Tachifludec Lemon Powder 10 Sachets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

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

CONTRAINDICATIONS

- 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.

WARNINGS AND PRECAUTIONS FOR USE

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 lemon flavor contains: - sodium: This medicinal product contains 112.86 mg sodium per sachet equivalent to 5.64% 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. TACHIFLUDEC lemon and honey flavor contains: - sodium: 135.79 mg of sodium per sachet equivalent to 6.79% of the maximum daily intake recommended by 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 suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. The sucrose content within TACHIFLUDEC is to be taken into consideration in people suffering from diabetes mellitus if they take more than 2 sachets per day (sucrose > 5g).

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

Below 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).

System and Organ Classification / Frequency | Undesirable effect

Pathologies of the blood and lymphatic 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

Municipality | 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

Cardiac diseases

Rare | Tachycardia², palpitations²

Vascular pathologies

Not known | Hypertension²

Respiratory, thoracic and mediastinal disorders

Rare | Bronchospasm^1,2

Not known | Edema of the larynx¹

Gastrointestinal disorders

Municipality | Nausea², vomiting²

Not known | Diarrhoea¹, gastrointestinal disease¹

Hepatobiliary disorders

Rare | Abnormal liver function¹

Not known | Liver disease¹, hepatitis¹

Pathologies of the skin and subcutaneous tissue

Rare | Skin rash^1,2, angioedema²

Not known | Toxic epidermal necrolysis¹, Steven Johnson Syndrome¹, erythema multiforme or polymorph¹

Kidney and urinary disorders

Very rare | Tubulointerstitial nephritis (after prolonged use of paracetamol at high doses)¹

Not known | 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.