Spididol 400mg Granules For Oral Solution Mint-Aniseed Flavor 12 Sachets

Granules based on ibuprofen.

Therapeutic indications

Spididol is used for the treatment of various origins and nature: headache, toothache, neuralgia, osteo-joint and muscle pain, menstrual pain and as an adjunct in the symptomatic treatment of fever and flu.

Dosage and Posology

The drug should be taken according to the following doses and methods:

• 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 adhere to 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.
• Caution should be exercised in the treatment of patients with impaired hepatic function. In such patients, periodic monitoring of clinical and laboratory parameters should be resorted to, especially in the case of prolonged treatment. The use of Spididol is contraindicated in patients with severe hepatic insufficiency
• Renal insufficiency: caution should be used in the treatment of patients with impaired renal function. In such patients, periodic monitoring of clinical and laboratory parameters should be resorted to, especially in the case of prolonged treatment. The use of Spididol is contraindicated in patients with severe renal insufficiency.
• In adolescents (aged ≥ 12 to <18 years): if use of the medicinal product is necessary for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms. The tablet should be swallowed with some water. For patients with a more sensitive stomach it is recommended to take it with food. The granulate must be dissolved in a glass of water (50-100 ml) and taken immediately after the preparation of the solution. The granules for oral solution should be taken with food.

Overdose

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.

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, metabolic acidosis, 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.

There is no specific antidote to ibuprofen overdose. In the event of an overdose, symptomatic and supportive treatment is therefore 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 clinical condition of the patient, other supportive measures may be necessary. For more information, contact your local poison control center.

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
• History of gastrointestinal bleeding or perforation related to previous treatment with non-steroidal 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 bleeding in progress such as cerebrovascular
• Ulcerative colitis and Crohn's disease.
• Severe hepatic and / or renal insufficiency
• Hemorrhagic 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

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 bleeding, sometimes fatal, may occur, particularly in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, heartburn, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of Spididol. Gastritis was observed less frequently. Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (very rarely). 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).

The following table shows the frequency of adverse events: Frequency: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1000 to <1/100); rare (≥1 / 10,000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data)

- 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, somnolence: Uncommon
• Depression, psychotic reaction, aseptic meningitis: Not known
• Sensory clouding: Very rare

- Ear and labyrinth disorders

• Tinnitus, hearing disorders: Rare

- Eye disorders

• Blurred vision, amblyopia: Rare
• Papilloedema: Not known

- Skin and subcutaneous tissue disorders

• Skin rash, skin disease: Common
• Pruritus, 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

- 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

• Liver disorders: Rare
• Liver damage, hepatitis, jaundice: Not known

- Diagnostic tests

• Liver function test abnormal (transaminases increased), color vision disorder: Rare
• Renal function test abnormal: Not known

- Disorders of the immune system

• Allergic reactions: Uncommon
• Anaphylaxis: Rare
• Anaphylactic shock: Not known

- Respiratory, thoracic and mediastinal disorders

• Asthma, asthma aggravation, 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

The appearance of undesirable effects during the course of treatment requires the immediate suspension of therapy and the consultation of the attending physician. 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).

Pregnancy and breastfeeding

The medicine is contraindicated in case of confirmed and presumed pregnancy, and during breastfeeding.

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 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. Furthermore, 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 bleeding time, and antiplatelet effect which may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labor.

Special warnings

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. 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. 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, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased 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.

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 could 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. 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 can be exacerbated.

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. 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. 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, periodic monitoring of clinical and laboratory parameters should be resorted to, especially in the case of prolonged treatment. 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 carry out 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 may cause impairment of female fertility through an effect on ovulation. Spididol administration 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.

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 56.96 mg and 82.62 mg of sodium for the granules and tablet packs, respectively. This information should be taken into consideration in the case of patients who are on a low sodium diet.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store below 25 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One sachet of Spididol contains:

Active principle

Ibuprofen arginine salt, equivalent to ibuprofen 400 mg

Excipients

-Arginine, Sodium bicarbonate, Saccharin sodium, Aspartame, Mint flavor, Anise flavor, Sucrose