Tachifludec Orange Powder 10 Sachets

INDICATIONS

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

ACTIVE INGREDIENTS

Each sachet contains: active ingredients: paracetamol 600 mg, ascorbic acid 40 mg and phenylephrine hydrochloride 10 mg (equal to phenylephrine 8.2 mg). Excipients with known effects: 2 g of sucrose; 135.82 mg of sodium; 33.25 mg of glucose. For the complete list of excipients see section 6.1.

EXCIPIENTS

Sucrose, anhydrous citric acid, sodium citrate, corn starch, sodium cyclamate, saccharin sodium, colloidal anhydrous silica, blood orange flavour, curcumin (E100), syrup glucose dried.

CONTRAINDICATIONS AND SIDE EFFECTS

- Children under the age of 12. - Hypersensitivity to the active substances or to any of the excipients (listed in paragraph 6.1). - Patients taking beta-blockers. - Patients taking tricyclic antidepressants and those taking or have taken in the last 2 weeks monoamine oxidase inhibitors. - Patients with bronchial asthma, pheochromocytoma, narrow-angle glaucoma, or who simultaneously take other sympathetic mimetic medicinal products (such as decongestants, appetite suppressants and amphetamine-like psychostimulants). - Patients suffering from liver or kidney failure, diabetes, hyperthyroidism, hypertension and cardiovascular diseases. - Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase insufficiency and in those suffering from severe hemolytic anemia. - Severe hepatocellular insufficiency.

DOSAGE

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. Pediatric population Children under 12 years: TACHIFLUDEC orange flavor is contraindicated in children under 12 years of age (see section 4.3). Method of administration Dissolve the contents of a sachet in a glass of hot or cold water and sweeten to taste. Once dissolved, the medicine gives rise to a yellow opalescent solution, free of foreign particles and with an orange flavour.

CONSERVATION

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

WARNINGS

Patients should be advised not to take other medicines containing paracetamol while taking TACHIFLUDEC as high doses of paracetamol may cause serious adverse reactions. Avoid alcohol consumption during treatment with TACHIFLUDEC. The danger of overdose is in fact greater in patients with liver problems. Invite 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-inflammatories. Caution is advised if acetaminophen is administered concurrently 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 acetaminophen. Close 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. TACHIFLUDEC orange flavor contains: - sodium: This medicine contains 135.82 mg sodium per sachet, equivalent to 6.79% of the maximum daily intake recommended by WHO which corresponds to 2 g sodium for an adult, to be taken into consideration in patients with reduced renal function or following a low-sodium diet. - sucrose: Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. Patients with diabetes must take into consideration the sucrose content within TACHIFLUDEC when taking more than 2 sachets per day (sucrose > 5g). - glucose: Patients suffering from rare problems of glucose-galactose malabsorption should not take this medicine.

INTERACTIONS

Paracetamol The hepatotoxic effect of paracetamol can be potentiated by the intake of other drugs active 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 control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, 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 can 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 as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). Phenylephrine Phenylephrine can antagonize the effect of beta-blocking and antihypertensive drugs (including debrisoquine, guanethidine, reserpine and methyldopa) and can potentiate the action of monoamine oxidase inhibitors (see section 4.3). The simultaneous use of phenylephrine with tricyclic antidepressants or sympathetic mimetic amines may increase the risk of cardiovascular effects. Phenylephrine can 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. Ascorbic acid Ascorbic acid can increase the absorption of iron and estrogen. Ascorbic acid is metabolised to oxalate, and can potentially cause hyperoxaluria and kidney stones in patients through the crystallisation of calcium oxalate in patients who are prone to forming calcium stones. Interference with some laboratory tests The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method). Ascorbic acid can interfere in the measurement of blood and urinary parameters (e.g. urate, glucose, bilirubin, hemoglobin).

SIDE EFFECTS

The following are the side effects organized according to the MedDRA System Organ classification. The frequency is defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Pathologies of the blood and lymphatic system.

Rare - Side effect: Agranulocytosis¹, leukopenia¹, thrombocytopenia¹

Not known - Side effect: Anemia¹

Immune system disorders.

Rare - Side effect: Allergic reactions1,2, hypersensitivity reactions1,2, anaphylaxis1,2.

Not known - Side effect: Anaphylactic shock1, 2.

Metabolism and nutrition disorders.

Common - Side effect: Anorexia²

Psychiatric disorders.

Very rare - Side effect: Insomnia², nervousness², anxiety², restlessness², confusion², irritability²

Nervous system disorders.

Very rare - Side effect: Tremor², dizziness², headache²

Eye pathologies.

Not known - Side effect: Mydriasis², acute angle-closure glaucoma²

Cardiac diseases.

Rare - Side effect: Tachycardia², palpitations²

Vascular pathologies.

Not known - Side effect: Hypertension²

Respiratory, thoracic and mediastinal disorders.

Rare - Side effect: Bronchospasm1,2.

Not known - Side effect: Edema of the larynx¹

Gastrointestinal disorders.

Common - Side effect: Nausea², vomiting²

Not known - Side effect: Diarrhoea¹, gastrointestinal pathology¹

Hepatobiliary disorders.

Rare - Side effect: Abnormal liver function¹

Not known - Side effect: Liver disease¹, hepatitis¹

Pathologies of the skin and subcutaneous tissue.

Rare - Side effect: Skin rash1,2, angioedema²

Not known - Side effect: Toxic epidermal necrolysis¹, Steven Johnson Syndrome¹, erythema multiforme or polymorph¹

Kidney and urinary disorders.

Very rare - Side effect: Tubulointerstitial nephritis (after prolonged use of paracetamol at high doses)¹

Not known - Side effect: Aggravated renal failure¹, haematuria¹, anuria¹ urine 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 authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system to the site https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Paracetamol At the recommended doses, or even if you were to take the entire pack, no symptoms of paracetamol overdose should appear. However, in case of ingestion of very high doses of paracetamol (greater than 10 g), the most commonly encountered complication is liver damage, which typically occurs 12-48 hours after ingestion. Risk factors a. Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort or other liver enzyme-inducing drugs; b. regular consumption of ethanol in quantities higher than recommended; c. glutathione depletion (e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia). Symptoms Early symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting, anorexia and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, brain edema, and death. Even in the absence of severe liver damage, acute renal failure with acute tubular necrosis, strongly suggested by flank pain, hematuria, and proteinuria can develop, even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Treatment In the management of paracetamol overdose, immediate treatment is essential. 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 must be in accordance with treatment guidelines. If overdose has occurred within 1 hour, treatment with activated charcoal should be considered. Paracetamol plasma concentration should be measured 4 or more hours after ingestion (initial concentrations are not reliable). Treatment with N-acetylcysteine ​​can be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is achieved up to 8 hours after ingestion. The effectiveness of the antidote declines sharply after this period. If necessary, the patient should be administered N-acetylcysteine ​​intravenously, in line with the established dosing regimen. If vomiting is not a problem, oral methionine may be a suitable alternative in more remote areas, outside of hospital. Management of patients who present with severe hepatic dysfunction more than 24 hours after ingestion should be discussed with the National Poison Control Center or liver unit. Phenylephrine Symptoms Symptoms of overdose caused by phenylephrine are irritability, headache and increased blood pressure. In more serious cases, confusion, hallucinations, convulsions and arrhythmias may occur. However, the amount needed to produce severe phenylephrine toxicity would be greater than that related to acetaminophen. Treatment Treatment must be clinically appropriate. Severe hypertension should be treated with alpha blocker drugs such as phentolamine. Ascorbic acid Symptoms High doses of ascorbic acid (>3000mg) may cause transient osmotic diarrhea and gastrointestinal effects such as nausea and abdominal discomfort. The effects of ascorbic acid overdose may be hidden by the severe liver toxicity caused by acetaminophen overdose. Treatment Treatment must be clinically appropriate.

PREGNANCY AND BREASTFEEDING

PREGNANCY Paracetamol A large amount of data on pregnant women indicates neither malformation 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. Epidemiological studies in pregnant women have shown that there are no contraindications in the use of paracetamol when used in the recommended doses, but the administration of the preparation during pregnancy and breastfeeding must take place under the direct supervision of a doctor. Phenylephrine Data regarding the use of phenylephrine in 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 relating to 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. The available published data do not contraindicate its use during breastfeeding. Phenylephrine No data are available regarding the excretion of phenylephrine in breast milk, nor is there information regarding the effects of phenylephrine on breast-fed infants. 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 infants 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 effects of paracetamol on male and female fertility at commonly used clinical doses. The effect of phenylephrine on male and female fertility has not been studied. There is sufficient evidence indicating the importance of ascorbic acid at different levels in the reproductive process. However, no definitive human data on the clinical potential of vitamin C are available.

EFFECTS ON DRIVING ABILITY

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