Fluibron influenza e raffreddore 600mg/10mg - 10 sachets

Product Description

Fluibron influenza and cold 600 mg/10 mg granules in sachet is a medicine based on paracetamol and phenylephrine hydrochloride.

Indications

Short-term treatment of cold and flu symptoms, including mild/moderate pain and fever, when associated with nasal congestion.

Composition

Active ingredients

Each sachet contains: Active ingredients: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to phenylephrine 8.2 mg). Each sachet contains sorbitol (E 420) 42 mg, aspartame (E 951) 25 mg. For the full list of excipients, see section 6.1.

Excipients

Mannitol (E 421), Xylitab 200 (xylitol, carboxymethylcellulose), lemon flavouring, sorbitol (E 420), ascorbic acid, citric acid, colloidal hydrated silica, aspartame (E 951), sodium saccharin.

Directions for use and dosage

Dosage 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 your doctor. Method of administration Place the granules directly on the tongue and swallow. Fluibron influenza e freddo dissolves in saliva, allowing it to be used without water. The contents of the sachet can also be dissolved in a glass of hot (not boiling) water, stirring with a teaspoon. If desired, dilute with cold water to cool and sweeten. Once prepared, the resulting solution should be drunk within a few minutes.

Warnings

Patients should be advised not to take other medicines containing paracetamol while taking Fluibron influenza e freddo, as high doses of paracetamol can cause serious adverse reactions. Avoid alcohol consumption during treatment with Fluibron influenza e freddo. The risk of overdose is greater in patients with liver problems. Instruct the patient to contact their doctor before combining it with warfarin or any other medication (see also section 4.5). Use of the product is not recommended if the patient is being treated with anti-inflammatory drugs. Consult your doctor before using the product in patients with prostate enlargement or occlusive vascular disease (e.g., Raynaud's syndrome). Do not exceed the recommended dose and do not administer for more than 3 consecutive days. Fluibron influenza e freddi contains aspartame: this substance may be harmful to people with phenylketonuria. Fluibron influenza e freddi contains less than 1 mmol (23 mg) sodium per sachet, i.e., it is essentially sodium-free. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g., chronic alcoholism), as well as in those using maximum daily doses of paracetamol. Careful monitoring, including measurement of urinary 5-oxoproline, is recommended.

Contraindications

- Children under 12 years of age; - Hypersensitivity to the active substances or to any of the excipients (listed in section 6.1); - Patients taking beta-blockers; - Patients taking tricyclic antidepressants and those taking or who have taken in the last 2 weeks monoamine oxidase inhibitors; - Patients with bronchial asthma, pheochromocytoma, narrow-angle glaucoma, or concomitantly taking other sympathomimetic medicinal products (such as decongestants, appetite suppressants and amphetamine-like psychostimulants); Patients with hepatic or renal insufficiency, diabetes, hyperthyroidism, hypertension and cardiovascular disease; - Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and in those affected by severe haemolytic anaemia; - Severe hepatocellular insufficiency.

Undesirable effects

The following undesirable effects are listed according to the MedDRA System Organ Class. The frequency is defined as follows: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

¹ Side effects associated with paracetamol.

² Side effects associated with phenylephrine. Very rare cases of serious skin reactions have been reported.

Overdose

Paracetamol At the recommended doses, or even if the entire pack is taken, symptoms of paracetamol overdose should not appear. However, if very high doses of paracetamol (more than 10 g) are ingested, the most common complication is liver damage, which usually occurs 12-48 hours after ingestion. Risk factors - Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort, or other drugs that induce liver enzymes; - Regular consumption of ethanol in quantities exceeding those recommended; - Glutathione depletion (e.g., eating disorders, cystic fibrosis, HIV infection, starvation, cachexia). Symptoms: Early symptoms of paracetamol overdose within the first 24 hours include pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities in glucose metabolism and metabolic acidosis may occur. In severe poisoning, liver failure may progress to encephalopathy, hemorrhage, hypoglycemia, cerebral edema, and death. Even in the absence of severe liver damage, acute renal failure with acute tubular necrosis, strongly suggested by flank pain, hematuria, and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Treatment: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant initial symptoms, patients should be referred to the hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines. If the overdose occurs within 1 hour, treatment with activated charcoal should be considered. Plasma paracetamol concentrations should be measured 4 or more hours after ingestion (initial concentrations are unreliable). Treatment with N-acetylcysteine ​​can be used up to 24 hours after paracetamol ingestion; however, maximum protective effect is achieved up to 8 hours after ingestion. The efficacy of the antidote declines sharply after this period. If necessary, the patient should be administered N-acetylcysteine ​​intravenously, in line with the established dosing regimen. If vomiting is not a problem, oral methionine may be a suitable alternative in more remote areas, outside of hospital. Management of patients who present with severe liver dysfunction more than 24 hours after ingestion should be discussed with the National Poisons Control Center or the liver unit. Phenylephrine Symptoms Symptoms of overdose caused by phenylephrine are irritability, headache, and increased blood pressure. In more severe cases, confusion, hallucinations, convulsions, and arrhythmias may occur. However, the amount required to produce serious phenylephrine toxicity would be greater than that produced by paracetamol. Treatment Treatment must be clinically appropriate. Severe hypertension should be treated with alpha-blocking drugs such as phentolamine.

Pregnancy and breastfeeding

Pregnancy Paracetamol A large amount of data on pregnant women indicate neither malformative nor fetal/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically necessary, paracetamol can be used during pregnancy, however, it should be used at the highest effective dose. low doses for the shortest possible time and with the lowest possible frequency. Administration of the preparation during pregnancy and breastfeeding should be under the direct supervision of a physician. Phenylephrine Data on the use of phenylephrine during pregnancy are limited. Vasoconstriction of the uterine vessels and reduction of blood flow to the uterus associated with the use of phenylephrine may result in fetal hypoxia. The use of phenylephrine during pregnancy should be avoided as further information is needed. Breastfeeding Paracetamol Paracetamol is excreted in breast milk but in clinically insignificant quantities. Available published data do not contraindicate its use during breastfeeding. Phenylephrine No data are available regarding the excretion of phenylephrine in breast milk, nor are there any information regarding the effects of phenylephrine on breast-fed children. In the absence of available data, the use of phenylephrine should be avoided during breastfeeding. Fertility There is no evidence in non-clinical studies to indicate an effect of paracetamol on male and female fertility at doses commonly used in clinical practice. The effect of phenylephrine on male and female fertility has not been studied.

Format

10 sachets