ASPIRINA C 10CPR EFFERS 400+240MG

ASPIRINA 400 MG COMPRESSE EFFERENCES WITH VITAMIN C

active ingredients

ASPIRINA 400 mg effervescent tablets with vitamin C One tablet contains: active ingredients: acetylsalicylic acid 400 mg ascorbic acid (Vitamin C) 240 mg For the complete list of excipients, see paragraph 6.1

Excellent

excipients: citrate monosodium sodium bicarbonate sodium carbonate citric acid

Therapeutic indications

Symptomatic therapy of fever states and flu and cooling syndromes.

Syntomatic treatment of headaches and teeth, nerves, menstrual pain, rheumatic and muscle pain.

Contraindications

ASPIRINA tablets tablets

effervescent with vitamin C is contraindicated in case of: - hypersensitivity to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics (antidolorphic) / antipyretics (antifebbrile) / non-steroidal anti-inflammatory drugs (FANS) or to any of the excipients; - gastroduodenal ulcer; - hemorrhagic diathesis; - kidney, heart or severe liver failure; - glucose deficit -6-phosphate dehydrogenase (G6PD/favism);- concomitant treatment with metotrexate (at doses of 15 mg/week or more) or with warfarin (see paragraph 4.5); - anamnesi of asthma induced by the administration of salicylates or substances to similar activity, in particular non-steroidal anti-inflammatory drugs; - last trimester of pregnancy and nursing (see paragraph 4.6); - children and children under the age of 16. - Nephrolithiasis or history of nephrolithiasis - Hyperossaluria - Emochromatosis

Population

Adults 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 adults only. Always use the effective minimum dosage and increase it only if it is not enough to relieve symptoms (sweet and fever). Persons most exposed to the risk of serious undesirable effects, which may use the drug only if prescribed by the doctor, must carefully follow the instructions (see paragraph 4.4). Use the medicine for the shortest period possible. Do not take the product for more than 3 - 5 days without the advice of your doctor. Consult your doctor if your symptoms persist. Take the medicine preferably after main meals or, however, on a full stomach. Special popularity Pediatric population Aspirin effervescent tablets with vitamin C is not indicated for use in the pediatric population (see paragraph 4.4). Seniors In older patients use the effective minimum dosage. Patients with impairment of liver function Acetylsalicylic acid must be used with caution in patients with impairment of liver function (see paragraph 4.4). Patients with renal function compromise Acetylsalicylic acid should be used with caution in patients with renal function impairment (see paragraph 4.4).

Conservation

Store at a temperature below 25° C.

Interactions

Contraindicated associations (avoid concomitant use -see paragraph 4.3): - Metotrexate (dose greater or equal to 15 mg/week): increased plasma levels and metotrexate toxicity; the risk of toxic effects is greater if the kidney function is compromised. - Warfarin: severe increase in the risk of hemorrhage for strengthening the anticoagulant effect. Unrecommended associations (the concomitant use of the two drugs requires the doctor’s prescription after careful assessment of the risk/benefit ratio - see paragraph 4.4): Anti-platelet aggregates: increased risk of hemorrhage by sum of the anti-aggregating effect. Trombolitics or Oral or parental anticoagulants: increased risk of hemorrhage by enhancing the pharmacological effect. FANS (top use excluded): increased risk of serious side effects. Metotrexate (doses less than 15mg/week): the increase in the risk of toxic effects (see above) must also be considered for treatment with Metotrexato at low dosages. Serotonin reuptake selective inhibitors (SSRI): increase of the risk of bleeding of the gastrointestinal apparatus higher due to a possible synergistic effect. Associations requiring special precautions or adjustment of the dosage (the concomitant use of the two drugs requires the doctor’s prescription after careful assessment of the risk/benefit ratio - see paragraph 4.4): ACE inhibitors: reduction of hypotensive effect; increased risk of renal function compromise. Valproic acid: increase in the effect of valproic acid (toxicity risk). Acids: antacids taken at the same time to other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalineized urine. Antidiabetics (e.g. insulin and oral hypoglycemics): increased hypoglycemic effect; the use of acetylsalicylic acid in the subjects in treatment with antidiabetics must take into account the risk of inducing hypoglycemia. Digoxin: increased plasma concentration of digoxin due to decreased kidney elimination. Diuretics: increased risk of nephrotoxicity of acetylicylic acid and other NSAIDs; reduction of the effect of diuretics. Acetazolamide: reduced elimination of acetazolamide (toxicity risk). Fenitoine: increased effect of phenytoin. Courtesy (excluding those for topical use and those used for corticosurrenal failure therapy): (a) increased risk of gastrointestinal injury; b) due to the increased elimination of salicylates induced by corticosteroids, plasma levels of salicylate have been reduced. On the other hand, after termination of corticosteroid treatment, it can occur overdosage of salicylates. Metoclopramide: an increase in the effect of acetylsalicylic acid by increase in absorption speed. Uricosurici (e.g. probenecid, benzbromarone): decrease in the uric effect. Zafirlukast: increased plasma concentration of zafirlukast. Deferoxamina Aspirin effervescent tablets with vitamin C: concomitant use of ascorbic acid can result in increased tissue toxicity of iron especially at heart level and cause heart failure. Aspirin effervescent tablets with Vitamin C contains buffer systems that could reduce the effects of the Levotiroxin thyroid hormone. Alcohol (see paragraph 4.4) The sum of the effects of alcohol and acetylsalicylic acid causes increased gastrointestinal mucosa damage and prolongation of bleeding time. Other oral medications should not be administered within 1 or 2 hours of use of the product. Interference with clinical laboratory tests Vitamin C Because vitamin C is a reducing agent (i.e. an electron donor), it can cause chemical interference in laboratory tests that involve oxide-reduction reactions, such as glucose, creatinine, carbamazepine, uric acid in the urine, serum and occult blood in the feces. Vitamin C can interfere with tests that measure urinary and blood glucose by leading to a falsified reading of the results even if it has no effect on blood glucose levels.

Effects

The most frequently observed side effects are on the gastrointestinal apparatus and can occur in about 4% of individuals taking acetylsalicylic acid as analgesic-antipyretic. This percentage increases significantly in the risk of gastrointestinal disturbances. These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both dose and duration of treatment. The undesirable effects observed with acetylsalicylic acid are generally common to other NSAIDs. Emolinfopoietic system pathologies Extension of bleeding time, anemia from gastrointestinal hemorrhage, reduction of platelets (trombocytopenia) in extremely rare cases. Following hemorrhage, hemorrhagic/sideropenic anemia (due, for example, to occult microemorrhages) may occur with the relative alterations of the laboratory parameters and its clinical signs and symptoms such as as athenia, pallor and hypoperfusion. Diseases of the nervous system Cephalea, chief. Rarely: Reye syndrome (*) From seldom to very rarely: cerebral hemorrhage, especially in patients with uncontrolled hypertension and/or in therapy with anticoagulants, which in isolated cases may be potentially lethal. Ear and labyrinth pathologies Tinnitus (rontium/fruit/tintintinnium/auricular whistle). Respiratory, chest and mediastinic pathologies Respiratory disease exacerbated by acetylsalicylic acid, asthmatic syndrome, rhinitis (prose recurrence), nasal congestion (associated with hypersensitivity reactions). Epistassi. Heart disease Cardiorespiratory stress (associated with hypersensitivity reactions) Pathologies of the eye Conjunctivitis (associated with hypersensitivity reactions) Gastrointestinal diseases Gastrointestinal bleeding (occult), gastric disorders, pirosis, gastrointestinal pain, gum. Vomito, diarrhea, nausea, abdominal crampiform pain (associated with hypersensitivity reactions). Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, hematomesis (vomite of blood or material “coffee laying”), melena (emission of black feces, picee), esophagitis. Very rarely: hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with its clinical signs and symptoms and alterations of laboratory parameters. Frequency not known (especially in long-term treatment): - Disease of intestinal diaphragms. Hepatobiliary diseases Rarely: hepatotoxicity (hepatocellular lesion generally mild and asymptomatic) that manifests with an increase of transamines. Diseases of the skin and subcutaneous tissues Skin rash, edema, hives, itching, erythema, angioedema (associated with hypersensitivity reactions). Kidney and urinary pathologies Alteration of renal function (in the presence of renal hemodynamic altered conditions) and acute kidney injury, urogenital hemorrhages. Systemic pathologies and conditions for administration Process bleeding, hematomas. Immune system disorders Rarely: anaphylactic shock with its alterations of laboratory parameters and clinical manifestations. (*) Reye Syndrome (SdR) The SdR initially manifests itself with vomiting (persistent or recurring) and with other signs of encephalic suffering of different entities: from distress, drowsiness or personality alterations (irritability or aggressiveness) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture must be taken into account: vomiting can also be lacking or replaced by diarrhea. If these symptoms arise in the days immediately after an influenza episode (or flu or varicella or other viral infection) during which acetylicylic acid or other medicines containing salicylates the attention of the doctor must immediately be addressed to the possibility of a SdR. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the national reporting system of the Italian Pharmaco Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Acetylsalicylic acid The toxicity from salicylates (a dosage greater than 100 mg/kg/day for 2 consecutive days may induce toxicity) may be the result of chronic intake of excessive doses, or acute overdose, potentially dangerous for life and also includes accidental ingestion in children. Chronic intoxication by salicylates Poisoning chronic from salicylates can be insidious since signs and symptoms are aspecific. A mild chronic intoxication from salicylates, or salicylism, usually occurs only after repeated use of considerable doses. Symptoms include dizziness, dizziness, 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 mi–crograms/ml, while at concentrations above 300 mi–crograms/ml there are more serious adverse events. Acute intoxication by salicylates The main characteristic of intoxication acute is a serious alteration of the acid-base balance, which may vary with the age and severity of intoxication; the most common presentation, in the child, is metabolic acidosis. It is not possible to estimate the severity of poisoning by plasma concentration alone; acetylsalicylic acid absorption can be delayed due to reduced gastric emptiness, concretion formation in the stomach, or as a result of ingestion of gastro-resistant preparations. The management of an intoxication from acetyllic acid 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 consist of the acceleration of the excretion of the drug and the restoration of electrolytic metabolism and acid-base. For complex physiopathological effects, connected with salicylate poisoning, signs and symptoms/results of biochemical and instrumental investigations, may include:

High dosages can also appear: Alterations of taste. Skin rashes (acneiform, erythematose, scarlattiniform, eczematoids, desquamative, bollose, purpuronic), itching. Others: conjunctivitis, anorexia, reduction of visual acuity, drowsiness. Rarely: aplastic anemia, agranulocytosis, intravascular coagulation disseminated, pancytopenia, leukopenia,thrombocytopenia,heosinopenia, purple, heosinophilia associated with hepatotoxicity, drug-induced nephrotoxicity (nephrititidal piline-intersti allergic urine),hematuria (preservation). Acute allergic reactions resulting from intake of acetylsalicylic acid, can be treated, if necessary, with adrenaline, corticosteroids and an antihistamine. In case of overdosing, please contact a poison center or the nearest hospital immediately. Acetylsalicylic acid is dialysable. Ascorbic acid Aspirin 400 mg effervescent tablets with vitamin C contains ascorbic acid: Individual cases of acute and chronic overdose are reported in literature ascorbic acid. Overdose of ascorbic acid can result in oxidative haemolysis in patients with glucose-6-phosphate dehydrogenase deficiency, intravascular coagulation scattered and significantly elevated serum and urinary levels of oxalates. It has been shown that increased levels of oxalate give rise to the formation of calcium oxalate deposits in dialized patients. High doses of vitamin C can cause calcium oxalate deposits, calcium oxalate chrystalluria in patients with predisposition to the formation of crystals, interstitial nephropathy and acute kidney failure resulting in calcium oxalate crystals.

Pregnancy

Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis, in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless necessary. If drugs containing acetylsalicylic acid are used by a woman seeking pregnancy, or during the first and second quarter of pregnancy, the treatment will be as short as possible and the dose as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can exhibit: fetus a: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress to renal failure with oligo-idroamnios; the mother and the unborn child, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy.

Food

ASPIRINA 400 mg effervescent tablets with vitamin C is contraindicated during lactation