Saridon Tablets Paracetamol / Propiphenazone Antipyretic 20 Tablets

WARNINGS
Do not take for more than 3 consecutive days without consulting your doctor. High or prolonged doses of the product can cause high-risk liver disease and even serious alterations to the blood. An increase in serum alanine aminotransferase (ALT) may occur during administration of therapeutic doses of paracetamol. Moderate alcohol intake in conjunction with paracetamol intake may increase the risk of liver toxicity. Administer with caution in subjects with renal or hepatic insufficiency (Child-Pugh <9), Gilbert's syndrome or haematopoietic dysfunction. Patients suffering from kidney disorders should consult their doctor before taking the product as a dose adjustment may be required. In general, continuous use of paracetamol, especially in combination with other analgesics, can lead to permanent renal damage and renal failure (analgesic nephropathy). Particular caution is required in patients with asthma, chronic rhinitis or chronic urticaria. There have been isolated reports of asthma attacks and anaphylactic shock associated with the intake of drugs containing propiphenazone and paracetamol in susceptible individuals. The erroneous intake of quantities higher than those recommended can cause convulsions. If during treatment resumption of fever or angina appear, discontinue therapy and consult your doctor. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. The drug should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity '. During therapy with oral anticoagulants it is recommended to reduce the doses. During treatment with paracetamol before taking any other drug check that does not contain the same active ingredient, since if paracetamol is taken at high doses, serious adverse reactions may occur. The use of the medicinal product should be closely monitored by a doctor in case of hyperthyroidism. Instruct the patient to contact the physician before combining any other medication. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Gastrointestinal Risks: Use should be avoided concomitantly with NSAIDs, including selective COX-2 inhibitors. Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially for gastrointestinal bleeding and perforation, which can be fatal. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with higher doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. When gastrointestinal bleeding or ulceration occurs in patients taking Saridon, the treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Use should be closely monitored by a physician in case of gastric or duodenal ulcers. Cardiovascular and cerebrovascular effects Clinical studies and epidemiological data suggest that the use of some NSAIDs may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are currently insufficient data to exclude a similar risk for propiphenazone when it is administered at a daily dose of 150-600 mg. Caution is required before starting treatment in patients with a history of hypertension and / or heart failure, since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs.
PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics; paracetamol, combinations except psycholeptics.
STORAGE
Do not store above 30 degrees C.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredients, to other closely related substances from a chemical point of view and / or to any of the excipients. History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Haemopathies such as granulocytopenia and intermittent porphyrias. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those suffering from severe haemolytic anemia. Severe hepatic insufficiency (Child-Pugh> 9). Severe renal insufficiency. Severe heart failure. Due to the presence of caffeine, the product should not be given to children under 12 years of age. Pregnancy and breastfeeding.
NAME
SARIDON TABLETS
EXCIPIENTS
Microgranular cellulose, povidone, corn starch, hypromellose, talc, magnesium stearate, precipitated silica.
SIDE EFFECTS
Skin and subcutaneous tissue disorders: skin reactions of various types and severity, including rash, pruritus, urticaria, allergic edema and angioedema, acute generalized exanthematous pustulosis, fixed erythema, erythema multiforme, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely and with possible fatal outcome). Immune system disorders: hypersensitivity reactions' such as dyspnoea, sweating, nausea, hypotension, asthma, larynx edema, anaphylactoid reaction, anaphylactic reaction, anaphylactic shock. Blood and lymphatic system disorders: changes in blood count, such as thrombocytopenia, thrombocytopenic purpura, leukopenia, anemia, agranulocytosis, pancytopenia. Nervous system disorders: dizziness, somnolence. Hepatobiliary disorders Hepatic impairment, hepatitis, dose-dependent hepatic failure, potentially fatal hepatic necrosis. Renal and urinary disorders: acute renal failure, interstitial nephritis, haematuria, anuria. Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Serious adverse events such as peptic ulcers, gastrointestinal perforation or haemorrhage (sometimes fatal, particularly in the elderly) may occur in association with the use of non-steroidal anti-inflammatory drugs. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of Saridon. Gastritis has been observed less frequently. Thoracic and mediastinal disorders: bronchospasm and asthma, including analgesic asthmatic syndrome. Edema, hypertension and heart failure have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
Inhibition of prostaglandin synthesis can negatively affect pregnancy and / or embryo-fetal development. Results from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase 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 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. It is not recommended to use in case of presumed pregnancy. Breastfeeding: the medicine is contraindicated in breastfeeding.
INDICATIONS
Symptomatic treatment of acute painful states (headache; ache; neuralgia; menstrual pains) and feverish states.
INTERACTIONS
Drugs that slow down gastric emptying (eg propanteline), can reduce the speed of paracetamol absorption, delaying its therapeutic effect. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Anticoagulants: NSAIDs can increase the effects of anticoagulants, such as warfarin. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be taken into consideration in patients taking the medicinal product concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy. The product can interact with alcohol; in case of alcohol abuse, taking paracetamol, even at low doses, can cause liver damage. The product can interact with some hypoglycemic agents (acetohexamide, chlorpropamide, tolbutamide). Probenecid causes at least a 2-fold reduction in paracetamol clearance through inhibition of its conjugation with glucuronic acid. In case of concomitant treatment with probenecid a reduction in paracetamol dosage should be considered. Metoclopramide and ildomperidone (drugs that accelerate gastric emptying) can accelerate the rate of absorption of paracetamol, while cholestyramine can slow down the rate and degree of absorption. Concomitant administration of chloramphenicol can induce a prolongation of the half-life of the paracetamol, with the risk of elevating its toxicity. The use of the product is not recommended if the patient is being treated with other anti-inflammatories. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic mono-oxygenases or in case of exposure to substances that can have this effect (for example phenytoin, rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital , carbamazepine). The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and with that of glycaemia (by the method of glucose-oxidase-peroxidase). Concomitant use of paracetamol and AZT (zidovudine) increases the tendency for a decrease in white blood cell count (neutropenia). Therefore, the product must not be taken in combination with AZT (zidovudine) except on medical prescription. The concomitant administration of NSAIDs or opioids determines a reciprocal enhancement of the analgesic effect. Paracetamol can reduce the efficacy of lamotrigine. Paracetamol (or its metabolites) interferes with enzymes involved in the synthesis of vitamin K-dependent coagulation factors. The interaction between paracetamol and warfarin or coumarin derivatives can cause an increase in the international normalized ratio and an increased risk of bleeding. Patients being treated with oral anticoagulants should not take paracetamol for long periods without medical supervision. Tropisetron and granisetron, serotonin 5-HT3 receptor antagonists, can completely inhibit the analgesic effect of paracetamol through a pharmacodynamic interaction.
DOSAGE
Adults: 1-2 tablets, up to 4 tablets in 24 hours, with a large sip of water. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. The assumption of oral analgesic preparations must take place on a full stomach. Do not take for more than 3 consecutive days without consulting your doctor.
ACTIVE PRINCIPLES
One tablet contains 250 mg paracetamol, 150 mg propiphenazone, 25 mg caffeine.