Tachifludec lemon and honey flavour 16 sachets powder for oral solution

Tachifludec lemon and honey flavor 16 sachets powder for oral solution is an over-the-counter drug formulated for the symptomatic treatment of flu and colds . Thanks to its composition based on paracetamol (600 mg), ascorbic acid (vitamin C) (40 mg) and phenylephrine hydrochloride (10 mg), this product is indicated for quickly relieving flu symptoms such as fever, headache, muscle pain and nasal congestion . The presence of lemon and honey gives the solution a pleasant and delicate taste, making it more pleasant to take even in moments of discomfort.

Each sachet of Tachifludec dissolves easily in hot water, offering rapid relief from cold and flu symptoms . Paracetamol acts as an antipyretic and analgesic, reducing fever and pain, while phenylephrine has a decongestant action on the respiratory tract, making breathing easier. The addition of vitamin C helps support the immune system during feverish states. The package contains 16 single-dose sachets , convenient to carry with you and use as needed.

Tachifludec lemon and honey flavor is ideal for those looking for an effective and fast treatment of flu symptoms , with the convenience of an oral solution powder to prepare in a few moments. Suitable for adults and children over 12 years old, it is the perfect solution to deal with seasonal ailments and quickly return to your daily activities.

ACTIVE INGREDIENTS

Active ingredients contained in Tachifludec lemon and honey flavour 16 sachets powder for oral solution - What is the active ingredient of Tachifludec lemon and honey flavour 16 sachets powder for oral solution?

Each sachet contains: active ingredients: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg). Excipients with known effects: TACHIFLUDEC lemon flavour contains: 1.817 g of sucrose , 112.86 mg of sodium , 6.65 mg of glucose . TACHIFLUDEC lemon and honey flavour contains: 1.892 g of sucrose , 135.79 mg of sodium . For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tachifludec lemon and honey flavour 16 sachets powder for oral solution - What does Tachifludec lemon and honey flavour 16 sachets powder for oral solution contain?

- TACHIFLUDEC powder for oral solution lemon flavour: sucrose , anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, sodium saccharin, anhydrous colloidal silica, lemon flavouring, curcumin (E100), dried glucose syrup. - TACHIFLUDEC powder for oral solution lemon and honey flavour: sucrose , anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, sodium saccharin, lemon flavouring, honey flavouring, caramel (E150), anhydrous colloidal silica.

DIRECTIONS

Therapeutic indications Tachifludec lemon and honey flavour 16 sachets powder for oral solution - Why is Tachifludec lemon and honey flavour 16 sachets powder for oral solution used? What is it 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 Tachifludec lemon and honey flavour 16 sachets powder for oral solution - When should Tachifludec lemon and honey flavour 16 sachets powder 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 Tachifludec lemon and honey flavour 16 sachets powder for oral solution - How do you take Tachifludec lemon and honey flavour 16 sachets powder 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: TACHIFLUDEC lemon, lemon and honey flavour is contraindicated in children under 12 years of age (see section 4.3). Method of administration Dissolve the contents of 1 sachet in half a glass of very hot water and, if desired, dilute with cold water to cool and sweeten as desired.

CONSERVATION

Storage Tachifludec lemon and honey flavour 16 sachets powder for oral solution - How do you store Tachifludec lemon and honey flavour 16 sachets powder for oral solution?

Store below 25°C. Store in the original container in order to protect from moisture and light.

WARNINGS

Warnings Tachifludec lemon and honey flavour 16 sachets powder for oral solution - About Tachifludec lemon and honey flavour 16 sachets powder for oral solution it is important to know that:

Patients should be advised not to take other paracetamol-containing medicinal products while taking TACHIFLUDEC as high doses of paracetamol may cause serious adverse reactions. Avoid alcohol consumption during treatment with TACHIFLUDEC. 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 is recommended, including measurement of urinary 5-oxoproline. Consult your doctor before using the product in patients with enlarged prostate gland or occlusive vascular diseases (e.g. Raynaud's syndrome). Do not exceed the recommended dose and do not administer for more than 3 consecutive days. TACHIFLUDEC lemon flavor contains: - sodium : this medicine contains 112.86 mg of sodium per sachet equivalent to 5.64% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult, to be taken into consideration in patients with reduced renal function or who follow a low-sodium diet. - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Patients with diabetes should take into account the sucrose content within TACHIFLUDEC when taking more than 2 sachets per day (sucrose> 5g). - glucose: patients with rare glucose-galactose malabsorption problems should not take this medicine. TACHIFLUDEC lemon and honey flavour contains: - sodium: 135.79 mg of sodium per sachet equivalent to 6.79% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult, to be taken into consideration in patients with reduced renal function or who follow a low-sodium diet. - sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The sucrose content within TACHIFLUDEC should be taken into consideration in people with diabetes mellitus in case of taking more than 2 sachets per day (sucrose> 5g).

INTERACTIONS

Interactions Tachifludec lemon and honey flavour 16 sachets powder for oral solution - Which medicines or foods can modify the effect of Tachifludec lemon and honey flavour 16 sachets powder 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 infarction, and with alkaloids (ergotamine and methylsergide), increasing the risk of ergotism. Ascorbic Acid Ascorbic acid may increase the absorption of iron and estrogens. Ascorbic acid is metabolized to oxalate, and may potentially cause hyperoxaluria and kidney stones in patients through the crystallization of calcium oxalate in patients who tend to form calcium stones. Interference with some laboratory tests Paracetamol administration may interfere with the determination of uric acid (by the phosphotungstic acid method) and blood glucose (by the glucose-oxidase-peroxidase method). Ascorbic acid may interfere with the measurement of blood and urine parameters (e.g. urate, glucose, bilirubin, hemoglobin).

SIDE EFFECTS

Like all medicines, Tachifludec lemon and honey flavour 16 sachets powder for oral solution can cause side effects - What are the side effects of Tachifludec lemon and honey flavour 16 sachets powder for oral solution?

The following adverse reactions are listed below, organised according to MedDRA System Organ Class. The 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 System 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, irritability²
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 retention²

Very rare cases of serious skin reactions have been reported. ¹ Side effects associated with paracetamol ² Side effects associated with phenylephrine 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 Tachifludec lemon and honey flavour 16 sachets powder for oral solution - What are the risks of Tachifludec lemon and honey flavour 16 sachets powder 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 a. Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes; b. Regular consumption of ethanol in quantities greater than recommended; c. 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 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 as clinically appropriate. Severe hypertension should be treated with alpha-blocking drugs such as phentolamine. Ascorbic Acid Symptoms High doses of ascorbic acid (>3000mg) may cause transient osmotic diarrhoea and gastrointestinal effects such as nausea and abdominal discomfort. The effects of ascorbic acid overdose may be obscured by the severe liver toxicity caused by paracetamol overdose. Treatment Treatment should be as clinically appropriate.

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 Tachifludec lemon and honey flavour 16 sachets powder 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. Epidemiological studies in pregnant women have shown that there are no contraindications to the use of paracetamol when used in the recommended doses, but the administration of the preparation during pregnancy and breastfeeding should take place under the direct supervision of a doctor. 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. Ascorbic Acid There are no controlled data on use during pregnancy. The use of ascorbic acid during pregnancy is recommended only when the benefit outweighs the risk. 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 breast milk nor are there any information on the effects of phenylephrine on breast-fed children. In the absence of available data, the use of phenylephrine should be avoided during breastfeeding. Ascorbic Acid Ascorbic acid is excreted in breast milk. The effects on breast-fed children are not known. In summary, the use of TACHIFLUDEC is not recommended during pregnancy and breastfeeding. FERTILITY There is no evidence in non-clinical studies to indicate an effect of paracetamol on male and female fertility at doses commonly used in clinic. The effect of phenylephrine on male and female fertility has not been studied. There is sufficient evidence to indicate the importance of ascorbic acid at different levels in the reproductive process. However, no definitive data in humans are available on the clinical potential of vitamin C.

DRIVING AND USE OF MACHINERY

Taking Tachifludec lemon and honey flavour 16 sachets powder for oral solution before driving or using machinery - Does Tachifludec lemon and honey flavour 16 sachets powder for oral solution affect driving or using machinery?

TACHIFLUDEC 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.