Aspirin Vitamin C Effervescent Tablets
Aspirin C 400mg + 240mg Acetylsalicylic Acid 10 Effervescent Tablets
Minsan
004763114
- Description
- Product Details
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 drugs and in subjects who have allergic reactions to other substances (eg skin reactions, itching, hives). 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: subjects at greater risk of hypersensitivity reactions; subject to increased risk of gastrointestinal lesions 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 have suffered from gastrointestinal ulcer or gastrointestinal bleeding in the past avoid its use. The risk of gastrointestinal lesions is a dose related effect, as gastric injury is greater in subjects who use higher doses of acetylsalicylic acid. Even subjects with a habit of taking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular). Subjects with coagulation defects or treated with anticoagulants: in subjects suffering from coagulation defects or treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacities, exposing them to the risk of bleeding. 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 higher in subjects being treated with diuretics. This can be particularly dangerous for the elderly and for those with impaired renal or cardiac or hepatic function. People with asthma: Acetylsalicylic acid and other NSAIDs can cause worsening of asthma. Geriatric age (especially over 75 years): the risk of serious side effects is greater in geriatric subjects. Subjects over 70 years of age, especially in the presence of concomitant therapies, should use the medicine only after consulting the doctor. Do not use in the pediatric population. Products containing acetylsalicylic acid should not be used in children and adolescents under the age of 16 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 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. Subjects with predisposition to calcium-oxalic nephrolithiasis (kidney stones) or with recurrent nephrolithiasis. 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 can 'increase the risk of serious side effects. Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. The use of acetylsalicylic acid as well as any drug that inhibits prostaglandin synthesis and cyclooxygenase could interfere with fertility; of this' must be informed female subjects and in particular women who have fertility problems' or who are undergoing investigation of fertility '. Sodium. Effervescent tablets with Vitamin C contains 933 mg of sodium per tablet: it may not be suitable for people 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 be the cause of 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; 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 risk of potentially serious side effects listed above. If in doubt consult your doctor or pharmacist. An imperfect and prolonged storage of the drug 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 must be taken on a full stomach.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics (non-opioids) and antipyretics. Acetylsalicylic acid and derivatives.
STORAGE
Tablets. Blisters: Store below 30 degrees C. Bottle: store below 30 degrees C. Effervescent tablets: store below 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients (acetylsalicylic acid and ascorbic acid), to other analgesics (painkillers) / antipyretics (antifebriles) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; gastroduodenal ulcer; hemorrhagic diathesis; severe kidney, heart or liver failure; glucose-6-phosphate dehydrogenase deficiency (G6PD / favism); concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin; 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; children and young people under the age of 16.
NAME
ASPIRIN
EXCIPIENTS
500 mg adult tablets: corn starch cellulose powder; effervescent tablets with vitamin C: monosodium citrate sodium bicarbonate sodium carbonate anhydrous citric acid.
SIDE EFFECTS
The most frequently observed side effects are affecting the gastrointestinal tract and can occur in about 4% of subjects who take acetylsalicylic acid as an analgesic-antipyretic. 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. Side effects seen with acetylsalicylic acid are generally common to other NSAIDs. Blood and lymphatic system disorders 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 amicrohaemorrhages) with the relative alterations of the 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 potentially lethal. Ear and labyrinth disorders: tinnitus (ringing / rustling / ringing / ringing in the ears). Respiratory, thoracic and mediastinal disorders: asthmatic syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions). Epistaxis. Cardiac disorders: cardiorespiratory distress (associated with hypersensitivity reactions). Eye disorders: conjunctivitis (associated with hypersensitivity reactions'). Gastrointestinal disorders: gastrointestinal (occult) bleeding, gastric disturbances, 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, pruritus, erythema, angioedema (associated with hypersensitivity reactions'). Renal and urinary disorders: impaired 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 the relative alterations of laboratory parameters and clinical manifestations Reye's Syndrome initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain distress of different nature: from listlessness, drowsiness or personality alterations (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be taken into account: vomiting may also be missing 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) during which acetylsalicylic acid or other salicylate containing medicinal products have been administered the doctor's attention should immediately be directed to the possibility. 'of an SDR. Report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency.
PREGNANCY AND BREASTFEEDING
The use of acetylsalicylic acid as well as any drug that inhibits prostaglandin synthesis and cyclooxygenase could interfere with fertility; of this' must be informed female subjects and in particular women who have fertility problems' or who are undergoing investigation of fertility '. Inhibition of prostaglandin synthesis can negatively 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 was increased from less than 1% to approximately 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals the 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, has been reported in animals administered 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 may progress to renal failure with oligo-hydroamnios; the mother and the unborn child, at the end of pregnancy, a 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: the drug is contraindicated during breastfeeding.
INDICATIONS
Symptomatic therapy of feverish states and flu and cold syndromes. Symptomatic treatment of head and tooth pain, neuralgia, menstrual pain, rheumatic and muscular pain.
INTERACTIONS
Contraindicated combinations (avoid concomitant use). Methotrexate (doses greater than or equal to 15 mg / week): increased 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). Antiplatelet agents: 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 (topical use excluded): increased risk of serious side effects. Methotrexate (doses below 15mg / week): The increased risk of toxic effects 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 a doctor's prescription after careful evaluation of the risk / benefit ratio). 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 (eg: insulin and oral hypoglycemic agents): increase in the 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): increased risk of gastrointestinal lesions; due to the increased elimination of salicylates induced by corticosteroids there is a reduction in plasma levels of salicylate. Conversely, after discontinuation of corticosteroid treatment, an overdose of salicylates may occur. Metoclopramide: increase in the effect of acetylsalicylic acid by increasing the speed of absorption. Uricosurics (eg 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 an increased tissue toxicity of iron especially in the heart and cause heart failure. Aspirin effervescent tablets with Vitamin C contain buffer systems that may reduce the effects of the thyroid hormone Levothyroxine. Alcohol: The sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolonged bleeding time. However, it is advisable not to administer other drugs by mouth within 1 or 2 hours of using the product.
DOSAGE
Adults. 500 mg tablets: 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. Effervescent tablets: 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 a doctor, must strictly follow its instructions. 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: Vitamin C tablets and effervescent tablets are not indicated for use in the pediatric population.
ACTIVE PRINCIPLES
500 mg adult tablets: 500 mg acetylsalicylic acid. Effervescent tablets with vitamin C of 400 mg: acetylsalicylic acid 400 mg ascorbic acid (Vitamin C) 240 mg.
004763114
170 Items
Specific References
Aspirin Vitamin C Effervescent Tablets
Source: https://farmaciarubino.net/en/over-the-counter-drugs/1-aspirin-c-400mg-240mg-acetylsalicylic-acid-10-effervescent-tablets.html
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