Neo Nisidine Tablets Acetylsalicylic Acid / Paracetamol 12 Tablets

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those suffering from severe haemolytic anemia. Severe hepatocellular insufficiency. The drug should not be used in case of active gastric or duodenal ulcer, in patients with a known tendency to bleeding (eg. Haemophilia) or who have hypersensitivity to salicylates or to paracetamol or to other components of the product. Asthmatic patients. The use of this medicine is contraindicated in children and young people under the age of sixteen. Due to the risk of Reye's syndrome, the product should however not be used in children and adolescents affected by chickenpox or influenza. For the presence of caffeine, do not administer to children and young people under the age of sixteen. Low doses of acetylsalicylic acid (up to 100 mg / day). Clinical studies indicate that doses up to 100 mg / day can be considered safe for use only in obstetrics, which requires specialist monitoring. Doses of 100-500 mg / day of acetylsalicylic acid. There are insufficient clinical data regarding the use of doses above 100 mg / day up 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 or more of acetylsalicylic acid. 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, 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 except in strictly necessary cases. If acetylsalicylic acid is used by a woman expecting conception, 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 may progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can 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. Prolonged intake of high amounts of caffeine can induce miscarriage or premature birth. Paracetamol and salicylates are excreted in breast milk. Caffeine is also excreted in breast milk and can influence the state and behavior of the baby. If regular therapy with higher doses of acetylsalicylic acid is required during lactation, weaning should be considered.
SIDE EFFECTS
Acetylsalicylic acid can cause epigastric disorders, nausea, vomiting, gastroduodenal ulcers and erosive gastritis which can lead to severe gastrointestinal bleeding. These effects are more likely related to high doses although they may also occur at low doses. When using products containing acetylsalicylic acid for prolonged periods, iron deficiency anemia may occur due to recurring bleeding in the digestive tract. Due to the presence of acetylsalicylic acid, otovestibular disorders (humming, etc.), dizziness, haemorrhagic phenomena (epistaxis, gingivorrhagia, etc.), prolongation of pregnancy and labor and reduction of platelet count may also occur. Occasionally, allergic reactions (bronchoconstriction, skin reactions) may occur. Skin reactions of various types and severity have been reported with the use of paracetamol, including rare cases of allergic rash and cases of erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis. Hypersensitivity reactions have been reported, such as angioedema, larynx edema, anaphylactic shock. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, pancytopenia, impaired liver function and hepatitis, renal changes (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness. In cases of overdosing, due to the presence of paracetamol, it can cause hepatic cytolysis, which can evolve towards massive and irreversible necrosis. Caffeine is a CNS stimulant and can cause agitation, insomnia, tremor, dyspeptic symptoms and tachycardia. Due to the presence of caffeine, in case of overdose, hyperstimulation syndrome with excitation, insomnia, buzzing, muscle tremor, nausea, vomiting, increased diuresis, tachycardia, ectopic beats, scotoma may occur. This medicinal specialty should not be used in children and young people under the age of sixteen (see contraindications); subjects aged over 70 years of age, especially in the presence of concomitant therapies, should use this medicine only after consulting a doctor. After three days of use at the maximum dose or after 5-7 days of continuous use without results, consult your doctor. If the pain or fever persists or worsens, if new symptoms occur or if there is redness or swelling, you should consult a doctor as these could be signs of an aggravation of the disease in progress. Administer with caution in subjects with renal or hepatic insufficiency. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Also, before combining any other medication, contact your doctor. In addition, the doctor should be consulted by patients with glucose-6-phosphate-dehydrogenase deficiency, chronic or recurrent gastric or intestinal disorders, or impaired renal function, asthma, allergic rhinitis and nasal polyps, hypersensitivity to non-steroidal anti-inflammatory drugs, liver dysfunction (e.g. due to chronic alcohol abuse, hepatitis), Gilbert's syndrome, pregnant women. High or prolonged doses of the product can cause high-risk liver disease and even serious changes in the kidney and blood. In case of viral diseases, such as flu or chicken pox, consult your doctor before administering the product to children; if prolonged vomiting and profound drowsiness occur during treatment, discontinue administration. the use of the product is not recommended if the patient is being treated with other anti-inflammatories. In rare cases of allergic reactions, administration should be discontinued. Medicinal product containing lactose is therefore not 'suitable for subjects with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.
INDICATIONS
Symptomatic treatment of headache, neuralgia, toothache, menstrual pain, joint pain, fever and cold syndromes.
INTERACTIONS
The drug can interact with anticoagulants, uricosurics, hypoglycemic sulfonylureas. Pre-operative use can hinder intraoperative haemostasis. Acetylsalicylic acid, one of the components of the drug, can enhance the effect of anticoagulants (eg coumarin and heparin derivatives). It may also increase the risk of gastrointestinal side effects when administered concomitantly with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. The effect of hypoglycemic agents and the toxicity of methotrexate may be enhanced by concomitant administration of acetylsalicylic acid. The product may decrease the natriuretic effect of spironolactone and inhibit the effect of uricosuric agents (eg probenecid, sulfinpyrazone). Patients being treated with rifampicin, cimetidine, or with antiepileptic drugs such as glutethimide, phenobarbital, carbamazepine should use paracetamol with extreme caution and only under strict medical supervision. The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). Drugs that slow gastric emptying, such as propantheline, they reduce the absorption rate of paracetamol and delay the onset of its effect. Drugs that accelerate gastric emptying, such as metoclopramide, lead to an increase in the rate of absorption. The combination of paracetamol with chloramphenicol can 'prolong the half-life of chloramphenicol, increasing the risk of toxicity'. It was not possible to evaluate the clinical relevance of the interactions between paracetamol and warfarin and with coumarin derivatives. Therefore, the prolonged use of paracetamol in patients being treated with oral anticoagulants is advisable only under medical supervision. The concomitant use of paracetamol and AZT (zidovudine) increases the risk of neutropenia induced by the latter. Therefore, the drug should be taken together with AZT only under medical supervision. Caffeine can antangonize the sedative effect of various drugs (eg barbiturates, antihistamines). It can also increase the tachycardia effect caused by other drugs (eg sympathomimetics, thyroxine). Oral contraceptives, cimetidine and disulfiram, slow down the metabolism of caffeine in the liver, barbiturates and smoking increase it. Caffeine reduces the excretion of theophylline. Concomitant administration of analgesics does not increase the risk of developing dependence. Administration of quinolone antibiotics can delay the elimination of caffeine.
DOSAGE
Adults: 1 to 4 tablets per day. Oral intake must take place on a full stomach. Do not exceed the recommended doses, in particular elderly patients should follow the minimum dosages indicated above.
USE / ROUTE OF ADMINISTRATION
Analgesic and antipyretic.