Tachipirina 100 mg/ml 30 ml oral drops solution

Tachipirina 100 mg/ml 30 ml oral drops solution is an over-the-counter drug based on paracetamol , indicated for the symptomatic treatment of fever and pain in children. Thanks to its formulation in oral drops solution , it is particularly suitable for the little ones, ensuring precise dosing and simple administration. The product is effective as an antipyretic to lower body temperature in case of influenza , exanthematous diseases and respiratory tract infections , as well as being a valid analgesic to relieve headaches, neuralgia, myalgia and other medium-level pain.

The 30 ml pack of Tachipirina drops allows for practical and safe use, with the possibility of adapting the dosage based on the child's weight. Each ml of solution contains 100 mg of paracetamol , ensuring rapid and targeted action. The selected excipients, such as sorbitol and propylene glycol , ensure good tolerability and pleasant administration. Ideal for the symptomatic treatment of feverish and painful conditions, Tachipirina drops is a reliable ally for the well-being of the little ones, offering relief in a safe and controlled way.

Tachipirina 100 mg/ml oral drops solution is a choice recommended by pediatricians for its effectiveness and practicality. Its rapid action and ease of dosing make it indispensable in the home pharmacy, especially during periods of greater incidence of influenza and seasonal diseases .

ACTIVE INGREDIENTS

Active ingredients contained in Tachipirina 100 mg/ml 30 ml oral drops solution - What is the active ingredient of Tachipirina 100 mg/ml 30 ml oral drops solution?

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

EXCIPIENTS

Composition of Tachipirina 100 mg/ml 30 ml oral drops solution - What does Tachipirina 100 mg/ml 30 ml oral drops solution contain?

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

DIRECTIONS

Therapeutic indications Tachipirina 100 mg/ml 30 ml oral drops solution - Why is Tachipirina 100 mg/ml 30 ml oral drops solution 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 100 mg/ml 30 ml oral drops solution - When should Tachipirina 100 mg/ml 30 ml oral drops solution not be used?

• Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. • Patients suffering from 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 100 mg/ml 30 ml oral drops solution - How is Tachipirina 100 mg/ml 30 ml oral drops solution taken?

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 age of the child does not correspond to the weight shown in the table, always refer to body weight when choosing the 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 the drops or the syrup as the dosage for each weight range is identical, between 12 and 32 kg it is recommended to use the syrup. The dosage schedule for Tachipirina drops is as follows.

TACHIPIRINA DROPS
Weight	Age (approximate)	Single dose	Daily dose
from 3.2 kg	0-30 days	8 drops	Up to 4 times (every 6 hours)
from 4.3 kg	1 month	10 drops	Up to 4 times (every 6 hours)
from 5.3 kg	2 months	13 drops	Up to 4 times (every 6 hours)
from 6.1 kg	3 months	22 drops	Up to 4 times (every 6 hours)
from 6.7 kg	4 months	25 drops	Up to 4 times (every 6 hours)
from 7.2 kg	5-6 months	27 drops	Up to 4 times (every 6 hours)
from 8 kg	7-10 months	30 drops	Up to 4 times (every 6 hours)
from 9 kg	11-14 months	33 drops	Up to 4 times (every 6 hours)
from 10 kg	15-19 months	36 drops	Up to 4 times (every 6 hours)
from 11 kg	20-23 months	39 drops	Up to 4 times (every 6 hours)

The dosage schedule for Tachipirina syrup is as follows.

TACHIPIRINA SYRUP
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	11ml	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, over 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 (over 10 years and under 12 years): 20 ml of syrup 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 syrup 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 Syrup The syrup contains 24 mg of paracetamol per ml of product. To open the bottle, push the cap down and simultaneously turn it to the left. To use the syringe, insert the tip of the syringe fully into the hole in the undercap: For doses greater than 5 ml, take the required amount with the syringe and pour the contents into the cup. Repeat the action until the mark corresponding to the indicated dosage is reached, and administer to the child, inviting him to drink. For doses in children over 10 years of age and in adults, equal to 20 ml, use the cup by 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 eliminated. 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. Drops Each drop contains 4 mg of paracetamol. Turn the bottle upside down and pour the number of drops corresponding to the dosage to be used in 25-50 ml of water, and have the child drink. 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 100 mg/ml 30 ml oral drops solution - How is Tachipirina 100 mg/ml 30 ml oral drops solution stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Tachipirina 100 mg/ml 30 ml oral drops solution - About Tachipirina 100 mg/ml 30 ml oral drops solution it is important to know that:

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 drops, solution contains : - sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine. - propylene glycol: may cause symptoms similar to those caused by alcohol. - The container of Tachipirina drops, solution is made of latex rubber. May cause serious 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 sucrose, for the 16.5 ml dose it contains 5.78 g sucrose, for the 18.5 ml dose it contains 6.48 g sucrose and for the 20 ml dose it contains 7 g sucrose. To be taken into consideration by people with diabetes mellitus. - methyl parahydroxybenzoate: may cause allergic reactions (possibly delayed). - sodium: this medicinal product contains 1.2 mmol (or 27.6 mg) sodium per 20 ml equivalent to 1.38% of the WHO recommended maximum daily intake of 2 g sodium for an adult. To be taken into consideration by people on a controlled sodium diet.

INTERACTIONS

Interactions Tachipirina 100 mg/ml 30 ml oral drops solution - Which medicines or foods can modify the effect of Tachipirina 100 mg/ml 30 ml oral drops solution?

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 100 mg/ml 30 ml oral drops solution can cause side effects - What are the side effects of Tachipirina 100 mg/ml 30 ml oral drops solution?

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 100 mg/ml 30 ml oral drops solution - What are the risks of Tachipirina 100 mg/ml 30 ml oral drops solution 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 that 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 100 mg/ml 30 ml oral drops solution.

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 take / administer this medicine only in cases of real need and under direct medical supervision.

DRIVING AND USE OF MACHINERY

Taking Tachipirina 100 mg/ml 30 ml oral drops solution before driving or using machines - Does Tachipirina 100 mg/ml 30 ml oral drops solution affect driving or using machines?

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