ASPIRINA OS GRAT 10BUST400+240

ASPIRINA 400 MG EFFERVESCENT GRANULATE WITH VITAMIN C

active principles

One sachet contains: active principles: acetylsalicylic acid: 400 mg; ascorbic acid (vitamin C): 240 mg. Excipients: sucrose, sicovit (E110). For the complete list of excipients see paragraph 6.1.

Exceptions

Citric acid; monobasic sodium citrate; sodium bicarbonate; sodium carbonate; orange concentrate; orange flavor powder; saccharin E 110; sucrose.

Therapeutic indications

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

Contraindications

ASPIRINA effervescent granules with vitamin C are contraindicated in case of: - hypersensitivity to the active substances (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; - bleeding diathesis; - severe renal, cardiac or hepatic impairment - glucose-6-phosphate dehydrogenase (G6PD/favism) deficiency; - concomitant treatment with methotrexate (at doses of 15 mg/week or more) or 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 under the age of 16; - Nephrolithiasis or previous history of nephrolithiasis; - Hyperoxaluria; - Hemochromatosis.

Posology

Adults pour the content of the sachet in half a glass of water. Mix with a teaspoon. Before drinking wait for the slight effervescence. 1 sachet by repeating, if necessary, the dose at intervals of 4-8 hours up to 3-4 times a day. The use of the product is reserved for adult patients alone. Always use the minimum effective dosage and increase it only if it is not enough to relieve symptoms (pain and fever). The subjects most exposed to the risk of serious side effects, who can use the drug only if prescribed by the doctor, must scrupulously follow their instructions (see section 4.4). Do not take the product for more than 3-5 days without the doctor's opinion. Consult the doctor in case the symptoms persist. Use the medicine for the shortest possible period. Take the medicine preferably after the main meals or, in any case, on a full stomach. Special populations Pediatric population Effervescent granules aspirin with vitamin C is not indicated for use in the pediatric population (see section 4.4). Elderly people In elderly patients, use the minimum effective dosage Patients with impaired liver function Acetylsalicylic acid should be used with caution in patients with hepatic impairment (see section 4.4). Patients with renal function impairment Acetylsalicylic acid should be used with caution in patients with impaired renal function (see section 4.4).

Storage

Store at a temperature below 25°C.

Warnings

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, urticaria) . In subjects with asthma and/or rhinitis (with or without nasal polyposis) and/or urticaria the 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: - Subject to greater risk of hypersensitivity reactions (see above) - Subjects at increased risk of gastrointestinal lesions Acetylsalicylic acid and other fans can cause serious side effects at the gastrointestinal level (bleeding, ulcer, perforation). For this reason these drugs must not be used by subjects with gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that those who have suffered from gastrointestinal ulcer or gastrointestinal bleeding are also prudent. The risk of gastrointestinal lesions is a related dose effect, as gastrolesiveness is greater in subjects that make a higher doses of acetylsalicylic acid. Even the subjects with habit of taking strong quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular) (see section 4.5). - Subjects with coagulation defects or in treatment 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 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 treated with diuretics. This can be particularly dangerous for the elderly and for people with impaired kidney or heart or liver function. - Subjects with asthma Acetylsalicylic acid and other NSAIDs can cause asthma to worsen. - Geriatric age (especially above 75 years) The risk of serious side effects is higher in elderly people. People over the age of 70, especially in the presence of concomitant therapies, should use Aspirin 400 mg effervescent granules only after consulting their doctor. Aspirin 400mg effervescent granules 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, whether or not they have a fever. In certain viral diseases, especially influenza A, influenza B and chicken pox, there is a risk of Reye's Syndrome, a very rare but life-threatening disease which requires immediate medical attention. The risk can '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 can 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 antagonizing effect with uricosuric drugs is also possible (see section 4.5).- People who are prone to calcium oxalic nephrolithiasis (kidney stones) or who have recurrent nephrolithiasis Vitamin C (ascorbic acid) should be used with caution by individuals predisposed to calcium-oxalic nephrolithiasis (kidney stones) or with recurrent nephrolithiasis. - Association of drugs not recommended or requires special precautions or a dosage adjustment. The use of acetylsalicylic acid in association with some drugs can increase the risk of serious side effects (see section 4.5). Do not use acetylsalicylic acid together with another fans or, in any case, do not use more than one fans at a time. Sodium This medicinal product contains 469 mg sodium per sachet, equivalent to 23% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Sucrose This medicinal product contains 5.6 g of sucrose per sachet. To be taken into consideration in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. Orange-yellow dye (E 110) May cause allergic reactions. If you have to undergo surgery (even a minor one, for example the extraction of a tooth) and you have used acetylsalicylic acid or another NSAID in the previous days, you must inform the surgeon for the possible effects on coagulation . Since l 'acetylsalicylic acid can cause gastrointestinal bleeding must be taken into account in case it is necessary to perform a search for occult blood. Before administering any medicine, all the precautions necessary to prevent unwanted reactions must be taken; particularly important is the exclusion of previous hypersensitivity reactions to this or other medicines and the exclusion of other contraindications or conditions that can expose you to the risk of potentially serious side effects listed above. If in doubt consult your doctor or pharmacist. The intake of the product must take place on a full stomach.

Interactions

Contraindicated associations (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 impaired. - Warfarin: severely increased risk of haemorrhage due to enhancement 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) Platelet aggregation inhibitors: increased risk of haemorrhage 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 (excluding topical use): 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 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 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 simultaneously with other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalized urine. Antidiabetics (e.g. insulin and oral hypoglycaemics): increased hypoglycaemic 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 therapy 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 salicylate levels. Conversely, after discontinuation of corticosteroid treatment, an overdose of salicylates can occur. Metoclopramide: increase in the effect of acetylsalicylic acid due to an increase in the rate of absorption. Uricosurics (e.g. probenecid, benzbromarone): decreased uricosuric effect. Zafirlukast: increased plasma concentration of zafirlukast. Deferoxamine: Concomitant use of ascorbic acid can lead to increased tissue toxicity of iron especially at the cardiac level and cause heart failure. Aspirin 400mg effervescent granules 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 prolongation of bleeding time. However, it is advisable not to administer other oral drugs within 1 or 2 hours of using the product. Interference with clinical laboratory tests Vitamin C Since vitamin C is a reducing agent (i.e. an electron donor), it may cause chemical interference in laboratory tests involving redox 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 though it has no effect on blood glucose levels.

Effects

The undesirable effects observed most frequently concern 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 ailments can be partially relieved by taking the medicine with food. Most side effects are dependent on both dose and duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs. Pathologies of the hemolymphopoietic system: prolonged bleeding time, haemorrhage from gastrointestinal bleeding, reduction of platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, haemorrhagic/iron deficiency anemia may occur (due, for example, to occult microhaemorrhages) with the relative alterations of laboratory parameters and the relative clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Pathologies of the nervous system: 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 potentially lethal. Pathologies of the ear and labyrinth: tinnitus (buzzing/rustling/ringing/whistling in the ear). Respiratory, thoracic and mediastinal disorders: respiratory disease exacerbated by acetylsalicylic acid, asthmatic syndrome, rhinitis (profuse rhinorrhoea), nasal congestion (associated with hypersensitivity reactions). Epistaxis. Heart pathologies : cardiorespiratory distress (associated with hypersensitivity reactions). Eye pathologies : conjunctivitis (associated with hypersensitivity reactions). Gastrointestinal pathologies: gastrointestinal bleeding (occult), gastric discomfort, heartburn, gastrointestinal pain, gingivorrhagia. Vomiting, diarrhoea, nausea, abdominal pain cramps forms (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting of blood or "coffee-staying" material), melena (emission of black stools, spruce), oesophagitis. Very rarely: haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and laboratory parameter changes. Frequency not known (especially in long-term treatment): - Disease of the intestinal diaphragms. Hepatobiliary pathologies : rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases. Pathologies of the skin and subcutaneous tissues : rash, oedema, urticaria, pruritus, erythema, angioedema (associated with hypersensitivity reactions). Renal and urinary pathologies : impaired renal function (in the presence of conditions of impaired renal haemodynamics) and acute renal injury, urogenital haemorrhage. General disorders and administration site conditions : procedural haemorrhages, hematomas. Immune system disorders : rarely: anaphylactic shock with related alterations of laboratory parameters and clinical manifestations. (*) Reye's Syndrome (SdR) The SR initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic suffering of various entities: from listlessness, drowsiness or personality alterations (irritability or aggressiveness) to disorientation, confusion or delirium leading to seizures or loss of consciousness. The variability of the clinical picture must be kept in mind: even vomiting may be absent or replaced by diarrhea. If these symptoms occur in the days immediately following an episode of flu (or flu-like or chicken pox or another viral infection) during which acetylsalicylic acid or other salicylate-containing medicines have been administered, medical attention should be immediately addressed to the possibility of a SdR. Reporting of suspected adverse reactions The reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Acetylsalicylic acid Salicylate toxicity (a dosage higher than 100 mg/kg/day for 2 consecutive days can induce toxicity) can be the consequence of a chronic assumption of excessive doses, or of acute overdose, potentially life-threatening and which also includes accidental ingestion in children. Chronic salicylate poisoning The poisoning chronic from salicylates can be insidious since the signs and symptoms are non-specific. Mild chronic salicylate poisoning, or salicylicism, usually 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. Acute salicylate poisoning The main feature of intoxication acute it is a serious alteration of the acid-base balance, which can vary with age and 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, formation of concretions in the stomach, or as a result of ingestion of gastro-resistant preparations. The management of an acetylsalicylic acid poisoning is determined by the extent, stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken are the acceleration of drug excretion and the restoration of 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 POISONING		Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis
Tachypnea, hyperventilation, respiratory alkalosis	Alkalemia, alcaluria	Fluid and electrolyte management
Sweating
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: Variables from hyperventilation and non-cardiogenic pulmonary edema to respiratory arrest and asphyxiation
Cardiovascular: ranging from arrhythmias and hypotension to cardiac arrest	E.g. blood pressure changes, ECG changes
Loss of fluids and electrolytes: dehydration, from oliguria to renal failure	E.g. hypokalaemia, hypernatremia, hyponatraemia, impaired renal function	Fluid and electrolyte management
Alterations of glucose metabolism, keto–si	Hyperglicemia, hypoglycaemia (especially in children) increased levels of ketones
Tinnitus, deafness
Gastrointestinal: gastrointestinal bleeding, gastric ulcer
Haematological: coagulopathy, iron deficiency anemia	E.g. PT extension, hypoprotrombinemia
Neurological: toxic encephalopathy and CNS depression with manifestations variable from lethargy and confusion up to coma and convulsions. Cerebral edema.
Liver: liver damage	Increased levels of liver enzymes

At high doses, the following may also appear: Taste alterations. Skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, scaling, bullous, purpuric), pruritus. Others: Conjunctivitis, anorexia, reduced visual acuity, somnolence. Rarely: aplastic anaemia, agranulocytosis, disseminated intravascular coagulation, pancytopenia, leukopenia, thrombocytopenia, eosinopenia, purpura, eosinophilia associated with drug-induced hepatotoxicity, nephrotoxicity (allergic tubulointerstitial nephritis), haematuria (presence of blood in the urine). Acute allergic reactions following the intake of aspirin can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine. In case of overdose, contact a poison control center or the nearest hospital immediately. Acetylsalicylic acid is dialyzable. Ascorbic acid Single cases of acute and chronic overdose of ascorbic acid. Overdose of ascorbic acid can lead to oxidative hemolysis in patients with glucose-6-phosphate dehydrogenase enzyme deficiency, disseminated intravascular coagulation, and significantly elevated serum and urinary oxalate levels. Increased levels of oxalates have been shown to result in the formation of calcium oxalate deposits in dialysis patients. High doses of vitamin C can cause calcium oxalate deposits, calcium oxalate crystalluria in patients prone to crystal formation, tubulointerstitial nephropathy, and acute renal failure resulting from calcium oxalate crystals.

Fertility

The use of acetylsalicylic acid like any drug that inhibits prostaglandin synthesis and cyclooxygenase could interfere with fertility; of what 'the female subjects and in particular women who have fertility problems or who are undergoing investigations on fertility should be informed.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% 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 increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have 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 may expose: the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the unborn child, at the end of pregnancy, to: - possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy.

Feeding time

ASPIRINA effervescent granules with vitamin C are contraindicated during breastfeeding (see section 4.3).

Source: Farmadati