DOC Generici

Paracetamol Doc

1. NAME OF THE MEDICINAL PRODUCT PARACETAMOL DOC Generici 500 mg tablets.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: paracetamol 500 mg. For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM White, round, biconvex tablet with score line. The tablet can be divided into equal halves.

4. CLINICAL INFORMATION

4.1 Therapeutic indications PARACETAMOL DOC Generici 500 mg tablets are indicated for the symptomatic treatment of mild to moderate pain and fever.

4.2 Posology and method of administration Posology For children it is essential to respect the posology defined according to their body weight. Approximate ages as a function of body weight are given for information only. Below three months, in case of jaundice, it is advisable to reduce the single oral dose. In adults, the maximum oral dose is 3000 mg of paracetamol per day (see section 4.9). The physician should evaluate the need for treatment for more than 3 consecutive days. The dosage schedule of PARACETAMOL DOC Generici 500 mg tablets in relation to body weight: Children weighing between 21 and 25 kg (approximately between 6 and 10 years): ½ tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day (3 tablets).  Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 doses per day.  Boys weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day.  Children weighing more than 50 kg (approximately over 15 years): 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day.  Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. In the case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours. Method of administration For oral use only. Taking food and drink with paracetamol does not affect the effectiveness of the medicine. Special populations Hepatic or renal insufficiency In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the time interval between administrations extended. Patients with renal insufficiency In patients with severe renal insufficiency (creatinine clearance <10 ml / min.), A time interval between administrations of at least 8 hours should be respected. Chronic alcoholism Chronic alcohol consumption can lower the toxicity threshold of paracetamol. In these patients, the time interval between two doses should be at least 8 hours. The dose of 2 g of paracetamol per day should not be exceeded. Elderly patients No dose adjustment is required in the elderly. Renal insufficiency: In case of renal insufficiency the dose must be reduced: Glomerular filtration

Dose 10 - 50 ml / min 500 mg every 6 hours <10 ml / min 500 mg every 8 hours 2 Impaired liver function In patients with impaired hepatic function or Gilbert's syndrome, the dose should be reduced or reduced or reduced prolonged the interval between single administrations. The effective daily dose should not exceed 60 mg / kg / day (up to a maximum of 3 g / day) in the following cases:  adults weighing less than 50 kg  mild to moderate hepatic insufficiency, Gilbert's syndrome (hereditary jaundice non-haemolytic)  dehydration  chronic malnutrition  chronic alcoholism.

4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  severe renal insufficiency.  alcohol abuse.

4.4 Special warnings and precautions for use To avoid the risk of overdose, it is necessary to check that any other drugs taken concomitantly do not contain paracetamol. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh> 9), acute hepatitis, concomitant treatment with drugs that impair liver function, deficiency glucose-6-phosphate dehydrogenase, haemolytic anemia, chronic alcohol abuse, severe renal insufficiency (creatinine clearance <10 ml / min. [see section 4.2]). If you have a high fever or signs of secondary infection, or if symptoms persist for more than 3 days, you should see your doctor. In general, paracetamol-containing medicines can only be taken for a few days and at low doses without consulting your doctor or dentist. In case of prolonged misuse of analgesics in high doses, headache episodes may occur which should not be treated with higher doses of the drug. In general, the habitual intake of analgesics, especially a combination of several analgesic substances, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy). Prolonged or frequent use is not recommended. Patients should be advised not to take other products containing paracetamol at the same time. Taking multiple daily doses in a single administration can severely damage the liver. In this case, the patient does not lose consciousness, but a doctor should be consulted immediately. Prolonged use without medical supervision can be harmful. In children treated with 60 mg / kg per day of paracetamol, the association with another antipyretic is not justified except in the case of ineffectiveness. Suddenly stopping analgesics after a prolonged period of misuse, at high doses, can cause headache, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until then, further analgesics should be avoided and should not be resumed without consulting your doctor. Care should be taken when taking paracetamol in combination with inducers of cytochrome CYP3A4 or when using substances that induce liver enzymes such as rifampicin, cimetidine and antiepileptics such as glutethimide, phenobarbital and carbamazepine. Care should be taken when administering paracetamol to patients with severe renal insufficiency (creatinine clearance  30 ml / min., See section 4.2). Alcohol consumption should be avoided during treatment with paracetamol. The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. Care should be taken in case of chronic alcoholism. In patients with alcohol abuse the dose should be reduced (see section 4.2). In this case, the daily dose should not exceed 2 grams. This medicine contains sorbitol and sucrose. Patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should avoid taking this medicine. In the presence of a high fever or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of the treatment should be carried out. Doses higher than recommended involve the risk of very serious liver injury. Treatment with antidote should be given as soon as possible (see section 4.9). Paracetamol should be used with caution in cases of chronic dehydration and malnutrition.

4.5 Interaction with other medicinal products and other forms of interaction Intake of probenecid inhibits the binding of paracetamol to glucuronic acid, resulting in an approximately two-fold reduction in paracetamol clearance. In patients taking probenecid concomitantly, the dose of paracetamol should be reduced. The metabolism of paracetamol is increased in patients taking medicinal products that induce enzymes, such as rifampicin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe unexpected hepatotoxicity in patients taking enzyme-inducing medicinal products.

Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, co-administration of this drug together with AZT should only be done on the advice of the physician. Concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of action of paracetamol. Concomitant use of drugs that slow gastric emptying can delay the absorption and the onset of action of paracetamol. Cholestyramine reduces the absorption of paracetamol and, therefore, cannot be administered until one hour has elapsed after paracetamol administration. Repeated intake of paracetamol for longer than one week increases the effect of anticoagulants, especially warfarin . Therefore, long-term administration of paracetamol in patients treated with anticoagulants should only take place under the supervision of the physician. Occasional paracetamol intake has no significant effect on bleeding tendency. Effects on laboratory tests Paracetamol can interfere with uric acid determinations using phosphotungstic acid and with blood glucose determinations using the glucose-oxidase-peroxidase reaction. Probenecid causes an almost two-fold reduction in the clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in paracetamol should be considered in case of concomitant treatment with probenecid. Paracetamol increases plasma levels of acetylsalicylic acid and chloramphenicol.

4.6 Fertility, pregnancy and lactation Pregnancy Epidemiological data from the use of oral therapeutic doses of paracetamol do not indicate any undesirable effects on pregnancy or on the health of the fetus or newborn. Prospective data on pregnancies exposed to overdoses did not show an increased risk of malformation. Reproductive studies with oral administration did not show any malformation or foetotoxic effects. Consequently, under normal conditions of use, paracetamol can be used for the entire duration of pregnancy, after carrying out a benefit and risk assessment. 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. Breastfeeding After oral intake, paracetamol is excreted in breast milk in small quantities. No undesirable effects have been reported in breastfed infants. Therapeutic doses of this medicine can be used during breastfeeding.

4.7 Effects on ability to drive and use machines Paracetamol does not affect the ability to drive or use machines. No studies on the ability to drive and use machines have been performed.

4.8 Undesirable effects The frequency is established according to the following convention: very common (≥ 1/10); common (from  1/100 to 1 / 10); uncommon ( 1 / 1,000 to  1/100); rare (from  1 / 10,000 to 1 / 1,000); very rare (≥1 / 10,000), including isolated cases; Not known: frequency cannot be estimated from the available data. Within each frequency class, undesirable effects are reported in descending order of severity.

Format: 20 tablets 500mg