Acetylsalicylic Acid And Vitamin C zentiva 10 Tablets Eff 400

PHARMACOTHERAPEUTIC CATEGORY
Other analgesic and antipyretic.

INDICATIONS
Symptomatic treatment of feverish and painful states (flu, colds, headache, toothache, rheumatic and muscular pain, menstrual pain, neuralgia).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients. Hypersensitivity 'to salicylates or other non-steroidal anti-inflammatory drugs. Active gastro-duodenal ulcer and other gastropathies. Hemorrhagic diathesis (in particular haemophilia, hypoprothrombinemia and vitamin K deficiency). Severe renal or hepatic insufficiency. Patients with bronchial asthma, particularly if associated with nasal polyposis and angioedema. Dose> 100 mg / day during the third trimester of pregnancy. The use of this medicine is contraindicated in children and young people under the age of sixteen. Pregnancy, low doses (up to 100 mg / day): Clinical studies indicate that doses up to 100 mg / day can be considered safe for use in obstetrics, which requires specialist monitoring. There are insufficient clinical data relating to the use of doses above 100 mg / di and down to 500 mg / day. Therefore, the recommendations below for doses of 500 mg / day and above also apply to this dose range. Doses of 500 mg / day and above, 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%. 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 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, acetylsalicic acid should not be administered except in strictly necessary cases. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept 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 can progress to renal insufficiency with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, with an antiplatelet effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses> 100 mg / day is contraindicated during the third trimester of pregnancy. from the mother.

DOSAGE
Adults, seniors and children over 16 years of age. The recommended doses are as follows: as an antipyretic and analgesic for mild or moderate pain: 1 tablet every 4-6 hours, as needed. Rheumatic and muscle pains, neuralgia: 1-2 tablets, two-three times a day. It is recommended to dissolve the tablets in a glass of water. Do not exceed the recommended dose; in particular elderly patients should follow the minimum dosages indicated above. The product should be taken on a full stomach, particularly when it is necessary to administer it in high doses or for prolonged periods.

INTERACTIONS
The administration of acetylsalicylic acid, particularly in case of prolonged therapy, can enhance the activity of anticoagulant drugs (for example coumarin derivatives, heparin), the undesirable effects of methotrexate, the risk of gastrointestinal haemorrhage in case of simultaneous treatment with corticosteroids, the effects and secondary manifestations of all NSAIDs, the effect of oral hypoglycemic agents (sulfonylureas). Acetylsalicylic acid, on the other hand, reduces the activity of substances such as spironolactone, furosemide and antigout preparations. Ascorbic acid can interfere, at high doses, with the results of some diagnostic tests, in particular the search for glucose in the urine by non-specific means. It is therefore advisable to stop taking vitamin C a few days before proceeding with this test.

SIDE EFFECTS
Gastric disturbances (heartburn, epigastralgia), constipation, nausea. In sporadic cases and in predisposed patients, bleeding episodes and ulcers may occur. Allergic reactions, such as rash, laryngeal edema, bronchospasm. An acute asthma attack may occur in sensitive patients. The clinical picture, in patients sensitive to acetylsalicylic acid, may present asthma, nasal polyps, rhinorrhea, angioedema. Tinnitus and decreased hearing can occur at high doses. Treatment should be temporarily suspended or the dosage reduced. In patients with impaired renal function, acetylsalicylic acid can decrease renal blood flow and induce acute renal failure. In extremely rare cases, thrombocytopenia is possible. At higher dosages than those recommended, ascorbic acid can give headaches and gastrointestinal disturbances, consisting mainly of laxative phenomena. In such cases it is advisable to interrupt the treatment. After three days of use at the maximum dose or after 5-7 days of use without appreciable results, consult your doctor. People over the age of 70, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor. Caution is also required in the following cases: elderly subjects with reduced renal function or decreased plasma albumin levels, due to the risk of increased toxicity; subjects with G-6-PD (Glucose-6-phosphate dehydrogenase) deficiency, due to the possible onset of hemolysis; subjects undergoing simultaneous treatment with anticoagulants due to an increased risk of bleeding. Subjects receiving concomitant treatment with corticosteroids, due to an increased risk of gastrointestinal bleeding. Ascorbic acid (vitamin C) should be used with caution by people who suffer, or have suffered in the past, from nephrolithiasis (kidney stones) and those with G6PD (glucose-6-phosphate dehydrogenase) deficiency, hemochromatosis, thalassemia or sideroblastic anemia. The activity of substances such as spironolactone, furosemide and antigout preparations is decreased by acetylsalicylic acid. Therefore, avoid the simultaneous use of the latter with the aforementioned drugs. Pre-operative use, as it can hinder intra-operative haemostasis. If prolonged vomiting and profound sleepiness occur during treatment, discontinue administration. In the case of a low sodium regimen, it should be borne in mind that one effervescent tablet contains 422.8 mg of sodium (equal to 18.4 mEq). This medicinal product should not be used in children and young people under the age of sixteen. In children over the age of 16 in case of viral diseases, such as influenza or chicken pox, carefully evaluate before administering the product.