Aspirin 400mg 10 effervescent tablets with vitamin C

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic therapy of feverish states and flu and cold syndromes. Symptomatic treatment of headaches and toothaches, neuralgia, menstrual pain, rheumatic and muscular pain.

CONTRAINDICATIONS

ASPIRIN tablets effervescent with vitamin C is contraindicated in case of: - hypersensitivity to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics (painkillers) / antipyretics (antipyretics) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; - gastroduodenal ulcer; - hemorrhagic diathesis; - severe renal, cardiac or hepatic failure; - 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 breastfeeding (see section 4.6); - children and young people under 16 years of age. - Nephrolithiasis or previous history of nephrolithiasis - Hyperoxaluria - Hemochromatosis

WARNINGS AND PRECAUTIONS FOR USE

Hypersensitivity reactions Acetylsalicylic acid and other NSAIDs may cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). The risk is greater in subjects who have already presented a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who present allergic reactions to other substances (e.g. skin reactions, itching, urticaria). In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria the reactions may be more frequent and serious. In rare cases, reactions can be very serious and potentially fatal. In the following cases, administration of the drug requires a doctor's prescription after careful evaluation of the risk/benefit ratio: - Subjects at increased risk of hypersensitivity reactions (see above) - Subjects at increased risk of gastrointestinal lesions Acetylsalicylic acid and other NSAIDs can cause serious side effects at the gastrointestinal level (bleeding, ulcer, perforation). For this reason these drugs should not be used by subjects suffering from gastrointestinal ulcers or gastrointestinal bleeding. It is prudent for those who have suffered from gastrointestinal ulcers or gastrointestinal bleeding in the past to avoid its use. The risk of gastrointestinal lesions is a dose-related effect, as gastrointestinal lesions are 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 paragraph 4.5). - Subjects with coagulation defects or being treated with anticoagulants In subjects suffering from coagulation defects or being treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacity, exposing them to the risk of haemorrhage. - Subjects with impaired renal, 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 treated with diuretics. This can be especially dangerous for the elderly and for those with impaired kidney, heart or liver function. - Subjects suffering from asthma Acetylsalicylic acid and other NSAIDs can cause an aggravation of asthma. - Geriatric age (especially above 75 years) The risk of serious side effects is greater in geriatric subjects. Individuals over the age of 70, especially in the presence of concomitant therapies, should use Aspirin only 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 16 years of age with viral infections, regardless of the presence or absence of 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 intervention. The risk may be increased in case of simultaneous 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, delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5).- Subjects with a predisposition to calcium-oxal 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-oxal 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. 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 due to the possible effects on coagulation. Since acetylsalicylic acid can cause gastrointestinal bleeding, this must be taken into account if it is necessary to carry out a search for occult blood. Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or other medicines and the exclusion of other contraindications or conditions that may expose you to the risk of potentially serious side effects listed above. If in doubt, consult your doctor or pharmacist. 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 tolerability of the active ingredient. In this case, it is still advisable to ask the pharmacy for the packaging to be replaced. The product must be taken on a full stomach. Information on excipients This medicinal product contains 467 mg sodium per effervescent tablet equivalent to 23% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONS

Contraindicated combinations (avoid concomitant use - see section 4.3): - Methotrexate (doses greater than or equal to 15 mg/week): increased plasma levels and toxicity of methotrexate; the risk of toxic effects is greater if renal function is compromised. - Warfarin: serious increase in the risk of hemorrhage due to enhancement of the anticoagulant effect. Associations not recommended (the 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 hemorrhage due to the sum of the anti-aggregating effect. Oral or parenteral thrombolytics or anticoagulants: increased risk of bleeding due to enhancement of the pharmacological effect. NSAIDs (topical use excluded): increased risk of serious side effects. Methotrexate (doses less than 15mg/week): the increased risk of toxic effects (see above) must also be considered for treatment with methotrexate at low doses. Selective serotonin re-uptake inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect. Associations requiring particular precautions or dosage adjustment (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk/benefit ratio - 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; the excretion of acetylsalicylic acid increases in alkalinized urine. Antidiabetics (e.g. insulin and oral hypoglycemics): increased hypoglycemic effect; the use of acetylsalicylic acid in subjects being treated with antidiabetics must take into account the risk of inducing hypoglycemia. Digoxin: increased plasma concentration of digoxin due to decreased renal elimination. Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; reduction of the 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. On the other hand, after discontinuation of corticosteroid treatment, overdose of salicylates may occur. Metoclopramide: increase in the effect of acetylsalicylic acid due to an increase in the speed of absorption. Uricosurics (e.g. probenecid, benzbromarone): decrease in the 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 at the cardiac level and cause heart failure. Aspirin effervescent tablets with Vitamin C contain buffer systems that 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 prolongation of bleeding time. However, it is advisable not to administer other drugs orally within 1 or 2 hours of using the product. Interference with clinical laboratory tests Vitamin C Because vitamin C is a reducing agent (i.e., an electron donor), it may cause chemical interference in laboratory tests involving oxidation-reduction reactions, such as analyzes of glucose, creatinine, carbamazepine, uric acid in urine, serum, and fecal occult blood. Vitamin C can interfere with tests that measure urine and blood glucose leading to a false reading of the results even if it has no effect on blood glucose levels.

SIDE EFFECTS

The most frequently observed side effects affect the gastrointestinal system and can occur in approximately 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 side effects are dependent on both the dose and duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs. Pathologies of the blood and lymphatic system Prolonged bleeding time, anemia due to gastrointestinal bleeding, reduction in platelets (thrombocytopenia) in extremely rare cases. Following hemorrhage, hemorrhagic/iron-deficiency anemia may occur (due, for example, to occult microhemorrhages) with the related alterations in laboratory parameters and the related clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Nervous system disorders Headache, dizziness. Rarely: Reye's syndrome (*) Rarely to very rarely: cerebral hemorrhage, especially in patients with uncontrolled hypertension and/or on anticoagulant therapy, which, in isolated cases, can be potentially lethal. Ear and labyrinth disorders Tinnitus (buzzing/rustling/ringing/ringing in the ears). Respiratory, thoracic and mediastinal disorders Respiratory disease exacerbated by acetylsalicylic acid, asthma syndrome, rhinitis (profuse rhinorrhoea), nasal congestion (associated with hypersensitivity reactions). Epistaxis. Cardiac diseases Cardiorespiratory distress (associated with hypersensitivity reactions) Eye pathologies Conjunctivitis (associated with hypersensitivity reactions) Gastrointestinal disorders Gastrointestinal bleeding (occult), gastric disorders, heartburn, gastrointestinal pain, gingivorrhagia. Vomiting, diarrhoea, nausea, crampy abdominal pain (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, hematemesis (vomiting of blood or "coffee-like" material), melena (emission of black stools, esophagitis). Very rarely: hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with the related clinical signs and symptoms and alterations of laboratory parameters. Frequency not known (especially in long-term treatment): - Disease of the intestinal diaphragms. Hepatobiliary disorders Rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases. Pathologies of the skin and subcutaneous tissues Rash, edema, urticaria, pruritus, erythema, angioedema (associated with hypersensitivity reactions). Renal and urinary disorders Alteration of renal function (in the presence of conditions of altered renal hemodynamics) and acute renal injury, urogenital haemorrhages. Systemic pathologies and conditions relating to the administration site Procedural hemorrhages, hematomas. Immune system disorders Rarely: anaphylactic shock with related alterations in laboratory parameters and clinical manifestations. (*) Reye's syndrome (SdR) SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic distress of varying degrees: from listlessness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture must be kept in mind: vomiting may also be absent or replaced by diarrhea. If these symptoms arise in the days immediately following a flu episode (or flu-like or chickenpox or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates were administered, the doctor's attention must immediately be paid to the possibility of an SdR. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 of the Italian Medicines Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.