FLUIBRON INFLUENCE AND RAFF 10BS

FLUIBRON INFLUENCE AND REPRESENTATION 600 MG/10 MG FREE IN BUSTINA PARACETOLO/FENILEFRINA CLORIDRATO

active ingredients

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

Excellent

Mannitol (E 421), Xylitab 200 (xilitol, carboxytylcellulose), lemon aroma, sorbitol (E 420) ascorbic acid, citric acid, colloidal silica moisturize, aspartame (E 951) sodium sac.

Therapeutic indications

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

Contraindications

- Children under the age of 12; - Hypersensitivity to active ingredients or any excipient (listed in paragraph 6.1); - Patients taking beta-blockers; - Patients taking tricyclic antidepressants and those taking or taking in the last 2 weeks monoaminooxidase inhibitors; - Patients with bronchial asthma, feocromocytoma, closed-angle glaucoma, or taking at the same time other mimetic sympathetic medicines (such as decongestants, appetite suppressants and psychostimulants similar to amphetamines); Patients suffering from liver or kidney failure, diabetes, hyperthyroidism, hypertension and cardiovascular disease; - Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and those with severe hemolytic anemia; - Severe hepatocellular failure.

Population

Population 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 the doctor. Pediatric population Children under 12 years: FLUIBRON INFLUENCE AND REFREDDORE is contraindicated in children under the age of 12 (see paragraph 4.3). Method of administration Place the granulate directly on the tongue and swallow. FLUIBRON INFLUENCE AND RAFFREDDORE dissolves with saliva: this allows the use without water. The contents of the sachet can also be dissolved in a glass of hot water (not hot), mixing with a teaspoon. To taste, dilute with cold water to cool and sweeten. Once prepared, the solution obtained must be drunk within a few minutes.

Conservation

This medicine does not require any special storage temperature. Store in the original container to protect the medicine from moisture and light.

Warnings

Patients should be advised not to take other medications containing paracetamol while taking FLUIBRON INFLUENCE AND FURNITURE As high doses of paracetamol may cause severe adverse reactions. Avoid alcohol consumption during treatment with FLUIBRON FLU AND COLD. The risk of overdose is higher in patients with liver problems. Ask your doctor for advice before combining warfarin or any other medicinal product (see also section 4.5). The use of the product is not recommended if the patient is being treated with anti-inflammatories. Consult your doctor before using this product in patients with enlarged prostate gland 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 INFLUENCE AND RAFFREDDORE contains aspartame: this substance can be harmful in subjects suffering from phenylchetonuria. FLUIBRON INFLUENCE AND RAFFREDDORE contains less than 1 mmol (23 mg) of sodium per bag, i.e. it is essentially without sodium. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to the increased risk of metabolic acidosis with high anionic gap (HAGMA), especially in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as in those using the daily maximum doses of paracetamine. Careful monitoring is recommended, including the measurement of 5-oxoproline urinary.

Interactions

Paracetamol The hepatotoxic effect of paracetamol can be enhanced by taking other active medications on the liver such as zidovudine and iisoniazide that can produce an inhibition of the metabolism of paracetamol. The administration of probenecid before paracetamol decreases the clearance of the paracetamol and the urinary elimination of sulphate and paracetamol-glucuronide, and increases the half-life of the paracetamol itself. Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. reampycin, cimetidine, antiepileptics such as glutetimmide, phenobarbital, carbamazepine). Paracetamol increases the half-life of chloramphenicol. The product taken in high doses can enhance the effect of cumarinic anticoagulants (warfarin). Metoclopramide and domperidone can increase the absorption of paracetamol, while it is reduced or delayed respectively by cholesteramine and anticholinergics. Be careful when paracetamol is used in conjunction with flucloxacillin since concurrent intake was associated with metabolic acidosis with high anionic gap, especially in patients with risk factors (see paragraph 4.4). Fenilef Phenylphrine can antagonize the effect of beta-blocking and antihypertensive drugs (including debrisochina, guanetidine, reserpine and methyldopa) and can enhance the action of monoaminooxidase inhibitors (see paragraph 4.3). The contemporary use of phenylephrine with tricyclic antidepressants or sympathomimetic amines can increase the risk of cardiovascular effects. Phenylphrine can interact with dygoxin and cardiac glycosides by increasing the risk of arrhythmia or infarction, and with alkaloids (ergotamine and methylsergid) increasing the risk of ergotism. Interferences with some laboratory tests Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase).

Effects

Below are the side effects organized according to the classification for MedDRA Systems and Organs. The frequency is so defined: very common (≥1/10), common (from ≥1/100 to Classification for Systems and Organs / Frequency Undesirable effect Emolinfopoietic system pathologies Rare Agranulocytosis1, leucopenia1, thrombocytopenia1 Notable Anemia Immune system disorders Rare Allergic reactions^1,2, hypersensitivity reactions^1,2, anaphylaxis^1,2 Notable Anaphylactic Shock^1,2 Disorders of metabolism and nutrition Town Anorexia Psychiatric disorders Very rare Insomnia2, nervousness2, anxiety2, restlessness2, confusion2, irritability2 Diseases of the nervous system Very rare Tremore2, capogiro2, cephalea2 Pathologies of the eye Notable Midriasi2, acute glaucoma closed angle2 Heart disease Rare Tachycardia2, palpitations2 Vascular diseases Notable Hypertension2 Respiratory, chest and mediastinic pathologies Rare Broncospasmo^1,2 Notable Larynx Edema1 Gastrointestinal diseases Town Nausea2, vomiting2 Notable Diarrea1, gastrointestinal pathology1 Hepatobiliary diseases Rare Abnormal liver function1 Notable Hepatic pathology1, hepatiti1 Pathologies of skin and subcutaneous tissue Rare Skin rash^1,2, angioedema2 Notable Epidermal toxic necrolysis1, Steven Johnson1 syndrome, multiform erythema or polymorph1 Kidney and urinary pathologies Very rare Interstitial piping nephritis (after prolonged use of paracetamol at high doses)1 Notable Aggravated kidney failure1, hematuria1, anuria1 retention of urine 1 Undesirable effects associated with paracetamol. 2 Side effects associated with phenylphrine. Very rare cases of severe skin reactions have been 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

Paracetamol Suggested doses, or even if the whole package should be taken, there should be no symptoms of overdose of paracetamol. However, in case of ingestion of very high doses of paracetamol (superiors at 10 g), the most commonly found complication is liver damage, which usually occurs 12-48 hours after intake. Risk factors • Long-term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampin, St. John-hyperic herb or other inductive drugs of liver enzymes; • Regular consumption of ethanol in quantities greater than recommended; • Depletion of glutathione (e.g. nutrition disorders, cystic fibrosis, HIV infection, inedia, cachesia). Synonyms Early symptoms of paracetamol overdose in the first 24 hours are pale, nausea, vomiting, anorexia and abdominal pain. There may be abnormalities of glucose metabolism and metabolic acidosis. In severe poisoning, liver failure can progress in encephalopathy, hemorrhage, hypoglycemia, cerebral edema and death. Even in the absence of severe liver damage, acute kidney failure can develop with acute tubular necrosis, strongly suggested by pain at the side, hematuria and proteinuria, can develop even in the absence of severe liver damage. Heart arrhythmias and pancreatis were reported. Treatment In the management of paracetamol overdose, immediate treatment is essential. Despite a lack of significant initial symptoms, patients must be addressed to the hospital urgently for immediate medical assistance. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. The management must be in accordance with the treatment established by the guidelines. If the overdose occurred within 1 hour, the treatment with activated carbon must be considered. Plasma concentration of paracetamol should be measured at 4 or more hours after ingestion (initial concentrations are not reliable). 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 declines sharply after this period. If necessary, the patient should be given N-acetylcysteine intravenously, in line with the established dose regime. If vomiting is not a problem, oral methionine may be an 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 National Antiveleni Center or liver unit. Fenilef Synonyms Overdose symptoms caused by phenylphrine are irritability, headache and increased blood pressure. In severe cases confusion, hallucinations, seizures and arrhythmias can occur. However, the amount needed to produce severe phenylphrine toxicity would be greater than the amount it produces related to paracetamol. Treatment Treatment should be clinically appropriate. A severe hypertension should be treated with alpha blocking drugs such as phenolamine.

Pregnancy

Paracetamol A large amount of data on pregnant women do not indicate neither malformative toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, paracetamol can be used during pregnancy, however it should be used at the lowest effective dose for as short as possible and with the lowest frequency possible. The administration of the preparation during pregnancy and breastfeeding must take place under the direct control of the doctor. Fenilef The data relating to the use of pregnant phenylphrine are limited. The vasoconstriction of uterine vessels and the reduction of blood flow at the uterus level associated with the use of phenylphrine can give rise to fetal hypoxia. The use of pregnant phenylphrine should be avoided as further information is needed.

Food

Paracetamol Paracetamol is excreted in breast milk but in clinically not significant amounts. The available data does not contraindicate its use during breastfeeding. Fenilef Data relating to the excretion of phenylphrine in breast milk are not available, nor is information on the effects of phenylphrine on breast-milk infants. In the absence of available data, the use of phenylphrine should be avoided during breastfeeding.

Fertility

There are no evidence in non-clinical studies that indicate effects of paracetamol on male and female fertility at commonly used doses in clinic. The effect of phenylphrine on male and female fertility has not been studied.

Source: Farmadati