Tachipirina tachifluactiv influenza and cold 500mg/60mg paracetamol pseudoephedrine hydrochloride 10 tablets

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Productor: Angelini
Medicine to relieve the symptoms of flu and colds.
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Product Description

Tachifluactiv Influenza E Fredreddore is an Angelini medicine based on paracetamol and pseudoephedrine hydrochloride, indicated for the treatment of cold and flu symptoms.

Indications

Treatment of cold and flu symptoms.

Composition

Active ingredients

Each tablet contains: Active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 60 mg. Excipients with known effect: sodium 324 mg, sorbitol (E420) 296 mg, aspartame (E951) 20 mg, benzoic acid contained in the simethicone emulsion. For a full list of excipients, see section 6.1.

Excipients

Each tablet contains: citric acid, sodium bicarbonate, sodium carbonate anhydrous, sorbitol (E420), lemon flavoring, aspartame (E951), sodium saccharin, simethicone emulsion, leucine, docusate sodium.

Directions for use and Dosage

Dosage

Adults and adolescents over 12 years of age: 1 effervescent tablet, 2-3 times a day for no more than 5 days in adults and for no more than 3 days in adolescents. Dissolve the tablet in a glass of water and drink the resulting solution immediately.

Paediatric population

Tachifluactiv Influenza E Cold is not recommended for children under 12 years of age (see section 4.3 “Contraindications”).

Interactions

The risk of serious side effects is also increased when paracetamol is taken together with other antipyretic analgesics; Concomitant use of this type of medicine should therefore be avoided.

Patients should be advised not to take other medicines containing paracetamol at the same time due to the risk of serious liver damage in case of overdose (See section 4.9).

Alcoholic drinks should be avoided while taking this medicine because alcohol used concomitantly with paracetamol can cause liver damage (See section 4.5). Paracetamol should be administered with caution to patients with alcohol dependence (See section 4.5).

This medicine should be given with caution to patients being treated with other medicinal products that affect the liver (See section 4.5).

During therapy with oral anticoagulants, it is advisable to reduce the dose. The patient should be advised to consult a doctor if he/she is already taking oral anticoagulants. under treatment with other medicinal products.

Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (Hagma), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Careful monitoring is recommended, including measurement of urinary 5-oxoproline.

In case of surgery, it is advisable to stop treatment a few days beforehand, because the risk of hypertensive crisis is high. increased if halogenated anaesthetics are used (See section 4.5).

Warnings

During treatment with Tachifluactiv Influenza E Cold, before taking any other medicine, check that it does not contain paracetamol, since serious adverse reactions may occur if this active ingredient is taken in high doses. Tachifluactiv Influenza E Cold should be used with caution in patients with:

  • renal failure;
  • hepatic failure;
  • acute hepatitis;
  • glucose-6-phosphate dehydrogenase deficiency;
  • hemolytic anemia;
  • chronic malnutrition and dehydration;
  • cardiovascular disease, tachycardia or palpitations, angina, arrhythmias;
  • diabetes mellitus;
  • prostatic hypertrophy that causes disorders of the urination;
  • psychosis;
  • hyperthyroidism;
  • asthma;
  • glaucoma;
  • hypertension.

Severe skin reactions

Severe skin reactions such as acute generalized exanthematous pustulosis (Agep) may occur with products containing pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from a widespread edematous erythema and located mainly in the skin folds, trunk, and upper limbs. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of Tachifluactiv Influenza E Cold should be discontinued and appropriate measures taken if necessary.

Ischemic colitis

Some cases of ischemic colitis have been reported with medicinal products containing pseudoephedrine. The use of pseudoephedrine should be discontinued and it is recommended to consult a doctor if abdominal pain, rectal bleeding or other symptoms of ischemic colitis suddenly appear.

Ischemic optic neuropathy

Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of scotoma.

For those who participate in sports: the use of this medicine may cause positive anti-doping tests.

Patients should consult their doctor if:

  • the pain or nasal congestion worsens or lasts more than 5 days (or if the symptoms do not improve within 5 days)
  • the fever ... Tachifluactiv Influenza E Raffreddore 500 mg/60 mg effervescent tablets contain:
  • Aspartame (E 951): a source of phenylalanine, may be harmful for people with phenylketonuria. No non-clinical or clinical studies are available. Clinical trials on the use of aspartame in children under 12 weeks of age.
Sorbitol (E 420): Patients with hereditary fructose intolerance should not be given this medicine.Sodium: This medicine contains 324 mg (14 mmol) per tablet, equivalent to approximately 16% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Simethicone emulsion also contains: Benzoic acid: This medicine contains 0.06 mg of benzoic acid per tablet equivalent to 0.06 mg/3 g.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.Patients who are taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks (see section 4.5).Pregnancy and breastfeeding (see section 4.6).Children under 12 years of age.Patients with manifest glucose-6-phosphate dehydrogenase insufficiency.Subjects suffering from a severe form of the following diseases: coronary heart disease (angina, previous infarction); hypertension; arrhythmias; hepatic insufficiency; renal insufficiency; asthma; diabetes; micturition disorders caused by prostatic hypertrophy or other diseases; haemolytic anaemia.Hyperthyroidism.Closed-angle glaucoma.Pheochromocytoma.Subjects taking tricyclic antidepressants (see section 4.5).Subjects taking beta-blocker drugs (see section 4.5).Subjects taking other sympathomimetic drugs (see section 4.5).

Undesirable effects

Adverse events are tabulated below by class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, <1/100); rare (≥ 1/10,000, < 1/1,000); very rare (<1/10,000), or not known (frequency cannot be estimated from the available data).

Disease ClassFrequencyUndesirable EffectsBlood and lymphatic system disordersVery rarethrombocytopenia, agranulocytosis, leukopenia, pancytopeniaImmune system disordersRarehypersensitivity, angioedemaNot knownanaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysisPsychiatric disordersRarenervousness, insomnia, anxiety, agitation, hallucinations (reported rarely, particularly in children)Symptoms nervous systemRaredizziness, headache, tremorEye disordersNot knownischemic optic neuropathyCardiac disordersRaretachycardia, palpitationsVascular disordersRarehypertensionGastrointestinal disordersRarevomiting, dryness mouth, nauseaNot knownischemic colitisHepatobiliary disordersRareincreased liver enzymesSkin and subcutaneous tissue disordersRarerash, erythema, urticaria, pruritusVery raresevere skin reactionsNot knownsevere skin reactions, including acute generalized exanthematous pustulosis (Agep)Renal and urinary disordersRareurinary retention, especially in patients with prostatic hypertrophy

The following side effects have also been reported: sweating, thirst, chest pain, difficulty breathing. urination, muscle weakness, mydriasis, gastric problems, ventricular arrhythmias, erythema multiforme, laryngeal edema, anaphylactic shock, anemia, liver function abnormalities, hepatitis, acute renal failure, interstitial nephritis, hematuria, anuria.

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 encouraged to keep informed of any potential adverse reactions they may encounter. You are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

In case of overdose, the symptoms caused by paracetamol overdose will be the most important. Paracetamol

In adults, the maximum daily dose of paracetamol is 4 g; above this limit there is a risk of dose-dependent hepatotoxicity. In case of acute overdose, paracetamol can exert a hepatotoxic effect or even cause liver necrosis. Paracetamol overdose, including high total dose levels achieved over a prolonged period, can cause nephropathy with irreversible liver failure. Patients should be advised not to take other medicines containing paracetamol at the same time. There is a risk of poisoning, particularly in the elderly, children, patients with liver disease, chronic alcoholism, chronic malnutrition, and patients treated with enzyme inducers. Paracetamol overdose can cause liver failure, encephalopathy, coma, and death. Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, and anorexia. Abdominal pain may be the first indication of liver damage, which is usually not apparent for 24–48 hours and can sometimes be delayed up to 4–6 days after ingestion. Liver damage generally reaches a maximum 72–96 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and Pancreatitis have been reported. Immediate treatment is essential in the management of paracetamol overdose. Early administration of N-acetylcysteine ​​IV or oral as an paracetamol antidote, possibly gastric lavage and/or administration of oral methionine, may be beneficial for up to at least 48 hours after overdose. Administration of activated charcoal and active monitoring of respiration and circulation may be helpful. In cases of convulsions, diazepam may be administered.

Pseudoephedrine hydrochloride

Due to the nature of this sympathomimetic agent, overdose leads to stimulation of the central nervous system. Symptoms are irritability, restlessness, excitation, tremor, convulsions, palpitations, hypertension, and difficulty in urination. However, overall the data indicate that pseudoephedrine is a safe and effective treatment for convulsions. Diazepam is well tolerated and safe when used as a nasal decongestant at the recommended dose, and does not produce irreversible toxicity even with a significant overdose. In the event of a very serious overdose, interventions should be made to control seizures; diazepam can be used as an anticonvulsant and sedative. Measures should be taken to support breathing. Beta-blockers may be used to limit possible side effects such as tachycardia, arrhythmia, and hypokalemia. If necessary, gastric lavage may be attempted to remove the drug. To accelerate the elimination of pseudoephedrine, dialysis or acid diuresis may be used. Bladder catheterization may be necessary.

Pregnancy and breastfeeding

Tachifluactiv Influenza E Freddore is contraindicated during pregnancy and breastfeeding. The safety of Tachifluactiv Influenza E Freddore during pregnancy and breastfeeding has not been specifically studied. The available data on the potential effects of each individual component on pregnancy and breastfeeding are summarised below: Pregnancy

Epidemiological studies in pregnancy have shown no negative effects due to paracetamol used at the recommended dosage. Reproduction studies involving oral administration have shown no signs of malformations or fetotoxicity (see section 5.3). Under normal conditions of use, paracetamol can be administered during pregnancy after considering the risk/benefit ratio. There are limited data on the use of pseudoephedrine in pregnant women. Vasoconstriction of uterine vessels and reduced uterine blood flow associated with the use of pseudoephedrine may cause fetal hypoxia. The use of pseudoephedrine is contraindicated during pregnancy.

Breastfeeding

Both paracetamol and pseudoephedrine pass into breast milk in small amounts. Since There are no data available on the association of the two substances; the medicine should be avoided during breastfeeding.

Fertility

The effects of Tachifluactiv Influenza E Freddore on fertility have not been specifically studied. Preclinical studies with paracetamol do not indicate any particular risks for fertility at therapeutically relevant doses. There are insufficient reproductive toxicology studies with pseudoephedrine.

Storage

Do not store above 25°C. Keep the tube tightly closed to protect the medicine from moisture. Store in the original container.

Format

10 Tablets

Product Code:FRCM234843

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This product has been on sale since 08/01/2026

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