TACHIPIRINA PR INF 10SUP 125M

TACHIPIRINA

active ingredients

TACHIPIRINA 500 mg tablets. Each tablet contains: active ingredient: paracetamol 500 mg. TACHIPIRINA 500 mg effervescent granulate. Each bag contains: active ingredient: paracetamol 500 mg. excipients with known effects: aspartame, maltitolo, 12,3 mmoli sodium per sachet TACHIPIRINA 125 mg effervescent granulate. Each bag contains: active ingredient: paracetamol 125 mg. excipients with known effects: aspartame, maltitolo, 3,07 mmoli sodium per sachet TACHIPIRINA Newborn 62.5 mg supposed. Each suppository contains. active ingredient: 62.5 mg paracetamol TACHIPIRINA First Infancy 125 mg assumed. Each suppository contains: active ingredient: paracetamol 125 mg. TACHIPIRINA Children 250 mg presumed. Each suppository contains: active ingredient: 250 mg paracetamol. TACHIPIRINA Children 500 mg supposed. Each suppository contains: active ingredient: paracetamol 500 mg. TACHIPIRINA Adults 1000 mg suppositories. Each suppository contains: active ingredient: 1000 mg paracetamol. For the full list of excipients, see par. 6.1.

Excellent

• Tablets: microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, sodium chroscarmellosa. • Effervescent granulate: maltitol, mannitol, sodium bicarbonate, citric acid anidro, citrus aroma, aspartame, sodium docusato. • Supposes: solid semisynthetic glycerides.

Therapeutic indications

How antipyretic: symptomatic treatment of feverish affections such as influenza, hexanthomatic diseases, acute affections of the respiratory tract, etc. As analgesic: cephales, neuralgies, myalgies and other painful manifestations of medium-sized, of various origin.

Contraindications

• Hypersensitivity to paracetamol or any of the excipients listed in paragraph 6.1. • Patients suffering from severe haemolytic anemia (this contraindication does not refer to 500mg oral formulations). • Severe hepatocellular insufficiency (this contraindication does not refer to 500mg oral formulations).

Population

For children it is essential to respect the defined dosage according to their body weight, and therefore to choose the suitable formulation. Approximate ages according to body weight are indicated as information. In adults the maximum oral posology is 3000 mg and by rectal means is 4000 mg of paracetamol per day (see par. 4.9). The doctor must assess the need for treatments for over 3 consecutive days. The posological scheme of Tachipirina in relation to body weight and the way of administration is as follows: 500 mg tablets. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): 1⁄2 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations per day (3 tablets). • Children weighing between 26 and 40 kg (approximately between 8 and 11 years): 1 tablet at a time, to be repeated if necessary after 6 hours, without exceeding 4 administrations 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 administrations 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 administrations per day. • Adults: 1 tablet at a time, to be repeated if necessary after 4 hours, without exceeding 6 administrations 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. 500 mg effervescent granulate in sachets. Melt the effervescent granulate into a glass of water. • Children weighing between 26 and 40 kg (approximately between 8 and 11 years): 1 bag at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Children weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. • Adults: 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. In case of severe pain or high fever, 2 500 mg sachets to be repeated if necessary after not less than 4 hours. Effervescent granulate of 125 mg in sachets. Melt the effervescent granulate into a glass of water. • Children weighing between 7 and 10 kg (approximately between 6 and 19 months): 1 bag at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 bag at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. • Children weighing between 13 and 20 kg (approximately between 30 months and below 6.5 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): 2 sachets at a time (corresponding to 250 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. Newborn 62.5 mg. • Children weighing between 3.2 and 5 kg (approximately between birth and 2 months): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Supposes First 125 mg infancy. • Children weighing between 6 and 7 kg (approximately between 3 and 5 months): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Children weighing between 7 and 10 kg (approximately between 6 and 19 months): 1 supposes at a time, to be repeated if necessary after 4 - 6 hours, without exceeding the 5 administrations per day. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 supposes at a time, to be repeated if necessary after 4 hours, without exceeding the 6 administrations per day. Suppose Children from 250 mg. • Children weighing between 11 and 12 kg (approximately between 20 and 29 months): 1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing between 13 and 20 kg (approximately between 30 months and below 6.5 years): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Suppose 500 mg children. • Children weighing between 21 and 25 kg (approximately between 6.5 and less than 8 years): 1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing between 26 and 40 kg (approximately between 8 and 11 years): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Adults of 1000 mg. • Children weighing between 41 and 50 kg (approximately between 12 and 15 years): 1 supposes at a time, to be repeated if necessary after 8 hours, without exceeding 3 administrations per day. • Children weighing more than 50 kg (approximately over 15 years): 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. • Adults: 1 supposes at a time, to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Renal failure. In case of severe renal failure (creatiny clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.

Conservation

Compressed and effervescent granulate: no special precaution for conservation. Suppose: store at a temperature not exceeding 25°C.

Warnings

In rare cases of allergic reactions, administration must be suspended and appropriate treatment must be established. Use carefully in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic beverages per day), anorexia, bulimia or cachesia, chronic malnutrition (low reserves of liver glutathione) dehydration, hypovolemia. Paracetamol should be administered with caution to patients with mild to moderate hepatocellular insufficiency (including Gilbert's syndrome), severe liver failure (Child-Pugh>9), acute hepatitis, in concomitant treatment with drugs that alter liver function, glucose deficiency-6-phosphate dehydrogenase, hemolytic anemia. High or prolonged doses of the product may cause serious alterations to the kidney and blood, so the administration in the subjects with kidney failure should be carried out only if effectively necessary and under direct medical control. In case of protracted use it is advisable to monitor the liver and renal function and the blood crasis. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Invite the patient to contact the doctor before associating any other medication. See also the par. 4.5. Important information about some excipients. Tachypirin 125 mg granulate effervescent contains : - aspartame, is a source of phenylalanine. It can be harmful in the case of phenylchetonuria (deficit of the phenylalanine hydroxylase enzyme) for the risk related to the accumulation of phenylalanin amino acid. - maltitol: use with caution in patients suffering from rare hereditary problems of fructose intolerance. 70.6 mg of sodium per sachet equivalent to 3.53% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult: to be considered in people with reduced kidney function or following a low sodium diet. Tachypyrin 500 mg effervescent granulate contains: - aspartame, is a source of phenylalanine. It can be harmful in the case of phenylchetonuria (deficit of the phenylalanine hydroxylase enzyme) for the risk related to the accumulation of phenylalanin amino acid. - maltitol: use with caution in patients suffering from rare hereditary problems of fructose intolerance. - 283 mg of sodium per sachet equivalent to 14.1% of the maximum daily intake recommended by the WHO that corresponds to 2 g sodium for an adult. The maximum dose for this product is 84.6% of the maximum daily sodium intake recommended by the WHO.: to be considered in people with reduced kidney function or following a low sodium diet.

Interactions

The oral absorption of the paracetamol depends on the speed of gastric emptying. Therefore, the concomitant administration of drugs that slow (e.g. anti-linergics, opioids) or increase (e.g. procinetics) the speed of gastric emptying can determine respectively a decrease or increase of the bioavailability of the product. Concurrent administration of cholesteramine reduces the absorption of paracetamol. The simultaneous intake of paracetamol and chloramphenicol can lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concurrent use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants can induce slight variations in INR values. In these cases a more frequent monitoring of INR values should be conducted during concurrent use and after its interruption. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). The same applies in cases of ethylism and in patients treated with zidovudine. Paracetamol administration may interfere with the determination of urine (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).

Effects

Below are the undesirable effects of the paracetamol organized according to the systemic and organic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed.

Emolinfopoietic system pathologies	Trombocytopenia, leucopenia, anemia, agranulocytosis
Immune system disorders	Hypersensitivity reactions (orticaria, larynx edema, angioedema, anaphylactic shock)
Diseases of the nervous system	Vertigo
Gastrointestinal diseases	Gastrointestinal reaction
Hepatobiliary diseases	Abnormal liver function, hepatitis
Pathologies of skin and subcutaneous tissue	Multiform erythema, Stevens Johnson syndrome, epidermal necrolysis, skin rash
Kidney and urinary pathologies	Acute renal insufficiency, interstitial nephritis, hematuria, anuria

Very rare cases of severe skin reactions have been reported. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

There is a risk of intoxication, especially in patients with liver disease, in case of chronic alcoholism, in patients suffering from chronic malnutrition, and in patients receiving enzyme inductors. In these cases overdose can be fatal. Synonyms In case of accidental intake of very high doses of paracetamol, acute intoxication manifests with anorexia, nausea and vomiting followed by deep decay of general conditions; such symptoms usually appear within the first 24 hours. In case of overdose the paracetamol can cause liver cytolysis that can evolve towards massive and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in levels of hepatic transaminasis, lactic-dedrogenase, and bilirubinemia are observed, and a reduction in levels of protrombine, which can occur in 12-48 hours after ingestion. Treatment The measures to be taken consist of early gastric emptiness and hospital treatment for the case, by administration, as early as possible, of N-acetylcysteine as an antidote: posology is 150 mg/kg e.v. in glucosated solution in 15 minutes, then 50 mg/kg in the next 4 hours and 100 mg/kg in the following 16 hours, for a total of 300 mg/kg in 20 hours.

Pregnancy: A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible. Nursing: It is recommended to administer the product only in cases of actual need and under the direct control of the doctor.

Source: Farmadati