Spididol 400mg 12 coated tablets

Spididol 400mg 12 coated tablets is a drug based on ibuprofen arginine salt , known for its anti-inflammatory and analgesic properties. Each coated tablet contains 400 mg of active ingredient, designed to relieve a wide range of pain of various origins , including headache, toothache, neuralgia, osteoarticular and muscular pain, as well as menstrual pain. It is also used as an adjuvant in the symptomatic treatment of feverish and flu states. The tablets are coated with film to facilitate intake and improve gastric tolerability. Spididol is an effective solution for those seeking rapid and long-lasting relief from painful symptoms.

ACTIVE INGREDIENTS

Active ingredients contained in Spididol 400mg 12 coated tablets - What is the active ingredient of Spididol 400mg 12 coated tablets?

SPIDIDOL 400 mg granules for oral solution, apricot flavour One sachet contains: Active ingredient 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, cola-lemon flavour One sachet contains: Active ingredient 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 tablets One film-coated tablet contains: Active ingredient Ibuprofen arginine salt, equivalent to ibuprofen 400 mg Excipients: Sodium Sucrose For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Spididol 400mg 12 coated tablets - What does Spididol 400mg 12 coated tablets contain?

Apricot flavoured oral solution granules: l-Arginine, Sodium bicarbonate, Sodium saccharin, Aspartame, Apricot flavour, Sucrose Cola-lemon flavoured oral solution granules: l-Arginine, Sodium bicarbonate, Sodium saccharin, Aspartame, Cola-lemon flavour, Sucrose Film-coated tablets: l-Arginine, Sodium bicarbonate, Crospovidone, Magnesium stearate, Hydroxypropyl methylcellulose, Sucrose, Titanium dioxide, Polyethylene glycol.

DIRECTIONS

Therapeutic indications Spididol 400mg 12 coated tablets - Why is Spididol 400mg 12 coated tablets used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Spididol 400mg 12 coated tablets - When should Spididol 400mg 12 coated tablets not be used?

• 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 paragraph 6.1. • History of gastrointestinal bleeding or perforation related to previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). • History of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Active and recurrent peptic ulcer. • Gastrointestinal bleeding • Other active bleeding such as cerebrovascular bleeding • Ulcerative colitis and Crohn's disease. • Severe hepatic and/or renal insufficiency • Haemorrhagic diathesis • Severe cardiac insufficiency (NYHA class IV). • Due to the possibility of cross-allergic reactions with acetylsalicylic acid or other nonsteroidal 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 must 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 cardiac surgery.

DOSAGE

Quantity and method of taking Spididol 400mg 12 coated tablets - How to take Spididol 400mg 12 coated tablets?

Adults and children over 12 years: 1 film-coated tablet or 1 sachet, two-three times a day. The maximum daily dose must not exceed 1200 mg per day. - Elderly: Elderly patients should adhere to the minimum dosages indicated above. In the treatment of elderly patients, the dosage must be carefully established by the doctor who must evaluate a possible reduction of the dosages indicated above. - In patients with impaired renal, hepatic or cardiac function, the dosages should be reduced. - Hepatic insufficiency: caution must be adopted in the treatment of patients with reduced hepatic function. In such patients, periodic monitoring of clinical and laboratory parameters is advisable, especially in the 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 must be adopted in the treatment of patients with reduced renal function. In such patients, periodic monitoring of clinical and laboratory parameters is recommended, especially in the 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 < 18 years): if the use of the medicinal product is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, a doctor must be consulted. The lowest effective dose should be used for the shortest period to relieve symptoms (see section 4.4). Method of administration: The tablet should be swallowed with a little water. For patients with a more sensitive stomach, it is recommended to take it with food. The granules should be dissolved in a glass of water (50-100 ml) and taken immediately after preparing the solution. The granules for oral solution should be taken with food.

CONSERVATION

Storage Spididol 400mg 12 coated tablets - How to store Spididol 400mg 12 coated tablets?

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

WARNINGS

Warnings Spididol 400mg 12 coated tablets - About Spididol 400mg 12 coated tablets it is important to know that:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and Gastrointestinal and cardiovascular risks below). Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, 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 II-III), established ischaemic 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 in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), especially if high doses (2400 mg/day) of ibuprofen are required. The use of SPIDIDOL with NSAIDs, including selective COX-2 inhibitors, should be avoided. 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 may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low dose aspirin or other drugs likely to increase GI risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. At daily doses exceeding 1000 mg ibuprofen may prolong bleeding time. Caution should be exercised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving SPIDIDOL the treatment should be withdrawn. 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). Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported in relation to medicinal products containing ibuprofen. SPIDIDOL should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Hepatotoxic reactions may occur in the context of generalized hypersensitivity reactions. Caution should be exercised when treating 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, periodic monitoring of clinical and laboratory parameters is recommended, especially in the case of prolonged treatment (see section 4.2). In patients with or with a history of bronchial asthma or allergic disease, bronchospasm may be aggravated. Systemic lupus erythematosus or other collagen diseases are risk factors for serious manifestations of generalized hypersensitivity, therefore caution is required in patients with these pathologies. Since ocular alterations have been observed, even if very rarely, during treatment with ibuprofen, it is recommended to stop treatment and perform an ophthalmological examination in the event of the onset of vision problems. The use of SPIDIDOL, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant, as it may cause impairment of female fertility through an effect on ovulation. SPIDIDOL should be discontinued in women who have fertility problems or who are undergoing investigation of fertility (see section 4.6). Caution should be exercised when initiating treatment with ibuprofen in patients with severe dehydration. Masking of symptoms of underlying infections SPIDIDOL may mask the symptoms of infection, which may delay initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. In isolated cases, exacerbation of infectious inflammation (e.g. development of necrotising fasciitis) has been described in temporal correlation with NSAIDs. Therefore, in patients affected by infection, ibuprofen therapy should be used with caution. When SPIDIDOL is administered for the relief of fever or pain related to infection, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. NSAIDs may cause an increase in liver function test results. Alcohol consumption should be avoided as it may intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. Medically assisted measures should be initiated by specialized medical personnel, in line with the symptoms. Ibuprofen acid may cause a prolongation of bleeding time by reversibly inhibiting platelet aggregation. SPIDIDOL contains 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 tablets respectively, equivalent to 2.85% and 4.15% respectively of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. This information should be taken into account in patients on a low-sodium diet. SPIDIDOL contains 60 mg of aspartame per sachet for the cola-lemon and apricot-flavored granules. Orally ingested aspartame is hydrolyzed in the gastrointestinal tract. Phenylalanine is the main product of its hydrolysis.

INTERACTIONS

Interactions Spididol 400mg 12 coated tablets - Which medicines or foods can modify the effect of Spididol 400mg 12 coated tablets?

Diuretics, ACE inhibitors and angiotensin II antagonists : NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is 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 consideration should be given to monitoring renal function 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 carefully monitored during the first weeks of combined treatment and the dosage of anticoagulants may require adjustment. 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, probably due to sodium retention associated with inhibition of prostaglandin synthase at renal level. Beta-blockers: the hypotensive effect of beta-blockers may be reduced. Concomitant use of NSAIDs and beta-blockers may be associated with the risk of acute renal failure. Other nonsteroidal 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 adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is 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 have been reported in the literature. Methotrexate : Ibuprofen may cause an increase in plasma levels of methotrexate. Zidovudine : Concomitant therapy with zidovudine and ibuprofen may increase the risk of haemarthrosis and haematoma in HIV(+) haemophiliac patients. Tacrolimus : Concomitant use of ibuprofen and tacrolimus may increase the risk of nephrotoxicity due to the reduction in renal synthesis of prostaglandins. Hypoglycaemic drugs : Ibuprofen increases the hypoglycaemic effect of oral hypoglycaemic drugs and insulin. It may be necessary to adjust the dosage. Ciclosporin : Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to an increased risk of ciclosporin nephrotoxicity. Voriconazole or fluconazole : Concomitant use of ibuprofen may lead to an increase in ibuprofen exposure and plasma concentration. Mifepristone : Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to an increase in NSAID exposure. A decrease in mifepristone efficacy may theoretically occur due to the antiprostaglandin properties of NSAIDs. 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 pregnancy termination protocol. Quinolone antibiotics : Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) may lead to an increased risk of convulsions. Herbal extracts : Ginkgo biloba may increase the risk of bleeding with NSAIDs. Alcohol, bisphosphonates, and pentoxifylline : May increase gastrointestinal side effects and the risk of bleeding and ulceration. Baclofen : High toxicity of baclofen. Aminoglycosides : NSAIDs may decrease the excretion of aminoglycosides. Interactions with diagnostic test results: - Bleeding time (may prolong bleeding time up to 1 day after discontinuation of therapy), - Serum glucose concentrations (may decrease), - Creatinine clearance (may decrease), - Haematocrit or haemoglobin (may decrease), - BUN, serum creatinine and potassium concentrations (may increase), - Liver function tests (an increase in transaminases may occur).

SIDE EFFECTS

Like all medicines, Spididol 400mg 12 coated tablets can cause side effects - What are the side effects of Spididol 400mg 12 coated tablets?

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, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, 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). Less frequently, gastritis has been observed. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (very rarely) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome). Cardiac and vascular disorders : Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). The following table shows the frequency of adverse events: Frequency: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).

*NSAID class effect The appearance of adverse reactions during treatment requires immediate suspension of therapy and consultation with the attending physician. Paediatric population From cumulative clinical experience, there is no clinically relevant difference in nature, frequency, severity and reversibility of adverse reactions between the safety profile in adults and the approved paediatric population (≥12 years). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance 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.

OVERDOSE

Overdose Spididol 400mg 12 coated tablets - What are the risks of Spididol 400mg 12 coated tablets in case of overdose?

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, in some cases supportive treatment may be necessary. 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 exhibit symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, gastralgia, abdominal pain, lethargy and somnolence. Central nervous system (CNS) effects include headache, tinnitus, dizziness, diplopia, spasms, ataxia, rhabdomyolysis, seizures, convulsions and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and CNS and respiratory depression have also been reported rarely. Disorientation, excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote for ibuprofen overdose. Symptomatic and supportive treatment is therefore indicated in the event of overdose. Particular attention should be paid to monitoring blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount. Alternatively, gastric lavage and correction of severe electrolyte abnormalities should be considered within one hour of ingestion of a potentially life-threatening overdose in adults. Given the high degree of plasma protein binding of ibuprofen (up to 99%), dialysis is unlikely to be beneficial in overdose. Adequate diuresis should be ensured and renal and hepatic function should be closely monitored. The patient should be observed for at least four hours following ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. Contact your local poison control center for more information.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Spididol 400mg 12 coated tablets.

Pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in 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. From the twentieth week of pregnancy onwards, the use of NSAIDs may cause oligohydramnios resulting from fetal renal dysfunction. This condition may occur soon after initiation of treatment and is usually reversible upon discontinuation of treatment. In addition, cases of constriction of the ductus arteriosus have been reported following treatment in the second trimester, most of which resolved after discontinuation of treatment. Therefore, during the first and second trimester of pregnancy, SPIDIDOL should not be administered unless clearly necessary. If SPIDIDOL is used by a woman planning a pregnancy, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Following exposure to SPIDIDOL for several days from the twentieth week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with SPIDIDOL should be discontinued. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating 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 (see sections 4.3 and 5.3). The use of the product during breastfeeding and in childhood is also not recommended.

DRIVING AND USE OF MACHINERY

Taking Spididol 400mg 12 coated tablets before driving or using machines - Does Spididol 400mg 12 coated tablets affect driving or using machines?

Due to the possible occurrence of drowsiness, dizziness, headache and depression, SPIDIDOL may compromise the ability to drive vehicles and use machines. Patients whose activity requires alertness should be cautious if they notice drowsiness, dizziness, headache or depression during therapy with ibuprofen.