BRONCHENOLO TOSS INFL RAF 10BS

BRONCHENOLO TOSSE, INFLUENCE AND REFREDDORE 500 MG + 200 MG + 10 MG POLVER FOR ORAL DEPARTMENT

active ingredients

Active Ingredient - mg/bustina Paracetamol: 500; Guaifenesina: 200; Fenilefrina hydrochloride: 10. Excipients with known effects: sucrose: 2077 mg; aspartame (E951): 12 mg; sodium: 129 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Saccarosio, citric acid E330, tartaric acid E334, cyclamate sodium E952, citrate sodium E331, potassium acesulfame E950, aspartame E951, powdered menthol aroma, lemon aroma, lemon juice aroma, chinoline yellow E104.

Therapeutic indications

For short-term relief of cold and flu symptoms including pain, headache, closed nose and sore throat, chills and fever, and for the relief of bronchial cough.

Contraindications

Hypersensitivity to paracetamol, conduitfenesin, phenylphrine hydrochloride or any of the excipients listed in paragraph 6.1. • Pregnancy and nursing. • Hepatic or severe kidney damage. • Cardiopathy and cardiovascular disorders, including severe hemolytic anemia. • Hypertension. • Hyperthyroidism. • Diabetes. • Feocromocytoma. • Patients taking antidepressants (see paragraph 4.5). • Patients taking other products containing paracetamol (see paragraph 4.4). • Closed corner Glaucoma. • Patients taking beta blockers. Contraindicated in patients in treatment with oxidase monoammine inhibitors or who have interrupted therapy for less than 2 weeks. Use in patients with glaucoma or urinary retention. The use in patients treated with other sympathetic medications (such as decongestants, appetite suppressants and anphetamineal psychostimulants).

Population

Population. . Adults, elders and children aged 12 or over: A bag every four hours according to the needs. Do not exceed 4 sachets (4 doses) within 24 hours. Do not administer children under the age of 12. Look for medical assistance if symptoms persist for more than 5 days. Method of administration: For oral use after dissolving the contents of the sachet in a standard cup of hot but not hot water (250 ml). Cold water until it reaches a temperature that allows consumption. Drink the whole solution within 1 hour and a half.

Conservation

Do not keep at tempering above 30°C.

Warnings

Paracetamol should be administered with caution in patients with severe kidney damage or liver impairment. The risks of overdose are greater in patients with non cirrhotic liver disease. The doctor or pharmacist must ensure that preparations containing sympathomimetic agents are not administered at the same time in different ways of administration, i.e. by mouth and topical ( nasal, auricular and ophthalmic preparations). Products containing sympathomimetic agents must be used with great caution in patients with angina. In patients suffering from the following conditions, the doctor's advice is necessary before taking this product: Prostatic hypertrophy (patients can develop increased difficulty in urination); Occlusive vasculopathy, e.g. Raynaud phenomenon; Cardiovasculopathy; Miastenia gravis - an autoimmune pathology; Severe gastrointestinal diseases. This medicine should only be recommended if all symptoms are present (sweet and/or fever, nasal congestion and bronchial cough). Patients with chronic cough or asthma should consult your doctor before taking this product. Do not take with a sedative cough medicine. Patients must stop using this medicine and consult a health care professional if the cough lasts more than 5 days or returns, or is accompanied by fever, rash or persistent headache. Concurrent use with alcohol must be avoided. This medicine should not be used by patients taking other nice mimetics (such as decongestants, appetite suppressants and anphetamineal psychostimulants). Concurrent use of other medicines containing paracetamol should be avoided. If symptoms persist, consult your doctor. Excipients: It contains sucrose. Patients suffering from hereditary problems of fructose intolerance, glucose-galactosis mal absorption or saccarosio-isomaltase deficiency should not take this medicine. Contains aspartame (E951), a source of phenylalanin. It can be harmful to patients suffering from phenylchetonuria. This medicine contains 129 mg sodium per bag, equivalent to 6.5% of the maximum daily intake recommended by the WHO of 2 g sodium for an adult. Special warnings on the label: Contains paracetamol. Do not hire with other products containing paracetamol. Look for medical assistance immediately in case of overdose even if you feel well. Do not hire with other products for influence, cold or other decongesting products. Special warnings in the leaflet: Contains paracetamol. Look for medical assistance immediately in case of overdose even if you feel well, due to the risk of severe delayed liver damage.

Interactions

PARACETAM: Paracetamol absorption speed can be increased by metoclopramide or domperidone and absorption can be reduced by choleramine. The anticoagulant effect of warfarin and other cumarines can be increased by the regular and prolonged use of paracetamol with an increase in the risk of bleeding, although occasional doses have not had significant effects. Hepatotoxicity of paracetamol can be enhanced by excessive alcohol consumption. Drugs that induce microsomal liver enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants can increase liver toxicity of paracetamol, especially after overdose. Contraindicated in patients in treatment with oxidase monoamine inhibitors or who have interrupted therapy for less than 2 weeks due to the risk of hypertensive crisis. Regular use of paracetamol probably reduces zidovudine metabolism (increased neutropenia risk). Salicylates/aspirin can prolong T1⁄2 elimination of paracetamol. Pharmacological interactions have been reported that involved paracetamol with numerous other medicines, whose clinical relevance is considered unlikely in acute use of the proposed dosage regime. Concurrent treatment with paracetamol and FANS increases the risk of kidney dysfunction. Paracetamol can affect tests for phosphotungstate uric acid and blood glucose tests. GUAIFENESINA: If the urine is collected within 24 hours of product administration, a metabolite may cause color interference in the laboratory determinations of 5 hydroxyndolacetic acid (5-HIAA) and vanylmandelic acid (VMA). Sheathin enhances the action of sedatives and myrelaxants. PHENYLEPHRINE CHLORIDE. Phenylphrine should be used with caution in association with the following medicines since interactions have been reported:

Monoamine oxidase inhibitors (including moclobemide)	Hypertensive interactions occur between sympathomimetic amines such as phenylphrine and monoamine oxidase inhibitors (see contraindications).
Sympathomimetic amines	Concurrent use of phenylphrine with other sympathomimetic amines can increase the risk of unwanted cardiovascular effects.
Beta-blockers and other antihypertensives (including debrisochina, guanetidine, reserpine, methyldopa)	Phenylphrine can reduce the effectiveness of beta blocking and antihypertensive agents. It can increase the risk of hypertension and other unwanted cardiovascular effects.
Antidepressants (e.g. amitriptiline)	It can increase the risk of unwanted cardiovascular effects with phenylphrine.
Used phenotiazides as sedatives	It can enhance the effects on the SNC.
Alkaloids of hergot (hergotamine and methylrgid)	Increased risk of ergotism
Digital cardiac codes	Increased risk of arrhythmia or heart attack
Halogenated anesthetic agents such as cyclopropane, alothane, enfluran, isofluran	Can cause or worsen ventricular arrhythmia

Effects

The frequency of occurrence of unwanted effects is usually classified as follows: Very common (≥1/10); Town (≥1/100, Not common (≥1/1.000, Raro (≥1/10.000, Very rare (Note (frequency cannot be defined on the basis of the available data). PARACETAM: The adverse effects derived from the data of historical clinical studies are infrequent and due to a limited patient exposure. The events reported in the extensive post-marketing experience at the therapeutic/label dose and considered as attributable to paracetamol are summarized in the table below according to the classification for systems and organs according to MedDRA. Due to the limited data from clinical studies, the frequency of these adverse events is not known (it cannot be defined on the basis of the available data), but the post-marketing experience indicates that adverse reactions to the paracetamol are rare (≥1/10.000, Systems and organs Undesirable effect Emolinfopoietic system pathologies Trombocytopenia Agranulocytosis These effects are not necessarily related to paracetamol Immune system disorders Anaphylaxis Reactions of skin hypersensitivity including erythys, angioedema and Stevens-Johnson syndrome, toxic epidermal necrolysis Respiratory, chest and mediastinic pathologies Broncospasm Hepatobiliary diseases Hepatic dysfunction Gastrointestinal diseases Acute pancreatis * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatic patients sensitive to aspirin or other NSAIDs. GUAIFENESINA: The frequency of these events is unknown but is considered as probably rare.

Systems and organs	Undesirable effect
Immune system disorders	Allergic reactions, angioedema, anaphylactic reactions
Respiratory, chest and mediastinic pathologies	Dispense
Gastrointestinal diseases	Nausea, vomiting, abdominal disorder, diarrhea
Pathologies of skin and subcutaneous tissue	Rash, hives

PHENYLEPHRINE CHLORIDE: The following adverse events have been observed in clinical trials with phenylphrine and can therefore represent adverse events that occur most commonly, although actual frequencies are not available.

Systems and organs	Undesirable effect
Psychiatric disorders	Nervosism, irritability, restlessness and excitability
Diseases of the nervous system	Kefalea, dizziness, insomnia
Heart disease	Increased blood pressure
Gastrointestinal diseases	Nausea, vomiting, diarrhea

The adverse reactions identified during the post-marketing experience are listed below. The frequency of these reactions is not known but is probably rare (≥1/10.000, Pathologies of the eye Midriasis, acute closed angle glaucoma, which occurs most likely in those patients with closed angle glaucoma Heart disease Tachycardia, palpitations Pathologies of skin and subcutaneous tissue Allergic reactions (e.g. erythema, hives, allergic dermatitis). Reactions of hypersensitivity - including crusade sensitivity that can arise with other sympathomimetics. Kidney and urinary pathologies Disuria, urinary retention. It is more likely that this occurs in those patients with bladder obstruction, such as prostate hypertrophy. 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

PARACETAM It is possible that hepatic damage occurs in adults who have taken 10 g or more paracetamol. Ingestion of 5 g or more of paracetamol can lead to liver damage if the patient has risk factors (see below). Risk factors If the patient a) is in long-term treatment with cabamazepine, phenobarbital, phenytoin, primidone, rifampin, St. John's herb or other medicines that induce liver enzymes or b) if they regularly consume excess ethanol compared to recommended doses or c) it is likely to have a glutathione depletion to e.g. appetite disorders, cystic fibrosis, infection. Signs and symptoms Symptoms of paracetamol overdose in the first 24 hours are pale, nausea, vomiting, anorexia and abdominal pain. Hepatic damage can occur 12-48 hours after ingestion. There may be abnormalities of glucose metabolism and metabolic acidosis. In case of severe poisoning, liver failure can progress in encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. It can develop acute kidney failure with acute tubular necrosis strongly suggested by hip pain, hematuria and proteinuria, even in the absence of severe liver damage. Heart arrhythmia and pancreatis were reported. Management In the management of paracetamol overdose, immediate treatment is essential. Despite the lack of significant initial symptoms, patients must urgently contact the hospital for immediate medical care. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management must take place according to the established guidelines of treatment. The treatment with activated charcoal must be taken into account within an hour of overdosing. Plasma concentration of paracetamol should be measured 4 or more hours after ingestion (initial concentrations are not detectable). 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 is significantly reduced after this period of time. If necessary, the patient should be administered N-acetylcysteine intravenously, in line with the established dosage program. If vomiting is not a problem, oral methionine may be an appropriate 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 Antiveleni Center or with a liver drive. GUAIFENESINA Signs and symptoms Dosi many big troublefenesin can cause nausea and vomiting. Treatment The vomiting must be treated with fluid reintegration and electrolyte monitoring if required. PHENYLEPHRINE CHLORIDE Signs and symptoms It is likely that overdose of phenylphrine causes similar effects to those listed in the paragraph of adverse reactions. Additional symptoms may include hypertension and possibly reflex bradycardia association. In serious cases confusion, hallucinations, epileptic attacks and arrhythmia may occur, however, the amount necessary to produce severe toxicity of phenylphrine is greater than that necessary to cause toxicity related to paracetamol. Treatment Clinically appropriate treatment measures must be established which may include immediate gastric lavender and symptomatic and support measures. Hypertensive effects can be treated with a blocking agent of alpha receptors (such as phenylamine 6-10 mg) administered intravenously, and bradycardia can be treated with atropine, preferably only after controlling arterial pressure.

Pregnancy

. .

PARACETAM

: Epidemiological data on oral administration of therapeutic doses of paracetamol do not indicate adverse effects on pregnancy or health of fetus or infant. Studies on reproduction that have examined oral administration have not shown signs of malformation or toxicity on the fetus.

GUAIFENESINA

: The safety of sheath during pregnancy has not been established. The product should not be used during pregnancy.

PHENYLEPHRINE CHLORIDE

: The safety of the use of phenylphrine hydrochloride during pregnancy has not been established. The product should not be used during pregnancy.

Food

. Paracetamol is excreted in breast milk but not in significant quantities. No side effects were reported in children. GUAIFENESINA: The safety of sheath during breastfeeding has not been established. The product should not be used during lactation.

PHENYLEPHRINE CHLORIDE

: The safety of the use of phenylphrine hydrochloride during breastfeeding has not been established. Phenylphrine can be excreted in breast milk. The product should not be used during lactation.

Fertility

: There is no available information that suggests an effect of active ingredients on human fertility.

Source: Farmadati