Paracetamol Farmakopea 500mg product 20 Tablets

NAME
PARACETAMOL FARMAKOPEA

PHARMACOTHERAPEUTIC CATEGORY
Analgesics and antipyretics, anilides.

ACTIVE PRINCIPLES
Paracetamol 500 mg.

EXCIPIENTS
Microcrystalline cellulose, povidone, croscarmellose sodium, magnesiostearate, colloidal silica.

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.

DOSAGE
For children it is essential to respect the dosage defined according to their body weight. Approximate ages as a function of body weight are given for information only. In adults, the maximum oral dose is 3000 mg of paracetamol per day. Children weighing between 21 and 25 kg (approximately between 6 and 10 years): half tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 doses per day. Children weighed 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. Children 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 case of severe pain or high fever, 2 tablets of 500 mg to be repeated if necessary after not less than 4 hours.

STORAGE
Store in the original container.

WARNINGS
In rare cases of allergic reactions, administration should be suspended and appropriate treatment instituted. Administer 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, glucose-6 deficiency. -phosphate dehydrogenase, haemolytic anemia. High or prolonged doses of the product can cause high-risk liver disease and even severe changes in the kidney and blood, therefore the administration in subjects with mild / moderate renal or hepatic insufficiency and in patients with Gilbert's syndrome should only be performed if actually needed. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur.

INTERACTIONS
Oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow down (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or an increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can 'induce an increase in the half-life of chloramphenicol, with the risk of elevating its toxicity'. The concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce variations in the INR values. In these cases, more frequent monitoring of INR values should be performed during concomitant use and after its discontinuation. Use with extreme caution during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (eg rifampicin, cimetidine, antiepileptics such as glutethimide, phenobarbital, carbamazepine). The same is true in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uric acid (by the method of phosphotungstic acid) and with that of blood sugar (by the method of glucose-oxidase-peroxidase).

SIDE EFFECTS
Skin reactions of various types and severity have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis. Hypersensitivity reactions have been reported such as skin rash with erythema or urticaria, angioedema, larynx edema, anaphylactic shock. In addition, the following undesirable effects have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, kidney disorders (acute renal failure, interstitial nephritis, haematuria, anuria), gastrointestinal reactions and dizziness.

PREGNANCY AND BREASTFEEDING
Although clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol nor caused undesirable effects affecting the mother or child, it is recommended to administer the product only in cases of actual necessity.