased 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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
Symptoms 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 case of severe poisoning, it is possible that metabolic acidosis occurs. 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
