SPIDIDOL * 12CPR RIV 400MG

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 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 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 disorders: 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,

* effect of the NSAID class. The appearance of undesirable effects during the course of treatment requires the immediate suspension of therapy and the consultation of the attending 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

Gli effetti indesiderati possono essere minimizzati con l’uso della più bassa dose efficace per la più breve durata possibile di trattamento che occorre per controllare i sintomi (vedere par. 4.2 e i paragrafi sottostanti Rischi gastrointestinali e cardiovascolari). Un adeguato monitoraggio ed opportune istruzioni sono necessarie nei pazienti con anamnesi positiva per ipertensione e/o insufficienza cardiaca congestizia da lieve a moderata poiché in associazione al trattamento con i FANS sono stati riscontrati ritenzione di liquidi ed edema. Studi clinici suggeriscono che l’uso di ibuprofene, specialmente ad alte dosi (2400 mg/die), può essere associato ad un modesto aumento del rischio di eventi trombotici arteriosi (es. infarto del miocardio o ictus). In generale, gli studi epidemiologici non suggeriscono che basse dosi di ibuprofene (es. ≤ 1200 mg/die) siano associate ad un aumento del rischio di eventi trombotici arteriosi. I pazienti con ipertensione non controllata, insufficienza cardiaca congestizia (II-III classe NYHA), cardiopatia ischemica accertata, malattia arteriosa periferica e/o malattia cerebrovascolare devono essere trattati con ibuprofene soltanto dopo attenta considerazione e si devono evitare dosi elevate (2400 mg/die). Attenta considerazione deve essere esercitata anche prima di avviare al trattamento a lungo termine i pazienti con fattori di rischio per eventi cardiovascolari (es. ipertensione, iperlipidemia, diabete mellito, abitudine al fumo di sigaretta), soprattutto se sono necessarie dosi elevate (2400 mg/die) di ibuprofene. L’uso di SPIDIDOL deve essere evitato in concomitanza di FANS, inclusi gli inibitori selettivi della COX-2. Negli adolescenti disidratati esiste il rischio di alterazione della funzionalità renale. Anziani: i pazienti anziani hanno un aumento della frequenza di reazioni avverse ai FANS, specialmente emorragie e perforazioni gastrointestinali, che possono essere fatali (vedi par. 4.2). Emorragia gastrointestinale, ulcerazione e perforazione: durante il trattamento con tutti i FANS, in qualsiasi momento, con o senza sintomi di preavviso o precedente storia di gravi eventi gastrointestinali, sono state riportate emorragia gastrointestinale, ulcerazione e perforazione, che possono essere fatali. Negli anziani e in pazienti con storia di ulcera, soprattutto se complicata da emorragia o perforazione (vedi par. 4.3), il rischio di emorragia gastrointestinale, ulcerazione o perforazione è più alto con dosi aumentate di FANS. Questi pazienti devono iniziare il trattamento con la più bassa dose disponibile. L’uso concomitante di agenti protettori (misoprostolo o inibitori di pompa protonica) deve essere considerato per questi pazienti e anche per pazienti che assumono basse dosi di aspirina o altri farmaci che possono aumentare il rischio di eventi gastrointestinali (vedi sotto e par. 4.5). Pazienti con storia di tossicità gastrointestinale, in particolare anziani, devono riferire qualsiasi sintomo gastrointestinale inusuale (soprattutto emorragia gastrointestinale) in particolare nelle fasi iniziali del trattamento. A dosi giornaliere superiori a 1000 mg l’ibuprofene può prolungare il tempo di emorragia. Cautela deve essere prestata ai pazienti che assumono farmaci concomitanti che potrebbero aumentare il rischio di ulcerazione o emorragia, come corticosteroidi orali, anticoagulanti come warfarin, inibitori selettivi del reuptake della serotonina o agenti antiaggreganti come l’aspirina (vedere par. 4.5). Quando si verifica emorragia o ulcerazione gastrointestinale in pazienti che assumono SPIDIDOL il trattamento deve essere sospeso. I FANS devono essere somministrati con cautela nei pazienti con una storia di malattia gastrointestinale (colite ulcerosa, morbo di Crohn) poiché tali condizioni possono essere esacerbate (vedere par. 4.8). Reazioni cutanee severe: Gravi reazioni cutanee alcune delle quali fatali, includenti dermatite esfoliativa, sindrome di Stevens-Johnson e necrolisi tossica epidermica, sono state riportate molto raramente in associazione con l’uso dei FANS (vedi par. 4.8). Nelle prime fasi della terapia i pazienti sembrano essere a più alto rischio: l’insorgenza della reazione si verifica nella maggior parte dei casi entro il primo mese di trattamento. È stata segnalata pustolosi esantematica acuta generalizzata (PEAG) in relazione a medicinali contenenti ibuprofene. SPIDIDOL deve essere interrotto alla prima comparsa di rash cutaneo, lesioni della mucosa o qualsiasi altro segno di ipersensibilità. Reazioni epatotossiche possono verificarsi nel quadro delle reazioni di ipersensibilità generalizzata. Cautela deve essere adottata nel trattamento di pazienti con precedenti di broncospasmo specie se a seguito dell'uso di altri farmaci, ed in quelli con disturbi delle coagulazione e con funzionalità renale e/o epatica o cardiaca ridotta. In tali pazienti è opportuno ricorrere al monitoraggio periodico dei parametri clinici e di laboratorio, specialmente in caso di trattamento prolungato (vedere par. 4.2). Nei pazienti affetti da o con un’anamnesi di asma bronchiale o malattia allergica il broncospasmo può aggravarsi. Il lupus eritematoso sistemico o altre affezioni del collagene, costituiscono fattori di rischio per gravi manifestazioni di ipersensibilità generalizzata, pertanto è richiesta cautela nei pazienti con queste patologie. Essendosi rilevate, anche se molto raramente, alterazioni oculari in corso di trattamento con ibuprofene, si raccomanda in caso di insorgenza di disturbi della vista di interrompere il trattamento e di effettuare un'esame oftalmologico. L’uso di SPIDIDOL, come di qualsiasi farmaco inibitore della sintesi delle prostaglandine e della cicloossigenasi è sconsigliato nelle donne che intendono iniziare una gravidanza, in quanto può causare compromissione della fertilità femminile tramite un’effetto sull’ovulazione. La somministrazione di SPIDIDOL deve essere sospesa nelle donne che hanno problemi di fertilità o che sono sottoposte a indagini sulla fertilità (vedere par. 4.6). Occorre usare cautela quando si inizia il trattamento con ibuprofene in pazienti con grave disidratazione. Macheramento dei sintomi di infezioni sottostanti: SPIDIDOL può mascherare i sintomi di infezione, cosa che potrebbe ritardare l’avvio di un trattamento adeguato e peggiorare pertanto l’esito dell’infezione. Ciò è stato osservato nella polmonite batterica acquisita in comunità e nelle complicanze batteriche della varicella. In casi isolati è stata descritta un’esacerbazione delle infiammazioni infettive (es. sviluppo di fascite necrotizzante) in correlazione temporale con i FANS. Pertanto, nei pazienti colpiti da infezione la terapia con ibuprofene deve essere utilizzata con cautela. Quando SPIDIDOL è somministrato per il sollievo dalla febbre o dal dolore correlati a infezione, è consigliato il monitoraggio dell’infezione. In contesti non ospedalieri, il paziente deve rivolgersi al medico se i sintomi persistono o peggiorino. I FANS possono causare un aumento nei risultati degli esami di funzionalità epatica. Il consumo di alcol deve essere evitato in quanto può intensificare gli effetti collaterali dei FANS, soprattutto quelli che interessano il tratto gastrointestinale o il sistema nervoso centrale. Misure medicalmente assistite devono essere iniziate da parte di personale medico specializzato, in linea con la sintomatologia.L’ibuprofene acido, può causare un prolungamento del tempo di emorragia inibendo in maniera reversibile l’aggregazione delle piastrine. SPIDIDOL contiene saccarosio. I pazienti affetti da rari problemi ereditari di intolleranza al fruttosio, da malassorbimento di glucosio-galattosio o insufficienza di sucrasi-isomaltasi non devono assumere questo medicinale. SPIDIDOL contiene 56,98 mg e 82,98 mg di sodio rispettivamente per le confezioni di granulato e di compresse, e quivalenti rispettivamente al 2,85% e al 4,15% dell’assunzione massima giornaliera raccomandata dall’OMS che corrisponde a 2 g di sodio per adulto. Tali informazioni devono essere tenute in considerazione in caso di pazienti che stanno effettuando una dieta a basso contenuto di sodio. SPIDIDOL contiene 25 mg e 60 mg di aspartame per bustina rispettivamente per le confezioni di granulato gusto menta-anice e gusto albicocca. L’aspartame ingerito oralmente è idrolizzato nel tratto gastrointestinale. La fenilalanina è il principale prodotto della sua idrolisi.

Pregnancy and breastfeeding

Pregnancy: Inhibition of prostaglandin synthesis may 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 from less than 1% to approximately 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 infancy.

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

ToxicitySigns 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.SymptomsMost 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.TreatmentThere 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 useful 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 flavorOne sachet contains:Active principle: Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium, Aspartame, Sucrose. For the full list of excipients, see section 6.1.SPIDIDOL 400 mg granules for oral solution mint-anise flavorOne sachet contains:Active principle: Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium, Aspartame, Sucrose. For the full list of excipients, see section 6.1.SPIDIDOL 400 mg film-coated tabletsOne film-coated tablet contains:Active principle: Ibuprofen arginine salt, equivalent to ibuprofen 400 mg. Excipients: Sodium, Sucrose. For the 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.