Tachifludec Lemon and Honey Powder 10 Sachets

Tachifludec Lemon and Honey Powder 10 Sachets is an over-the-counter analgesic and antipyretic powder based on Paracetamol, Ascorbic Acid and Phenylephrine hydrochloride. Tachifludec Lemon and Honey Powder is indicated for the symptomatic treatment of influenza, colds and feverish and painful conditions related to them. The decongestant action of Tachifludec on the upper airways fluidifies and frees from mucus and phlegm in case of cough and cold.

Tachifludec Lemon and Honey Flavor 10 Sachets is a preparation formulated with:

• Paracetamol : active ingredient with antipyretic and analgesic action which makes the medicine particularly suitable in cases of: pain and spasms in the stomach and intestines, pain caused by obstacles in the flow of the urinary tract and biliary tract and menstrual pain.

• Vitamin C (Ascorbic Acid): active ingredient that participates in the body's defense system.

• Phenylephrine Hydrochloride : sympathomimetic active ingredient that acts by causing vasoconstriction of the local vascular bed, improving the symptoms of nasal obstruction.

ACTIVE INGREDIENTS

Active ingredients contained in Tachifludec Lemon and Honey Powder 10 Sachets - What is the active ingredient in Tachifludec Lemon and Honey Powder 10 Sachets?

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 Powder 10 Sachets - What does Tachifludec Lemon and Honey Powder 10 Sachets 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 Powder 10 Sachets - Why is Tachifludec Lemon and Honey Powder 10 Sachets 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 SIDE EFFECTS

Contraindications Tachifludec Lemon and Honey Powder 10 Sachets - When should Tachifludec Lemon and Honey Powder 10 Sachets 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); 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 Powder 10 Sachets - How do you take Tachifludec Lemon and Honey Powder 10 Sachets?

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 Powder 10 Sachets - How do you store Tachifludec Lemon and Honey Powder 10 Sachets?

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

WARNINGS

Warnings Tachifludec Lemon and Honey Powder 10 Sachets - About Tachifludec Lemon and Honey Powder 10 Sachets 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. 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-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 kidney 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 in 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 Powder 10 Sachets - Which medicines or foods can modify the effect of Tachifludec Lemon and Honey Powder 10 Sachets?'

Paracetamol: hepatotoxicity of paracetamol can be enhanced 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 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 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 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 Powder 10 Sachets can cause side effects - What are the side effects of Tachifludec Lemon and Honey Powder 10 Sachets?

The following adverse reactions are listed below, organised according to the MedDRA System Organ Class. Frequency is defined as follows: very common (>=1/10), common (from >=1/100 to <1/10), uncommon (from >=1/1000 to <1/100), rare (from >=1/10,000 to <1/1000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Blood and lymphatic system disorders. Rare: agranulocytosis1, leucopenia1, thrombocytopenia1; not known: anaemia1. Immune system disorders. Rare: allergic reactions1,2, hypersensitivity reactions1,2, anaphylaxis1,2; not known: anaphylactic shock1,2. 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 disorders. Not known: mydriasis2, acute angle-closure glaucoma2. Cardiac disorders. Rare: tachycardia2, palpitations2. Vascular disorders. Not known: hypertension2. Respiratory, thoracic and mediastinal disorders. Rare: bronchospasm1,2; not known: laryngeal oedema1. Gastrointestinal disorders. Common: nausea2, vomiting2; not known: diarrhoea1, gastrointestinal disorder1. Hepatobiliary disorders. Rare: liver function abnormal1; not known: liver disorder1, hepatitis1. Skin and subcutaneous tissue disorders. Rare: rash1,2, angioedema2; not known: toxic epidermal necrolysis1, Steven Johnson syndrome1, erythema multiforme or polymorphic1. Renal and urinary disorders. Very rare: tubulointerstitial nephritis (after prolonged use of paracetamol at high doses)1; not known: aggravated renal failure1, haematuria1, anuria1 urinary retention2. Very rare cases of serious skin reactions have been reported. ^1 Undesirable effects associated with paracetamol. ^2 Undesirable 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.

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 Powder 10 Sachets.

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 unknown. 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 doses commonly used in clinic. Phenylephrine has not been studied on male and female fertility. 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.