Vivinduo fever and nasal congestion 500 mg + 60 mg 10 sachets granule for oral solution

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Treatment of cold and flu symptoms.

ACTIVE INGREDIENTS

A 1.5 g sachet contains: Active ingredients: Paracetamol 500 mg; Pseudoephedrine hydrochloride 60 mg (equivalent to 49.15 mg of pseudoephedrine). Excipients with known effects: Sorbitol (E420): 95.2 mg; Sucrose: 418.7 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Sucrose, lemon flavouring, anhydrous citric acid, sorbitol, sucralose, polysorbate 20, beetroot red colouring, riboflavin sodium phosphate colouring.

CONTRAINDICATIONS AND SIDE EFFECTS

- Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. - Pregnancy and breastfeeding. - Children under the age of 12. - Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase. - Subjects suffering from a severe form of the following diseases: • coronary heart disease (angina, previous heart attack); • hypertension; • arrhythmias; • liver failure; • renal failure; • hyperthyroidism; • asthma; • diabetes; • urination disorders caused by prostatic hypertrophy or other pathologies; • glaucoma; • hemolytic anemia. Subjects who are being treated with dihydroergotamine or monoamine oxidase inhibitors (MAOIs) or who have discontinued this treatment less than two weeks ago (see section 4.5).

DOSAGE

Dosage 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 section 4.3). Use the lowest effective dose. That is, start treatment at the minimum intended dosage by increasing the dose only if the symptoms are not sufficiently controlled. The maximum dose (both for single administration and for total daily dose) must never be exceeded. In adolescents, the elderly or in subjects with impaired hepatic or renal function it may be necessary to reduce the dosage in relation to the patient's clinical condition; in these cases the patient must be advised to consult the doctor before using VIVINDUO FEVER AND NASAL CONGESTION. The medicine must be used: maximum 5 days of therapy for the adult population; 3 days maximum therapy for the pediatric population (12-18 years). Method of administration Dissolve the granules in a glass of water and immediately drink the solution obtained. You can also use hot water.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. This medicine must be used correctly, respecting the instructions for use and in particular the authorized dosage. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short-term treatment and in patients without pre-existing liver dysfunction (see section 4.8). Caution is recommended in patients with a history of sensitivity to aspirin and/or nonsteroidal anti-inflammatory drugs (NSAIDs). Caution is advised if acetaminophen is administered concurrently 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 acetaminophen. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. The risk of serious side effects is also increased when paracetamol is taken together with other antipyretic analgesics; the simultaneous use of this type of medicines must therefore be avoided. This medicine can cause even serious side effects (see section 4.8); the patient must be advised to discontinue the medicine and to immediately consult a doctor if he suspects the onset of a serious side effect. Serious skin reactions: Potentially fatal reactions such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. Patients should be informed about the signs and symptoms and monitored carefully for skin reactions. If symptoms or signs of Stevens-Johnson syndrome, toxic epidermal necrolysis or acute generalized exanthematous pustulosis occur (e.g. progressive skin rash associated with blistering or mucosal lesions), the patient should immediately discontinue treatment with paracetamol and consult a doctor. The use of the medicine requires an accurate evaluation of the risk/benefit ratio in the elderly and in subjects suffering from a mild/moderate form of the following diseases: - coronary heart disease (angina, previous heart attack); - hypertension; - arrhythmias; - liver failure; - renal failure; - hyperthyroidism; - asthma; - diabetes; - urination disorders caused by prostatic hypertrophy or other pathologies; - glaucoma; - hemolytic anemia; - glucose-6-phosphate dehydrogenase deficiency. Patients taking acetaminophen should avoid using alcoholic beverages because alcohol increases the risk of liver damage. Heavy consumers of alcoholic beverages should consult their doctor before taking a medicine containing paracetamol. During the use of VIVINDUO FEVER AND NASAL CONGESTION it is necessary to avoid drinking bitter orange juice (see paragraph 4.5). During therapy with oral anticoagulants, the administration of paracetamol can increase the effect of anticoagulants, making it necessary to monitor the anticoagulant therapy more closely; furthermore, potentially harmful interactions are also possible with several other drugs (see section 4.5). In these cases VIVINDUO FEVER AND NASAL CONGESTION can only be used under strict medical supervision. The patient must be advised of the need to consult the doctor if he is already being treated with other drugs. Ischemic colitis Some cases of ischemic colitis have been reported with medicines containing pseudoephedrine. The use of pseudoephedrine should be discontinued and it is recommended to consult a doctor if abdominal pain, rectal bleeding or other symptoms of ischemic colitis suddenly occur. Ischemic optic neuropathy Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma. Important information about some excipients This medicine contains: Sorbitol: The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. Patients with hereditary fructose intolerance should not be given this medicine. Sucrose: Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per sachet, i.e. it is essentially 'sodium-free'.

INTERACTIONS

Interactions related to paracetamol Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example cimetidine and ranitidine). The risk of paracetamol toxicity may be increased in patients taking other potentially hepatotoxic drugs or drugs that induce hepatic microsomal enzymes, such as some antiepileptics (such as glutethimide, phenobarbital, phenytoin, carbamazepine, topiramate), rifampin and alcohol. The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method). Anticoagulants: Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking paracetamol and vitamin K antagonists should be monitored for appropriate clotting and bleeding. Flucloxacillin: Caution should be exercised when paracetamol is used concomitantly with flucloxacillin as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4). Cytotoxic: possible inhibition of the metabolism of intravenous busulfan (caution is recommended in the 72 hours following the use of paracetamol). Domperidone: increased absorption of paracetamol. Hypolipidemic drugs: reduction of paracetamol absorption with cholestyramine. Metoclopramide: increased absorption of paracetamol (increased effect). Interactions related to pseudoephedrine Due to the possibility of serious reactions, the simultaneous administration of pseudoephedrine and: monoamine oxidase inhibitors (MAOI) (see section 4.3). Monoamine oxidase inhibitors are used in therapy as: - antiparkinsonians (such as selegiline or rasagiline); - antidepressants (such as isocarboxazid, nialamide, phenelzine, tranylcypromine, iproniazid, iproclozide, moclobemide and toloxatone); - antineoplastics (such as procarbazine). Concomitant use of pseudoephedrine and MAOIs can trigger a severe hypertensive crisis (hypertension, hyperpyrexia, headache). The use of pseudoephedrine is contraindicated even in patients who have stopped treatment with MAOIs for less than two weeks. - dihydroergotamine: the combination of the two drugs can cause a dangerous increase in blood pressure. Due to the possible effects caused by their interaction, the association of pseudoephedrine with some medicines is only possible under the strict supervision of a doctor who will evaluate the risk/benefit ratio in the individual case. Use VIVINDUO FEVER AND NASAL CONGESTION only under strict medical supervision when you are already being treated with one of these drugs: - linezolid: the association of the two drugs can cause an increase in blood pressure; - methyldopa: reduction of the antihypertensive effect of methyldopa; - midodrine: increase in the hypertensive effect of midodrine. Due to the presence of pseudoephedrine, avoid association with other sympathomimetics (risk of hypertensive episodes) or with guanethidine (cancellation of the antihypertensive effect). Bitter orange: bitter orange (also called melangolo) can trigger a serious hypertensive crisis (hypertension, hyperpyrexia, headache) in patients taking pseudoephedrine.

SIDE EFFECTS

Side effects due to paracetamol - Pathologies of the blood and lymphatic system: thrombocytopenia, neutropenia, leukopenia; agranulocytosis, haemolytic anemia in patients with basic glucose-6-phosphate dehydrogenase deficiency. - Nervous system disorders: dizziness. - Immune system disorders: hypersensitivity reactions such as angioedema, laryngeal edema, anaphylactic shock. - Cardiac disorders: Kounis syndrome. - Respiratory, thoracic and mediastinal disorders: bronchospasm, pneumonia. - Gastrointestinal disorders: gastrointestinal hemorrhage; gastrointestinal reactions. - Renal and urinary disorders: nephrotoxicity; alterations affecting the kidney (acute renal failure, interstitial nephritis, hematuria, anuria). - Skin and subcutaneous tissue disorders: erythema, urticaria, rash, fixed drug eruption. Very rare cases of serious skin reactions such as erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SSJ) and acute generalized exanthematous pustulosis have been reported (see section 4.4). - Hepatobiliary disorders: hepatotoxicity; alteration of liver function and hepatitis; cytolytic hepatitis which can lead to acute liver failure. In case of overdose, paracetamol can cause hepatic cytolysis which can evolve towards massive and irreversible necrosis. Side effects due to pseudoephedrine - Cardiac disorders: myocardial infarction, atrial fibrillation, tachyarrhythmia, hypertension, hypotension, ventricular extrasystoles, precordial pain, palpitations. - Nervous system disorders: convulsions, insomnia, tremors, ataxia, dizziness, headache. - Eye disorders: mydriasis, ischemic optic neuropathy (frequency not known). - Gastrointestinal disorders: ischemic colitis (frequency not known), taste changes, nausea, vomiting, dry mouth. - Skin and subcutaneous tissue disorders: eczema, fixed erythema, pseudo-scarlet fever. - Metabolism and nutrition disorders: hyperthermia, thirst, sweating. - Psychiatric disorders: anxiety, agitation, nervousness, irritability, confusion, hallucinations. - Difficulty urinating: cases of urinary retention may occur in patients with prostatic hypertrophy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Paracetamol In case of accidental intake of very high doses of paracetamol, acute intoxication manifests itself with pallor, nausea, vomiting, anorexia and abdominal pain which generally appear within the first 24 hours after overdose with paracetamol. In adults, the maximum daily dosage of paracetamol is 3 g; above this limit there is a risk of dose-dependent hepatotoxicity. Nausea and vomiting, the only early signs of poisoning, usually disappear within 24 hours. Persistence beyond this time, often associated with subcostal pain on the right side or hyperesthesia, may indicate the development of hepatic necrosis. Liver damage is maximum 3-4 days after ingestion and paracetamol overdose can cause hepatic cytolysis which can lead to hepatocellular failure, metabolic acidosis, encephalopathy, hemorrhage, hypoglycemia, cerebral edema, coma and death. Therefore, despite the lack of significant early symptoms, patients who have taken an overdose of paracetamol should be urgently transferred to hospital. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with decreased prothrombin levels may occur 12 to 48 hours after acute overdose. Overdose can also lead to pancreatitis, acute renal failure and pancytopenia. A dose of 10-15 g (20-30 tablets) or 150 mg/kg of paracetamol taken over 24 hours can cause severe hepatocellular necrosis and, much less frequently, renal tubular necrosis. The administration of activated charcoal should be taken into consideration if it is thought that paracetamol has been taken within the last hour in quantities greater than 150 mg/kg or 12 g (however consider the lower limit). Acetylcysteine ​​protects the liver if administered by infusion within 24 hours of ingesting paracetamol. Pseudoephedrine The most common signs/symptoms of pseudoephedrine overdose include: mydriasis, tachycardia, hypertension, agitation/anxiety, sinus arrhythmia, hallucinations, tremors/hyperreflexia, vomiting; less frequently the following are observed: hyperglycemia, rhabdomyolysis, acute renal failure. Most patients require only a short period of observation in hospital; pharmacological treatment is required in the most serious cases (e.g. arrhythmias, hypertensive crisis, convulsions).

PREGNANCY AND BREASTFEEDING

VIVINDUO FEVER AND NASAL CONGESTION is contraindicated during confirmed or presumed pregnancy and during breastfeeding.

EFFECTS ON DRIVING ABILITY

VIVINDUO FEVER AND NASAL CONGESTION does not alter the ability to drive and use machinery.