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SPIDIDOL * 12CPR RIV 400MG

039600010
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039600010

SPIDIDOL * 12CPR RIV 400MG

Therapeutic indications

Pain of various origins and nature: headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain. Adjuvant in the symptomatic treatment of fever and flu.

Dosage and method of use

Adults and children over 12 years: 1 film-coated tablet or 1 sachet, two to three times a day. The maximum daily dose should not exceed 1200 mg per day. - Elderly: Elderly patients should follow the minimum dosages indicated above. In the treatment of elderly patients, the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above. - Dosages should be reduced in patients with impaired renal, hepatic or cardiac function. - Hepatic insufficiency: caution should be adopted in the treatment of patients with impaired hepatic function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe hepatic insufficiency (see section 4.3). - Renal insufficiency: caution should be adopted in the treatment of patients with impaired renal function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see section 4.4). The use of SPIDIDOL is contraindicated in patients with severe renal insufficiency (see section 4.3). In adolescents (aged ≥ 12 years to

Contraindications

• Hypersensitivity to the active substance or to other closely related substances from a chemical point of view and / or to any of the excipients listed in section 6.1. • History of gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs). • History of recurrent peptic bleeding / ulcer (two or more distinct episodes of proven ulceration or bleeding). • Active and recurrent peptic ulcer. • Gastrointestinal bleeding • Other ongoing bleeding such as cerebrovascular • Ulcerative colitis and Crohn's disease. • Severe hepatic and / or renal insufficiency • Bleeding diathesis • Severe heart failure (NYHA class IV). • Due to the possibility of cross-allergic reactions with acetylsalicylic acid or with other non-steroidal anti-inflammatory drugs, the product is contraindicated in patients in whom these drugs induce allergic reactions such as bronchospasm, asthma, urticaria, rhinitis, nasal polyposis, angioedema. • In case of systemic lupus erythematosus and collagen diseases, the attending physician should be consulted before using SPIDIDOL. • The granules, as they contain aspartame, are contraindicated in patients with phenylketonuria. • Third trimester of pregnancy (see section 4.6). • Before or after heart surgery.

Side effects

Undesirable effects are mainly related to the pharmacological effect of ibuprofen on prostaglandin synthesis. Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, heartburn, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of SPIDIDOL (see section 4.4). Gastritis has been observed less frequently. Skin and subcutaneous tissue disorders: bullous reactions including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis (very rarely) and drug reactions with eosinophilia and systemic symptoms (DRESS syndrome). Cardiac and vascular diseases: Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Below is a table relating to the frequency of adverse events: Frequency: very common (≥1 / 10); common (≥1 / 100, .

Organ and system classification Frequency
Gastrointestinal disorders
Dyspepsia, diarrhea Very common
Abdominal pain, heartburn, nausea, flatulence, abdominal discomfort Common
Peptic ulcers, gastrointestinal haemorrhage, vomiting, melaena, gastritis, stomatitis Uncommon
Gastrointestinal perforation, constipation, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease Rare
Anorexia Not known
General disorders and administration site conditions
Edema, fever Not known
Cardiac pathologies
Heart failure Not known
Vascular pathologies
Hypertension, arterial thrombosis, hypotension Not known
Nervous system disorders
Headache, dizziness Common
Confusion, sleepiness Uncommon
Depression, psychotic reaction, aseptic meningitis Not known
Clouding of the sensory Very rare
Cerebrovascular accident * Rare
Ear and labyrinth disorders
Tinnitus, hearing disorders Rare
Eye disorders
Blurred vision, amblyopia, color vision disorder Rare
Papilloedema Not known
Skin and subcutaneous tissue disorders
Skin rash, skin disease Common
Itching, urticaria, purpura, angioedema, rash Uncommon
Bullous dermatosis (erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis), allergic vasculitis Very rare
photosensitivity reactions, aggravation of skin reactions Not known
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Not known
Acute generalized exanthematous pustulosis (PEAG) Not known
Disorders of the blood and lymphatic system
Thrombocytopenia, agranulocytosis, aplastic anemia, granulocytopenia, haemolytic anemia Rare
Anemia Not known
Renal and urinary disorders
Hematuria, dysuria Rare
Interstitial nephritis, papillary necrosis, renal failure, acute renal failure Very rare
Hepatobiliary disorders
Hepatotoxicity Rare
Liver damage, hepatitis, jaundice Not known
Diagnostic tests
Liver function test abnormal (transaminases increased), alkaline phosphatase increased, hematocrit decreased, bleeding time prolonged, blood calcium decreased *, uric acid increased * Rare
Decrease in the level of hemoglobin in the blood Very rare
Abnormal renal function test Not known
Disorders of the immune system
Allergic reactions Uncommon
Anaphylaxis Rare
Anaphylactic shock Not known
Respiratory, thoracic and mediastinal disorders
Asthma, aggravation of asthma, bronchospasm, dyspnoea Uncommon
Throat irritation Not known
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness Not known
Metabolism and nutrition disorders
Uricemia increased, sodium and fluid retention or edema Not known
Reproductive system and breast disorders
Menstrual disorder Not known

* effect of the NSAID class The appearance of undesirable effects during the course of treatment requires the immediate suspension of therapy and consultation with the treating physician. Pediatric population: From cumulative clinical experience, there is no clinically relevant difference in the nature, frequency, severity and reversibility of adverse reactions between the safety profile in adults and the approved pediatric population (≥12 years). Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the sections below Gastrointestinal and cardiovascular risks). Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg / day), may be associated with a modest increased 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 / day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg / day) should be avoided. ). Careful consideration should also be exercised before initiating long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking), especially if high doses (2400 mg / die) of ibuprofen. The use of SPIDIDOL should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. There is a risk of impaired renal function in dehydrated adolescents. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: 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 (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). . 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. At daily doses above 1000 mg ibuprofen can prolong the bleeding time. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking SPIDIDOL 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 (see section 4.8). Severe 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 (see section 4.8). 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. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with medicinal products containing ibuprofen. SPIDIDOL should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Hepatotoxic reactions can occur in the framework of generalized hypersensitivity reactions. Caution should be adopted in the treatment of patients with a history of bronchospasm, especially if following the use of other drugs, and in those with coagulation disorders and with reduced renal and / or hepatic or cardiac function. In such patients it is advisable to resort to periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment (see section 4.2). Bronchospasm may be aggravated in patients with or with a history of bronchial asthma or allergic disease. Systemic lupus erythematosus or other collagen diseases are risk factors for severe manifestations of generalized hypersensitivity, therefore caution is required in patients with these diseases. Since ocular alterations have been detected, albeit very rarely, during treatment with ibuprofen, it is recommended in the event of onset of visual disturbances to interrupt the treatment and perform an ophthalmological examination. The use of SPIDIDOL, as with any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant, as it can cause impairment of female fertility through an effect on ovulation. The administration of SPIDIDOL should be discontinued in women who have fertility problems or who are undergoing fertility investigations (see section 4.6). Caution should be used when initiating treatment with ibuprofen in patients with severe dehydration. Ibuprofen can mask the objective and subjective signs of an infection. In isolated cases an exacerbation of infectious inflammations (eg development of necrotizing fasciitis) has been described in temporal correlation with NSAIDs. Therefore, ibuprofen therapy should be used with caution in infected patients. NSAIDs can cause an increase in liver function test results. Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. Acid ibuprofen can cause a prolongation of bleeding time by reversibly inhibiting platelet aggregation. Due to the presence of sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. SPIDIDOL contains 56.98 mg and 82.98 mg of sodium for the granules and tablet packs, respectively, and equivalent to 2.85 mg, respectively.% and at 4.15% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium per adult. This information should be taken into consideration in the case of patients who are on a low sodium diet.

Pregnancy and breastfeeding

Pregnancy. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased by less than 1%, up to about 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, SPIDIDOL should not be administered except in strictly necessary cases. If SPIDIDOL is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as 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 can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, SPIDIDOL is contraindicated during the third trimester of pregnancy. It is also not recommended to use the product during breastfeeding and childhood.

Expiry and retention

Tablets: Store at a temperature not exceeding 30 ° C.

Interactions with other drugs

Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. 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 SPIDIDOL 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. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin (see section 4.4). Prothrombin time should be closely monitored during the first few weeks of combined treatment and the dosage of anticoagulants may need to be adjusted. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). Furosemide and thiazide diuretics: A reduction in the efficacy of furosemide and thiazide diuretics may occur, possibly due to sodium retention associated with inhibition of prostaglandin synthetase in the kidney.Beta blockers: the hypotensive effect of beta-blockers can be reduced. Concomitant use of NSAIDs and beta-blockers may be associated with the risk of acute renal failure. Other non-steroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors: ibuprofen should be used with caution in combination with other NSAIDs as it may increase the risk of adverse reactions in the gastrointestinal tract. Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). Digoxin, phenytoin and lithium: Isolated cases of elevated plasma levels of digoxin, phenytoin and lithium as a result of combined therapy with ibuprofen are reported in the literature. Methotrexate: Ibuprofen can cause an increase in plasma levels of methotrexate. Zidovudine: Concomitant therapy with Zidovudine and ibuprofen may increase the risk of haemarthrosis and hematoma in HIV (+) haemophiliac patients. Tacrolimus: Concomitant use of ibuprofen and tacrolimus may increase the risk of nephrotoxicity due to the reduction in the renal synthesis of prostaglandins. Hypoglycemic drugs: Ibuprofen increases the blood glucose lowering effect of oral hypoglycemic drugs and insulin. The dosage may need to be adjusted. Cyclosporine: Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may lead to an increased risk of cyclosporine nephrotoxicity. Voriconazole or fluconazole: Concomitant use of ibuprofen may lead to an increase in ibuprofen exposure and plasma concentration. Mifepristone: Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may lead to increased exposure to NSAIDs. A decrease in the efficacy of mifepristone can theoretically occur due to the antiprostaglandin properties of NSAIDs. Some studies on the effect of single or repeated administration of ibuprofen starting on the day of prostaglandin administration (or when needed) have found no evidence of a negative influence on the action of mifepristone, and on the overall clinical efficacy of the discontinuation protocol. of pregnancy. Quinolone antibiotics: Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) may lead to an increased risk of seizures. Herbal extracts: Ginkgo biloba may increase the risk of bleeding with NSAID drugs. Alcohol, bisphosphonates and pentoxifylline: can potentiate gastrointestinal side effects and the risk of bleeding and ulcer. Baclofen: high toxicity of baclofen. Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides. Interactions with diagnostic test results: - Bleeding time (may extend bleeding time up to 1 day after discontinuation of therapy). - Serum glucose concentrations (may decrease). - Creatinine clearance (may decrease). - Hematocrit or hemoglobin (may decrease). - BUN, serum creatinine and potassium concentrations (may increase). - Liver function test (there may be an increase in transaminases).

Overdose

Toxicity Signs and symptoms of toxicity were generally not observed at doses below 100 mg / kg in children or adults. However, supportive treatment may be required in some cases. Children have been observed to exhibit signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg / kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported symptoms of overdose include: nausea, vomiting, stomach pain, abdominal pain, lethargy and somnolence. Effects on the central nervous system (CNS) include headache, tinnitus, dizziness, diplopia, spasms, ataxia, radbomyolysis, seizures, convulsions, and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal state, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote to ibuprofen overdose. In the event of an overdose, therefore, symptomatic and supportive treatment is indicated. Particular attention is paid to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic amount. Alternatively, gastric lavage and correction of severe electrolyte abnormalities should be considered in adults within one hour of ingesting a potentially life-threatening overdose. Given the high degree of binding of ibuprofen to plasma proteins (up to 99%), dialysis is unlikely to be helpful in the event of an overdose. Adequate diuresis must be ensured and renal and hepatic functions closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged seizures should be treated with intravenous diazepam. Depending on the patient's clinical condition, other supportive measures may be necessary. For more information, contact your local poison control center.

Active principles

SPIDIDOL 400 mg granules for oral solution apricot flavor. One sachet contains: Active principle Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium 56.98 mg Aspartame 60 mg Sucrose 1770 mg For a full list of excipients, see section 6.1. SPIDIDOL 400 mg granules for oral solution mint-anise flavor. One sachet contains: Active principle Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium 56.98 mg Aspartame 25 mg Sucrose 1835 mg For a full list of excipients, see section 6.1. SPIDIDOL 400 mg film-coated tablets. One film-coated tablet contains: Active principle Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium 82.98 mg Sucrose 16.7 mg For a full list of excipients, see section 6.1.

Excipients

Apricot flavor granules for oral solution: l-Arginine, Sodium bicarbonate, Saccharin sodium, Aspartame, Apricot flavor, Sucrose. Mint-anise flavor granules for oral solution: l-Arginine, Sodium bicarbonate, Saccharin sodium, Aspartame, Mint flavor, Anise flavor, Sucrose. Film-coated tablets: l-Arginine, Sodium bicarbonate, Crospovidone, Magnesium stearate, Hydroxypropylmethylcellulose, Sucrose, Titanium dioxide, Polyethylene glycol.

039600010

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