SPIDIDOL OS GRAT 12BS 400MG ME

SPIDIDOL 400 MG

active ingredients

SPIDIDOL 400 mg granulated for oral solution apricot taste A bag contains: Active ingredient: Ibuprofene salt of arginine, equal to ibuprofene 400 mg Sodium, Aspartame, Sucrose. For the full list of excipients, see paragraph 6.1. SPIDIDOL 400 mg granulated oral solution mint-anise taste A bag contains: Active ingredient: Ibuprofene salt of arginine, equal to ibuprofene 400 mg Sodium, Aspartame, Sucrose. For the full list of excipients, see paragraph 6.1. SPIDIDOL 400 mg tablets coated with film A movie-coated tablet contains: Active ingredient: Ibuprofene salt of arginine, equal to ibuprofene 400 mg Sodium, sucrose. For the full list of excipients, see paragraph 6.1.

Excellent

Granulated for oral solution apricot taste: l-Arginine, Sodium bicarbonate, Sodium Saccarina, Aspartame, Aroma apricot, Saccarosio. Granulated for oral solution mint-anise taste: l-Arginine, Sodium bicarbonate, Sodium saccharin, Aspartame, Aroma mint, Aroma anise, Saccarosio. Tablets covered with film: l-Arginine, Sodium bicarbonate, Crospovidone, Magnesium stearate, Hydroxypropylmethylcellulose, Saccarosio, Titanium bioxide, Polyethyleneglycol.

Therapeutic indications

Pain from various origins and nature: headaches, toothache, nerves, osteo-articocular and muscle pain, menstrual pain. Helpful in the symptomatic treatment of feverish and flu states.

Contraindications

• Hypersensitivity to the active ingredient or other substances closely related to a chemical point of view and/or any of the excipients listed in the paragraph 6.1. • History of gastrointestinal hemorrhage or drilling related to previous treatments with non-steroidal anti-inflammatory drugs (NSAID). • History of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). • Active and recurrent peptic ulcer. • Gastrointestinal bleeding • Other bleeding in place such as cerebrovascular bleeding • ulcerative and Crohn's disease. • Severe liver and/or kidney failure • Hemorrhagic diathesis • Severe heart failure (IV class NYHA). • Due to the possibility of allergic reactions crusaded with acetylsalicylic acid or with other non-steroidal anti-inflammatory drugs, the product is contraindicated in patients in which such drugs induce allergic reactions such as bronchospasm, asthma, hives, rhinitis, nasal polyposi, angioedema. • In case of systemic erythematous lupus and collagen diseases, before use of SPIDIDOL must be consulted by the doctor. • The granulate, as containing aspartame, is contraindicated in patients suffering from phenylchetonuria. • Third quarter of pregnancy (see par. 4.6). • Before or after cardiac surgery.

Population

Adults and boys over 12 years: 1 tablet coated with film or 1 bag, two-three times a day. The maximum daily dose should not exceed 1200 mg per day. - Senior patients should stick to the above minimum dosages. In the treatment of elderly patients, posology must be carefully established by the doctor who will have to assess a possible reduction of the dosages indicated above. - In patients with altered kidney, liver or heart function, dosages should be reduced. - Hepatic insufficiency: caution should be taken in the treatment of patients with reduced liver function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.4). The use of SPIDIDOL is contraindicated in patients with severe liver failure (see par. 4.3). - Renal insufficiency: caution should be taken in the treatment of patients with reduced kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.4). The use of SPIDIDOL is contraindicated in patients with severe kidney failure (see par. 4.3). In teenagers (aged ≥ 12 years to

Conservation

Tablets: Store at temperature not exceeding 30°C.

Warnings

Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment that is necessary to control symptoms (see par. 4.2 and below Gastrointestinal and cardiovascular risk). Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure, since in association with the treatment with NSAIDs, fluid and edema retention was found. 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 with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) are required of ibuprofen. The use of SPIDIDOL should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors. In dehydrated adolescents there is a risk of alteration of kidney function. Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see par. 4.2). Gastrointestinal hemorrhage, ulceration and drilling: during treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see par. 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must 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 par. 4.5). Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. At daily doses greater than 1000 mg, ibuprofen can prolong the hemorrhage time. Caute should be lent to patients taking concomitant drugs 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 aspirin (see par. 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking SPIDIDOL treatment must be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see par. 4.8). Strict skin reactions: Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis, have been reported very rarely in association with the use of NSAIDs (see par. 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. SPIDIDOL must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Hepatotoxic reactions may occur in the context of generalized hypersensitivity reactions. Caute should be adopted in the treatment of patients with bronchospasm precedents, especially if following the use of other drugs, and in those with clotting disorders and kidney and/or liver or reduced heart function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment (see par. 4.2). In patients with bronchial asthma or allergic disease, bronchospasm may aggravate. Systemic lupus erythematose or other collagen affections constitute risk factors for serious manifestations of generalized hypersensitivity, therefore caution is required in patients with these pathologies. Having been detected, although very rarely, eye alterations in the course of treatment with ibuprofen, it is recommended in case of occurrence of sight disturbances to stop treatment and to carry out an ophthalmological examination. The use of SPIDIDOL, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenases it is not recommended in women who intend to start a pregnancy, as it can cause impairment of female fertility through an effect on ovulation. The administration of SPIDIDOL must be suspended in women who have fertility problems or who are subject to fertility surveys (see par. 4.6). It is necessary to use caution when you start treatment with ibuprofen in patients with severe dehydration. Macheration of the symptoms of underlying infections: SPIDIDOL 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. In isolated cases an exacerbation of infectious inflammations (e.g. development of necrotizing fascites) was described in temporal correlation with the NSAIDs. Therefore, in patients affected by infection ibuprofen therapy should be used with caution. When SPIDIDOL 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. NSAIDs can cause an increase in the results of liver function tests. Alcohol consumption must be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. Medically assisted measures must be initiated by specialized medical personnel, in line with symptomatology. Acid ibuprofen, can cause an extension of hemorrhage time by reversible inhibiting platelet aggregation. SPIDIDOL contains sucrose. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption or sucrasis-isomaltase failure should not take this medicine. SPIDIDOL it contains 56.98 mg and 82.98 mg of sodium for granulate and tablets respectively, and quivalent to 2.85% and 4.15% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium per adult. This information must be taken into account in case of patients who are making a low-sodium diet. SPIDIDOL contains 25 mg and 60 mg of aspartame per sachet respectively for mint-anonymous granulates and apricot taste. The aspartame orally ingested is hydrolyzed in the gastrointestinal tract. Phenylolin is the main product of its hydrolysis.

Interactions

Diuretics, ACE inhibitors 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 or an angiotensin II antagonist and agents inhibiting the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking SPIDIDOL in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring the kidney function should be taken into consideration after the start of the concomitant therapy. Courtesy: increased risk of gastrointestinal ulceration or hemorrhage (see par. 4.4). Antiagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin (see par. 4.4). Protrombine time should be kept carefully under control during the first weeks of combined treatment and the dosage of anticoagulants may require adjustment. Selective serotonin reuptake inhibitors and anti-aggregating agents (SSRIs): increased risk of gastrointestinal hemorrhage (see par. 4.4). Furosemide and tiazide diuretics: a reduction in the effectiveness of thiazide furosemide and diuretics, probably due to sodium retention associated with the inhibition of synthetic prostaglandin at renal level.Beta-blockers: the hypotensive effect of beta-blockers can be reduced. Concurrent use of NSAIDs and beta-blockers can be associated with the risk of acute renal failure. Other non-steroidal anti-inflammatory drugs (FANS) including selective COX-2 inhibitors: ibuprofen should be used with caution in association with other NSAIDs because it can increase the risk of adverse reactions in the gastrointestinal tract. Acetylsalicylic acid: the concomitant administration of ibuprofen and acetylylylethyl 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 par. 5.1). Digoxin, phenytoin and lithium: isolated cases of high plasma levels of digoxin, phenytoin and lithium are reported in literature as a result of the therapy combined with ibuprofen. Methodology: ibuprofen can cause an increase in plasma levels of metotrexate. Zidovudina: concomitant therapy with Zidovudine and ibuprofen can increase the risk of hematoma and hematoma in HIV hemophiliacs(+). Tacrolimus: the concomitant use of ibuprofene and tacrolimus can increase the risk of nephrotoxicity due to the reduction in the renal synthesis of prostaglandine. Hypoglycemic drugs: ibuprofen increases the hypoglycemic effect of oral hypoglycemic drugs and insulin. You may need to adjust the dosage. Ciclosporin: Concurrent use of non-steroidal anti-inflammatory drugs (FANS) can lead to an increase in the risk of nephrotoxicity of cyclosporin. Voriconazole or fluconazole: concurrent use of ibuprofen can lead to increased exposure to ibuprofen and plasma concentration. Mifepristone: Concurrent use of non-steroidal anti-inflammatory drugs (NSAID) can lead to an increase in exposure to NSAIDs. A decrease in the effectiveness of mifepristone can theoretically occur due to the antiprostaglandinic properties of NSAIDs. Some studies on the effect of the single or repeated administration of ibuprofen from the day of administration of prostaglandin (or when necessary) have not found evidence of a negative influence on the action of mifepristone, and the overall clinical effectiveness of the protocol of termination of pregnancy. Chinolonic Antibiotics: Concurrent use of non-steroidal anti-inflammatory drugs (NSAID) can lead to an increase in the risk of seizures. Herbal Extracts: Biloba ginkgo can enhance the risk of bleeding with NSAID drugs. Alcohol, biphosphonate and pentoxyphylline: can enhance gastrointestinal side effects and the risk of bleeding and ulcer. Baclofene: high toxicity of baclofene. Aminoglycosides: NSAIDs can decrease aminoglycoside excretion. Interactions with diagnostic examination results: - Hemorrhage time (can extend hemorrhage time up to 1 day after the suspension of therapy); - Serum concentrations of glucose (can decrease); - Clearance of creatinine (can decrease); - Ematocrite or hemoglobin (can decrease); - Azotemia, concentrations of creatinine sierica and potassium (can increase); - Examination of liver function (an increase in transamines may occur).

Effects

The side effects are mainly related to the pharmacological effect of ibuprofen on the synthesis of prostaglandins. Gastrointestinal diseases: the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see par. 4.4). After administration SPIDIDOL were reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, gastric pyrosis, melena, hematitis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see par. 4.4). Less frequently gastritis were observed. Pathologies of skin and subcutaneous tissue: bollose reactions including Stevens-Johnson Syndrome, Epidermal Toxic Necrolysis (very rarely) and drug reactions with heosinophilia and systemic symptoms (DrESS syndrome). Heart and vascular disease: edema, hypertension and heart failure were reported in conjunction with NSAID treatment. 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) (see par. 4.4). Below is a table for the frequency of adverse events: Frequency: very common (≥1/10); common (≥1/100,

Classification for organs and systems	Frequency
Gastrointestinal diseases
Dispepsia, diarrhea	Very common
Abdominal pain, gastric pyrosis, nausea, flatulence, abdominal discomfort	Town
Peptic ulcer, gastrointestinal hemorrhage, vomiting, melena, gastritis, stomatitis	Not common
Gastrointestinal perforation, constipation, hematemesis, ulcerative stomatitis, colitis exacerbation and Crohn's disease	Rare
Anorexia	Notable
Systemic pathologies and conditions for administration
Edema, fever	Notable
Heart disease
Heart failure	Notable
Vascular diseases
Hypertension, arterial thrombosis, hypotension	Notable
Diseases of the nervous system
Kefalea, dizziness	Town
Confusion, sleepiness	Not common
Depression, psychotic reaction, aseptic meningitis	Notable
Sensor Obnubilation	Very rare
Accident cerebrovascular	Rare
Ear and labyrinth pathologies
Tinnitus, hearing disorders	Rare
Pathologies of the eye
Confuse vision, ambliopia, color vision disorder	Rare
Papilloedema	Notable
Pathologies of skin and subcutaneous tissue
Skin Rash, Skin Disease	Town
Prurito, urticaria, porpora, angioedema, exantema	Not common
Bollose dermatosis (mulform erythema, exfoliative dermatitis, Stevens-Johnson syndrome and Toxic Necrolysis Epidermal), allergic vasculitis	Very rare
photosensitivity reactions, aggravation of skin reactions	Notable
Drug reaction with eosinophilia and systemic symptoms (DrESS syndrome)	Notable
Generalized acute exantelosis (PEAG)	Notable
Emolinfopoietic system pathologies
Trombocytopenia, agranulocytosis, aplastic anemia, granulocytopenia, hemolytic anemia	Rare
Anemia	Notable
Kidney and urinary pathologies
Ematuria, disuria	Rare
Interstitial nephritis, papillar necrosis, kidney failure, acute kidney failure	Very rare
Hepatobiliary diseases
Hepatotoxicity	Rare
Hepatic damage, hepatitis, ittero	Notable
Diagnostic examinations
Alteration test liver function (transaminasis increased), increased alkaline phosphatease, reduced hematocrite, prolonged bleeding time, decreased blood calcium*, increased uric acid*	Rare
Decrease in blood haemoglobin level	Very rare
Alteration test renal function	Notable
Immune system disorders
Allergic reactions	Not common
Anafilas	Rare
Anaphylactic Shock	Notable
Respiratory, chest and mediastinic pathologies
Asthma, aggravation of asthma, bronchospasm, dispnea	Not common
Irritation of the throat	Notable
Diseases of musculoskeletal system and connective tissue
Musculoskeletal rigidity	Notable
Disorders of metabolism and nutrition
Increased urchemia, sodium and liquid retention or edema	Notable
Pathologies of the reproductive apparatus and of the breast
Menstrual disorder	Notable

* effect of the class FANS. The appearance of side effects during treatment requires immediate suspension of therapy and consultation of the attending physician. Pediatric population: From the cumulative clinical experience, there is no clinically relevant difference by nature, frequency, severity and reversibility of adverse reactions between the safety profile in adults and the approved pediatric population (≥12 years). 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 risk/benefit ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, gastralgia, abdominal pain, lethargy and drowsiness. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, diplopia, spasms, ataxia, radbomiolisis, seizures, seizures and loss of consciousness. Rarely, nistagm, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdose, a symptomatic and support treatment is therefore indicated. Particular attention is given to the control of blood pressure, acid-base balance and gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in adults, within an hour of the ingestion of a potentially life-threatening overdose, gastric lavender and the correction of severe electrolytic abnormalities must be taken into account. Given the high degree of ibuprofen link to plasma proteins (up to 99%), dialysis is unlikely to be useful in case of overdose. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with intravenous diazepam. Other support measures may be required in relation to the patient's clinical conditions. For more information, contact the local anti-veleni center.

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, SPIDIDOL it must not be administered unless clearly necessary. If SPIDIDOL 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 a: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can be necessary at very low doses; - inhibition of uterine contractions resulting in delay or prolongation of labor, SPIDIDOL is contraindicated during the third trimester of pregnancy It is also not recommended to use the product during breastfeeding and childhood.

Source: Farmadati