Paracetamol 500mg ACCORD 20 Effervescent Tablets

Paracetamol 500mg ACCORD - Medical Device

Paracetamol Accord Healthcare 500 mg is useful in the treatment of mild to moderate pain and / or fever.

Active principles

Each effervescent tablet contains 500 mg of paracetamol.

Excipients with known effect: Sodium approximately 503 mg / tablet. It also contains sorbitol (E420) 131 mg / tablet.

Excipients

Citric acid, Sodium bicarbonate, Sorbitol E420, Sodium carbonate anhydrous, Povidone K 25 (E1201), Simethicone, Saccharin sodium, Lemon flavor (containing maize maltodextrin, acacia gum (E414) and alpha-tocopherol (E307)), Macrogol 6000.

Dosage

The use of this presentation is reserved for adults and adolescents from 12 years of age only. Doses depend on body weight and age: a single dose is between 10 and 15 mg / kg body weight up to a maximum of 60 mg / kg body weight for the total daily dose.

Pediatric population

• Children under 12 years of age: Accord Healthcare Paracetamol effervescent tablets are not recommended for children under 12 years of age.
• Adolescents aged between 12 and 15 years and weighing between 41 and 50 kg: the dosage is one tablet per dose, repeated if necessary after 6-4 hours, without exceeding 4 tablets per day.
• Adolescents aged 16 to 18 years and weighing more than 50 kg: like adults.

Adults

The usual adult dose is 1-2 tablets of 500 mg, repeated if necessary after 4 hours, without exceeding 3 g of paracetamol per day (i.e. 6 tablets).

Maximum daily dose

• The maximum daily dose of paracetamol should not exceed 3 g.
• The maximum single dose is 1 g (2 effervescent tablets).

Frequency of administration

The specific dosing interval depends on the symptoms and the maximum daily dose. Systematic administration avoids the fluctuation of pain or fever. Depending on the recurrence of symptoms (fever and / or pain), repeat administration is allowed, which should preferably never occur before 6 hours and in no case before 4 hours. In adolescents, administration should be given at regular intervals, including overnight, preferably at 6 hour intervals, or at intervals of a minimum of 4 hours. If the pain persists for more than 5 days or the fever lasts more than 3 days, or worsens or other symptoms arise, stop treatment and consult a doctor. Kidney failure. In case of renal insufficiency the dose should be reduced:

Impaired liver function

In patients with impaired hepatic function or Gilbert's syndrome, the dose should be reduced or the interval between individual administrations extended. The effective daily dose should not exceed 60 mg / kg / day (up to a maximum of 2 g / day) in the following cases:

• adults weighing less than 50 kg;
• mild to moderate liver failure, Gilbert's syndrome (hereditary non-haemolytic jaundice);
• dehydration;
• chronic malnutrition;
• chronic alcoholism. Taking food and drink with paracetamol does not affect the effectiveness of the medicine.

Method of administration

Paracetamol Accord Healthcare 500 mg effervescent tablet is for oral use. Dissolve the tablets completely in a glass of water before ingesting them.

Warnings

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 there is no loss of consciousness. However, immediate medical attention should be sought. Prolonged use, if not under close medical supervision, can be harmful. In adolescents treated with daily doses of paracetamol equal to 60 mg / kg, the association with other antipyretics is not justified except in case of ineffectiveness.

Paracetamol should be administered with caution to patients with moderate to severe renal insufficiency, mild to moderate hepatic insufficiency (including Gilbert's syndrome), severe hepatic insufficiency (Child-Pugh> 9), acute hepatitis, concomitantly treated with drugs. impaired liver function, with glucose-6-phosphate dehydrogenase deficiency, haemolytic anemia, alcohol abuse, dehydration and chronic malnutrition. The risks of overdose are greater in people with non-cirrhotic alcoholic liver disease. Caution should be exercised in the presence of chronic alcoholism. In this case the daily dose should not exceed 2 grams. Do not consume alcohol while taking acetaminophen.

Caution should be exercised in aspirin-sensitive asthma patients, as mild paracetamol-reactive bronchospasm (cross-reaction) was reported in less than 5% of patients tested. This medicine contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine. This drug contains 503 mg of sodium per dose, equivalent to 25.15% of the WHO recommended maximum daily intake of sodium. The maximum daily dose of this medicinal product is equivalent to 150.19% of the WHO recommended maximum daily intake of sodium. Paracetamol Accord Healthcare 500 mg effervescent tablets has a high sodium content. Particularly to be taken into consideration in people on a low sodium diet. A doctor should be consulted in the event of a high fever or signs of secondary infection or persistence of symptoms. A doctor should be consulted immediately in the event of an overdose, even if the patient feels well, due to the risk of irreversible liver damage.

Contraindications

Hypersensitivity to paracetamol or to any of the excipients.

Side effects

The frequency is established according to the following convention: very common (≥ 1/10); common (≥1 / 100; <1/10); uncommon (≥1 / 1,000; <1/100); rare (≥1 / 10,000; <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.

Not known: some cases of toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, larynx edema, anaphylactic shock, bronchospasm *, anemia, liver function impairment and hepatitis, renal impairment (severe renal damage) have been reported , interstitial nephritis, haematuria, anuresis), gastrointestinal effects and dizziness. * Cases of bronchospasm have been reported with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Overdose

There is a risk of intoxication, especially in the elderly, in young adolescents, in patients with liver disease, in the case of chronic alcoholism, in patients with chronic malnutrition. Overdose can be fatal. Liver damage can occur in adults who have taken 10 g or more of acetaminophen. Ingestion of 5 g or more of paracetamol can cause liver damage if the patient has risk factors (see below).

Risk factors

If the patient: a) is on prolonged treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other liver enzyme inducing drugs. Or: b) regularly consume more than recommended ethanol. O: c) probably has a glutathione depletion, eg. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of acetaminophen overdose in the first 24 hours include: paleness, nausea, vomiting, anorexia and abdominal pain. Liver damage can occur 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure can progress to encephalopathy, hemorrhage, hypoglycemia, brain edema and death. Even in the absence of severe liver damage, acute renal failure with acute tubular necrosis can occur, highly likely if accompanied by low back pain, hematuria, and proteinuria. Cardiac arrhythmias and pancreatitis have been reported. At the same time, increased levels of hepatic transaminases (AST, ALT), lactic dehydrogenase and bilirubin are observed together with an increase in prothrombin levels which can occur 12-48 hours after administration.

Treatment

In the management of acetaminophen overdose, immediate treatment is essential. Even in the absence of significant early symptoms, patients must be rushed to the hospital for immediate medical attention. Symptoms may be limited to nausea and vomiting and may not reflect the severity of the overdose or the risk of organ damage. The treatment must be carried out according to the guidelines in force. Activated charcoal treatment should be considered if no more than 1 hour has elapsed since the overdose. The plasma concentration of paracetamol should be measured 4 hours or more after ingestion (concentrations measured earlier are not reliable). N-acetylcysteine treatment can be used up to 24 hours after paracetamol ingestion; however, the maximum protective effect is obtained up to 8 hours after ingestion. After this time, the effectiveness of the antidote decreases rapidly. If necessary, in line with the established dosing regimen, N-acetylcysteine should be administered intravenously to the patient. In cases where vomiting is not a problem and the patient lives in an area far from the hospital, administration of oral methionine may represent an adequate alternative. High doses of sodium bicarbonate are expected to induce gastrointestinal symptoms, including belching and nausea. Also, high doses of sodium bicarbonate can cause hypernatremia; electrolytes should be monitored and patients treated appropriately.

Pregnancy and breastfeeding

Pregnancy : A large amount of data on pregnant women indicate neither malformative nor fetal / neonatal toxicity. Epidemiological studies of neurodevelopmental in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Lactation : After oral administration, paracetamol is excreted in breast milk in small quantities. To date, no adverse reactions or undesirable effects have been reported in association with breastfeeding. At therapeutic doses, paracetamol can be administered during breastfeeding.

Format

Box of 20 effervescent tablets.