TACHIFLUDEC 10 MINT BUST

TACHIFLUDEC POWER FOR ORAL DEPOSURE

active ingredients

Each bag contains: active ingredients: 600 mg paracetamol, ascorbic acid 40 mg and phenylphrine hydrochloride 10 mg (equal to phenylphrine 8,2 mg). Excipients with known effects: 2070.9 mg sucrose; 138.47 mg sodium. For the full list of excipients see paragraph 6.1.

Excellent

Sucrose, citric acid anidro, sodium citrate, corn starch, sodium cyclamate, mint aroma, saccharin soda, colloidal silica anidra.

Therapeutic 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 active ingredients or any excipient (listed in paragraph 6.1). - Patients taking beta-blockers. - Patients who take tricyclic antidepressants and those who take or hire in the last 2 weeks monoaminooxidase inhibitors. - Patients with bronchial asthma, feocromocytoma, closed-angle glaucoma, or taking at the same time other mimetic sympathetic medicines (such as decongestants, appetite suppressants and psychostimulants similar to amphetamines). - Patients with liver or kidney failure, diabetes, hyperthyroidism, hypertension and cardiovascular disease. - Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and those with severe haemolytic anemia. - Severe hepatocellular failure.

Population

Population 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 the doctor. Pediatric population Children under 12 years: TACHIFLUDEC mint taste is not recommended in children under the age of 12 (see paragraph 4.3). Method of administration Dissolve the contents of a sachet in a glass of hot or cold water and sweeten as you like. Once dissolved the medicinal product gives rise to a white opalescent solution, free of foreign particles and mint flavor.

Conservation

Store at a temperature below 25°C. Store in the original container to protect the medicine from moisture.

Warnings

Patients should be advised not to take other medications containing paracetamol while taking TACHIFLUDEC as high doses of paracetamol can cause severe 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 associating warfarin or any other drug (see also paragraph 4.5). It is not recommended to use the product if the patient is in treatment with anti-inflammatory drugs. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary. Consult your doctor before using the product in patients with prostate gland enlargement or occlusive vascular disease (e.g. Raynaud syndrome). Do not exceed the recommended dose and do not administer for over 3 consecutive days. TACHIFLUDEC mint taste contains:- sodium: This medicine contains 138.47 mg sodium per sachet, equivalent to 6.92% of the maximum daily intake recommended by the WHO which corresponds to 2g sodium for an adult, to be considered in patients with reduced kidney function or following a low sodium diet. - sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or insufficiency of isomaltase sucrasis should not take this medicine. The content of sucrose within the TACHIFLUDEC is to be taken into consideration in people with diabetes mellitus in case of taking more than 2 sachets per day (saccharosio> 5g).

Interactions

Paracetamol The hepatotoxic effect of paracetamol can be enhanced by taking other active medications on the liver, such as zidovudine and iisoniazide that can produce an inhibition of the metabolism of paracetamol. The administration of probenecid before paracetamol decreases the clearance of the paracetamol and the urinary elimination of sulphate and paracetamol-glucoronide, and increases the half-life of the paracetamol itself. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). Paracetamol increases the half-life of chloramphenicol. The product taken in high doses can enhance the effect of cumarinic anticoagulants (warfarin). Metoclopramide and domperidone can increase the absorption of paracetamol, while it is reduced or delayed respectively by cholesteramine and anticholinergics. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). Fenilef Phenylphrine can antagonize the effect of beta-blocking and antihypertensive drugs (including debrisochina, guanetidine, reserpine and methyldopa) and can enhance the action of monoaminooxidase inhibitors (see paragraph 4.3). The simultaneous use of phenylphrine with tricyclic antidepressants or mimetic amines can increase the risk of cardiovascular effects. Phenylphrine can interact with dygoxin and cardiac glycosides by increasing the risk of arrhythmia or infarction, and with alkaloids (ergotamine and methylsergid) increasing the risk of ergotism. Ascorbic acid Ascorbic acid can increase the absorption of iron and estrogen. Ascorbic acid is metabolized to oxalate, and can potentially cause in patients of hyperoxluria and kidney stones through crystallization of calcium oxalate in patients who tend to form calcium calculations Interferences with some laboratory tests Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Ascorbic acid can interfere in measuring hematochemical and urinary parameters (e.g. urates, glucose, bilirubin, hemoglobin).

Effects

Below are the side effects organized according to the classification for MedDRA Systems and Organs. The frequency is so defined: very common (≥1/10), common (from ≥1/100 to Classification for Systems and Organs / Frequency Undesirable effect Emolinfopoietic system pathologies Rare Agranulocytosis1, leucopenia1, thrombocytopenia1 Notable Anemia Immune system disorders Rare Allergic reactions^1,2, hypersensitivity reactions^1,2, anaphylaxis^1,2 Notable Anaphylactic Shock^1,2 Disorders of metabolism and nutrition Town Anorexia Psychiatric disorders Very rare Insomnia2, nervousness2, anxiety2, restlessness2, confusion2, irritability2 Diseases of the nervous system Very rare Tremore2, capogiro2, cephalea2 Pathologies of the eye Notable Midriasi2, acute glaucoma closed angle2 Heart disease Rare Tachycardia2, palpitations2 Vascular diseases Notable Hypertension2 Respiratory, chest and mediastinic pathologies Rare Broncospasmo^1,2 Notable Larynx Edema1 Gastrointestinal diseases Town Nausea2, vomiting2 Notable Diarrea1, gastrointestinal pathology1 Hepatobiliary diseases Rare Abnormal liver function1 Notable Hepatic pathology1, hepatiti1 Pathologies of skin and subcutaneous tissue Rare Skin rash^1,2, angioedema2 Notable Epidermal toxic necrolysis1, Steven Johnson1 syndrome, multiform erythema or polymorph1 Renal and urinary disorders Very rare Interstitial piping nephritis (after prolonged use of paracetamol at high doses)1 Notable Increased kidney failure1, hematuria1, anuria1 urine retention2 Very rare cases of severe skin reactions have been reported. 1 Side effects associated with paracetamol 2 Side effects associated with phenylphrine Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction via the national reporting system to the site at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Paracetamol Suggested doses, or even if the whole package should be taken, there should be no symptoms of overdose of paracetamol. However, in case of ingestion of very high doses of paracetamol (superior to 10 g), the most commonly found complication is liver damage, which usually occurs 12-48 hours after intake. Risk factors a. Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampin, St. John's herb- hyperico or other inductive drugs of liver enzymes; b. regular consumption of ethanol in quantities greater than recommended; c. glutathione depletion (e.g. nutrition disorders, cystic fibrosis, HIV infection, inedia, cachessia). Synonyms Early symptoms of paracetamol overdose in the first 24 hours are pale, nausea, vomiting, anorexia and abdominal pain. There may be abnormalities of glucose metabolism and metabolic acidosis. In severe poisoning, liver failure can progress in encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Even in the absence of severe liver damage, acute kidney failure can develop with acute tubular necrosis, strongly suggested by pain at the side, hematuria and proteinuria, can develop even in the absence of severe liver damage. Heart arrhythmias and pancreatis were reported. Treatment In the management of paracetamol overdose, immediate treatment is essential. Despite a lack of significant initial symptoms, patients must be addressed to the hospital urgently for immediate medical assistance. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. The management must be in accordance with the treatment established by the guidelines. If the overdose occurred within 1 hour, the treatment with activated carbon must be considered. Plasma concentration of paracetamol should be measured at 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 protection 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 given N-acetylcysteine intravenously, in line with the established dose regime. If vomiting is not a problem, oral methionine may be an alternative to remote areas outside the hospital. The management of patients with severe liver dysfunction over 24 hours from ingestion must be discussed with the National Antiveleni Center or liver unit. Fenilef Synonyms Overdose symptoms caused by phenylphrine are irritability, headache and increased blood pressure. In severe cases confusion, hallucinations, seizures and arrhythmias can occur. However, the amount needed to produce severe phenylphrine toxicity would be greater than the amount it produces related to paracetamol. Treatment Treatment should be clinically appropriate. A severe hypertension should be treated with alpha blocking drugs such as phenolamine. Ascorbic acid Synonyms High doses of ascorbic acid (>3000mg) can cause osmotic diarrhea transient and gastrointestinal effects such as nausea and abdominal disorders. The effects of overdose from ascorbic acid can be hidden from severe liver toxicity caused by overdose of paracetamol. Treatment Treatment should be clinically appropriate

FREEDOM

Paracetamol

A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible. Epidemiological studies in pregnant women showed that there are no contraindications in the use of paracetamol when used in recommended doses, but the administration of the preparation in pregnancy and lactating must take place under the direct control of the doctor.

Fenilef

The data relating to the use of pregnant phenylphrine are limited. The vasoconstriction of uterine vessels and the reduction of blood flow at the uterus level associated with the use of phenylphrine can give rise to fetal hypoxia. The use of pregnant phenylphrine should be avoided as further information is needed.

Ascorbic acid

There are no controlled data for pregnant use. The use of ascorbic acid in pregnancy is recommended only when the benefit exceeds the risk. ACTIVITY

Paracetamol

Paracetamol is excreted in breast milk but in clinically not significant amounts. The available data does not contraindicate its use during breastfeeding.

Fenilef

Data relating to the excretion of phenylphrine in breast milk are not available, nor is information on the effects of phenylphrine on breast-milk infants. In the absence of available data, the use of phenylphrine should be avoided during breastfeeding.

Ascorbic acid

Ascorbic acid is excreted in breast milk. Effects on breast-milk infants are not known. In summary, the use of TACHIFLUDEC is not recommended during pregnancy and nursing. FERTRUARY There are no evidence in non-clinical studies that indicate effects of paracetamol on male and female fertility at commonly used doses in clinic. The effect of phenylphrine on male and female fertility has not been studied. There are sufficient evidence indicating the importance of ascorbic acid at different levels in the reproductive process. However, there is no definitive human data on the clinical potential of vitamin C.

Source: Farmadati