EFFERALGAN FEBRUARY AND CONG 10BUS

EFFERALGAN FEBRUARY AND NASAL CONGESTION 500 MG + 60 MG

active ingredients

Granulated oral solution A 1.5 g bag contains: Active ingredients: paracetamol 500 mg. pseudoephedrine hydrochloride 60 mg (equivalent to 49.15 mg of pseudoephedrine). . Excipients with known effects: Aspartame (E951): 45,307 mg Sorbitol (E420): 95,184 mg Saccarosio: 388,098 mg Saccarina soda: 22,654 mg (including 2.54 mg sodium) Riboflavin sodium phosphate: 0.388 mg (including 0.02 mg sodium) Effervescent tablets An effervescent tablet contains: Active ingredients: paracetamol 500 mg. pseudoephedrine hydrochloride 60 mg (equivalent to 49.15 mg of pseudoephedrine). . Excipients with known effects: Sodium bicarbonate: 700 mg (including 191, 56 mg sodium) Sodium anidro carbonate: 300 mg (including 130.14 mg sodium) Sorbitol (E420): 296 mg Aspartame (E951): 20 mg Saccarin soda: 20 mg (including 2,24 mg sodium) Docusato sodium: 4 mg (including 0.21 mg sodium) For the full list of excipients, see paragraph 6.1

Excellent

Granulated oral solution Sucrose, citric acid anidro, tropical aroma, grapefruit aroma, sorbitol, aspartame, sucralose, saccharin soda, polysorbed 20, beet red coloring, riboflavin coloring sodium phosphate. Effervescent tablets Citric acid anidro, sodium bicarbonate, sodium anidro carbonate, sorbitol, lemon aroma, aspartame, saccharin soda, simeticone, leucine, docusato sodium.

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. - Children under the age of 12. - Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase. - Subjects with a serious form of the following diseases: - coronary disease (angina, previous heart attack); - hypertension; - arrhythmias; - liver failure; - kidney failure; - hyperthyroidism; - asthma; - diabetes; - urination disorders caused by prostate hypertrophy or other pathologies; - glaucoma; - hemolytic anemia. - Subjects that are in treatment with dihydroergotamine or with monoamino oxidase inhibitors (IMAO) or have interrupted this treatment for less than two weeks (see paragraph 4.5).

Population

Posology - Oral Granulate Adults and children over 12 years of age: 2-3 sachets per day, dissolved in a glass of water. Children: It is not recommended in children under 12 years (see paragraph 4.3) Use the minimum effective dose. Initiate, that is, the treatment to the expected minimum dosage increasing the dose only if the symptoms are not sufficiently controlled. The maximum dose (both for single administration and for total daily dose) should never be exceeded. In adolescents, elders or subjects with a compromised hepatic or kidney function it may be necessary to reduce the dosage in relation to the patient's clinical conditions; in these cases the patient must be advised to consult the doctor before using EFFERALGAN FEBRUARY AND NASAL CONGESTION. The medicinal product must be used: 5 days maximum therapy for adult population 3 days maximum therapy for pediatric population (12-18 years) Mode of administration - Granulate per oral solution The medicine must be taken on a full stomach. Melt the granulate into a glass of water and immediately drink the solution obtained. You can also use hot water. Posology - Effervescent tablets Adults and children over 12 years of age: 1 effervescent tablet (equal to 500 mg of paracetamol and 60 mg of pseudoephedrine hydrochloride). Such doses can be repeated up to three times a day. Children: It is not recommended in children under 12 years (see paragraph 4.3) Use the minimum effective dose. Initiate, that is, the treatment to the expected minimum dosage increasing the dose only if the symptoms are not sufficiently controlled. The maximum dose (both for single administration and for total daily dose) should never be exceeded. In adolescents, elders or subjects with a compromised hepatic or kidney function it may be necessary to reduce the dosage in relation to the patient's clinical conditions; in these cases the patient must be advised to consult the doctor before using EFFERALGAN FEBRUARY AND NASAL CONGESTION. The medicinal product must be used: 5 days maximum therapy for adult population 3 days maximum therapy for pediatric population (12-18 years) Mode of administration - Effervescent tablets The medicine must be taken on a full stomach. Dissolve the tablet in a glass of water and immediately drink the solution obtained.

Conservation

Granulated oral solution This medicine does not require any special condition of conservation. Effervescent tablets Do not store at temperature above 25°C. Keep the pipe tight. Store in the original packaging to protect the medicine from moisture.

Warnings

During treatment with paracetamol, before taking any other medication, check that it does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. This medicine should be used correctly, respecting the instructions for use and in particular authorized dosage. Hepatotoxicity with paracetamol can also occur at therapeutic doses, after short-term treatment and in patients without pre-existing liver dysfunction (see paragraph 4.8). Caution is recommended in patients with a history of aspirin sensitivity and/or non-steroidal anti-inflammatory drugs (NSAID). 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. This medicine may cause serious side effects (see paragraph 4.8); the patient must be advised to suspend the medicinal product and to immediately consult a doctor in case he suspects the occurrence of a serious unwanted effect. Severe skin reactions: with the use of paracetamol, potentially fatal reactions such as Stevens-Johnson's syndrome (SSJ), toxic epidermal necrolysis (NET) and generalized acute urstolosis have been reported. Patients should be informed about signs and symptoms and carefully monitored for skin reactions. If symptoms or signs of Stevens-Johnson's syndrome, toxic epidermal necrolysis or generalized acute esantematic pulstolosis occur (eg progressive skin rash associated with bladders or mucous membrane lesions), the patient must immediately suspend treatment with paracetamol and consult a doctor. It is recommended caution if the paracetamol is administered in conjunction with flucloxacillin due to increased risk of metabolic acidosis with high anionic gap (HAGMA), in particular 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. Ischemic Optical Neuropatia 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. Ischetical Colite There have been reports of ischemic colitis with the use of pseudoephedrine. The use of pseudoephedrine should be stopped immediately and a medical opinion should be required if abdominal pain, rectal bleeding or other symptoms of ischemic colitis occur suddenly. The use of the medicinal product requires an accurate assessment of the risk/benefit ratio in the elderly and in the subjects suffering from a mild/moderate form of the following diseases: - coronary disease (angina, previous heart attack); - hypertension; - arrhythmias; - liver failure; - kidney failure; - hyperthyroidism; - asthma; - diabetes; - urination disorders caused by prostate hypertrophy or other pathologies; - glaucoma; - hemolytic anemia; - glucose-6-phosphate deficiency dehydrogenase. Patients taking paracetamol should avoid the use of alcoholic beverages because alcohol increases the risk of liver damage. Strong consumers of alcoholic beverages should consult their physician before taking a medication containing a paracetamol. During the use of EFFERALGAN FEBRUARY AND NASAL CONGESTION Avoid drinking bitter orange juice (see paragraph 4.5). In the course of oral anticoagulant therapy, paracetamol administration can increase the effect of anticoagulants, making it necessary to monitor the anticoagulant therapy more closely; moreover, potentially harmful interactions are also possible with different other drugs (see paragraph 4.5). In these cases EFFERALGAN FEBRUARY AND NASAL CONGESTION can only be used under strict medical control. The patient must be warned of the need to consult the doctor if he is already in treatment with other drugs. Important information about some excipients - GRANULATE FOR ORAL SOLUTION This medicine contains: Aspartame: This medicine contains 45,307mg of aspartame for oral solution granulate, equivalent to 0.65 mg/kg and 0.79 mg/kg respectively in subjects of 70 kg and 50 kg. The aspartame orally ingested is hydrolyzed in the gastrointestinal tract. Phenylolin is the main product of its hydrolysis. It can be harmful to subjects suffering from phenylchetonuria. Sorbitol: to patients with hereditary intolerance to fructose, this medicine should not be administered. Sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. Sodium: This medicine contains less than 1 mmol (23 mg) of sodium per bag, i.e. essentially “without sodium”. Important information about some excipients - COMPRESSE EFFERVESCENTS An effervescent tablet contains: Sodium: this medicine contains about 14 mmol (324 mg) of sodium (main component of kitchen salt) per dose equivalent to 16,20% of the maximum daily dose recommended by the WHO which corresponds to 2 g sodium for an adult. The maximum daily dose of this medicine is 48.6% of the maximum daily sodium dose recommended by the WHO. EFFERALGAN FEBRUARY AND NASAL CONGESTION is considered to be high in sodium. This should be taken into account in the case of patients following a hypothetical dietary regime. Sorbitol: patients with hereditary intolerance to fructose should not be given this medicine. Aspartame: This medicine contains 20 mg of aspartame per effervescent tablet, equivalent to 0.28 mg/kg and 0.4 mg/kg respectively in subjects of 70 kg and 50 kg. The aspartame orally ingested is hydrolyzed in the gastrointestinal tract. Phenylolin is the main product of its hydrolysis. It can be harmful to subjects suffering from phenylchetonuria.

Interactions

Paracetamol Interactions Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of liver monoxygenases or in case of exposure to substances that may have such an effect (e.g. cimetidine and ranitidine). The risk of paracetamol toxicity can be increased in patients taking other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as some antiepileptics (such as glutethymide, phenobarbital, phenytoin, carbamazepine, topiramate), rifampin and alcohol. Paracetamol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Antiagulants: Paracetamol can increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking vitamin K paracetamol and antagonists must be monitored for appropriate coagulation and bleeding. Flucloxacillin: attention should be paid 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). Cytotoxics: possible inhibition of the metabolism of busulfano by intravenosa (it is recommended caution in the 72 hours following the use of paracetamol). Domperidone: increased paracetamol absorption. Pharmacies: reduction of the absorption of paracetamol with cholesteramine. Metoclopramide: increased paracetamol absorption (increasing effect). Interactions related to pseudophedrine For the possibility of serious reactions is contraindicated the simultaneous administration of pseudophedrine and: - monoamino oxidase inhibitors (IMAO) (see paragraph 4.3). Monoamino oxidase inhibitors are used in therapy such as: - antiparkinsonians (such as selegilina or rasagilina); - antidepressants (such as isocarboxazide, nialamide, fenelzine, tranilcipromine, iproniazide, iproclozide, moclobemide and toloxatone); - antineoplastics (such as procarbazine). Concurrent use of pseudoephedrine and IMAO can trigger a severe hypertensive crisis (hypertension, hyperpyressia, headache). It is contraindicated the use of pseudoephedrine also in patients who have stopped treatment with IMAO for less than two weeks. - dihydroergotamine: the association of the two drugs can determine a dangerous increase in blood pressure. 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. Use EFFERALGAN FEBRUARY AND NASAL CONGESTION only under strict control of your doctor when you are already in therapy with one of these drugs: - linezolid: the association of the two drugs can determine an increase in blood pressure; - methildopa: reduction of the antihypertensive effect of methyldopa; - odour: increase of the hypertensive effect of midodrine. Due to the presence of pseudoephedrine, avoid the association with other sympathomimetics (risk of hypertensive episodes) or with guanetidine (revocation of the antihypertensive effect). Black orange: bitter orange (also called melangle) can trigger a severe hypertensive crisis (hypertension, hyperpyressia, cephalea) in patients taking pseudoephedrine.

Effects

Undesirable effects due to paracetamol - Emolinfopoietic system pathologies: thrombocytopenia, neutropenia, leucopenia; agranulocytosis, hemolytic anemia in patients with basic glucose-6-phosphate dehydrogenase deficiency. - Diseases of the nervous system: dizziness. - Immune system disorders: hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock. - Heart disease: Kounis syndrome. - Respiratory, chest and mediastinic pathologies: bronchospasm, pneumonia. - Gastrointestinal diseases: gastrointestinal hemorrhage; gastrointestinal reactions. - Kidney and urinary pathologies: nephrotoxicity; kidney damage (acute kidney failure, interstitial nephritis, hematuria, anuria). - Pathologies of skin and subcutaneous tissue: erythema, hive, rash, eruption fixed by medication. Very rare cases of severe skin reactions such as multiform erythema, toxic epidermal necrolysis (NET), Stevens-Johnson syndrome (SSJ) and generalized acute acute edema (see paragraph 4.4) have been reported. - Hepatobiliary diseases: hepatotoxicity; alteration of liver and hepatitis function; cytolithic hepatitis that can lead to acute liver failure. In case of overdose the paracetamol can cause liver cytolysis that can evolve towards massive and irreversible necrosis. Undesirable effects due to pseudoephedrine - Heart disease: myocardial infarction, atrial fibrillation, tachyrithmia, hypertension, hypotension, ventricular extrasistles, precordial pain, palpitations. - Diseases of the nervous system: seizures, insomnia, tremors, ataxia, dizziness, headaches. - Pathologies of the eye: midriasis, ischemic optic neuropathy (not known frequency). - Gastrointestinal diseases: ischemic colitis (unknown frequency), alterations of taste, nausea, vomiting, dry mouth. - Pathologies of skin and subcutaneous tissue: eczema, fixed erythema, pseudo-cancer. - Disorders of metabolism and nutrition: hyperthermia, thirst, sweating. - Psychiatric disorders: anxiety, agitation, nervousness, irritability, confusion, hallucinations. - Difficulty to urinate: In patients with prostate hypertrophy, urinary retention cases may occur. 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: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Paracetamol In case of accidental intake of very high doses of paracetamol, acute intoxication manifests with pallor, nausea, vomiting, anorexia and abdominal pains that generally appear within the first 24 hours from overdose with paracetamol. In the adult the maximum daily dose of paracetamol is 3 g; above this limit there is a risk of dose-dependent hepatotoxicity. Nausea and vomiting, the only early signs of intoxication, usually disappear within 24 hours. Persistence beyond this time, often associated with undercostal pain at the right flank or hyperesthesia, may indicate the development of liver necrosis. Hepatic damage is maximum 3-4 days after ingestion and paracetamol overdose can be caused by hepatic cytolysis that can lead to hepatocellular insufficiency, metabolic acidosis, encephalopathy, hemorrhage, hypoglycemia, cerebral edema, coma and death. Therefore, despite the lack of significant early symptoms, patients who have taken overdose of paracetamol must be transferred urgently to the hospital. Increased levels of hepatic transaminasis, lactate dehydrogenase and bilirubin with a reduction in protrombine levels can occur from 12 to 48 hours from acute overdose. Overdose can also lead to pancreatis, acute kidney failure and pancitopenia. A dose of 10-15 g (20-30 tablets) or 150 mg/kg paracetamol assumed within 24 hours may cause severe hepatocellular necrosis and, much less frequently, kidney tubular necrosis. The administration of activated charcoal must be taken into account if the paracetamol is thought to have been taken within the last hour in quantities greater than 150 mg/kg or 12 g (consider the lower limit). Acetylcysteine protects the liver if administered by infusion within 24 hours of paracetamol ingestion. Pseudoefedrine The most common signs/sets of pseudoephedrine overdose include: midriasis, tachycardia, hypertension, agitation/anxiety, sinus arrhythmia, hallucinations, tremors/hyperreflexia, vomiting; less frequently observed: hyperglycemia, rabdomiolisis, acute kidney failure. Most patients only require a short observation period in the hospital; a pharmacological treatment is required in severe cases (e.g. arrhythmias, hypertensive crisis, seizures).

EFFERALGAN FEBRUARY AND NASAL CONGESTION is contraindicated in pregnancy, ascertained or presumed, and during lactation.

Source: Farmadati