FLUIMUCIL INFLUENZA COOL * 8BST

FLUIMUCIL INFLUENZA COOL * 8BST

Therapeutic indications

Treatment of cold and flu symptoms.

Dosage and method of use

DosageAdults and children over 12 years of age: 2-3 sachets per day. Duration of therapy: maximum 5 days of therapy for the adult population; 3 days maximum of therapy for the pediatric population (12-18 years). Pediatric population FLUIMUCIL FLU AND COLD is not recommended in children under 12 years (see section 4.3 "Contraindications")Method of administrationDissolve the contents of one sachet in a glass of water, stirring with a teaspoon and immediately drink the solution obtained. Hot water can also be used.

Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Pregnancy and lactation (see section 4.6). • Children under the age of 12. • Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase. • Subjects who are being treated with monoamine oxidase inhibitors or who have stopped this treatment for less than two weeks (see section 4.5 "Interactions with other medicinal products and other forms of interaction") • Subjects with a severe form of the following diseases: - coronary heart disease (angina, previous heart attack); - hypertension; - arrhythmias; - hepatic insufficiency; - kidney failure; - asthma; - diabetes; - urination disorders caused by prostatic hypertrophy or other pathologies; - haemolytic anemia. • Hyperthyroidism • Closed-angle glaucoma • Pheochromocytoma • Patients taking tricyclic antidepressants (see section 4.5) • Patients taking beta-blocker medicinal products (see section 4.5) • Patients taking other sympathomimetic medicinal products (see section 4.5).

Side effects

Adverse events are tabulated below by class and frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, Blood and lymphatic system disorders Very rare: thrombocytopenia, agranulocytosis, leukopenia, pancytopenia.Disorders of the immune systemRare: hypersensitivity, angioedema. Not known: anaphylactic reactions, Stevens Johnson syndrome, toxic epidermal necrolysis.Psychiatric disordersRare: nervousness, insomnia, anxiety, agitation, hallucinations have been reported rarely, particularly in children.Nervous system disordersRare: dizziness, headache, tremorCardiac pathologiesRare: tachycardia, palpitationsVascular pathologiesRare: hypertensionGastrointestinal disordersRare: vomiting, dry mouth, nausea Not known: ischemic colitisHepatobiliary disordersRare: increase in liver enzymesSkin and subcutaneous tissue disordersRare: rash, erythema, urticaria, pruritus Not known: severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)Renal and urinary disordersRare: urinary retention, especially in patients with prostatic hypertrophyEye disordersNot known: ischemic optic neuropathy The following side effects have also been reported: sweating, thirst, precordial pain, difficulty urinating, muscle weakness, mydriasis, gastrointestinal problems, ventricular arrhythmias, erythema multiforme, edema of the larynx, anaphylactic shock, anemia, alterations liver function, hepatitis, acute renal failure, interstitial nephritis, haematuria, anuria. In very rare cases, severe skin reactions have been reported.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemhttps://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

During treatment with FLUIMUCIL FLU 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 is also increased when paracetamol is taken together with other antipyretic analgesics; the simultaneous use of this type of medicinal product should therefore be avoided. The medicine should be used with caution in patients with: • cardiovascular disease, tachycardia or palpitations, angina, arrhythmias • hypertension; • liver failure; • acute hepatitis; • kidney failure; • hyperthyroidism; • asthma; • diabetes mellitus; • disturbances in urination caused by prostatic hypertrophy or other pathologies; • glaucoma; • psychosis; • chronic malnutrition and dehydration; • glucose-6-phosphate dehydrogenase deficiency; • haemolytic anemia. Patients should be advised not to take other medicinal products containing paracetamol at the same time due to the risk of serious liver damage in case of overdose (see section 4.9). Patients taking acetaminophen should avoid the use of alcoholic beverages because alcohol increases the risk of liver damage. Paracetamol should be administered with caution in patients with alcohol dependence (see section 4.5). This medicinal product should be given with caution to patients being treated with other medicinal products that affect the liver (see section 4.5). During therapy with oral anticoagulants it is recommended to reduce the doses. Serious skin reactions Severe skin reactions such as acute and generalized exanthematous pustulosis (AGEP) can occur with products containing pseudoephedrine. This acute pustular rash can occur within the first two days of treatment, with fever and numerous, small, mostly non-follicular pustules resulting from a widespread edematous erythema and located mainly on the skin folds, trunk and upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of Fluimucil Influenza e Raffreddore should be discontinued and appropriate measures taken if necessary. Ischemic colitis A few cases of ischemic colitis have been reported with medicinal products containing pseudoephedrine. The use of pseudoephedrine should be discontinued and medical attention is recommended if abdominal pain, rectal bleeding or other symptoms of ischemic colitis occur suddenly. Ischemic optic neuropathy Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity occurs, for example in the case of scotoma. The patient should be warned of the need to consult the doctor if he is already being treated with other medicines. In case of surgery, it is recommended to stop treatment a few days earlier, because the risk of hypertensive crisis is increased if halogenated anesthetics are used (see section 4.5). For those who practice sports: the use of this medicine can determine a positive anti-doping test. Patients should see their doctor if: • nasal pain or congestion gets worse or lasts more than 5 days (or if symptoms do not improve within 5 days) • fever gets worse or lasts more than 3 days • redness or swelling is present or if new symptoms occur. Important information about some of the ingredients -sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. -sorbitol: This medicine contains 95.184 mg of sorbitol per dose (sachet). Patients with rare hereditary problems of fructose intolerance should not take this medicine. -aspartame: This medicine contains 45.307 mg of aspartame per dose (sachet). Aspartame is a source of phenylalanine, therefore it may be harmful to people with phenylketonuria - This medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

FLUIMUCIL INFLUENZA E COLFFREDDORE is contraindicated in pregnancy, established or suspected, and during breastfeeding. The safety of FLUIMUCIL INFLUENZA E COLFFREDDORE during pregnancy and lactation has not been specifically studied. The available data on the potential effects of each individual component on pregnancy and lactation are summarized below:PregnancyEpidemiological studies in pregnancy have shown no adverse effects due to paracetamol used at the recommended dosage. Reproduction studies involving oral administration did not reveal any signs of malformation or fetotoxicity (see section 5.3). Under 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. Vasoconstriction of uterine vessels and reduced uterine blood flow associated with the use of pseudoephedrine can cause fetal hypoxia. The use of pseudoephedrine is contraindicated in pregnancy.Feeding timeBoth paracetamol and pseudoephedrine pass into breast milk in small amounts. Since no data are available on the combination of the two substances, the medicinal product should be avoided during breastfeeding.FertilityThe effects of FLUIMUCIL INFLUENCE AND COOLING have not been specifically studied. Preclinical studies with paracetamol do not indicate particular risks for fertility at relevant therapeutic doses. There are insufficient reproductive toxicology studies with pseudoephedrine.

Expiration and retention

No special storage precautions.

Interactions with other drugs

The drug interactions that can be caused by each individual component are well known and are listed below. There is no indication that these will change with combined use. Interactions related to paracetamol Use with extreme caution and under strict control during chronic treatment with medicinal products that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example: rifampicin, cimetidine, ranitidine). interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method). The anticoagulant effect of warfarin and other coumarin derivatives may be enhanced by regular prolonged use of paracetamol, with an increased risk of bleeding. Occasional intake of paracetamol has no significant effect. Hepatotoxic substances may increase the possibility of paracetamol accumulation and overdose. The risk of hepatotoxicity of paracetamol may be increased by medicinal products with induction of microsomal enzymes such as barbiturates, antiepileptics (e.g. phenytoin, phenobarbital, carbamazepine, glutethymide) and medicinal products for the treatment of tuberculosis such as rifampicin and isoniazid. Metoclopramide can increase the absorption rate of paracetamol by increasing its plasma levels. Similarly, domperidone can increase the absorption rate of paracetamol. The half-life of chloramphenicol can be prolonged by paracetamol. Paracetamol may reduce the bioavailability of lamotrigine, with a possible reduction of its effects, due to the potential induction of its metabolism in the liver. Cholestyramine can reduce the absorption of paracetamol. Cholestyramine should not be administered until one hour has elapsed after paracetamol administration. Regular use of paracetamol at the same time as zidovudine can cause neutropenia and increase the risk of liver damage. Probenecid treatment for gout reduces the clearance of paracetamol, therefore the dose of paracetamol can be reduced in case of concomitant treatment. Paracetamol hepatotoxicity may be potentiated by excessive alcohol intake (see section 4.4). Interactions related to pseudoephedrine For the severity of the possible reactions it iscontraindicatedthe simultaneous administration of pseudoephedrine and: •monoamine oxidase inhibitors (MAOIs)(see “Contraindications”) The concomitant use of pseudoephedrine and MAOIs can trigger a severe hypertensive crisis (hypertension, hyperpyrexia, headache). The medicine is therefore contraindicated in patients who are taking or have taken MAOIs in the last two weeks.Due to the possible effects caused by their interaction, the association of pseudoephedrine with some medicines is possible only under strict supervision of the doctor who will evaluate the risk ratio / benefit in the individual case.Pseudoephedrine may reduce the effect of other antihypertensive drugs (e.g. methyldopa, debrisoquine, guanethidine, reserpine: The risk of hypertension and other cardiovascular side effects may be increased. Concomitant use of midodrine may increase the hypertensive effect of midodrine. Halogenated Anesthetics: Pseudoephedrine can interact with halogenated anesthetics. Concomitant use of pseudoephedrine with other sympathomimetics (risk of hypertensive episodes) or tricyclic antidepressants may increase the risk of cardiovascular side effects. Concomitant use of pseudoephedrine with digoxin and cardiac glycosides may increase the risk of an irregular heartbeat or heart attack. Ergot alkaloids (ergotamine and methysergide): Concomitant use may cause an increased risk of ergotism. Concomitant use of linezolid may increase the risk of hypertension.

Overdose

In the event of an overdose, the symptoms caused by the paracetamol overdose will be the most prominent. Paracetamol In adults, the maximum daily dosage of paracetamol is 4 g; above this limit there is a risk of dose-dependent hepatotoxicity. In case of acute overdose, paracetamol can exert a hepatotoxic effect or even cause liver necrosis. Paracetamol overdose, including high total dose levels achieved over a prolonged period, may cause nephropathy with irreversible hepatic failure. Patients should be advised not to take other paracetamol-containing medicinal products at the same time. There is a risk of poisoning, particularly in the elderly, in children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients treated with enzyme inducers. Paracetamol overdose can result in liver failure, encephalopathy, coma and death. Symptoms of paracetamol overdose in the first 24 hours are paleness, nausea, vomiting and anorexia. Abdominal pain may be the first indication of liver damage, which is usually not evident for 24 to 48 hours and can sometimes be delayed for up to 4 to 6 days after ingestion. Liver damage generally reaches a maximum 72-96 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. Acute renal failure with acute tubular necrosis can develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Immediate treatment is essential in the management of acetaminophen overdose. Early administration of IV or oral N-acetylcysteine as an antidote to paracetamol, possibly gastric lavage and / or oral methionine administration, may have beneficial effects up to at least 48 hours after overdose. Administration of activated charcoal and monitoring of respiration and circulation may be helpful. In cases of seizures, diazepam can be administered. Pseudoephedrine Due to the nature of this sympathomimetic agent, overdose leads to central nervous system stimulation. The most common signs / symptoms of pseudoephedrine overdose include: irritability, restlessness, excitement, tremor, seizures, palpitations, hypertension, difficulty urinating, however, overall the data indicate that pseudoephedrine is well tolerated and safe when used as a nasal decongestant. at the recommended dose, and does not produce irreversible toxicity even with a major overdose. In the event of a very severe overdose, action should be taken to control the seizures; diazepam can be used as an anticonvulsant and sedative. Measures should be taken to support breathing. Beta-blockers can be used to limit possible side effects such as tachycardia, arrhythmia and hypokalaemia. If necessary, an attempt can be made to remove the drug by performing a gastric lavage. To accelerate the elimination of pseudoephedrine, dialysis or acid diuresis can be used. Bladder catheterization may be required.

Active principles

One sachet contains: Active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 60 mg.Excipients with known effects: contains sucrose, sorbitol, aspartame. For the full list of excipients, see section 6.1

Excipients

Each sachet contains: Sucrose, anhydrous citric acid, tropical fruit flavor, grapefruit flavor,sorbitol (E420), aspartame (E951), sucralose, sodium saccharin, polysorbate 20, beet red dye, riboflavin sodium phosphate dye.