EFFERALGAN INFLUENCE AND R 16CPR

EFFERALGAN INFLUENCE AND REPRESENTATION 500 MG + 4 MG COMPRESSE RIVESTITES WITH FILM

active ingredients

Paracetamol 500,00 mg Clorfenamina maleate 4,00 mg for a tablet coated with film Excipient(s) with known effects: Carmoisina (E122) For the full list of excipients, see paragraph 6.1.

Excellent

Sodium crusty, ipromellose, microcrystalline cellulose, povidone K90, glyceril beenato, magnesium stearate, coating agent*, polishing agent************** Coating agent: Ipromellose (E464), propylene glycol (E1520), titanium dioxide (E171), carmoisin (E122), indigo carmine (E132) ** Polishing agent: Purified water, bees wax (E901), carnauba wax (E903), polysorbate 20 (E432), sorbic acid (E200)

Therapeutic indications

This medicine is indicated, in course of colds, rhinitis, rhinopharmaceuticals and flu-like conditions in adults and adolescents aged 15 years, for the treatment of: • clear nasal secretion and eye tearing, • sneezing, • cephalee and/or fever.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Children under 15 years of age. Due to the presence of paracetamol: • severe hepatocellular insufficiency or uncompensated liver disease in place. Due to the presence of malato chlordamine: • risk of closed angle glaucoma. • risk of urinary retention related to uretroprostatic disorders.

Population

Posology Reserved for adults and adolescents aged 15 years.

Weight (age)	Dose for administration	Intake interval	Maximum daily dose
Adults and teenagers >50 kg (>15 years)	1 tablet or 500 mg paracetamol 4 mg chlorfenamine	4 hours	4 tablets or 2,000 mg of paracetamol 16 mg of chlorfenamine

Do not exceed the maximum dosage of 4 tablets in 24 hours. Patients with kidney failure In case of kidney failure and except for other medical advice, it is recommended to reduce the dose and increase the minimum interval between 2 doses, according to the following table:

Creatine Clearance	Intake interval
≥50 ml/min	4 hours
10-50 ml/min	6 hours
	8 hours

The total dose of paracetamol should not exceed 3 g/die. Patients with liver failure In patients with chronic hepatopathy, active or compensated, especially in patients with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low liver glutathione reserves) and dehydration, the paracetamol dose should not exceed 3 g/day. Special clinical situations In the following conditions, the lowest possible effective dose of paracetamol should be used without exceeding 60 mg/kg/die (without exceeding 3 g/die): • adult body weight less than 50 kg, • mild to moderate hepatocellular insufficiency, • chronic alcoholism, • chronic malnutrition, • dehydration. Recommended maximum doses: • in adults and adolescents weighing more than 50 kg, THE TOTAL COURT OF PARACETY DOES NOT HAVE TO MAKE 4 THANKS TO YOU (see paragraph 4.9). • in adults and adolescents weighing more than 50 kg, THE TOTAL CUSTOMS OF MALEATO CLORFENAMINE DOES NOT have to exceed 16 MILLIGRAMMES TO YOU (see paragraph 4.9). Mode of administration Oral use. Tablets should be swallowed whole with a drink (p.e. water, milk, fruit juice). Evening administration is preferable due to the sedative effect of malato chlordamine. Frequency of administration 1 tablet, to be repeated, to need, after a interval of at least 4 hours, without exceeding 4 tablets per day. Duration of treatment If fever or pain persist for more than 3 days or if symptoms do not improve after 5 days of treatment, treatment management should be reassessed.

Conservation

This medicine does not require any special condition of conservation.

Warnings

In case of high or persistent fever, if signs of overinfection appear or if symptoms last more than 5 days, it is necessary to reevaluate the treatment. To avoid the risk of overdose • check that in the composition of other medicines (medicinals obtained with or without prescription) there are no paracetamol or malato chlorphenamine, • adhere to the recommended maximum doses (see paragraph 4.2). This medicine contains an azoic dye (E122) that can cause allergic reactions. Relative to the presence of paracetamol : Paracetamol should be used with caution in case of: • body weight Relative to the presence of malato chlorphenamine : This medicine must be used with caution in patients (especially elderly) with: • higher susceptibility to orthostatic hypotension, dizziness and sedation, • chronic constipation (risk of paralytic ileo), • possible prostatic hypertrophy, • severe liver and/or kidney failure, due to the risk of accumulation. Given the presence of chlorfenamine, it is not recommended to take alcoholic beverages, medicines containing alcohol or sedatives (especially barbiturates) during treatment, since they enhance the sedative effect of antihistamines (see paragraph 4.5).

Interactions

Relative to the presence of paracetamol: Associations requiring precautions for use + Antivitamin K Increased risk of antivitamin K effect and the risk of hemorrhage in case of intake of maximum doses of paracetamol (4 g/die) for at least 4 days. More frequent control of the INR. Potential adjustment of the dosage of antivitamin K during treatment with paracetamol and after its interruption. + Flucloxacillin Precaution is recommended in cases where paracetamol is co-administrated with flucloxacillin seen the greatest risk of metabolic acidosis onset with high anionic gap (AMGAE), particularly in patients with a risk factor for glutathione deficiency as severe kidney failure, sepsis, malnutrition and chronic alcoholism. Accurate monitoring is recommended to detect the occurrence of acid-base balance disorders, i.e. AMGAE, including the search for 5-oxoproline in the urine. + Interactions with laboratory tests: Paracetamol administration can cause errors in the determination of blood sugar by means of the glucose-oxidase-peroxidase method in case of high anomalous concentrations. Paracetamol administration can cause errors in the determination of urine by means of the phosphotungistic acid method. Relative to the presence of malato chlorphenamine: Not recommended associations + Alcohol (drinking or excipient) Increased sedative effect of antihistamine H₁ by alcohol. The alteration of supervision can make vehicle driving dangerous and the use of machinery. Avoid drinking alcohol and medicines containing alcohol. + Sodium oxibate Increase in the depression of the central nervous system. The alteration of supervision can make vehicle driving dangerous and the use of machinery. Associations to be considered + Other atropic drugs: Imipraminic antidepressants, much of H1 atropynic anti-histamines, anti-Parkinson medications of the class of anticholinergics, atropynic antispastics, disopiramide, phenotiazine neuroleptics and chlozapine. Added to the side effects of atropynic drugs such as urinary retention, constipation, dry mouth. + Other sedative drugs: morphine derivatives (analgesics, antitussives and substitute drugs), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (meprobamato), hypnotics, sedative antidepressants (amitriptiline, doxepine, mianserin, mirtazapine, trimipramine), antihistamine; other: baclofen and talidomide. Increase in the depression of the central nervous system. The alteration of supervision can make vehicle driving dangerous and the use of machinery.

Effects

REPORTS TO PARACET Undesirable effects are listed according to the classification for systems and organs. The frequencies are defined as follows:- Very common (≥1/10) - Common (≥1/100, Immune system disorders Rare: reactions from hypersensitivity such as anaphylactic shock, Quincke edema, erythema, hives, rash. Their appearance requires the definitive suspension of the medicinal product and related drugs. Pathologies of skin and subcutaneous tissue Very rare: severe skin reactions. Emolinfopoietic system pathologies Very rare: thrombocytopenia, leucopenia and neutropenia. Increase or reduction of the INR. Hepatobiliary diseases Notable: increased liver enzymes Gastrointestinal diseases Not known: diarrhoea, abdominal pain REPORTS TO MALEATO CLORFENAMINA The pharmacological characteristics of chlorphenamine can cause undesirable effects of variable intensity, which may be or may not be related to the dose (see paragraph 5.2): Neurovegetic effects • Sedation or drowsiness, more pronounced at the beginning of treatment, • Anticholinergic effects, such as mucosa dryness, constipation, mating disorders, midriasis, palpitations, risk of urinary retention, • Orthostatic hypotension, • Balance disorders, dizziness, memory reduction or concentration, more common in older patients, • Mental disorder. Reactions from hypersensitivity • Erythema, itching, eczema, purple, hives, • Edema, more rarely edema of Quincke, • Anaphylactic Shock. Ematologic effects • Leucopenia, neutropenia, • Trombocytopenia, • Hemolytic anemia. 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

The risk of severe intoxication (therapeutic or accidental poisoning) can be particularly high in the elderly, children, patients with liver failure, chronic alcoholism, patients with chronic malnutrition and patients with enzymatic inductors. In these cases, intoxication can be fatal. Paracetamol overdose : Synonyms Nausea, vomiting, anorexia, pallors, dizziness, sweating and abdominal pain generally appear in the first 24 hours. Overdose with 10 g paracetamol in single administration in adults and with 150 mg/kg body weight in single administration in children causes hepatic cytolysis that can evolve in complete and irreversible necrosis with hepatocellular insufficiency, metabolic acidosis and encephalopathy that can lead to coma and death. At the same time, there is an increase in hepatic transaminasis, lactic-dehydrogenase, bilirubin and a decrease in protrombine time that can occur from 12 to 48 hours after ingestion. Clinical symptoms of liver damage are generally observed after 1 or 2 days and reach the maximum after 3 - 4 days. Emergency measures • Immediate Ospedalization. • Relief of a blood sample for an initial dose of plasma paracetamol as soon as possible, from 4^a now after ingestion. • Rapid evacuation of the product ingested with gastric lavender. • The treatment of overdose normally includes the administration of the N-acetylcysteine antidote intravenously or oral as soon as possible, if possible before the tenth hour. • Syntomatic treatment. • Hepatic tests must be performed at the beginning of the treatment and repeated every 24 hours. In most cases, hepatic transaminers return to the norm in one or two weeks with full resumption of liver function. However, in very serious cases, a liver transplant may be necessary. Overdose from clorfenamin malato : Overdose from malato chlorphenamine can cause: convulsions (especially in children), disorders of consciousness, coma.

Pregnancy

If clinically necessary, EFFERALGAN INFLUENCE AND RAFFREDDORE can be used during pregnancy, however it should be used at the lowest effective dose for the shortest time possible and with the lowest frequency possible. Paracetamol A large amount of data on pregnant women do not indicate either malformation toxicity, nor fetal/neonatal toxicity. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. Clorfenamine The results of clinical epidemiological studies seem to exclude a specific malformation or a fetotoxic effect of chlorfenamine. However, in case of administration at the end of pregnancy, consider the possible repercussions of the atropinic and sedative properties of chlorphenamine for infants.

Food

It is not known whether chlordnamine is excreted in breast milk. Due to the possibility of sedation or paradox excitation of the newborn, this medicine is not recommended during breastfeeding.

Fertility

Given the potential mechanism of action on cycloxygenase and the synthesis of prostaglandins, paracetamol can alter female fertility through an effect on ovulation that is reversible with the suspension of treatment. Effects on male fertility have been observed in a study conducted on animals. The importance of such effects in man is not known.

Source: Farmadati