TACHIFLUACTIV 12CPR 500+200MG

TACHIFLUACTIV ADULTS 500 MG / 200 MG COMPRESSE EFFERENCES

active ingredients

Each effervescent tablet contains: Active ingredients: paracetamol 500 mg and vitamin C 200 mg.Excipients with known effects: sodium, sorbitol, yellow sunset (E110). For the full list of excipients, see paragraph 6.1.

Excellent

Citric acid anidro Sodium bicarbonate Sodium carbonate anidro Acesulfame K Sorbitol Orange Aroma Symetic Emulsion Sodium docused Yellow sunset (E110)

Therapeutic indications

Symptomatic therapy of the influence and fever of all kinds (fever from cooling, esantematic or infectious diseases). As analgesic for joint and muscle rheumatic pains, nerves, headaches and menstrual pains.

Contraindications

- Hypersensitivity to paracetamol or vitamin C, or to any of the excipients listed in the paragraph 6.1. - Children and adolescents (aged under 18).

Population

Population Pediatric population TACHIFLUACTIV is contraindicated in children and adolescents under the age of 18. Adults 1 effervescent 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, take 2 effervescent tablets to be repeated if necessary after not less than 4 hours. Do not administer for more than 3 consecutive days without consulting your doctor. Method of administration The effervescent tablet must be dissolved in a glass of water.

Conservation

This medicine does not require any special condition of conservation.

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-6-phosphate deficiency of dehydrogenase, hemolytic anemia. High or prolonged doses of the medicinal product may cause hematic alterations and severe kidney damage. The administration in subjects with kidney failure should only be carried out 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. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. During treatment with paracetamol, before taking any other medication, check that it 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 consult the doctor before associating any other medication (see also paragraph 4.5). Important information about some excipients TACHIFLUACTIV effervescent tablets contains: - sodio: 280,197 mg of sodium per tablet equivalent to 14% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium per adult. To be considered in people with reduced kidney function or following a low sodium diet. - sorbitol: 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 suffering from rare hereditary problems of fructose intolerance should not take this medicine - yellow sunset (E110): can cause allergic reactions.

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 medicinal 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 both 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. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). Paracetamol administration may interfere with the determination of uricemia (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 professionals are required to report any suspected adverse reaction through the national reporting system to the site 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.

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.

Source: Farmadati