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Symptomatic therapy of febrile states and flu and cold syndromes. Symptomatic treatment of head and tooth pain, neuralgia, menstrual pain, rheumatic and muscular pain.
Adults a) 1-2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours up to 2-3 times a day. The tablets should always be taken with water, tea, lemonade, etc. b) 1-2 tablets as a single dose, repeating, if necessary, the dose at intervals of 4-8 hours up to 3-4 times a day. Aspirin C must always be dissolved before use (1 tablet in half a glass of water). The use of the product is reserved for adult patients only. Always use the lowest effective dosage and only increase it if it is not sufficient to relieve symptoms (pain and fever). Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. Those most exposed to the risk of serious side effects, who can use the drug only if prescribed by the doctor, must strictly follow the instructions (see section 4.4) . Use the medicine for the shortest period possible. Do not take the product for more than 3 - 5 days without medical advice. Consult your doctor if symptoms persist. Take the medicine preferably after main meals or, in any case, on a full stomach. Pediatric population Aspirin tablets and Aspirin effervescent tablets with vitamin C are not indicated for use in the pediatric population (see section 4.4).
ASPIRIN tablets and ASPIRIN tablets Effervescent with vitamin C are contraindicated in case of: - hypersensitivity to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics (painkillers) / antipyretics (antifebrile) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; - gastroduodenal ulcer; - hemorrhagic diathesis; - severe renal, cardiac or hepatic insufficiency; - glucose -6-phosphate dehydrogenase deficiency (G6PD / favism); - concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin (see section 4.5); - history of asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs; - last trimester of pregnancy and lactation (see section 4.6); - children and young people under the age of 16.
The most frequently observed side effects are affecting the gastrointestinal tract and can occur in about 4% of subjects taking acetylsalicylic acid as an analgesic-antipyretic. This percentage increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most undesirable effects are dependent on both the dose and the duration of treatment. The side effects seen with acetylsalicylic acid are generally common to other NSAIDs. Disorders of the blood and lymphatic system Prolonged bleeding time, gastrointestinal bleeding anemia, reduced platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia may occur (due, for example, to occult micro-haemorrhages) with the relative alterations of laboratory parameters and the relative clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Nervous system disorders Headache, dizziness. Rarely: Reye's syndrome (*) Rarely to very rarely: cerebral haemorrhage, especially in patients with uncontrolled hypertension and / or on anticoagulant therapy, which, in isolated cases, can be life threatening. Ear and labyrinth disorders Tinnitus (buzzing / rustling / ringing / ear whistling). Respiratory, thoracic and mediastinal disorders Asthmatic syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions). Epistaxis. Cardiac pathologies Cardiorespiratory distress (associated with hypersensitivity reactions) Eye disorders Conjunctivitis (associated with hypersensitivity reactions) Gastrointestinal disorders Gastrointestinal (occult) bleeding, gastric upset, heartburn, gastrointestinal pain, gingivorrhagia. Vomiting, diarrhea, nausea, crampy abdominal pain (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting of blood or "coffee" material), melaena (emission of black stools, picee), esophagitis. Very rarely: haemorrhagic gastrointestinal ulcer and / or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters. Hepatobiliary disorders Rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular lesion) manifested by an increase in transaminases. Skin and subcutaneous tissue disorders Rash, edema, urticaria, itching, erythema, angioedema (associated with hypersensitivity reactions). Renal and urinary disorders Alteration of renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding. General disorders and administration site conditions Peri-operative haemorrhages, hematomas. Disorders of the immune system Rarely: anaphylactic shock with related changes in laboratory parameters and clinical manifestations. (*) Reye's Syndrome (SdR) The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of various entities: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea. If these symptoms arise in the days immediately following a flu (or flu-like or chickenpox or other viral infection) episode during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. to the possibility of a SdR. Reporting of suspected adverse reactions The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency. Website: http://www.agenziafarmaco.gov.it/it/responsabili.
Hypersensitivity reactions Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). The risk is greater in subjects who have already experienced a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who have allergic reactions to other substances (e.g. skin reactions, itching, hives) . In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, reactions may be more frequent and severe. In rare cases, the reactions can be very serious and potentially fatal. In the following cases, the administration of the drug requires a doctor's prescription after careful evaluation of the risk / benefit ratio: - People at increased risk of hypersensitivity reactions (see above) - Subjects at increased risk of gastrointestinal injury Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason, these drugs should not be used by subjects suffering from gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that even those who in the past have suffered from gastrointestinal ulcer or gastrointestinal bleeding avoid its use. The risk of gastrointestinal lesions is a dose related effect, as gastrolysis is greater in subjects who use higher doses of acetylsalicylic acid. Even subjects with a habit of drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular) (see section 4.5). - Subjects with coagulation defects or treated with anticoagulants Acetylsalicylic acid and other NSAIDs can cause a severe reduction in haemostatic capacity in subjects suffering from coagulation defects or treated with anticoagulants, exposing them to the risk of bleeding. - Subjects with impaired renal or cardiac or hepatic function Acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and water retention; the risk is greater in subjects being treated with diuretics. This can be particularly dangerous for the elderly and for people with impaired kidney or heart or liver function. - People with asthma Acetylsalicylic acid and other NSAIDs can cause aggravation of asthma. - Geriatric age (especially over 75 years) The risk of serious side effects is higher in people of geriatric age. People over the age of 70, especially in the presence of concomitant therapies, should only use Aspirin after consulting their doctor. Aspirin should not be used in the pediatric population (see section 4.3). Products containing acetylsalicylic acid should not be used in children and adolescents under the age of 16 with viral infections, regardless of whether or not they have a fever. In certain viral diseases, especially influenza A, influenza B and chickenpox, there is a risk of Reye's Syndrome, a very rare but life-threatening disease that requires immediate medical attention. The risk may be increased in case of concomitant intake of acetylsalicylic acid, although a causal relationship has not been demonstrated. Persistent vomiting in patients with these diseases may be a sign of Reye's syndrome. - Subjects with hyperuricemia / gout Acetylsalicylic acid can interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses can reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5). Subjects with predisposition to calcium-oxalic nephrolithiasis (kidney stones) or with recurrent nephrolithiasis Aspirin effervescent tablets with vitamin C: Vitamin C (ascorbic acid) should be used with caution by subjects with a predisposition to calcium-oxalic nephrolithiasis (kidney stones) or with recurrent nephrolithiasis. - Combination of drugs not recommended or requiring special precautions or dosage adjustment. The use of acetylsalicylic acid in combination with some drugs may increase the risk of serious side effects (see section 4.5). Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. Fertility The use of acetylsalicylic acid as well as any drug inhibiting prostaglandin synthesis and cyclooxygenase could interfere with fertility; Female subjects should be informed of this and in particular women who have fertility problems or who are undergoing fertility investigations (see section 4.6). Sodium Aspirin effervescent tablets. with Vitamin C contains 933 mg of sodium per tablet: it may not be suitable for individuals who must follow a low sodium diet. If you have to undergo surgery (even a small one, for example the extraction of a tooth) and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon for the possible effects on coagulation . Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to perform a search for occult blood. Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions; of particular importance is the exclusion of previous hypersensitivity reactions to this or other medicinal products and the exclusion of other contraindications or conditions that may expose you to risk of potentially serious side effects listed above. If in doubt consult your doctor or pharmacist. An imperfect and prolonged storage of Aspirin C can cause variations in the color of the tablet which in themselves do not affect either the activity or the tolerability of the active ingredient. In this case it is still advisable to ask for the replacement of the package at the pharmacy. The product should be taken on a full stomach.
Fertility The use of acetylsalicylic acid as well as any drug inhibiting prostaglandin synthesis and cyclooxygenase could interfere with fertility; female subjects should be informed of this and in particular women who have fertility problems or who are undergoing fertility investigations (see section 4.4) Pregnancy Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased by less than 1% up to about 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless clearly needed. If drugs containing acetylsalicylic acid are used by a woman trying to become pregnant, or during the first and second trimester of pregnancy, the treatment should be as short as possible and the dose 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 unborn child, at the end of pregnancy, to: - possible prolongation of the bleeding time, an antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. Breastfeeding Aspirin 500 mg tablets and ASPIRIN 400 mg effervescent tablets with vitamin C are contraindicated during breastfeeding (see section 4.3).
a) Blister packs Store below 30 ° C b) Store below 25 ° C.
Contraindicated combinations (avoid concomitant use - see section 4.3): - Methotrexate (doses greater than or equal to 15 mg / week): increase in plasma levels and methotrexate toxicity; the risk of toxic effects is greater if renal function is impaired. - Warfarin: severe increased risk of bleeding due to potentiation of the anticoagulant effect. Combinations not recommended (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk / benefit ratio - see section 4.4) Antiplatelet agents: increased risk of bleeding due to the sum of the antiplatelet effect. Thrombolytics or oral or parenteral anticoagulants: increased risk of haemorrhage due to enhancement of the pharmacological effect. NSAIDs (topical use excluded): increased risk of serious side effects. Methotrexate (doses below 15mg / week): The increased risk of toxic effects (see above) should also be considered for treatment with low dose methotrexate. Selective Serotonin Re-uptake Inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect. Combinations requiring special precautions or dosage adjustment (concomitant use of the two drugs requires physician prescription after careful risk / benefit assessment - see section 4.4) ACE inhibitors: reduction of the hypotensive effect; increased risk of impaired renal function. Valproic Acid: increased effect of valproic acid (risk of toxicity). Antacids: antacids taken at the same time as other drugs can reduce their absorption; excretion of acetylsalicylic acid increases in alkalized urine. Antidiabetics (e.g. insulin and oral hypoglycemic agents): increased hypoglycemic effect; the use of acetylsalicylic acid in subjects treated with antidiabetics must take into account the risk of inducing hypoglycaemia. Digoxin: increase in plasma digoxin concentration due to decreased renal elimination. Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; reduced effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (risk of toxicity). Phenytoin: increased effect of phenytoin. Corticosteroids (excluding those for topical use and those used for the treatment of adrenocortical insufficiency): a) increased risk of gastrointestinal lesions; b) due to the increased elimination of salicylates induced by corticosteroids there is a reduction in plasma levels of salicylate. Conversely, salicylate overdose may occur after discontinuation of corticosteroid treatment. Metoclopramide: increase in the effect of acetylsalicylic acid by increasing the absorption rate. Uricosurics (ex: probenecid, benzbromarone): decreased uricosuric effect. Zafirlukast: increased plasma concentration of zafirlukast. Deferoxamine Aspirin effervescent tablets with vitamin C: the concomitant use of ascorbic acid can cause increased tissue toxicity of iron especially in the heart and cause heart failure. Aspirin effervescent tablets with Vitamin C contain buffer systems which may reduce the effects of the thyroid hormone Levothyroxine. Alcohol (see section 4.4) The sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolonged bleeding time. It is however advisable not to administer other drugs orally within 1 or 2 hours of using the product.
Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of chronic overdose, or acute overdose, which is potentially life-threatening and also includes accidental ingestion in children. The poisoning chronic salicylates can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate intoxication, or salicilism, typically occurs only after repeated use of large doses. Symptoms include dizziness, vertigo, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations between 150 and 300 micrograms / ml, while more serious adverse events occur at concentrations above 300 micrograms / ml. The main feature of intoxication acute it is a serious alteration of the acid-base balance, which can vary with age and the severity of intoxication; the most common presentation in children is metabolic acidosis. It is not possible to estimate the severity of poisoning from plasma concentration alone; Absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, the formation of concrements in the stomach, or as a result of the ingestion of gastro-resistant preparations. The management of acetylsalicylic acid intoxication is determined by the extent, stage and clinical symptoms of the latter, and must be carried out according to conventional poisoning management techniques. The main measures to be taken consist in accelerating the excretion of the drug and restoring electrolyte and acid-base metabolism. Due to the complex pathophysiological effects associated with salicylate poisoning, the signs and symptoms / results of biochemical and instrumental investigations may include:
|Signs and symptoms||Results of biochemical and instrumental investigations||Therapeutic measures|
|Mild to moderate intoxication||Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis|
|Tachypnea, hyperventilation, respiratory alkalosis||Alkalemia, alkaluria||Fluid and electrolyte management|
|Nausea, vomiting, headache, dizziness|
|MODERATE TO SEVERE POISONING||Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, hemodialysis in severe cases|
|Respiratory alkalosis with compensatory metabolic acidosis,||Acidemia, aciduria||Fluid and electrolyte management|
|Hyperpyrexia||Fluid and electrolyte management|
|Respiratory: ranging from hyperventilation and non-cardiogenic pulmonary edema to respiratory arrest and asphyxiation|
|Cardiovascular: variable from arrhythmias and hypotension up to cardiocirculatory arrest||Eg. change in blood pressure, ECG change|
|Loss of fluids and electrolytes: dehydration, from oliguria to kidney failure||Eg. hypokalaemia, hypernaÂ – triemia, hyponatremia, impaired renal function||Fluid and electrolyte management|
|Alterations of glucose metabolism, ketoÂ – yes||Hyperglycaemia, hypoglycaemia (especially in children) Increased ketone levels|
|Gastrointestinal: gastrointestinal bleeding, gastric ulcer|
|Hematological: coagulopathy, iron deficiency anemia||Eg. prolongation of PT, hypoprothrombinemia|
|Neurological: toxic encephalopathy and CNS depression with manifestations ranging from lethargy and confusion to coma and convulsions. Cerebral edema.|
|Hepatic: liver damage||Increased levels of liver enzymes|
a) ASPIRIN 500 mg adult tablets One tablet contains: active principle: acetylsalicylic acid 500 mg b) ASPIRIN 400 mg effervescent tablets with vitamin C One tablet contains: active principles: acetylsalicylic acid 400 mg ascorbic acid (Vitamin C) 240 mg For a full list of excipients, see section 6.1
to) excipients: corn starch cellulose powder b) excipients: monosodium citrate sodium bicarbonate sodium carbonate anhydrous citric acid
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