analgesics and antipyretic, anilids.
sorbitol, talco, buttile methacrylate basic copolimero, magnesium oxid or light, ipromellous, carmellosa sodium, stearic acid, sodium lauri lsolfato , Magnesio Stearato (Ph.eur.), Titanium Dioxide (and 171), Sucra Losio, Simeticone, n, 2, 3-trimetyl-2- (propan-2-the) buttamide, strawberry aroma (contains maltodextrin, arabic rubber (E414), natural and/or identical aroma aroma substances to natural ones, propylene glycol (E1520), triacetin (E1518), Maltolo (E636)), vanilla aroma (cont an iene maltodestrina, natural and/or identical flavored substances to qu Natural, propylene glycol (E1520), sucrose).
hypersensitivity to the active ingredient or to any of the excipien you; severe renal failure; alcohol abuse. "> dosage: < /p>
doses indicate from body weight and age. Font>
a single dose goes d at 10 to 15 mg/kg of body weight up to a maximum of 60 - 75 mg/kg for the total daily dose.
the time interval between the individual d Osi depends on the symptoms and the maximum daily dose.
in any case, must not be less than 4 hours.
must not be used for over three days without consulting the doctor.
500 mg sachet
> 26-40 kg (8-12 years): single dose: 500 mg of paracetamol (1 sachet); dose m assimes daily 1500 mg paracetamolo (3 sachets).
40 kg (children over 12 years and adults): single dose: 500-1000 mg of paracetamol (1-2 sachets); maximum daily dose 3000 mg paracetamol (6 sachets of 500 mg).
< Font style = "vertical-align: inherit;"> only for oral use.
the granulate must be taken by placing it directly on the tongue and must be swallowed without water.
do not take a full stomach.
liver or kidney failure: in patients with liver or kidney failure or Gilbert syndrome, The dose should be reduced or the time interval must be prolonged between the sums. patients with inscription Renal fficienza: in patients with gray renal failure (creatinine clearance & lt; 10 ml/min.), A time interval between the administrations of at least 8 hours must be respected. "> chronic alcoholism: chronic alcohol consumption can lower the toxicity threshold of paracetamol.
in these patients, the interval or time between two doses must be at least 8 hours.
the dose of 2 g of paracetamol per day.
Elderly patients: nor the elderly is not required to adjust the dose. Style = "vertical-align: inherit;"> Children and teenage perfumes of reduced weight: paracetamolo 500 mg bust Inestro is not suitable for B Ambini of age of less than 8 years and of body weight of less than 26 kg. : inherit; "> for this group of patients, other formulations are available ie dosages.
for all indications.
adults, elderly and children over the age of 12: the usual dose is 500 - 1000 mg every 4 - 6 Hours up to a maximum of 3 g per day.
the dose should not be repeated before four hours.
renal failure: the dose must be eighth in case of renal failure.
glomerular filtration 10-50 ml /min: 500 mg each 6 hours; glomerular filtration & lt; 10 ml/node; 500 mg or gni 8 hours.
the effective daily dose should be considered, without exceeding 60 mg/kg/day (without exceeding 3 g/day), in the following situations: adults weighing less than 50 kg; entep insufficiency (mild to moderate); chronic alcoholism; dehydration; chronic malnutrition.
liver or kidney failure: in patients with liver or renal failure or Gilbert syndrome, the dose must be reduced or the interval of one administration should be prolonged.
the prescription in sachets is not recommended In children of age of 4 years.
children of ETA 'major (4 - 12 years) can be administered 250 - 500 mg every 4 - 6 hours up to a maximum of 4 d Osi within 24 hours. Font>
conservation:
do not keep at temperature greater than 30 degrees c.
keep in the original packaging to protect the medicine from light and from humbledity.
warnings:
to avoid the risk of overdose, it is necessary to verify that the entries other drugs taken in conjunction do not contain paracetam olo.
the Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's Sind Rome), severe hepatic failure (Child-Pugh & GT; 9), acute hepatitis, in treatm Ento concomitant with drugs that alter the NATO Hepatic function, deficiency of glucose-6-phosphate dehydrogenase, anemia and molitics, chronic alcohol abuse, severe renal failure (Clearanc and creatinine & lt; 10 ml/min).
In the presence of high fever or signs of secondary infection or if the symptoms persist for over 3 days, oc runs the doctor.
in general, the medicines containing parac eTamolo can be taken only for a few days and low doses if nza have consulted the doctor or dentist. Font>
in case of prolonged incorrect use of analgesics At high doses, episodes of headache can occur that should not be treated with higher drug doses.
in general, the usual intake of analgesics, specials and of an association of different substances analyzes which can determine and permanent renal lesion with risk of renal failure (n efropathy from analgesics).
prolonged or frequent use is not recommended.
patients should be warned not to take simultaneously and other products containing paracetamol.
the intake of more ornaver doses in a single administration can seriously damage the liver. < /font>
in that case, the patient does not It loses knowledge, however it takes a doctor immediately consult. : inherit; "> l prolonged use in the absence of medical supervision can be harmful.
in children treated with 6 0 mg/kg per day of paracetamol, the association with another anti -prosec ico is not justified except in case of ineffectiveness.
the sudden interruption of the intake of analgesics after a prolonged or use period incorrect, at high doses, it can cause headache, brushed a, muscle pain, nervousness and autonomic symptoms.
these abstinence symptoms are resolved within a few days.
until that moment, the additional intake of analgesics must be avoided and must not be Ere resumed without having consulted the doctor.
Attention must be paid and in case of intake of paracetamol in association with the inductors of the cytochrome cyp3a4 or to the use of substances that induce enzymes EP Athics such as rifampicin, cimetidine and anti -epileptics such as glutetimide, phenobarbital and carbamazepine.
attention must be paid when it is administered Paracetamla with patients with renal failure (creatinine clearance â ‰ ¤ 30 ml/min).
alcohol consumption should be avoided during treatment with the Etamolo Parac.
the risks of overdo Essay are greater in patients with non-cirrhotic alcoholic hepatopathy.
Attention must be paid in case of chronic alcoholism.
in patients with alcohol abuse the dose should be reduced.
in this case, the daily dose must not exceed the 2 grams.
this medicine contains sorbitol and sucrose.
in the presence of high fever or signs of secondary infection or persistence of symptoms over 3 days, an evaluation must be carried out treatment.
the doses superior to what is recommended imply the risk of very serious injury liver.
must be administered as possible the possible Treatment with antidote.
the paracetamol must be used with caution in case of dehydration and chronic malnutrition.
interactions:
the intake of probenecid inhibits the bond of paracetamol to the acac glucuronic, determining a reduction in the clearance of the amolo paracet around twice.
in patients who assume the probenecid in conjunction, the paracetamol dose should be reduced. < BR>
the metabolism of paracetamol has increased in patients taking medic inal who induce The enzymes, such as rifampicin and some antiepileptic ttes (carbamazepine, phenytoin, phenobarbital, primidone).
some isolated reports describe unexpected hepatotoxicity in patients who assumed medicines that enzymatic inductors.
concomitant administration of paracetamol and azt (zidovudine) increases the tendency to neutropenia. >
therefore, the co-administration of this drug together with the Izt must take place exclusively on the advice of the doctor.
the concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates absorption and onset of the action of paracetamol.
The concomitant intake of drugs that raise gastric emptying can delay the absorption and the onset of the action of paracetamol.
cholestiramine reduces the absorbed absorber and, therefore, cannot be administered to an hour has passed from Paracetamol administration. IGN: inherit; "> the repeated intake of paracetamol for periods higher than an upstairs sett increases the effect of anticoagulants, in particular the warfar in. < /font>
therefore, the administration of long-term paracetamol in patients treated with anticoagulants must take place only under the supervision of the doctor.
The occasional intake of paracetamol has no significant effects on the tendency to bleeding.
effects on laboratory tests: paracetamol can interfere with the determination of uricemia that use phosphotong acid and with those of blood sugar that use the glucose reaction oxidase-peroxida yes.
probenecid causes a reduction of almost two Sometimes of the Clearan ce of Paracetamol inhibiting its conjugation with glucuronic acid.
a reduction in paracetamol in case of concomitant treatment with probenecid must be taken into consideration.
the paracetamol increases the plasma levels of acetylsalicylic acid and chloramf enlication.
unwanted effects:
frequencies adverse reactions: very common (& gt; = 1/10), common (& GT; = 1/100, & lt; 1/10), uncommon (& gt; = 1/1,000, & lt; 1/100), rare (& gt; = 1/10,000, & lt; 1/1,000), very rare (& lt; 1/10,000). Font>
pathologies of the emolinphopoietic system.
rare: anemia, non-hemolytic anemias and depression medullary; trombocytope nie.
vascular pathologies. rare: edema.
gastrointestinal pathologies.
rare: conditions of the exocrine pancreas, acute and chronic pancreatitis, gastrointestinal emo rhragias, abdominal pain, diarrhea, nausea, vomiting.
hepatobiliary pathologies.
rare: liver failure, liver necrosis, jaundice.
disorders of the immune system.
rare: allergic conditions, anaphylactic reaction, food allergies, food additives, drugs and other chemicals. < BR>
pathologies of the skin and the Undercut fabric Aneo.
rare: urticaries, itching, rash, sweating, purple, purple , angioedema; very rare.
very rare cases of serious skin ions have been reported.
kidney and urinary pathologies. Align: inherit; "> rare: nephropathies, nephropathies and tubular disorders.
very rare cases of serious skin reactions have been reported.
The nephrotoxic effects are not very frequent and have not been reported in association with therapeutic doses, except after a prolonged administration .
report any reaction and adverse suspect through the national reporting system.
pregnancy and breastfeeding:the epidemiological data obtained on the use of oral therapeutic paracetamol therapeutic doses do not indicate any unwanted effect on the pregnancy or health of the fetus or newborn.
i Prospective data on the pregnant anze exposed to overdoseness did not show an increased risk of malformation.
reproductive studies with oral administration have not shown any fettootoxic malformation or effect.
of utilities, in normal conditions d 'Employment, paracetamol can be ot -ilized for the duration of pregnancy, after carrying out an assessment of the risks and benefits.
during pregnancy, the paracetam olo must not be taken for long periods, at high doses or in the asset to other drugs 'drugs' of use in these cii is not established.
After oral intake, the paracetamol is escaped in breast milk in small quantities.
no side effects have been reported in breastfeeding infants.