FLUIMUCIL RAFFR 8BST INFLUENCE

FLUIMUCL INFLUENCE AND FURNITURE 500 MG/ 60 MG FREE FOR ORAL DEPOSURE

active ingredients

A bag contains: Active ingredients: Paracetamol 500 mg, Pseudoefedrine Hydrochloride 60 mg. Excipients with known effects: contains sucrose, sorbitol, aspartame. For the full list of excipients, see paragraph 6.1

Excellent

Each bag contains: Saccarosio, citric acid anidro, aroma tropical fruits, aroma grapefruit, sorbitol (E420), aspartame (E951), sucralose, sodium saccharin, polysorbate 20, red beet colorant, riboflavin sodium phosphate dye.

Therapeutic indications

Treatment of symptoms of cold and flu.

Contraindications

• Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. • Pregnancy and nursing (see paragraph 4.6). • Children under the age of 12. • Patients with manifest lack of glucose-6-phosphate dehydrogenase. • Subjects that are in treatment with monoamino oxidase inhibitors or who have interrupted this treatment for less than two weeks (see paragraph 4.5 “Interactions with other medicines and other forms of interaction”) • Subjects with a serious form of the following diseases: - coronary disease (angina, previous heart attack); - hypertension; - arrhythmias; - liver failure; - kidney failure; - asthma; - diabetes; - urination disorders caused by prostate hypertrophy or other pathologies; - hemolytic anemia. • Hyperthyroidism • Closed corner Glaucoma • Feocromocytoma • Patients taking antidepressants (see paragraph 4.5) • Patients taking betabloccant medicines (see paragraph 4.5) • Patients taking other sympathomimetic medicines (see paragraph 4.5).

Population

Population Adults and children aged 12: 2-3 sachets per day. Duration of therapy: 5 days maximum therapy for adult population; 3 days maximum therapy for the pediatric population (12-18 years). Pediatric population FLUIMUCIL INFLUENCE AND REFREDDORE is not recommended in children under 12 years (see paragraph 4.3 “Controindications”) Method of administration Dissolve the contents of a sachet in a glass of water mixing with a teaspoon and immediately drink the solution obtained. You can also use hot water.

Conservation

No special precaution for conservation.

Warnings

During treatment with FLUIMUCIL INFLUENCE AND FURNITURE Before taking any other medicine, check that it does not contain paracetamol, since if this active ingredient is taken in high doses, severe adverse reactions may occur. The risk of serious side effects increased even when the paracetamol is taken together with other antipyretic analgesics; the use of this type of medicine must 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; • urination disorders caused by prostate hypertrophy or other pathologies; • glaucoma; • psychosis; • chronic malnutrition and dehydration; • glucose-6-phosphate dehydrogenase deficiency; • hemolytic anemia. Patients should be advised not to take other medications containing paracetamol at the same time due to the risk of severe liver damage in case of overdose (see paragraph 4.9). Patients taking paracetamol 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 paragraph 4.5). This medicine must be given with caution to patients in treatment with other medicines that affect the liver (see paragraph 4.5). In the course of therapy with oral anticoagulants it is recommended to reduce doses. Severe skin reactions Severe skin reactions such as acute and generalized exantematic pustolosis (AGEP) can occur with products containing pseudophedrine. This acute pustolose eruption may occur within the first two days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from a widespread and localized edematous erythema mainly on the skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustulas are observed, the administration of Fluimucil Influence and Cooling must be interrupted and appropriate measures should be taken if necessary. Ischemic Colite Some cases of ischemic colitis have been reported with medicines containing pseudophedrine. The use of pseudoephedrine should be interrupted and it is recommended to consult a doctor if there is sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis. Ischemic optics Cases of ischemic optical neuropathy have been reported with the pseudoephedrine. The pseudoephedrine should be interrupted if sudden loss of sight or reduction of visual acuity should occur, for example in case of scotoma. The patient must be warned of the need to consult the doctor if he is already in treatment with other medicines. In case of surgery, it is recommended to stop treatment a few days before, because the risk of hypertensive crisis has increased if halogenated anesthetics are used (see paragraph 4.5). For those who carry out sports activities: the use of this medicine can determine positivity to anti-doping texts. Patients should consult the doctor if: • pain or nasal congestion worsens or lasts more than 5 days (or if symptoms do not improve within 5 days) • fever worsens or lasts more than 3 days • there are redness or swelling or if new symptoms occur. Important information about some excipients - sucrose: patients with rare hereditary problems of fructose intolerance, glucose mal absorption - galactose, or sucrasis-isomaltase failure, should not take this medicine. - sorbitol: this medicine contains 95,184 mg of sorbitol per dose (button). Patients with rare hereditary problems of fructose intolerance should not take this medicine. - aspartame: this medicine contains 45,307 mg of aspartame per dose (button). Aspartame is a source of phenylalanine, therefore it can be harmful to individuals suffering from phenylchetonuria - This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'without sodium'.

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 combined use. Paracetamol Interactions Use with extreme caution and under strict control during chronic treatment with medicines that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (for example: reampin, cimetidine, ranitidine) Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). The anticoagulant effect of warfarin and other cumarinic derivatives can be enhanced by prolonged regular use of paracetamol, with increased risk of bleeding. 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 microsomal enzymes such as barbiturates, antiepileptics (e.g. phenytoin, phenobarbital, carbamazepine, glutetimide) and medicines for the treatment of tuberculosis as reampycin and isoniazide. Metoclopramide can increase the absorption rate of paracetamol by increasing plasma levels. Similarly, domperidone can increase the absorption rate of paracetamol. The half-life of chloramphenicol can be prolonged by the paracetamol. Paracetamol can reduce the bioavailability of lamotrigine, with a possible reduction of its effects, due to the potential induction of its metabolism at a liver level. Colestramine can reduce the absorption of paracetamol. Colestramine should not be administered before it is spent an hour from paracetamol administration. Regular use of paracetamol at the same time as zidovudine can cause neutropenia and increase the risk of liver damage. Treatment for gout probenecid reduces the clearance of the paracetamol, therefore the dose of paracetamol can be reduced in case of concomitant treatment. Hepatotoxicity of paracetamol can be enhanced by excessive alcohol intake (see paragraph 4.4). Interactions related to pseudophedrine For the severity of possible reactions is contraindicated the simultaneous administration of pseudophedrine and: • monoamino oxidase inhibitors (IMAO) (see “Controindications”) Concurrent use of pseudoephedrine and IMAO can trigger a severe hypertensive crisis (hypertension, hyperpyressia, headache). The medicine is therefore contraindicated in patients who are taking or taking IMAO in the last two weeks. For the possible effects caused by their interaction, the association of pseudo-ephedrine with some medicines is only possible under strict control of the doctor who will assess the risk/benefit ratio in the individual case. Pseudoephedrine can reduce the effect of other antihypertensive drugs (e.g. methyldopa, debrisochina, guanetidine, reserpine: The risk of hypertension and other unwanted cardiovascular effects can be increased. Concurrent use of midodrin can increase the hypertensive effect of midodrine. Halogenated anesthetics: Pseudoephedrine can interact with halogenated anesthetics. Concurrent use of pseudoephedrine with other sympathomimetics (risk of hypertensive episodes) or antidepressants triceclic may increase the risk of unwanted cardiovascular effects. Concurrent use of pseudoephedrine with digoxin and cardiac glycosides can increase the risk of irregular heartbeat or heart attack. Alkaloids of the horned rye (ergotamine and methylrgid): concurrent use may cause an increase in the risk of ergotism. Concurrent use of linezolid can increase the risk of hypertension.

Effects

Adverse events are tabulated below by classes and frequency. The frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, Pathologies of the emolinfopoietic system Very rare: thrombocytopenia, agranulocytosis, leucopenia, pancitopenia. Immune system disorders Rare: hypersensitivity, angioedema. Notable: anaphylactic reactions, Stevens Johnson syndrome, toxic epidermal necrolysis. Psychiatric disorders Rare: nervousness, insomnia, anxiety, agitation, hallucinations were rarely reported, especially in children. Diseases of the nervous system Rare: dizziness, headache, tremor Heart disease Rare: tachycardia, palpitations Vascular diseases Rare: hypertension Gastrointestinal diseases Rare: vomiting, dry mouth, nausea Notable: ischemic colitis Hepatobiliary diseases Rare: increased liver enzymes Pathologies of skin and subcutaneous tissue Rare: rash, erythema, hives, itching Not to mention: severe skin reactions, including generalized acute exantematic pustolosis (AGEP) Kidney and urinary pathologies Rare: urinary retention, especially in patients with prostate hypertrophy Pathologies of the eye Notable: ischemic optic neuropathy The following side effects have been reported: sweating, thirst, precordial pain, difficulty urinating, muscle weakness, midriasis, gastrointestinal problems, ventricular arrhythmias, multiform erythema, larynx edema, anaphylactic shock, anemia, alterations of liver function, hepatitis, acute kidney failure, interstitial nephrite, hematuria, anuria. In very rare cases serious skin reactions were reported. 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 workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

Overdosing

In case of overdose, the symptoms caused by overdose of paracetamol will be the most important ones. Paracetamol In the adult the maximum daily dose of paracetamol is 4 g; above this limit there is a risk of dose-dependent hepatotoxicity. In case of acute overdose, the paracetamol may exert a hepatotoxic effect or even cause liver necrosis. Paracetamol overdose, including high levels of total dose reached for a prolonged period, can cause neuropathy with irreversible liver failure. Patients should be advised not to take other medications containing paracetamol at the same time. There is a risk of poisoning, especially in elderly people, children, patients with liver disease, chronic alcoholism, patients with chronic malnutrition and patients treated with enzymatic inductors. Paracetamol overdose can cause liver failure, encephalopathy, coma and death. Symptoms of paracetamol overdose in the first 24 hours are pale, nausea, vomiting and anorexia. Abdominal pain can be the first indication of liver damage, which is usually not evident for 24-48 hours and can sometimes be delayed up to 4-6 days after ingestion. The liver damage generally reaches a maximum of 72-96 hours after ingestion. There may be abnormalities of glucose metabolism and metabolic acidosis. Acute kidney failure with acute tubular necrosis can also develop in the absence of severe liver damage. Heart arrhythmias and pancreatis have been reported. Immediate treatment is essential in the management of paracetamol overdose. Premature administration of N-acetylcysteine I.V. or os as an antidote to paracetamol, possibly gastric lavender and/or oral methionine administration, may have beneficial effects up to at least 48 hours after overdosing. Active carbon administration and breathing and circulation monitoring can be useful. In cases of seizures, diazepam may be administered. Pseudoefedrine Due to the nature of this sympathomimetic agent, overdose leads to a central nervous system stimulation. The most common signs/sets of pseudophedrine overdose include: irritability, restlessness, excitement, tremor, seizures, palpitations, hypertension, difficulty in urination, However, overall the data indicate that pseudoephedrine is well tolerated and safe if used as a nasal decongestant at 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 the seizures; diazepam can be used as an anticonvulsant and sedative. Measures must be taken to support breathing. Beta-blockers can be used to limit possible unwanted effects such as tachycardia, arrhythmia and hypokaliemia. If necessary you can try to remove the drug by performing a gastric lavender. To accelerate the elimination of pseudoephedrine, dialysis or acid diuresis can be used. The catheterization of the bladder may be necessary.

FLUIMUCIL INFLUENCE AND RAFFREDDORE is contraindicated in pregnancy, ascertained or presumed, and during breastfeeding. Safety FLUIMUCIL INFLUENCE AND REFREDDORE during pregnancy and lactation was not specifically studied. The data available on the potential effects of each individual component on pregnancy and nursing are summarized below: Pregnancy Epidemiological studies in pregnancy have not shown negative effects due to the paracetamol used at the recommended dosage. Studies on the reproduction of oral administration did not show signs of malformation or fetotoxicity (see paragraph 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. The vasoconstriction of the uterine vessels and the reduced uterine blood flow associated with the use of pseudoephedrine can cause fetal hypoxia. The use of pseudophedrine is contraindicated in pregnancy. Food Both paracetamol and pseudoephedrine pass into breast milk in small quantities. Since no data are available on the association of the two substances, the medicinal product must be avoided during breastfeeding. Fertility The effects of FLUIMUCIL INFLUENCE AND REFREDDORE were not specifically studied. Preclinical studies with paracetamol do not indicate particular risks to fertility at relevant therapeutic doses. There are not enough reproductive toxicology studies with pseudo-ephedrine.

Source: Farmadati