Aspirin C Granules 400 mg Acetylsalicylic acid 10 Sachets Orange

WARNINGS
Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions'. In subjects with asthma and / or rhinitis and / or urticaria the reactions can 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 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. 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. Even subjects with a habit of taking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions. 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. Acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and water retention. Acetylsalicylic acid and other NSAIDs can cause aggravation of asthma. The risk of serious side effects is greater in geriatric subjects. The effervescent granules should not be used in children and young people under the age of 16. 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. Vitamin C (ascorbic acid) should be used with caution by people with a predisposition to calcium-oxalic nephrolithiasis or with recurrent nephrolithiasis. 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 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 '. The effervescent granules with vitamin C contains sodium. The medicine contains sucrose. The presence of the dye E 110 can cause allergic reactions. If you have to undergo surgery and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon about the possible effects on coagulation. Acetylsalicylic acid can cause gastrointestinal bleeding and should be taken into account in case it is necessary to perform a search for occult blood. Before administering any medicinal product, all necessary precautions must be taken to prevent unwanted reactions. The product must be taken on a full stomach.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics-analgesics (non-opioids) and antipyretics-acetylsalicylic acid and derivatives.
STORAGE
Store at a temperature not exceeding 25 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to active ingredients, to other analgesics / antipyretics / 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; 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 400 MG EFFERVESCENT GRANULATE WITH VITAMIN C
EXCIPIENTS
Citric acid, monobasic sodium citrate, sodium bicarbonate, sodium carbonate, orange concentrate, orange flavor powder, saccharin, E 110, sucrose.
SIDE EFFECTS
The most frequently observed side effects are related to the gastrointestinal tract. These disorders can be partially alleviated by taking the medicine on a full stomach. Blood and lymphatic system disorders: prolongation of bleeding time, gastrointestinal bleeding anemia, reduction of platelets in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia may occur with the relative alterations in 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 which in isolated cases can be life threatening. Ear and labyrinth disorders: tinnitus. Respiratory, thoracic and mediastinal disorders: asthmatic syndrome, rhinitis, nasal congestion, epistaxis. Cardiac disorders: cardiorespiratory distress. Eye disorders: conjunctivitis. Gastrointestinal disorders: gastrointestinal bleeding (occult), gastric upset, heartburn, gastrointestinal pain, gingivorrhagia. Vomiting, diarrhea, nausea, cramping abdominal pain forms; rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis, melaena, 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 manifested by an increase in transaminases. Skin and subcutaneous tissue disorders: rash, edema, urticaria, pruritus, erythema, angioedema. Renal and urinary disorders: impaired renal function, 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. The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of different entities: from listlessness, drowsiness or personality changes to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: even vomiting may be missing or be replaced by diarrhea. If these symptoms arise in the days immediately following a flu episode during which acetylsalicylic acid or other medicinal products containing salicylates have been administered, attention should immediately be directed to the possibility of an SDR.
PREGNANCY AND BREASTFEEDING
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. 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, renal dysfunction; the mother and the unborn child, at the end of pregnancy, to: possible prolongation of bleeding time, inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy. 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 associations. Methotrexate: increased plasma levels and toxicity of methotrexate; 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. 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: increased risk of serious side effects. Methotrexate (doses below 15 mg / 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. ACE inhibitors: reduction of the hypotensive effect; increased risk of impaired renal function. Valproic acid: increased effect of valproic acid. Antacids: antacids taken at the same time as other drugs can reduce their absorption; excretion of acetylsalicylic acid increases in alkalized urine. Antidiabetics: 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 therapy 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. On the other hand, 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: decreased uricosuric effect. Zafirlukast: increased plasma concentration of zafirlukast. Deferoxamine: the concomitant use of ascorbic acid can cause an increased tissue toxicity of iron especially in the heart and cause heart failure. The effervescent granules contain buffer systems which may reduce the effects of the thyroid hormone levothyroxine. 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
Pour the contents of the sachet into half a glass of water, or more. Mix with a teaspoon. Before drinking, wait for the slight effervescence to stop. 1 sachet 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 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 dose. Those most at risk of serious side effects must strictly follow the instructions. Do not take the product for more than 3-5 days. Use the medicine for the shortest period possible. Take the medicine preferably after main meals or, in any case, on a full stomach.
ACTIVE PRINCIPLES
One sachet contains: acetylsalicylic acid 400 mg, ascorbic acid (vitamin C) 240 mg.