TACHIPIRINA SOSP 120ML VAN/CAR

TACHIPIRINA 120 MG/5 ML ORAL SOSPENSION

active ingredients

Each ml of oral suspension contains 24 mg of paracetamol. 5 ml of suspension contain 120 mg of paracetamol. Excipients with known effects: 1 ml oral suspension contains: sorbitol (90.30 mg), sucrose (500 mg), methyl parahydroxybenzoate (1.25 mg). For the full list of excipients, see par. 6.1.

Excellent

Sorbitol; Sucrose; Gomma xantana; Edetate disode (dididrate); Metil parahydroxybenzoate; Microcrystalline cellulose; Carmellosa sodica (Avicel RC591); Sodium citrate; Sodium chloride; Potassium sorbate; Anidra colloidal silica; Citric acid monohydrate; Aroma vanillina-caramello; Purified water.

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

Population

In children up to 10 years of age it is essential to respect the defined posology according to body weight and not according to age, which is approximate and indicated only for information. If the age of the child does not correspond to the weight shown in the table, always refer to the body weight for the choice of the dosage. The posological scheme of Tachipirina suspension is the following.

TACHIPIRINA SOSPENSION
Weight	Age (approximately)	Single dose	Daily dose
7.2 kg	5-6 months	4.5 ml	Up to 4 times (every 6 hours)
8 kg	7-10 months	5 ml	Up to 4 times (every 6 hours)
9 kg	11 months	5.5 ml	Up to 4 times (every 6 hours)
10 kg	15-19 months	6 ml	Up to 4 times (every 6 hours)
from 11 kg	20-23 months	6,5 ml	Up to 4 times (every 6 hours)
from 12 kg	2 years	7.5 ml	Up to 4 times (every 6 hours)
from 14 kg	3 years	8.5 ml	Up to 4 times (every 6 hours)
16 kg	4 years	10 ml	Up to 4 times (every 6 hours)
from 18 kg	5 years	11 ml	Up to 4 times (every 6 hours)
from 20 kg	6 years	12.5 ml	Up to 4 times (every 6 hours)
from 22 kg	7 years	13,5 ml	Up to 4 times (every 6 hours)
25 kg	8 years	15.5 ml	Up to 4 times (every 6 hours)
from 28 kg	9 years	17,5 ml	Up to 4 times (every 6 hours)
from 31 kg up to 32 kg	10 years	19 ml	Up to 4 times (every 6 hours)

In case of jaundice in children under three months, the single dose should be reduced. In children over 10 years of age the relationship between weight and age becomes no more homogeneous due to the puberal development that, at the same age, has a different impact on body weight depending on sex and individual characteristics of the child. Therefore, over 10 years of age, the suspension posology is indicated in terms of weight and age ranges, as shown below. Children weighing between 33 and 40 kg (aged over 10 years and under 12 years): 20 ml of suspension at a time (corresponding to 480 mg), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day. Adolescents weighing more than 40 kg (aged 12 years or older) and adults: 20 ml of suspension at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 administrations per day. The doctor must assess the need for treatments for over 3 consecutive days. Method of administration A dosing syringe is attached to the packaging, with a level notches corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4,5 ml and 5 ml and a dosing cup with indicated level notches corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 15.5 ml, 15.5 ml, 15.5 ml, 17.5 ml, 19 ml. Shake the bottle before use then follow the instructions below. The suspension contains 24 mg of paracetamol for ml of product. For the opening of the bottle, push the cap down and simultaneously turn left. For the use of the syringe, put the syringe at the bottom of the hole: Turn the bottle: Holding the syringe firmly, gently pull the plunger down by filling the syringe to the heel corresponding to the desired dose. Reject the bottle vertically: Remove the syringe by turning it gently Introduce the syringe tip into the baby's mouth and exert a slight pressure on the plunger to cause the suspension to flow. The product must be used immediately after picking from the bottle. Any product residue in the syringe must be eliminated. For dosages greater than 5 ml, take the necessary quantity with the syringe and pour the content into the glass. Repeat the act until reaching the notch corresponding to the dosage indicated, and administer to the child inviting him to drink. For dosages in children older than 10 years and in adults, equal to 20 ml, use the cup filling it 2 times until the notch of 10 ml. The product must be used immediately after picking from the bottle. Any residue of product in the syringe or in the glass must be eliminated. After use close the bottle by screwing the cap thoroughly and wash the syringe and the glass with hot water. Let them dry, keeping them out of reach and sight of children. Renal insufficiency In case of severe renal failure (creatiny clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.

Conservation

Do not store at temperature above 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 paragraph 4.5). Important information about some excipients Tachipirina suspension containsSucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or sucrasis-isomaltasis failure, should not take this medicine. - methyl parahydroxybenzoate: can cause allergic reactions (also delayed). - sodium: this medicine contains less than 1 mmol (23 mg) of sodium for 20 ml, i.e. it is essentially “without sodium”. - sorbitol: this medicine contains 1806 mg of sorbitol for the dose of 20 ml. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given this medicine.

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 cholasteramine reduces the absorption of paracetamol. Contemporary 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 disorders	Gastrointestinal reaction
Hepatobiliary diseases	Abnormal liver function, hepatitis
Pathologies of skin and subcutaneous tissue	Erythema multiforme, 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 occurring 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. . Symptoms 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. glucosate 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.

Food

It is recommended to administer the product only in cases of actual need and under the direct control of the doctor.

Source: Farmadati