Descrizione Clinica
Tachifluactiv influenza and cold 500 mg / 60 mg effervescent tablets
active principles
Each tablet contains: active ingredients: paracetamol 500 mg, pseudoefedrine hydrochloride 60 mg. Excipients with known effects: sodium 324 mg, sorbitol (E420) 296 mg, aspartame (E951) 20 mg, benzoic acid contained in the simeticone emulsion. For the complete list of excipients, see section 6.1
Eccepienti
Each tablet contains: citric acid, bicarbonate sodium, anhydrous carbonate sodium, sorbitol (E420), lemon aroma, aspartame (E951), sodium saccharina, simple emulsion, leucine, documented sodium.
Therapeutic indications
Treatment of the symptoms of cold and influenza.
Contraindications
Hypersensitivity to the active ingredients or to any of the excipients listed in the paragraph 6.1. Patients who are assuming or have taken inhibitors of the monoamine oxidase (IMAO) in the last two weeks (see section 4.5). Pregnancy and lactation (see section 4.6). Children under the age of 12. Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase. Subjects suffering from a serious form of the following diseases: coronary disease (angina, previous infarction); hypertension; arrhythmias; liver failure; kidney failure; asthma; diabetes; Minction disorders caused by prostatic hypertrophy or other pathologies; Hemolytic anemia. Hyperthyroidism. Closed angle glaucoma. Pheochromocytoma. Subjects taking tricyclic antidepressants (see section 4.5). Subjects taking beta-locking medicines (see section 4.5). Subjects that take other sympathomimetic medicines (see section 4.5).
Dosage
Dosage Adults and adolescents over 12 years old: 1 effervescent tablet, 2-3 times a day for no more than 5 days in adults and for no more than 3 days in adolescents. Dissolve the tablet in a glass of water and drink the obtained solution immediately. Pediatric population Tachifluactiv influence and cold is not recommended in children under 12 (see section 4.3 "Contraindications").
Storage
Do not store at a temperature above 25 ° C. Keep the tube tightly closed to protect the medicine from moisture. Store in the original container.
Warnings
During treatment with tachifluactiv influence and cold before taking any other medicine check that it does not contain paracetamol, since, if this active ingredient is taken in high doses, serious adverse reactions can occur. The risk of serious side effects has increased even when paracetamol is taken together with other antipyretic analgesics; The simultaneous use of this type of medicinal must therefore be avoided. Tachifluactiv influence and cold should be used with caution in patients with: kidney failure; liver failure; acute hepatitis; glucose-6-phosphate dehydrogenase deficiency; Hemolytic anemia; chronic malnutrition and dehydration; cardiovascular disease, tachycardia or palpitations, angina, arrhythmias; diabetes mellitus; Prostatic hypertrophy such as to cause urination disorders; psychosis; hyperthyroidism; asthma; glaucoma; hypertension. Serious skin reactions serious skin reactions such as acute and generalized exermental pustulosis (agep) can occur with products containing pseudoefedrina. This acute pustulous eruption can occur within the first 2 days of treatment, with fever and numerous, small pustules, mostly non-follicular, deriving from a very common edematous erythema mainly located on skin pleats, On the trunk and upper limbs. Patients must be carefully monitored. If you observe signs and symptoms such as pitessia, erythema or numerous small pustules, the administration of tachifluactiv influence and cold must be interrupted and if necessary appropriate measures must be taken. Ischemic colitis Some cases of ischemic colitis with medicines containing pseudoefedrine have been reported. The use of pseudoefedrine must be interrupted and is recommended to consult a doctor if abdominal pain, rectal bleeding or other symptoms of ischemic colitis are suddenly manifested. Ischemic optical neuropathy with pseudoefedrine cases of ischemic optical neuropathy have been reported. Pseudoefedrine must be interrupted if sudden loss of sight or reduction of visual acuity occurs, for example in case of scotoma. Patients should be notified not to take other medicines simultaneously that contain paracetamol due to the risk of serious liver damage in the event of overdose (see section 4.9). Alcoholic beverages must be avoided while assuming this medicine because the alcohol used simultaneously with paracetamol can cause hepatic damage (see section 4.5). Paracetamol must be given carefully in patients with alcohol dependence (see section 4.5). This medicine must be given caution to patients treating other medicines that have effect on the liver (see section 4.5). During therapy with oral anticoagulants it is advisable to reduce doses. The patient must be warned of the need to consult the doctor if he is already being treated with other medicines. Caution is advised if paracetamol is administered in conjunction with flucloxacillin due to the humorous 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 (eg chronic alcoholism), as well as in those who use the maximum daily doses of paracetamol. A careful monitoring is recommended, including the measurement of 5-oxoproline urinary. In the event of surgery, it is advisable to interrupt the treatment a few days before, because the risk of hypertensive crisis has increased if halogenated anesthetics are used (see section 4.5). For those who carry out sports activities: the use of this medicine can determine positivity to anti-doping tests. Patients should consult your doctor if: • The pain or the nasal congestion gets worse or lasts more than 5 days (or if the symptoms do not improve within 5 days) • The fever gets worse or lasts more than 3 days • There are redness or swelling or if they occur New symptoms. Tachifluactiv influenza and cold 500 mg / 60 mg effervescent tablets contains: - Aspartame (And 951): A source of phenylalanine, can be harmful to subjects suffering from phenylchetonuria. No non-clinical studies are available or clinical on the use of aspartame in children under 12 weeks of age. - Sorbitol (And 420): Patients with hereditary fructose intolerance, this medicine should not be administered. - Sodium: This medicine contains 324 mg (14 mmol) per tablet, equivalent to 16% of the maximum daily assumption recommended by the WHO that corresponds to 2 g of sodium for an adult. The simple emulsion also contains: Benzoic acid: This medicine contains 0.06 mg of benzoic acid for tablet equivalent to 0.06 mg / 3 g.
Interactions
Pharmacological interactions that can be caused by each individual component are well known and are listed below. There is no indication that these can change with the combined use. The administration of paracetamol can interfere with the determination of the uricemia (through the phosphetungal acid method) and with that of blood glucose (through the glucose-oxidase-peroxidase method). Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxyigenases or in the event of exposure to substances that can have this effect (for example: rifampicin, cimetidine, ranitidine). Paracetamol The anticoagulant effect of Warfarin and other coumarin derivatives can be strengthened by prolonged regular use of paracetamol, with increased risk of bleeding. The occasional intake of paracetamol has no significant effects. Hepatotoxic substances can increase the possibility of accumulation of paracetamol and overdose. The risk of hepatotoxicity of paracetamol can be increased by medicines with induction of micro-mirror hepatic enzymes such as barbiturates, anti-epileptics (for example phenytoin, phenobarbital, carbamazepine, Glutetimide) and medicines for the treatment of tuberculosis as a rifampicin and Isoniazide. Metoclopramide can increase the speed of paracetamol absorption by increasing plasma levels. Similarly, Domperidone can increase the speed of paracetamol absorption. The half-life of chloramphenicol can be prolonged by paracetamol. Paracetamol can reduce the bioavailability of lamotrigine, with a possible reduction of its effects, due to the potential induction of its hepatic metabolism. Cholestiramine can reduce the absorption of paracetamol. Cholestiramine should not be administered before an hour has passed from paracetamol administration. Regular use of paracetamol simultaneously to Zidovudine can cause neutropenia and increase the risk of liver damage. Treatment for Gotta Probenecid reduces paracetamol clearance, therefore the dose of paracetamol can be reduced in the event of concomitant treatment. Attention must be taken when the paracetamol is used in conjunction with flucloxacillin since the concomitant hiring has been associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). The hepatotoxicity of paracetamol can be strengthened by excessive alcohol intake (see section 4.4). Pseudoephedrine Monoamino oxidase inhibitors (IMAO): pseudoefedrine can enhance the action of monamino oxidase inhibitors and can induce hypertensive crisis (hypertension, hyperpires, headache). The medicine is therefore contraindicated in patients who are taking or have taken Moo in the last two weeks. PseudoEfedrine can reduce the effect of other antihypertensive drugs (eg deblrisochina, guinea straked, Reserpine, Metildopa). The risk of hypertension and other cardiovascular undesirable effects can be increased. Halogenated anesthetics: pseudoefedrine can interact with halogenated anesthetics. Concomitant use of pseudoefedrine with other tricyclic sympathomimics or antidepressants can increase the risk of cardiovascular side effects. Concomitant use of pseudoefedrine with digoxin and cardiac glycosides can increase the risk of irregular heartbeat or heart attack. Horned rye alkaloids (ergotamine and metisergide): Concomitant use can cause an increase in the risk of ergotism. The concomitant use of Linezolid can increase the risk of hypertension. Concomitant use of Midodrina can increase the hypertensive effect of Midodrina. For the possible effects caused by their interaction, the PseudoEfedrine association with some medicines is only possible under strict control of the doctor who will evaluate the risk / benefit ratio in the single case.
Effects
Adverse events are recorded below for classes and frequency. The frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1 / 10,000, <1 / 1,000); Very rare (<1 / 10,000), or not known (frequency cannot be defined based on available data). Bemolyfopoiet system diseases. Very rare: thrombocytopenia, agranulocytosis, leucopenia, pancitopenia. Immune system disorders. Rare: hypersensitivity, angioedema; Not note: Anaphylactic reactions, Stevens Johnson syndrome, toxic epidermal necrolisi. Psychiatric disorders. Rare: nervousness, insomnia, anxiety, agitation, hallucinations have rarely reported, particularly in children. Nervous system pathologies. Rare: Vertigo, headache, tremors. Eye pathologies. Not note: ischemic optical neuropathy. Cardiac disorders. Rare: tachycardia, palpitations. Vascular disorders. Rare: hypertension. Gastrointestinal disorders. Rare: vomiting, dry mouth, nausea; Not note: Ischemic colitis Hepatobiliary disorders. Rare: increase in liver enzymes. Cute and subcutaneous fabric pathologies. Rare: rash, erythema, urticaria, itching; Very rare: serious skin reactions have been reported; Not known: serious skin reactions, including generalized acute pustulosis (AGEP). Renal and urinary disorders. Rare: urinary retention, especially in patients with prostatic hypertrophy. The following side effects have also been reported: sweating, thirst, pre-drive pain, difficulty urinating, muscle weakness, Midriary, gastric problems, ventricular arrhythmias, multi-faceted erythema, larynx edema, shock Anaphylactic, anemia, hepatic function alterations, hepatitis, acute renal failure, interstitial nephritis, hematuria, anuria. Reporting suspicious adverse reactions The reporting of suspected adverse reactions occurring after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk report of the medicine. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system to the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Overdose
In case of overdose, the symptoms caused by paracetamol overdose will be the most important ones. Paracetamol In the adult the daily dosage of paracetamol is 4 g; Above this limit there is a risk of dose-dependent hepatotoxicity. In the case of acute overdose, paracetamol can exercise an hepatotoxic effect or even cause liver necrosis. Paracetamol overdose, including high total dose levels achieved for a prolonged period, can cause nephropathy with irreversible hepatic impairment. Patients should be advised not to take other medicines simultaneously containing paracetamol. There is a risk of poisoning, particularly in elderly subjects, children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients treated with enzymatic inductors. Paracetamol overdose can cause hepatic impairment, encephalopathy, coma and death. The symptoms from overdose of paracetamol in the first 24 hours are pallor, nausea, vomiting and anorexia. Abdominal pain can be the first indication of liver damage, which is not usually evident for 24-48 hours and sometimes can be delayed up to 4-6 days after ingestion. Hepatic damage generally reaches a maximum of 72-96 hours after ingestion. Anomalies of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis can also develop in the absence of severe hepatic damage. Heart and pancreatitis arrhythmias have been reported. Immediate treatment is essential in managing paracetamol overdose. Early administration of N-acetylcysteine I.V. o For OS as an antidote to paracetamol, possibly gastric lavage and / or administration of oral methionine, may have beneficial effects up to at least 48 hours after overdose. The administration of activated carbon and the monitoring of breathing and active circulation can be useful. In convulsion cases, diazepam can be given. Pseudoefedrine hydrochloride Due to the nature of this sympathomimetic agent, overdose leads to a stimulation of the central nervous system. Symptoms are irritability, restlessness, excitement, tremor, convulsions, palpitations, hypertension and difficulty in urination. However, overall the data indicate that pseudoefedrine is well tolerated and safe if used as a nasal decongestant to the recommended dose, and does not produce irreversible toxicity even with an important overdose. In the event of a very serious overdose, it is necessary to intervene to control convulsions; Diazepam can be used as an anticonvulsising and sedative. Measures must be taken to support breathing. Beta-blockers can be used to limit possible undesirable effects such as tachycardia, arrhythmia and ipokalemia. If necessary, you can try to remove the medication by performing a gastric lavage. To accelerate the elimination of pseudoefedrine, dialysis or acid diuresis can be used. Bladder catheterization may be required.
Tachifluactiv influence and cold is contraindicated during pregnancy and during breastfeeding. The safety of tachifluactiv influence and cold during pregnancy and lactation has not been specifically designed. The data available on the potential effects of each individual component on pregnancy and breastfeeding are summarized below:
Pregnancy
Pregnancy epidemiological studies showed no negative effects due to paracetamol used to the recommended dosage. Reproduction studies inherent to oral administration did not show signs of malformations or fetotoxicity (see section 5.3). In normal conditions of use, paracetamol can be administered during pregnancy after considering the risk / benefit ratio. There are limited data on the use of pseudoephedrine in pregnant women. The vasoconstriction of uterine vessels and the reduced uterine blood flow associated with the use of pseudoefedrine can cause fetal hypoxia. The use of pseudoefedrine is contraindicated during pregnancy.
Nursing
Both the paracetamol and pseudoefedrine pass into maternal milk in small quantities. Since data is not available on the two substances association, the medicine must be avoided during breastfeeding.
Fertility
The effects of tachifluactiv influence and colds on fertility have not been specifically designed. Preclinical studies with paracetamol do not indicate particular risks for fertility to therapeutically relevant doses. There is no sufficient reproductive toxicology studies with pseudoefedrine.
Source: Phandates
