Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution

Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution is an over-the-counter medicine indicated for the short-term treatment of cold and flu symptoms , such as mild/moderate pain, fever and nasal congestion . Each sachet contains paracetamol 600 mg and phenylephrine hydrochloride 10 mg , an effective combination to quickly relieve pain and fever and reduce nasal congestion . The granules, with a lemon flavour , dissolve easily in the mouth or can be dissolved in hot water, offering a practical and quick solution even away from home, without the need for water.

Thanks to the synergistic action of its active ingredients, Tachiflutask acts on multiple fronts: paracetamol lowers fever and relieves pain, while phenylephrine decongests the nasal passages, facilitating breathing. This makes it particularly suitable for those seeking a complete treatment of flu and cold symptoms in a single solution. The formulation in single-dose sachets is ideal for precise dosing and simple administration, even away from home.

Tachiflutask 600 mg + 10 mg is a non-prescription drug designed for adults and children over 12 years old, perfect for those who want quick and targeted relief from flu and cold symptoms , with the convenience of a pleasant-tasting granule. The presence of paracetamol and phenylephrine guarantees effective action against fever, pain and nasal congestion , helping to quickly regain well-being on days of seasonal malaise.

ACTIVE INGREDIENTS

Active ingredients contained in Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - What is the active ingredient of Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution?

Each sachet contains: Active ingredients: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg). Each sachet contains sorbitol (E 420) 42 mg, aspartame (E 951) 25 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - What does Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution contain?

Mannitol (E 421), Xylitab 200 (xylitol, carboxymethylcellulose), lemon flavouring, sorbitol (E 420), ascorbic acid, citric acid, colloidal hydrated silica, aspartame (E 951), sodium saccharin.

DIRECTIONS

Therapeutic indications Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - Why is Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution used? What is it used for?

Short-term treatment of cold and flu symptoms, including mild to moderate pain and fever, when associated with nasal congestion.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - When should Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution not be used?

- Children under 12 years of age. - Hypersensitivity to the active substances or to any of the excipients (listed in section 6.1). - Patients taking beta-blockers. - Patients taking tricyclic antidepressants and those taking or who have taken in the last 2 weeks monoamine oxidase inhibitors. - Patients with bronchial asthma, pheochromocytoma, narrow-angle glaucoma, or who are taking other sympathomimetic medicinal products (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) at the same time. Patients with hepatic or renal insufficiency, diabetes, hyperthyroidism, hypertension and cardiovascular disease. - Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase insufficiency and in those with severe haemolytic anaemia. - Severe hepatocellular insufficiency.

DOSAGE

Quantity and method of taking Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - How do you take Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution?

Dosage Adults and children over 12 years: 1 sachet every 4-6 hours and up to a maximum of 3 sachets in 24 hours. The medicine should not be used for more than 3 consecutive days without consulting your doctor. Paediatric population Children under 12 years: TACHIFLUTASK is contraindicated in children under 12 years of age (see section 4.3). Method of administration Place the granules directly on the tongue and swallow. TACHIFLUTASK dissolves in saliva: this allows it to be used without water. The contents of the sachet can also be dissolved in a glass of hot (not boiling) water, stirring with a teaspoon. If desired, dilute with cold water to cool and sweeten. Once prepared, the solution obtained should be drunk within a few minutes.

CONSERVATION

Storage Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - How is Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution stored?

This medicine does not require any special temperature storage. Store in the original container in order to protect from moisture and light.

WARNINGS

Warnings Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - About Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution it is important to know that:

Patients should be advised not to take other paracetamol-containing medicinal products while taking TACHIFLUTASK as high doses of paracetamol may cause serious adverse reactions. Avoid alcohol consumption during treatment with TACHIFLUTASK. The risk of overdose is greater in patients with liver problems. Instruct the patient to contact the doctor before combining warfarin or any other drug (see also section 4.5). The use of the product is not recommended if the patient is being treated with anti-inflammatory drugs. 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, including measurement of urinary 5-oxoproline, is recommended. Consult your doctor before using the product in patients with enlarged prostate gland or occlusive vascular disease (e.g. Raynaud's syndrome). Do not exceed the recommended dose and do not administer for more than 3 consecutive days. TACHIFLUTASK contains aspartame: this substance may be harmful to people with phenylketonuria. TACHIFLUTASK contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially sodium-free.

INTERACTIONS

Interactions Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - Which medicines or foods can modify the effect of Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution?

Paracetamol The hepatotoxic effect of paracetamol may be enhanced by the intake of other drugs that act on the liver such as zidovudine and isoniazid which can produce an inhibition of the metabolism of paracetamol. The administration of probenecid before paracetamol decreases the clearance of paracetamol and the urinary elimination of paracetamol sulphate and paracetamol-glucuronide, and increases the half-life of paracetamol itself. Use with extreme caution and under strict 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). Paracetamol increases the half-life of chloramphenicol. The product taken in high doses can enhance the effect of coumarin anticoagulants (warfarin). Metoclopramide and domperidone may increase the absorption of paracetamol, while it is reduced or delayed by cholestyramine and anticholinergics, respectively. Caution should be exercised when paracetamol is used concomitantly with flucloxacillin since concomitant intake has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). Phenylephrine Phenylephrine may antagonise the effect of beta-blocking and antihypertensive drugs (including debrisoquine, guanethidine, reserpine and methyldopa) and may potentiate the action of monoamine oxidase inhibitors (see section 4.3). Concomitant use of phenylephrine with tricyclic antidepressants or sympathomimetic amines may increase the risk of cardiovascular effects. Phenylephrine may interact with digoxin and cardiac glycosides, increasing the risk of arrhythmia or heart attack, and with alkaloids (ergotamine and methylsergide), increasing the risk of ergotism. Interference with some laboratory tests The administration of paracetamol may 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, Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution can cause side effects - What are the side effects of Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution?

The following adverse reactions are listed below, organised according to MedDRA System Organ Class. Frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

Classification by Systems and Organs /	Frequency	Side effect
Pathologies of the haemolymphopoietic system	Rare	Agranulocytosis¹, leukopenia¹, thrombocytopenia¹
	Not known	Anemia¹
Immune system disorders	Rare	Allergic reactions 1.2 , hypersensitivity reactions 1.2 , anaphylaxis 1.2
	Not known	Anaphylactic shock 1.2
Metabolism and nutrition disorders	Common	Anorexia²
Psychiatric disorders	Very rare	Insomnia², nervousness², anxiety², restlessness², confusion², irritability22
Nervous system disorders	Very rare	Tremor², dizziness², headache²
Eye pathologies	Not known	Mydriasis², acute angle-closure glaucoma²
Heart disease	Rare	Tachycardia², palpitations²
Vascular pathologies	Not known	Hypertension²
Respiratory, thoracic and mediastinal pathologies	Rare	Bronchospasm 1,2
	Not known	Laryngeal edema¹
Gastrointestinal disorders	Common	Nausea², vomiting²
	Not known	Diarrhea¹, gastrointestinal disease¹
Hepatobiliary pathologies	Rare	Abnormal liver function¹
	Not known	Liver disease¹, hepatitis¹
Skin and subcutaneous tissue disorders	Rare	Skin rash 1,2 , angioedema²
	Not known	Toxic epidermal necrolysis¹, Stevens Johnson syndrome¹, erythema multiforme or polymorphous¹
Kidney and urinary disorders	Very rare	Tubulointerstitial nephritis (after prolonged use of paracetamol at high doses)¹
	Not known	Aggravated renal failure¹, hematuria¹, anuria¹ urinary retention

¹ Side effects associated with paracetamol ² Side effects associated with phenylephrine 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 Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution - What are the risks of Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution in case of overdose?

Paracetamol At the recommended doses, or even if the entire pack is taken, no symptoms of paracetamol overdose should appear. However, if very high doses of paracetamol (more than 10 g) are ingested, the most common complication is liver damage, which usually occurs 12-48 hours after ingestion. Risk factors • Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes; • Regular consumption of ethanol in quantities greater than recommended; • Glutathione depletion (e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia). Symptoms The early symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, haemorrhage, hypoglycemia, cerebral edema and death. Acute renal failure with acute tubular necrosis, strongly suggested by flank pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Treatment Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant initial symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines. If overdose has occurred within 1 hour, treatment with activated charcoal should be considered. Plasma paracetamol concentrations should be measured 4 or more hours after ingestion (early concentrations are unreliable). Treatment with N-acetylcysteine ​​may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours after ingestion. The efficacy of the antidote declines sharply after this period. If necessary, the patient should be given N-acetylcysteine ​​intravenously, in line with the established dose regimen. If vomiting is not a problem, oral methionine may be a suitable alternative in more remote, out-of-hospital areas. Management of patients presenting with severe liver dysfunction more than 24 hours after ingestion should be discussed with the National Poisons Control Centre or liver unit. Phenylephrine Symptoms Symptoms of overdose caused by phenylephrine are irritability, headache and increased blood pressure. In more severe cases, confusion, hallucinations, convulsions and arrhythmias may occur. However, the amount needed to produce serious phenylephrine toxicity would be greater than that produced by paracetamol. Treatment Treatment should be clinically appropriate. Severe hypertension should be treated with alpha-blocking drugs such as phentolamine.

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 Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution.

Pregnancy Paracetamol 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 duration and with the lowest possible frequency. The administration of the preparation during pregnancy and breastfeeding should take place under the direct supervision of a physician. Phenylephrine Data on the use of phenylephrine during pregnancy are limited. Vasoconstriction of the uterine vessels and reduction of blood flow to the uterus associated with the use of phenylephrine may result in fetal hypoxia. The use of phenylephrine during pregnancy should be avoided as further information is needed. Breastfeeding Paracetamol Paracetamol is excreted in breast milk but in clinically insignificant quantities. Available published data do not contraindicate its use during breastfeeding. Phenylephrine There are no data on the excretion of phenylephrine in human milk nor are there any reports on the effects of phenylephrine on breast-fed infants. In the absence of available data, the use of phenylephrine should be avoided during breastfeeding. Fertility There is no evidence in non-clinical studies to indicate effects of paracetamol on male and female fertility at doses commonly used in clinical practice. The effect of phenylephrine on male and female fertility has not been studied.

DRIVING AND USE OF MACHINERY

Taking Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution before driving or using machines - Does Tachiflutask 600 mg + 10 mg 10 sachets granules for oral solution affect driving or using machines?

TACHIFLUTASK does not alter the ability to drive or use machines. However, patients should be advised not to drive or operate machines if they feel dizzy.