TACHIPIRIN * SCIR 120ML 120MG / 5

TACHIPIRIN * SCIR 120ML 120MG / 5

Therapeutic indications

As antipyretic: symptomatic treatment of febrile diseases such as flu, exanthematous diseases, acute respiratory tract diseases, etc. As an analgesic: headaches, neuralgia, myalgia and other painful manifestations of medium entity, of various origins.

Dosage and method of use

In children up to 10 years of age it is essential to respect the posology defined on the basis of body weight and not on the basis of age, which is approximate and indicated for information only. 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 dosage. In children weighing up to 7.2 kg it is recommended to use the formulation in drops, between 7.2 and 11 kg it is possible to use drops or syrup as the dosage per weight range is identical, between 12 and 32 kg it is recommended to use the syrup. The dosage schedule of Tachipirina drops is as follows.

The dosage schedule of Tachipirina syrup is as follows.

In case of jaundice in infants under three months, the single dose should be reduced. In children over 10 years of age, the relationship between weight and age becomes no longer homogeneous due to pubertal development which, at the same age, has a different impact on body weight depending on the sex and individual characteristics of the child. Therefore, above 10 years of age, the dosage of the syrup is indicated in terms of weight and age ranges, as reported below. Children weighing between 33 and 40 kg (older than 10 years and less than 12 years): 20 ml of syrup at a time (corresponding to 480 mg), to be repeated if necessary after 6 hours, without exceeding 4 doses per day . Adolescents weighing more than 40 kg (aged 12 years or more) and adults: 20 ml of syrup at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. The physician should assess the need for treatment for more than 3 consecutive days.Method of administrationThe package includes a dosing syringe with indicated level marks corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml and a measuring cup with indicated level marks corresponding to 5.5 ml, 6 ml, 6.5ml, 7.5ml, 8.5ml, 10ml, 11ml, 12.5ml, 13.5ml, 15.5ml, 17.5ml, 19mlSyrupThe syrup contains 24 mg of paracetamol per ml of product. To open the bottle, push the cap down and simultaneously turn to the left. To use the syringe, insert the tip of the syringe fully into the hole of the undercap; Turn the bottle upside down; While holding the syringe firmly, gently pull the plunger down filling the syringe to the mark corresponding to the desired dose. Put the bottle back upright; Remove the syringe by twisting it gently; Insert the tip of the syringe into the child's mouth and exert a slight pressure on the plunger to drain the solution. The product should be used immediately after withdrawal from the bottle. Any residual product in the syringe must be eliminated. For dosages greater than 5 ml, withdraw the required quantity with the syringe and pour the contents into the cup. Repeat the action until the notch corresponding to the indicated dosage is reached, and administer to the child inviting him to drink. For dosages in children over 10 years of age and adults, equal to 20 ml, use the cup by filling it 2 times up to the 10 ml mark. The product should be used immediately after withdrawal from the bottle. Any residual product in the syringe or cup must be eliminated. After use, close the bottle by screwing the cap tightly and wash the syringe and the cup with warm water. Allow them to dry, keeping them out of the reach and sight of children.DropsEach drop contains 4 mg of paracetamol. Invert the bottle and pour the number of drops corresponding to the dosage to be used in 25–50 ml of water, and let the child drink. Kidney failure In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between dosing should be at least 8 hours.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Patients with severe haemolytic anemia (this contraindication does not refer to oral formulations of 500mg). • Severe hepatocellular insufficiency (this contraindication does not refer to oral formulations of 500mg).

Side effects

The following are the side effects of acetaminophen organized according to the MedDRA systemic and organic classification. Insufficient data are available to establish the frequency of the individual effects listed.

Very rare cases of severe skin reactions have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

In rare cases of allergic reactions, administration should be discontinued and appropriate treatment instituted. Use with caution in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low reserves of hepatic glutathione), dehydration, hypovolemia. 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. High or prolonged doses of the product can cause alterations in the kidney and blood, even serious, therefore the administration in subjects with renal insufficiency must be carried out only if actually necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and kidney function and blood count. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur. Instruct the patient to contact the physician before combining any other drugs (see section 4.5). Important information about some of the ingredients Tachipirina drops, solution contains: - sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. - propylene glycol: can cause symptoms similar to those caused by alcohol. The container ofTachipirina drops, solutionis made of latex rubber. It can cause severe allergic reactions.Tachipirina syrup contains: - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency, should not take this medicine. For the 15 ml dose this medicinal product contains 5.25 g of sucrose, for the 16.5 ml dose it contains 5.78 g of sucrose, for the 18.5 ml dose it contains 6.48 g of sucrose and for the 20 ml dose contains 7 g of sucrose. To be taken into consideration in people with diabetes mellitus. - methyl parahydroxybenzoate: can cause allergic reactions (even delayed). - sodium: this medicine contains 1.2 mmol (or 27.6 mg) sodium per 20 ml. To be taken into consideration in people on a low sodium diet.

Pregnancy and breastfeeding

Clinical studies in pregnant or lactating patients have not shown particular contraindications to the use of paracetamol or caused undesirable effects affecting the mother or child. However, it is recommended to take / administer this medicine only in cases of real need and under the direct supervision of your doctor.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

The oral absorption of paracetamol depends on the rate of gastric emptying. Therefore, concomitant administration of drugs that slow (e.g. anticholinergics, opioids) or increase (e.g. prokinetics) the rate of gastric emptying may result in a decrease or 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 may induce slight 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 and under strict control 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 (for example 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 uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method).

Overdose

There is a risk of intoxication, especially in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal. SymptomsIn case of accidental intake of very high doses of paracetamol, acute intoxication is manifested by anorexia, nausea and vomiting followed by a profound deterioration of the general condition; these symptoms usually appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis, with consequent hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in hepatic transaminase levels, lactic-dehydrogenase, and bilirubin levels, and a decrease in prothrombin levels are observed, which may occur 12–48 hours after ingestion.TreatmentThe measures to be adopted consist of early gastric emptying and hospitalization for appropriate treatment, by administering N-acetylcysteine as an antidote as early as possible: the dosage is 150 mg / kg iv in a glucose solution in 15 minutes, then 50 mg / kg in the following 4 hours and 100 mg / kg in the following 16 hours, for a total of 300 mg / kg in 20 hours.

Active principles

TACHIPIRINA 120mg / 5ml syrup 5 ml of syrup containactive ingredient: paracetamol 120 mgexcipients with known effects: sucrose, methyl parahydroxybenzoate, sodium. TACHIPIRINA 100mg / ml oral drops, solution 1 ml of solution containsactive ingredient: paracetamol 100 mgexcipients with known effects: sorbitol, propylene glycol For the full list of excipients, see par. 6.1.

Excipients

•Syrup: sucrose, sodium citrate, sodium saccharin, methyl parahydroxybenzoate, potassium sorbate, Macrogol 6000, citric acid monohydrate, strawberry flavor, mandarin flavor, purified water. •Oral drops: propylene glycol, Macrogol 6000, sorbitol, sodium saccharin, citrus vanilla flavor, propyl gallate, caramel (E150a), sodium edetate, purified water.