Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup

Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavoured oral suspension is a solution specifically formulated for the symptomatic treatment of fever and pain in children . Thanks to its active ingredient, paracetamol , this oral suspension acts effectively as an antipyretic and analgesic , making it ideal for combating feverish states due to influenza, exanthematous diseases and acute respiratory tract conditions , as well as for relieving headaches, neuralgia and myalgia of medium severity.

The syrup formulation with a pleasant vanilla-caramel flavour makes it easy to administer even to the littlest ones, making the treatment simpler and more well-accepted. The 120 ml pack includes a practical adapter, a measuring syringe and a measuring cup , tools that allow you to precisely measure the necessary dose based on the child's weight, thus ensuring maximum safety of use.

Tachipirina oral suspension is particularly indicated for pediatric use and represents a reliable solution for the reduction of fever and the treatment of pain in children . The presence of selected excipients and the absence of sodium make the product also suitable for subjects with particular dietary needs. Choosing Tachipirina 120 mg/5 ml means relying on a safe, practical and proven effective drug for the health of the little ones.

ACTIVE INGREDIENTS

Active ingredients contained in Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - What is the active ingredient of Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup?

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

EXCIPIENTS

Composition of Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - What does Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup contain?

Sorbitol; Sucrose; Xanthan gum; Disodium edetate (dihydrate); Methyl parahydroxybenzoate; Microcrystalline cellulose; Sodium carmellose (Avicel RC591); Sodium citrate; Sodium chloride; Potassium sorbate; Colloidal anhydrous silica; Citric acid monohydrate; Vanillin-caramel flavour; Purified water.

DIRECTIONS

Therapeutic indications Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - Why is Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup used? What is it used for?

As an antipyretic: symptomatic treatment of febrile conditions such as influenza, exanthematous diseases, acute respiratory tract conditions, etc. As an analgesic: headaches, neuralgia, myalgia and other moderately severe painful conditions of various origins.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - When should Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup not be used?

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

DOSAGE

Quantity and method of taking Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - How do you take Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup?

In children up to 10 years of age, it is essential to respect the dosage defined based on body weight and not based on age, which is approximate and indicated for information purposes only. If the child's age does not correspond to the weight reported in the table, always refer to body weight when choosing the dosage. The dosage schedule for Tachipirina suspension is as follows.

TACHIPIRINA SUSPENSION
Weight	Age (approximate)	Single dose	Daily dose
from 7.2 kg	5-6 months	4.5 ml	Up to 4 times (every 6 hours)
from 8 kg	7-10 months	5 ml	Up to 4 times (every 6 hours)
from 9 kg	11-14 months	5.5 ml	Up to 4 times (every 6 hours)
from 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)
from 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)
from 25 kg	8 years old	15.5 ml	Up to 4 times (every 6 hours)
from 28 kg	9 years old	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, it is advisable to reduce the single dose. 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 suspension is indicated in terms of weight and age ranges, as reported below. Children weighing between 33 and 40 kg (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 4 administrations per day. Adolescents weighing more than 40 kg (aged 12 years or over) 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 evaluate the need for treatments for more than 3 consecutive days. Method of administration The package contains a dosing syringe with level marks corresponding to 1 ml, 2 ml, 3 ml, 4 ml, 4.5 ml and 5 ml and a measuring cup with level marks corresponding to 5.5 ml, 6 ml, 6.5 ml, 7.5 ml, 8.5 ml, 10 ml, 11 ml, 12.5 ml, 13.5 ml, 15.5 ml, 17.5 ml, 19 ml. Shake the bottle before use and then follow the instructions below . The suspension 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 in the undercap: Turn the bottle upside down: Holding the syringe firmly, gently pull the plunger down, filling the syringe to the mark corresponding to the desired dose. Return the bottle to an upright position: Remove the syringe by gently twisting it. Insert the tip of the syringe into the child's mouth and apply gentle pressure to the plunger to release the suspension. The product must be used immediately after taking it from the bottle. Any residual product in the syringe must be discarded. For doses greater than 5 ml, take the required amount with the syringe and pour the contents into the cup. Repeat the procedure until the mark corresponding to the indicated dosage is reached, and administer to the child, inviting him or her to drink. For doses in children over 10 years of age and in adults, equal to 20 ml, use the cup, filling it twice up to the 10 ml mark. The product must be used immediately after taking it from the bottle. Any residual product in the syringe or cup must be discarded. After use, close the bottle by screwing the cap tightly and wash the syringe and cup with hot water. Leave them to dry, keeping them out of the reach and sight of children. Renal impairment In case of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between administrations must be at least 8 hours.

CONSERVATION

Storage Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - How is Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup stored?

Do not store above 25°C.

WARNINGS

Warnings Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - It is important to know that Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup:

In rare cases of allergic reactions, administration should be suspended and appropriate treatment should be instituted. Use with caution in cases 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, in concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia. High or prolonged doses of the product can cause even serious alterations to the kidney and blood, therefore administration to subjects with renal insufficiency should be carried out only if really necessary and under direct medical supervision. In case of prolonged use it is advisable to monitor liver and renal function and blood count. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Invite the patient to contact the doctor before combining any other medicine (see section 4.5). Important information about some of the excipients Tachipirina suspension contains : - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. - methyl parahydroxybenzoate: may cause allergic reactions (possibly delayed). - sodium: this medicine contains less than 1 mmol (23 mg) sodium per 20 ml, i.e. essentially “sodium-free”. - sorbitol: this medicine contains 1806 mg sorbitol per 20 ml dose. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content of oral medicinal products may alter the bioavailability of other concomitantly administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicinal product.

INTERACTIONS

Interactions Tachipirina 120 mg/5 ml 120 ml oral suspension vanilla-caramel flavour with adapter, syringe and cup - Which medicines or foods can modify the effect of Tachipirina 120 mg/5 ml 120 ml oral suspension vanilla-caramel flavour with adapter, syringe and cup?

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 lead to a decrease or increase in the bioavailability of the product, respectively. Concomitant administration of cholestyramine reduces the absorption of paracetamol. Concomitant intake of paracetamol and chloramphenicol may lead to an increase in the half-life of chloramphenicol, with the risk of increasing its toxicity. Concomitant use of paracetamol (4 g per day for at least 4 days) with oral anticoagulants may lead to slight variations in 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 close monitoring 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 applies in cases of alcoholism and in patients treated with zidovudine. The administration of paracetamol can interfere with the determination of uricemia (by the phosphotungstic acid method) and with that of glycemia (by the glucose-oxidase-peroxidase method).

SIDE EFFECTS

Like all medicines, Tachipirina 120 mg/5 ml 120 ml oral suspension vanilla-caramel flavour with adapter, syringe and cup can cause side effects - What are the side effects of Tachipirina 120 mg/5 ml 120 ml oral suspension vanilla-caramel flavour with adapter, syringe and cup?

The following are the adverse reactions of paracetamol organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed.

Pathologies of the haemolymphopoietic system	Thrombocytopenia, leukopenia, anemia, agranulocytosis
Immune system disorders	Hypersensitivity reactions (urticaria, laryngeal edema, angioedema, anaphylactic shock)
Nervous system disorders	Dizziness
Gastrointestinal disorders	Gastrointestinal reaction
Hepatobiliary pathologies	Abnormal liver function, hepatitis
Skin and subcutaneous tissue disorders	Erythema multiforme, Stevens Johnson syndrome, Epidermal necrolysis, Skin rash
Kidney and urinary disorders	Acute renal failure, interstitial nephritis, hematuria, anuria

Very rare cases of serious skin reactions have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup - What are the risks of Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup in case of overdose?

There is a risk of intoxication, especially in patients with liver disease, in chronic alcoholism, in patients with chronic malnutrition, and in patients receiving enzyme inducers. In these cases, overdose can be fatal . Symptoms In case of accidental ingestion of very high doses of paracetamol, acute intoxication manifests itself with anorexia, nausea and vomiting followed by a profound deterioration of general conditions; these symptoms generally appear within the first 24 hours. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve into massive and irreversible necrosis, with consequent hepatocellular insufficiency, metabolic acidosis and encephalopathy, which can lead to coma and death. Simultaneously, an increase in the levels of hepatic transaminases, lactate dehydrogenase, and bilirubinemia, and a reduction in prothrombin levels are observed, which may occur within 12-48 hours after ingestion. Treatment The measures to be taken consist of early gastric emptying and hospitalization for appropriate treatment, by administering, as early as possible, N-acetylcysteine ​​as an antidote: the dosage is 150 mg/kg iv in glucose solution over 15 minutes, then 50 mg/kg over the next 4 hours and 100 mg/kg over the next 16 hours, for a total of 300 mg/kg over 20 hours.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup.

Pregnancy A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment 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 with the lowest possible frequency. Breastfeeding It is recommended to administer the product only in cases of real need and under direct medical supervision.

DRIVING AND USE OF MACHINERY

Taking Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup before driving or using machines - Does Tachipirina 120 mg/5 ml 120 ml vanilla-caramel flavour oral suspension with adapter, syringe and cup affect driving or using machines?

Tachipirina does not alter the ability to drive vehicles or use machinery.