Sanipirina*20cpr 500mg

NAME
SANIPIRINA 500 MG TABLETS

PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics.

ACTIVE PRINCIPLES
Paracetamol 500 mg.

EXCIPIENTS
Modified maize starch, maize starch, sodium carboxymethylcellulose, anhydrous colloidal silica, microcrystalline cellulose, talc, magnesium stearate

INDICATIONS
As antipyretic: symptomatic treatment of febrile diseases such as influenza, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other painful manifestations of medium entity, of various origins.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to paracetamol or to any of the excipients. 500 mg tablets: patients with glucose-6-phosphate dehydrogenase deficiency (G6PD / favism); severe renal and heart failure.

DOSAGE
500 mg tablets. Adults and adolescents over 12 years: 1 tablet, 3-4 times a day; sanipirine should not be used for more than 3 days without consulting your doctor.

STORAGE
This medicine does not require any special storage conditions. Store in the outer carton.

WARNINGS
In cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. Very rare cases of severe skin reactions have been reported. In case of skin redness, skin rash, blistering or peeling, or other signs of hypersensitivity, treatment with paracetamol should be discontinued. High or prolonged doses of the medicine can cause serious changes in the blood. Prolonged use of high doses can cause liver and kidney damage. Due to its hepatotoxicity, paracetamol should not be taken at higher doses and for longer periods than those recommended. Prolonged use can give rise to severe consequences for the liver, such as liver cirrhosis. Acute or chronic overdose can cause severe hepatotoxicity, potentially with fatal outcome. Patients with liver disease or liver-borne infections, such as viral hepatitis, should be carefully evaluated before taking this medicinal product. Patients with mild or moderate (Child-Pugh <9) hepatic impairment (including Gilbert's syndrome) should use the medicine with caution. Use by patients with Gilbert's syndrome can induce an accentuation of hyperbilirubinemia and its clinical manifestations, such as jaundice. Therefore, these patients should use the medicine with caution. Paracetamol (500 mg tablets) should be administered with caution to patients with severe hepatic insufficiency (Child-Pugh> 9), acute hepatitis, concomitantly treated with drugs that alter liver function, haemolytic anemia. Elevation of serum alanine aminotransferase (ALT) may occur during administration of therapeutic doses of paracetamol. Moderate alcohol intake concomitantly with paracetamol intake may increase the risk of liver toxicity. All conditions that increase hepatic oxidative stress and that reduce the hepatic glutathione reserve, such as concomitant medications, alcoholism, infections or diabetes mellitus, can increase the risk of liver toxicity even at therapeutic doses. In patients with kidney disease the medicine should be used with caution and a dosage adjustment may be necessary. In general, continuous use of paracetamol, especially in combination with other analgesics, can lead to permanent renal damage and renal failure (analgesic nephropathy). Concomitant intake with other drugs containing paracetamol should be avoided since if paracetamol is taken in high doses, serious adverse reactions may occur. It is advisable to avoid the use in combination of more than one painkiller; in fact, there is little evidence on the additional benefits for the patient while the incidence of undesirable effects is generally enhanced.

INTERACTIONS
Effects of other medicinal products on paracetamol: drugs that slow down gastric emptying (eg propanteline) can reduce the rate of absorption of paracetamol delaying its therapeutic effect; on the contrary, drugs that increase gastric emptying speed (eg metoclopramide, domperidone) lead to an increase in the rate of absorption. The concomitant use of drugs that induce liver enzymes, such as certain hypnotics and antiepileptics (glutethymide, phenobarbital, phenytoin, carbamazepine, etc.) or rifampicin, causes liver damage even with otherwise harmless doses of paracetamol. In case of alcohol abuse, the intake of paracetamol, even at low doses, can cause liver damage. Tropisetron and granisetron, serotonin 5-HT3 receptor antagonists, can completely inhibit the analgesic effect of paracetamol through a pharmacodynamic interaction. Effects of paracetamol on other medicinal products: the combination of paracetamol with chloramphenicol can prolong the half-life of the latter and therefore, potentially, increase its toxicity. Paracetamol (or its metabolites) interferes with the enzymes involved in the synthesis of factors of vitamin K dependent coagulation. The interaction between paracetamol and warfarin or coumarin derivatives may cause an increase in the international normalized ratio and an increased risk of bleeding. Patients treated with oral anticoagulants should not take paracetamol for long periods without medical supervision. Paracetamol can reduce the efficacy of lamotrigine. Concomitant use of paracetamol and AZT (zidovudine) increases the tendency for a decrease in white blood cell count (neutropenia). Paracetamol, therefore, must not be taken in combination with AZT (zidovudine) unless prescribed. blood glucose (using the glucose-oxidase-peroxidase method).

SIDE EFFECTS
The adverse reactions listed below derive from spontaneous reports and therefore an organization by frequency categories is not possible. Blood and lymphatic system disorders: changes in the level of the corpuscular elements of the blood, such as thrombocytopenia, porporathrombocytopenia, leukopenia, anemia (very rarely), neutropenia, agranulocytosis, pancytopenia. Disorders of the immune system. Hypersensitivity reactions such as, for example, allergic edema and angioedema, edema of the larynx, anaphylactic reaction, anaphylactic shock, asthma, sweating, nausea, hypotension, dyspnoea have been reported very rarely. Nervous system disorders: dizziness, somnolence. Respiratory, thoracic and mediastinal disorders: bronchospasm and asthma, including analgesic asthma syndrome. Gastrointestinal disorders: nausea, vomiting, stomach upset, diarrhea, abdominal pain. Hepatobiliary disorders: hepatic impairment, hepatitis, dose-dependent hepatic failure, potentially fatal hepatic necrosis. Skin and subcutaneous tissue disorders: Very rare cases of severe skin reactions have been reported. Rash, pruritus, urticaria, acute generalized exanthematous pustulosis, fixed erythema, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (with possible fatal outcome) have been reported. Renal and urinary disorders: acute renal failure, interstitial nephritis, hematuria, anuria. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
Epidemiological data on the use of oral therapeutic doses of paracetamol and on possible adverse effects in pregnancy and on the development of the fetus / newborn did not change the positive benefit / risk ratio of the drug. Consequently, in normal conditions of use, paracetamol can 'be used for the duration of pregnancy, on the advice of the doctor. During pregnancy, paracetamol should not be taken for long periods, in high doses or in combination with other drugs as the safety of use in these cases is not established. After oral intake, paracetamol is excreted in breast milk in small quantities. Although no side effects have been reported in breast-fed infants, the medicine should be used on the advice of your doctor during lactation.